Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Heart, Lung, and Blood Institute (NHLBI)
Funding Opportunity Title	Coordination Center for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE) (R01)
Activity Code	R01 Research Project Grant
Announcement Type	Reissue of RFA-HL-10-019
Related Notices	January 30, 2018 - This RFA has been reissued as RFA-HL-19-001. January 23, 2014 - See Notice NOT-HL-14-209. NHLBI Announces a Technical Assistance Webinar.
Funding Opportunity Announcement (FOA) Number	RFA-HL-14-022
Companion Funding Opportunity	RFA-HL-14-021, R25 Education Projects
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.837, 93.838, 93.839, 93.233
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) solicits grant applications from institutions/organizations to serve as the Coordination Center (CC) for the Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE). This FOA runs parallel with a separate FOA that solicits applications for eight Summer Institutes (See RFA-HL-14-021). The Summer Institutes are designed to enable junior faculty and postdoctoral scientists transitioning into academic faculty positions, from underrepresented backgrounds, to further develop their research skills and knowledge to enhance their career development as faculty members and scientists. The purpose of the CC is to support and complement the activities of the Summer Institutes as they enhance the development of a workforce to meet the nation’s biomedical, behavioral, and clinical research needs. The primary tasks of the CC will be to: facilitate outreach, participant recruitment, candidate selection, program-wide organization, and assist with identification and orientation of mentors; support research experiences through webinar and in person learning activities and; facilitate coordination of the education and evaluation activities between the Summer Institute awardees, Summer Institutes participants and the NHLBI; develop orientation and facilitate skills development activities for mentors support the mentoring of program participants by assisting the Summer Institutes with the formation of participants' mentorship committees; conduct cross-site and cross-program evaluations. In addition, the CC will plan, arrange, support, and facilitate the Annual Program-wide Meetings, Steering Committee meetings, and other PD/PI meetings for the PRIDE program. The CC application should evidence expertise in both program evaluation and program coordination.

Posted Date	December 20, 2013
Open Date (Earliest Submission Date)	February 13, 2014
Letter of Intent Due Date(s)	February 13, 2014
Application Due Date(s)	March 13, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June-July 2014
Advisory Council Review	August 2014
Earliest Start Date	September 2014
Expiration Date	March 14, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the 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 and NHLBI recognize a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce. The NIH 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 to improve the Nation's capacity to address and eliminate health disparities.

The goal of this funding opportunity announcement (FOA) is to support the Coordination Center (CC) for the Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE). The primary goal of PRIDE is to encourage, through Summer Institute experiences, "research-oriented" faculty and transitioning postdoctoral scientists, who are underrepresented in the biomedical sciences, to further develop their research skills and gain experience in advanced methods and experimental approaches in basic and applied sciences that are relevant to NHLBI mission areas. In particular, these mission areas are in the prevention and treatment of heart, lung, blood, and sleep (HLBS) disorders.

The purpose of the CC is to support and complement the activities of the Summer Institutes as they enhance the development of a workforce to meet the nation’s biomedical, behavioral, and clinical research needs. The primary tasks of the CC will be to facilitate coordination of research education and evaluation activities between the Summer Institute awardees, past program participants and the NHLBI, and to be responsible for the conduct of cross-site evaluations. The PD/PI team should have expertise in both program evaluation and program coordination. The CC will also facilitate recruitment and provide support for candidate selection, program-wide organization, and mentor identification and orientation. In addition, the CC will plan, arrange, and support annual meetings, steering committee meetings and other PD/PI meetings for the PRIDE program. The primary tasks of the CC will be to:

• facilitate outreach, participant recruitment, candidate selection, program-wide organization, and assist with identification and orientation of mentors;
• support research experiences through webinar and in person learning activities and;
• facilitate coordination of the education and evaluation activities between the Summer Institute awardees, Summer Institutes participants and the NHLBI;
• develop orientation and facilitate skills development activities for mentors
• support the mentoring of program participants by assisting the Summer Institutes with the formation of participants' mentorship committees;
• conduct cross-site and cross-program evaluations.

The CC application should evidence expertise in outreach, program evaluation and program coordination.

