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 a unique and compelling need to promote diversity in the NIH -funded biomedical, behavioral, clinical, and social sciences workforce. The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs; (2) enhance the diversity of the biomedical, behavioral and clinical research workforce; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications. The National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups, improve the quality of the educational and training environment, balance and broaden the perspective in setting research priorities, improve the ability to recruit subjects from diverse backgrounds into clinical research protocols, and improve the Nation's capacity to address and eliminate health disparities.

Purpose and Description of the Program

The overarching goal of the NHLBI PRIDE program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce through SI programs.

The major goal of the PRIDE program is to establish long-term mentoring that will enable junior faculty and transitioning postdoctoral scientists who are underrepresented in the biomedical sciences, as defined by NOT-OD-18-122, to develop a research program and obtain NIH funding. The goal is that through these experiences participants will further develop their research skills and gain experiences in advanced methods and experimental approaches in basic and applied sciences that are relevant to NHLBI mission areas. These include the prevention and treatment of heart, lung, blood, and sleep (HLBS) disorders. Ultimately, participants in the PRIDE programs will use these enhanced skills to apply for NIH grants in the areas relevant to the of NHLBI mission. It should be noted that participants and mentees are used interchangeably in this FOA.

The goal of this Funding Opportunity Announcement (FOA) is to support the creation of a Coordination Center (CC) for the Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE) Summer Institutes (SI). The PRIDE CC will support and complement the activities of the SIs (as detailed in RFA-HL-19-002) as they foster the development of a diverse workforce to meet the nation's biomedical, behavioral, and clinical research needs. The SI grantees will develop their PRIDE SI programs (as detailed in the companion FOA RFA-HL-19-002) during the last quarter of 2018 and early part of 2019, and implement them during the summers of 2019, 2020, 2021, 2022, and 2023 with appropriate modifications or refinements following each of the preceding years. The primary tasks of the CC will be to facilitate, coordinate and support execution of research education activities between the SI awardees and mentees, and to conduct ongoing evaluation of the program as per NIH requirements. As such, the PD/PI applicants of the CC team should exhibit strong expertise in both program evaluation and program coordination.

The CC's role is also to facilitate recruitment and candidate selection across the program, program-wide organization, and mentor identification and orientation. Additionally, the CC will also plan, arrange, and facilitate the PRIDE annual meetings, monthly steering committee meetings, and other PD/PI meetings for the PRIDE program overall.

Specific activities and roles of the PRIDE CC will include, but are not limited to:

Outreach and Recruitment

• Develop, coordinate, and support outreach efforts to recruit participants to the SI programs.
• Facilitate mentorship and networking activities.
• Coordinate the identification, formation and evaluation of mentees' mentorship committees.
• Develop, conduct and/or facilitate skills development and training programs for mentors.
• Identify, coordinate, administrate and disseminate information on additional research training and networking opportunities for mentees throughout the academic year. For example, applicants may suggest ways that linkages can be made with existing NHLBI programs of research, such as the Jackson Heart Study, Strong Heart Study, and TOPMED program or data resources such as BioLINCC, or may propose the use of elements from existing mentoring/networking programs (e.g., the Sarnoff fellowship program, or the National Research Mentoring Network) in order to increase applicants' long-term opportunities for learning, networking and funding success.
• Propose a plan to work with the NHLBI program office to appoint an Advisory Committee consisting of 4-5 individuals from outside of the applicant's institution to periodically advise the PRIDE program.

Program-wide Communications

• Coordinate and facilitate all conference calls, including monthly calls between SI directors/staff and NHLBI.
• Co-plan and distribute the agenda for the monthly calls between SI directors, staff, and the NHLBI program office.
• Develop, share, and post minutes of the conference calls and in-person meetings on the program website.
• Create web-based resources for SI faculty, mentees, and mentors, including a program-wide website addressing such areas as: NIH policies, procedures and application information and materials (e.g., application timelines and templates), web-based courses, and email and other web-based systems for group communication.
• Facilitate information exchange across the PRIDE summer institute sites and the NHLBI program office.
• Oversee the equitable use and distribution of research education resources across PRIDE summer institute sites.

Facilitate Recruitment of Mentors

• Facilitate and support SIs in the recruitment of qualified, research-focused mentors including individuals from underrepresented backgrounds. Each mentor should have research expertise and experience relevant to the proposed program and be committed to continue their involvement throughout the total period of their assigned mentees' participation in their respective SI program.

