Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

T32 Training Program for Institutions That Promote Diversity (T32 – Clinical Trial Not Allowed)

Activity Code

T32 Institutional National Research Service Award (NRSA)

Announcement Type

Reissue of RFA-HL-16-007

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-19-023  

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.837, 93.838, 93.839, 93.233, 93.840     

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to enhance the participation of individuals from nationally underrepresented backgrounds in cardiovascular, pulmonary, hematologic and sleep disorders research across the career development continuum by providing support to institutions that promote diversity. The NHLBI's T32 Training Program for Institutions That Promote Diversity is a Ruth L. Kirschstein National Research Service Award Program intended to support training of predoctoral and health professional students and individuals in postdoctoral training institutions with an institutional mission focused on serving health disparity populations not well represented in scientific research, or institutions that have been identified by federal legislation as having an institutional mission focused on these populations, with the potential to develop meritorious training programs in cardiovascular, pulmonary, and hematologic diseases, and sleep disorders. These institutions are uniquely positioned to engage minority and other health disparity populations in research, translation, and implementation of research advances that impact health outcomes, as well as provide health care for these populations.

This FOA does not allow appointed trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

Key Dates

 

Posted Date

April 27, 2018

Open Date (Earliest Submission Date)

August 4, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date.  

Application Due Date(s)

September 4, 2018; February  26, 2019; September 4, 2019; February  26, 2020; September 4, 2020; February  26, 2021, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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)

September 4, 2018, May 6, 2019, September 4, 2019, May 6, 2020, September 4, 2020, May 6, 2021, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

November 2018; August 2019; November 2019; August 2020; November 2020; August 2021

Advisory Council Review

January 2019; October 2019; January 2020; October 2020; January 2021; October 2021

Earliest Start Date

July 2019; January 2020; July 2020; January 2021; July 2021; January 2022

Expiration Date

May 7, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Training (T) 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.  In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

    Purpose and Background Information

    The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. The program helps shape the next generation of investigators by recruiting students, newly trained research doctorates, physicians, and other clinicians into research training.  In particular, the program is expected to provide research training opportunities in a manner that will result in the recruitment and the provision of research training to women and individuals from groups that have been shown to be nationally underrepresented in health-related research. See, Section 487(a)(4) of the Public Health Service Act and the NIH Notice of Interest in Diversity.  Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

    Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH support levels.

    Program Objective

    The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for  research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and sleep disorders and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, disseminates and implements evidence-based interventions into communities, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide.

    Current population trends predict that by the year 2050 nearly 50 percent of the US population will include medically underserved, vulnerable populations. Given the substantial need for physicians, physician scientists and others to care for vulnerable populations, and to contribute to the study of diseases and conditions that disproportionately affect these groups, more efforts are needed to enhance the pipeline of well-trained biomedical researchers from nationally underrepresented backgrounds. See, Recommendation 8, NIH Physician-Scientist Workforce Working Group Report (2014) and Notice of NIH's Interest in Diversity.   An analysis of NHLBI-supported trainees (independent of individuals supported by diversity related programs) indicates that less than 20 percent of NHLBI trainees are from nationally underrepresented backgrounds. To address this critical need, this NRSA T32 training program for institutions that promote diversity will provide graduate, and post-doctoral research training to promote diversity in the graduate and health professional populations to contribute to the pool of a future diverse research workforce to address cardiovascular, pulmonary, hematologic, and sleep disorders and conditions.

    The NHLBI encourages research training and career development crossing disciplinary boundaries (examples: biophysics, biostatistics, bioinformatics, bioengineering, systems science, and big data science) to develop a new interdisciplinary workforce. Also of interest to NHLBI are training and career development efforts that focus on implementation research, which studies the optimal and sustainable delivery of evidence-based interventions. Novel strategies are needed to disseminate and implement "real world" interventions that produce optimal health outcomes, particularly in underserved populations.

    Dependent on the proposed training program, resident scientific resources and personnel, applicant institutions may choose to identify and collaborate with a research center (medical school or comparable institution) that has strong, well-established cardiovascular, pulmonary, or hematologic diseases research and research training programs to help meet research training needs. NHLBI anticipates that this arrangement will provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, or hematologic diseases and sleep disorders research and who will assist the research advisor at the applicant institution with the trainee's development and research plan. NHLBI expects plans for summer training as well as academic year training to be developed by the student and advisor at the trainee's home institution in collaboration with the mentor at the research center. It is expected that the mentor(s) will guide the trainee through the initial training period and continue this interaction throughout the award. The development of strong mentoring relationships is essential to the success of the trainees and the program.

    If the applicant chooses to collaborate with an established cardiovascular, pulmonary, and hematologic diseases and sleep disorders research center(s), arrangements must be completed before submitting an application. The trainee and his or her faculty research advisor at the applicant institution will jointly select a faculty mentor at the research center.