Program Organization and Coordination

The CC is expected to support the PRIDE Summer Institute programs as detailed in RFA HL-14-021. The Summer Institute grantees will develop their program during the last quarter of 2014 and early part of 2015, and implement their program during the summers of 2015, 2016, 2017, and 2018 with appropriate modifications or refinements following each of the previous years.

Coordination Center

The CC will recruit candidates and facilitate coordination of research education and evaluation activities among awardees and the NHLBI. See RFA HL-14-021 for details of the Summer Institute program activities and timeline. The CC will be responsible for conducting a number of tasks, including the following:

Outreach

• Develop, coordinate, and support outreach efforts to recruit Summer Institute program candidates.
• Facilitate mentorship and networking activities.
• Coordinate the identification, development, conduct, and evaluation of each mentee’s mentorship committee and each Summer Institute program and the overall PRIDE program.
• Develop, conduct and or facilitate skills development training programs for mentors.
• Identify and disseminate information on additional 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 or Strong Heart Study, and may propose the use of elements from existing mentoring/networking programs (e.g., the Sarnoff fellowship program) in order to increase applicants' long-term opportunities for learning, networking and funding success.

Meetings

• Plan to meet annually in the Washington, D.C. metropolitan area for the annual conference with Summer Institute Directors and staff, mentees, mentors, the CC Director, and NHLBI program staff. Additionally, the CC should plan the agenda and handle the logistics of this annual conference. CC applicants should budget for travel for their Director and staff as well as any experts to conduct mentorship and mentee skill development activities during the meetings.
• Plan the agenda and handle the logistics of at least one additional in-person meeting of Program Directors and NHLBI staff per year in the Washington, D.C. metropolitan area. CC applicants should budget for their Director to travel to this meeting annually.

Mentors

• Facilitate and support 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 the mentee's participation in this award.

Communications

• Coordinate and facilitate all conference calls, including monthly calls between Summer Institute directors/staff and NHLBI.
• Co-plan the agenda for monthly calls between Summer Institute directors, staff, and NHLBI.
• Create web-based resources for Summer Institute 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 systems for group communication.
• Facilitate information exchange across the sites and NHLBI.
• Post minutes of the conference calls and in-person meetings on the program website.

Evaluation

• Coordinate a unified and robust evaluation protocol across the entire PRIDE program. Each Summer Institute will propose an evaluation protocol. The CC will work to coordinate these protocols across the Summer Institutes to ensure common measures and reporting. The proposed evaluation protocol for the program should include specific and detailed plans for evaluation of 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 the curriculum and conduct of the program, as well as the longer-term impact, as measured by mentees' success in receipt of external funding from government agencies or private foundations. The desired outcome of the PRIDE program is that each mentee would submit a grant application focusing on a HLBS disorder within 2 years of completing the program. Evaluation must be ongoing to permit evidence-based modification of the program or specific activities of the program (e.g., changing recruitment strategies). 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.
• In addition to the evaluation plan described above, the CC applicants should submit an evaluation proposal to track the mentees from the six cohorts of mentees funded via the previous FOAs related to this program (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) to assess their success in obtaining external funding, in publishing their research in refereed journals, and in career progression. The evaluation plan must describe the organization and operation of a four-year follow-up of the previous six cohorts from the previous Summer Institute sites and programs. This evaluation plan must describe how the applicant will use the data from previous programs to conduct evaluation. This evaluation plan should also describe contents of an annual report on new and old mentees whose information will be provided.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NHLBI intends to commit $1.85 million in FY2014 to fund 1 award.
Award Budget	Application budgets should reflect the actual needs of the proposed project but no more than $300,000 in direct costs for any given year.
Award Project Period	The maximum project period is 4 years

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Institutions may apply for both the Summer Institute 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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. The application must consist of key personnel (not just consultants) with strong evaluation expertise and strong coordination 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, evaluating, etc., who are integral to the proposed program) participating in the program may also be assigned as Key Personnel.