Research Education Development Activities

• Coordinate the application and review process, and evaluate the overall small research projects (SRPs) component of the PRIDE program. The CC will not disburse SRP funds, since they will be allocated only to the SIs. Distribution of the SRP funds, and scientific oversight of the SRP program will reside solely with the SI programs (full details of the SRP are described in RFA-HL-19-002).

Evaluation

• Propose a plan to coordinate a unified and robust evaluation protocol across the entire PRIDE program including both accessing and assessing data from previous cohorts that are currently under evaluation. Each SI will propose an evaluation protocol and the CC will work to coordinate these protocols across the SIs to ensure common measures and reporting.

Applications must contain the following to be considered responsive to this FOA. Non-responsive applications will not proceed to review.

• Evidence of a planned program that occurs during the summer for no less than the length of time specified and for two summers for each cohort.
• The appropriate type and number of the targeted beneficiaries defined in this FOA (specifically HLBS-oriented junior faculty and/or transitioning postdoctoral scientists) with intent to recruit nationally. (Transitioning postdoctoral scientists are those who have received a formal full-time faculty appointment letter in hand by the time the Summer Institute program to which they are recruited is convened.)

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)

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.

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

Institutions may apply for both the Summer Institute (RFA-HL-19-002) and CC components of this program. However, the PD/PI for the CC must not be the same PD/PI for the Summer Institute application.

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, including Supplemental Grant Application Instructions 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:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
Telephone: 301-435-0270
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.

Other Attachments:

1. Progress of Previous PRIDE Program Participants (required for renewal applications only)

If applicable, progress of previous PRIDE program participants must be provided as an attachment called "Previous PRIDE Participants.pdf" and may not exceed 3 pages.

All instructions in the SF424 (R&R) Application Guide must be followed. The application must consist of a PD/PI and key personnel (not just Other Significant Contributors) with strong evaluation expertise and program coordination/administration skills. It is highly encouraged that the evaluation and coordination experts be separate individuals. A program coordinator and other key persons (such as those involved in developing, implementing, directing, monitoring, and evaluating) who are integral to participating in the program may also be assigned as Key Personnel.

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

• Outline the cost estimate for all key personnel.
• Individuals (PDs/PIs) designing, directing, and implementing the CC may request salary and fringe benefits appropriate for the person months devoted to the program.
• Since the CC will maintain primary responsibility for the oversight and management of all program-wide research related resources, applicants may consider budgeting for a program coordinator/staff with expertise in these functions which will begin in earnest in the first summer of the PRIDE program.
• Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).
• Limited program-related and clerical salary costs distinctly associated with the program and that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Normally, all personnel costs (including program-related and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 50% of the total direct cost over the five years of the program (not including consultant fees associated with mentors outside of the grantee institution).
• The individual members of the PD/PI administrative and evaluation team of the CC must provide a minimum of 1.8 person months to accomplish the aims of the program.
• Applicants should include the cost of meeting rooms and equipment for all in-person and virtual meetings. The budget should include the direct costs and facility and administrative (F&A) costs for the CC. The CC will meet in the Washington, D.C. metropolitan area for the first kick-off meeting with the SI Directors and NHLBI staff, and annually for the program-wide meetings with SI Directors and staff, mentees, mentors, and NHLBI program staff. Additionally, applicants should budget for all logistics related to the program-wide annual meetings, including travel for their Director and staff as well as relevant experts to conduct mentorship activities as well as skill development activities for mentees and mentors during the meetings.

Requested expenses must be itemized. Include all allowable categories of funds requested to support program participants in the budget. Provide detailed justification for each category for which funds are requested. Refer to Section II for clarification on allowable categories of 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

The following items are critical review elements and should be addressed concisely and satisfactorily by the applicant. Applicants should describe how team members' expertise and experiences are synergistic and support the CC's proposed program goals. Applicants must not duplicate information on the Biographical sketch.

Leadership and Performance Experience for each member of the CC Team that facilitates synergy

• Describe previous leadership and experience in either research education, program evaluation and/or coordination. The team as a whole should evidence complementary expertise of administration, coordination and evaluation.

Coordination Functions

• Describe how the CC will promote collaboration across sites, among SIs, and establish partnerships with other institutions/agencies to perform outreach for potential SI program mentees and mentors for mentorship committees.
• Describe how the CC will provide expert assistance in supporting the development of an evaluation protocol and common evaluation measures (constructs and instruments) across the SI sites.
• Describe intended metrics and benchmarks to be used.
• Describe how procedures will be standardized, including the screening and application procedures for applicants to the SIs.

Capacity and Ability to Manage Data and Communications

• Indicate capability to utilize electronic technology to meet the goal for coordinating the Sis.
• Describe experience in developing and maintaining data management systems for collecting evaluation data.
• Describe methods that will be employed to facilitate communication between CC staff and SI investigators, mentees, mentors and NHLBI program staff as well as with external partners for outreach and mentorship. If collaborating sites are proposed, a brief justification must be included for each site.

Academic and Management Capabilities

• Describe how previous scholarship experience as PD/PI of a coordinating unit or similar research education collaborative, or evidence of scholarship in mentorship or research education/training is complemented by other team members.
• Demonstrate skills as a manager for a CC or similar entity.
• Provide evidence of knowledge in HLBS-related research.

Outreach and Recruitment

• Propose a plan to work with the NHLBI program office to appoint an Advisory Committee consisting of 4-5 individuals from outside the applicant's institution to periodically advise the PRIDE program.

Staffing Expertise and Capabilities

• Propose an operational structure for coordinating functions at the CC, including lines of responsibility for professional staff at the CC.

Evidence of Communication Capabilities

• The CC is responsible for supporting infrastructure for meetings and teleconferences. Applicants should describe experience arranging logistical services for multiple sites, such as assuring that meetings are held and that minutes are recorded and communicated to investigators and to the NHLBI in a timely manner.
• Describe how the communication capabilities of the team as a whole are synergistic and integral to accomplishing this CC goal.

Evidence of Expertise in Evaluating Education/Training or Research Programs

• The CC is responsible for coordinating the evaluation protocol across all the awarded SIs. Thus, applicants must demonstrate experience in the development, conduct, and support of common evaluation measures.
• Applicants are encouraged to describe special or unique strengths that may be relevant to research education (described in RFA-HL-19-002).

Evaluation

• Provide a plan to coordinate a unified and robust evaluation protocol across the entire PRIDE program including accessing and assessing data from previous cohorts that are currently under evaluation. Describe how the CC will coordinate protocols across the SIs to ensure common measures and reporting. The proposed evaluation protocol for the program should include specific and detailed plans for evaluating both the mentees and mentors. The evaluation protocol should also include plans to assess the effectiveness of the program in terms of the mentees' perceptions of their PRIDE program site-specific curriculum and the overall conduct of the program, as well as the longer-term impact, as measured by mentees' success in receipt of external funding from NIH, other government agencies or private foundations. The evaluation plan must be dynamic and ongoing to permit evidence-based modifications of the program or specific activities of the program (e.g., changing recruitment strategies) over time. Annual evaluation data must be provided with the non-competing continuation application (progress report) and a summary of the final evaluations must be provided to the NHLBI as part of the final report and to the advisory committee periodically as warranted.
• The plan must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short and long-term success of the PRIDE SI research education awards in achieving objectives. The evaluation plan should address a proposed process to obtain feedback from mentees, mentors, SI program directors and staff that will help identify weaknesses and to provide suggestions for improvement.
• In addition to the evaluation plan described above, applicant(s) should submit a proposed plan for tracking the mentees from the previous cohorts matriculated under FOAs (http://www.biostat.wustl.edu/sipid/sipid.html, RFA HL-04-035, www.biostat.wustl.edu/pridecc, RFA HL-10-019, RFA HL-10-028, RFA HL 14-021 and RFA HL 14-022) to assess their success in obtaining external funding, in publishing their research in peer-reviewed journals, and in career progression. This proposed plan must describe the organization and operation of concurrent follow-up of the previous SI programs (FY2010-2014; FY2015-2018), and the FY2019-2023 program and must specifically describe how the applicant will use data from previous programs to conduct program evaluation and to assess program's aims. This proposed plan should also describe contents of an annual report on new and former mentees whose information will be assessed.
• A plan for a curated dataset transfer of this diversity-targeted program to facilitate ongoing tracking of participants' progress by the NIH and NHLBI should also be included. Specifically describe how the data from previous programs will be used to conduct evaluation and how that data will be used to assess program's aims. This evaluation plan should also describe contents of an annual report on new and former mentees whose information will be assessed. Lastly, plans regarding annual submission of the collected and curated data to an approved NHLBI data repository (e.g., BioLINCC) must be clearly delineated with a timeline incorporated.