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

• Outline the cost estimate for all key personnel.
• Individuals (PD/PIs) designing, directing, and implementing the CC may request salary and fringe benefits appropriate for the person months devoted to the program; 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 associated distinctly with the program 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 four years of the program (not including consultant fees associated with mentors outside of the grantee institution).
• 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 four years of the program (not including consultant fees associated with mentors outside of the grantee institution).
• The PDs/PIs of the CC must have at least 1.8 Person months effort individually.
• Applicants should include in the budget for the CC the cost of meeting rooms and equipment for all in-person meetings. The budget and budget narrative should include the direct and facility and administrative (F&A) costs for the CC component.

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 should be addressed satisfactorily by the applicant:

Leadership and Performance Experience for each member of the CC team:

• Describe previous leadership and experience in either research education, program evaluation and/or coordination. The team should as a whole, evidence complementary expertise of evaluation and coordination.
• Coordination Functions:
  • Describe how the CC will promote collaboration across sites and among Summer Institutes, establish partnerships with other institution/agencies to outreach for potential 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). Describe intended metrics and benchmarks to be used.
  • Describe how procedures will be standardized including the application procedures for Institute candidates.

Capacity and Ability to Manage Data and Communications:

• Indicate capability to utilize electronic technology to meet the goal for coordination of Institutes.
• Describe experience in developing and maintaining data management systems for collection of evaluation data.
• Describe methods to be employed to facilitate communication between CC staff and investigators, 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 previous experience of scholarship as PI of a coordinating unit or similar research education collaborative, or evidence of scholarship in mentorship or research education/training.
• Applicants should demonstrate skills as a manager for a CC.
• Evidence of knowledge in HLBS-related research.

Staffing Expertise and Capabilities:

• Applicants must 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 have experience arranging logistical services for multiple sites, such as assuring that meetings are held and that minutes are recorded and communicated to investigators and NHLBI in a timely manner.

Evidence of Expertise in Evaluation of Education/Training or Research Programs:

• The CC is responsible for coordinating the evaluation protocol across up to eight Summer Institutes. Applicants should have experience developing, conducting and supporting common evaluation measures.
• The evaluation protocol can include metrics such as the effectiveness of the didactic portions of the program in terms of the mentees' perceptions of the material and conduct of the program, as well as the longer-term impact, as measured by mentee success in receipt of external funding from government agencies or private foundations, in publishing articles in refereed scientific journals, and in tracking career progression. Of the primary metrics for evaluation, submission of a grant application is the primary goal, and publications in scientific journals and career advancement are secondary goals.

Applicants are encouraged to describe special or unique strengths that may be relevant to research education such as that described in RFA HL-14-021.

Evaluation Plan:

• Applications must include a plan for evaluating the activities supported by the award. The application 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 Summer Institute research education awards in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from mentees, mentors, Summer Institute program directors and staff to help identify weaknesses and to provide suggestions for improvement. 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.
• Additionally, the CC applicant should submit an evaluation proposal to track the mentees from the six cohorts who participated in summer institute programs funded via previous FOAs related to this program (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) to assess their success in obtaining external funding, in publishing their research in refereed journals, and in career progression. This evaluation plan must describe how the applicant would subcontract with the previous awardees to provide the resources needed to participate in the follow-up evaluation.

Letters of Support: Applicants must demonstrate departmental and/or institutional commitment to participate in research and must provide letters of support from appropriate individuals. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. Support in areas of secure transfer of data, information technology, and equipment should also be described along with evidence of previous research education support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Lack of the following elements would deem the application as non-responsive:

• Evidence of activities requested as the functions of the Coordination Center
• Presence of key personnel (not consultants) with program evaluation and program coordination expertise
• Evaluation protocol that includes plans for continuous evaluation of the summer institutes and plans to periodically evaluate the progress of previous program participants.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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? Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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?

Innovation

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? Taking into consideration the nature of the proposed research 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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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? Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program?

Is the approach feasible and appropriate to achieve the stated Coordination Center 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 sites adequate? Is there evidence that the outreach proposed will be sufficient to achieve the goals for establishing partnerships with other institution/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? Is the proposed CC evidence adequate capacity and ability to manage data and communications, and also coordinate academic/research training objectives?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the scientific and educational environment of the proposed program 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 educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS). Not applicable

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI, 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 Heart, Lung, and Blood Institute 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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]

Josephine Boyington, Ph.D., M.P.H.
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]

Tammi Simpson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0150
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 Parts 74 and 92.