Letters of Support

Applicants must demonstrate departmental and/or institutional commitment to participate in research education and must provide Letters of Support from appropriate individuals. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources, including evidence of previous education support, to contribute to the planned research education program. The Letter of Support must also indicate the plan for secure transfer of data, information technology needs, research oversight, and any considerations regarding subcontracting (i.e., commitment of facilities as appropriate, institutional acceptance to provide scientific oversight, etc.).

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:

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

Appendix

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Blank evaluation forms, tables, questionnaires and/or screening forms may be included but should not exceed 3 pages.

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 with the following additional instructions:

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 components of participating organizations, 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. For all Clinical Trial FOAs, use the Clinical Trial text insert.

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 Center address the needs of the research education program (PRIDE) that it will coordinate and serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?

Specific to this FOA:

Does the proposed Center address the intended target populations as well as an important aspect or important need in research education relative to those populations? Is there convincing evidence in the application that the proposed program will significantly advance the stated goals of PRIDE? Is the scope of activities proposed by the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research education program and to the NHLBI overall?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research education programs? Do the investigators demonstrate significant experience with coordinating collaborative research education activities?

If the Center is multi-PD/PI, does the team of investigators have complementary and integrated expertise and skills; are their leadership approaches, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

Do the PD/PI collaborators demonstrate experience and an ongoing record of accomplishments in managing research education projects? Do the investigators demonstrate significant experience with coordinating collaborative research education projects? Does the PD/PI team demonstrate appropriate training and expertise, and evidence in ongoing record of accomplishments in coordinating and administering large, collaborative networks, implementing common metrics for the evaluation of large and complex research education programs, coordinating data and analyses, and communicating and messaging to stakeholders? Do the investigators demonstrate significant experience with these tasks? Does the project team have appropriate experience with fulfilling the mission of the PRIDE program, including the proper scientific background, experience with the administrative management of large research-education projects or consortium activities, experience with databases, web portal design and curation, dissemination of various resources and information to stakeholders and to the broader scientific community, planning and successfully executing large-scale meetings, the development and implementation of metrics for large initiatives, and research-education program evaluation?

Does the application propose novel organizational con instrumentation in coordinating the research education program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Specific to this FOA:

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program's offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience? Does the application propose novel management strategies for coordinating the PRIDE program? Are the concepts, strategies, or instrumentation novel or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed? How innovative are the proposed team structure/interactions, strategies, and tools compared to standard project coordination/ management, and data capture and sharing approaches?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? If applicable, have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Is the proposed approach for the overall program management as well as for managing the research education activities feasible and appropriate to achieve the stated CC's program goals? Are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Does the application contain an adequate description of plans for facilitating the provision of appropriate mentoring experiences for mentees? Does the application contain an adequate description of plans for effective program administration and coordination among faculty/mentors? Does the application contain an adequate description of plans and methods for outreach, selection, and retention of candidates from diverse backgrounds? Is the proposed plan for promoting collaboration across the SI sites adequate? Is there evidence that the outreach proposed will be sufficient to achieve the goals for establishing partnerships with other institutions/agencies and mentors for mentorship committees? Is the plan for providing assistance in supporting the development of an evaluation protocol and common evaluation measures (constructs and instruments) adequate? Does the proposed CC have adequate capability to utilize electronic technology to meet the coordination goals? Does the proposed CC demonstrate adequate capacity and ability to manage data and communications and the ability to coordinate the academic/research training objectives? If applicable, how strong is the Previous PRIDE Participants attachment in demonstrating mentees' success in previous PRIDE cohorts?

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

Specific to this FOA:

Will the scientific and educational environment of the proposed CC contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound CC that will facilitate the goals of the PRIDE program for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institution?

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 which 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

For Renewals, the committee will consider the progress made overall including progress of past

PRIDE participants or cohorts trained; and the adequacy and appropriateness of the evaluation

methods/materials used for assessing the program's goals and participants' outcomes.

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

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 the NHLBI Office of Scientific Review , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory 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

These special terms of award are in addition to and not in lieu of otherwise applicable OMB

administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74, and other HHS, PHS, and NIH grant administration policy statements.

The cooperative agreement is an award instrument establishing an assistance relationship in contrast to an acquisition relationship between NHLBI and a recipient, in which substantial NHLBI scientific and/or programmatic involvement with the recipient is anticipated during performance of the activity. The purpose of NHLBI involvement is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the recipient(s) for the project as a whole, in discussion with NHLBI staff. The terms and conditions below elaborate on these actions and responsibilities, and the recipient agrees to these collaborative actions with the NHLBI Project Scientist to achieve the study objectives. It is anticipated that these terms and conditions will enhance the relationship between the NHLBI staff and the principal investigator(s), and will facilitate the successful conduct and completion of the PRIDE initiative. These agreements will be in addition to, and not in lieu of, the relevant NIH procedures for grants administration. The terms will be as follows:

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

Program governance

Recipient(s) agree to the governance of the study through an Executive Committee composed of the CC's principal investigator(s) and NHLBI staff; and to a steering committee consisting of at least one voting representative each from the SI, the CC and the NHLBI. Meetings of the Executive Committee will be held by conference call or in the metropolitan Washington, D.C. area. Meetings of the SI will be held monthly by telephone and annually in-person in the metropolitan Washington Area.

The recipient(s) will have primary and lead responsibilities for the project as listed in Section I.

The PD(s)/PI(s) also assume(s) responsibility and accountability to the applicant organization officials and to the NHLBI for the performance and proper conduct of the project supported by the U24 award in accordance with these terms and conditions of the award. As such, the awardee PD(s)/PI(s) will be

responsible for all coordinating, administrative and evaluating aspects of the program, as well as any modification(s) agreed upon by the Executive committee, unless otherwise provided for in these terms or by action of the Steering Committee.

Specific responsibilities include:

• Defining objectives and approaches of the coordinating center
• Collaboratively defining the data collection and data evaluation plan and goals
• Coordinating Center protocol design and development
• Obtaining all requisite protocol approvals
• Participant follow-up
• Data collection and quality control
• Safety and data monitoring
• Conducting overall evaluation and providing assistance with SI site-specific evaluation activities, such as data analysis and interpretation, manuscript preparation, and dissemination of program results
• Overseeing/performing other scientific-related activities of the program
• Monitoring completion of the supported activities and taking corrective actions if needed
• Convening, facilitating, and participating in the activities of the Steering Committee
• Accepting and implementing the policies approved by the Steering Committee to the extent consistent with applicable grant regulations
• Creating web-based resources for SI faculty, participants, and mentors, including a program-wide website addressing such areas as: NIH policies, procedures and application information and materials (e.g., application timelines and templates), web-based courses, email, and other web- based systems for group communication
• Developing collaborations with external mentors
• Assisting with the formation of an advisory group
• Making site-specific study data accessible to PRIDE investigators in a timely manner
• Providing well-curated analytical data files (illustrative examples include: derived/calculated data variables; finalized questionnaire data; participant follow-up data) to the NHLBI periodically, annually, and at the end of the period of this award, along with documentation necessary for their use
• Developing the process for the CC and the SIs to use OMB and NSF guidance to resolve issues of eligibility.
• Awardee will have primary rights to the data developed under the award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Study investigators are encouraged to publish their data but cannot publicly share identifiable data on participants of the program.

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

NHLBI staff (Project Office team) will serve on the Executive and Steering committees, monitor compliance with recruitment, and provide technical assistance on issues regarding participant enrollment. NHLBI staff cannot make decisions on eligibility of mentees.

The NHLBI reserves the right to phase-out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable protocol in a timely manner, (b) substantial shortfall in subject recruitment and inadequate screening of eligible applicants, (c) problems with data capture and data reporting, quality control in a timely manner, (d) substantive changes in the agreed-upon protocol with which NHLBI cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of CC's continuation. Post award monitoring of the SRPs would be jointly managed with the NHLBI and the SI programs' institutions with the above listed terms and conditions applicable.

Areas of Joint Responsibility

The CC and the NHLBI program office will work jointly to:

• Develop meeting agendas for all program-wide meetings
• Determine the scope and frequency of the program-wide evaluation
• Provide technical assistance to relevant program subcommittees
• Provide input to summer institute sites on interim data, safety processes, final data analysis and interpretation, and preparation of publications
• Facilitate timely submission of curated program data to the NHLBI or NIH as may be requested

Dispute Resolution

Any disagreement that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHLBI may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Executive Committee (with the NHLBI member not voting) or by the individual recipient in the event of an individual disagreement, a second member selected by NHLBI, and the third member selected by the two selected members. This special arbitration procedure in no way affects the recipient's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, Subpart D and HHS regulation at 45 CFR part 16, or the rights of NHLBI under applicable statutes, regulations and terms of the award.

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

Josephine Boyington, Ph.D., MPH, CNS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0446
Email: [email protected]

Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]

Kimberly Stanton
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8054
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.