    The NHLBI T32 Training Program for Institutions That Promote Diversity's goals and objectives are to: (1) enhance the pool of individuals from nationally underrepresented backgrounds in research areas of interest to the NHLBI in the biomedical science enterprise, (2) increase trainee competitiveness for peer-review research funding, (3) strengthen trainee publication records, and (4) foster institutional environments conducive to professional development in the biomedical sciences.

    The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution, but the proposed program must be clearly distinct from related programs currently receiving Federal support.

    Program Considerations

    The duration of training, the transition of trainees to individual support mechanisms, and their transition to the next career stage are important considerations in institutional training programs.  Training PDs/PIs should limit appointments to individuals who are committed to a research career and who plan to remain in training for no less than two years, whether that support comes from a training grant or some combination of NRSA and non-NRSA support programs. Training PDs/PIs should encourage and make available appropriate skills training so that trainees are prepared to apply for subsequent independent support for their training or research program (e.g., an individual fellowship award, mentored career development award, or research project grant), as appropriate for their career stage. In addition, past studies have shown that health professional trainees who train in programs with postdoctoral researchers who have intensive research backgrounds are more likely to apply for and receive subsequent research grant support.  Programs that emphasize research training for individuals with the MD or other health-professional degrees are therefore encouraged to develop ties to basic science departments and include trainees with research doctorates when this approach is consistent with the goals of the proposed training program. 

    Biomedical research and the resulting scientific knowledge are increasingly complex and multidisciplinary in nature. Training PDs/PIs are encouraged to develop institutional training programs that will expose trainees to a diversity of scientific approaches, systems for study, research approaches, and tools and technologies. Consideration of team-based research approaches may also be warranted depending upon the goals of the proposed training program.  

    Within the framework of the NRSA program's longstanding commitment to excellence and the projected need for investigators in particular areas of research, the program is expected to provide research training opportunities in a manner that will result in the recruitment and the provision of research training to women and individuals from groups that have been shown to be nationally underrepresented in health-related research. See, Section 487(a)(4) of the Public Health Service Act and the NIH Notice of Interest in Diversity. 

    The career outcomes of individuals supported by NRSA training programs include both research-intensive careers in academia and industry and research-related careers in various sectors, e.g., academic institutions, government agencies, for-profit businesses, and private foundations. Training programs should make available structured, career development advising and learning opportunities (e.g., workshops, discussions, Individual Development Plans). Through such opportunities, trainees would obtain a working knowledge of various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.  

    Institutional research training grants must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training except when those studies are part of a formal combined research degree program, such as the MD/PhD. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

    Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training. Short-term positions should be requested at the time of application as described in the NIH Grants Policy Statement.  Research training programs solely for short-term research training should not apply to this announcement, but rather the T35 NRSA FOA, which can be found in the NIH Training Kiosk.

    Institutions choosing to submit applications for the September receipt dates are advised that the program should ideally be prepared to start in July of the following year.

    Responsiveness

    This FOA does not allow appointed trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research; therefore, gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

    NHLBI expects that the research training proposed will be directly responsive to the mission of the NHLBI. The NHLBI does not support projects primarily focused on malignancy-related research. Studies that address a mechanistic correlation between cancer (i.e., lung cancer) and primary pulmonary diseases may be considered within the mission of the NHLBI. Applications on vaccine development will be considered outside NHLBI's focused intent for this FOA. Applications on respiratory pathogens will be considered within NHLBI's intent for this FOA if studies focus on the host immune response. Other potential overlapping areas of interest shared by the NHLBI and other Institutes/Centers of the NIH include myeloproliferative and myelodysplastic disorders, hematological malignancies resulting from disruptions in hematopoiesis, and the use of hematopoietic stem cell transplantation and other cellular therapies. Applicants are strongly encouraged to contact the NHLBI before submitting an application to determine the NHLBI programmatic appropriateness for this FOA and the mission of the NHLBI.

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

    Section II. Award Information
    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
    Resubmission
    Revision

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

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

    Note: Appointed trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NHLBI intends to commit $7,484,000 in FY2019 through FY2025 to fund up to 2 new awards per fiscal year in FY2019, FY2020, and FY2021.

    Award Budget

    Application budgets should not exceed $231,000 per year in direct costs. However, applications should reflect the actual needs of the proposed project.

    Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

    Award Project Period

    Applications may request a maximum project period of five years.

    Other Award Budget Information
    Stipends, Tuition, and Fees
     
     

    Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience.

    NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award.

    Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

    Trainee Travel
     
     

    Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual's research training experience is an allowable trainee expense for predoctoral and postdoctoral trainees. Trainee travel to attend scientific meetings may be requested up to $1,400 per trainee per year. If the institution determines that specialized off-site training is necessary for the individual's training experience, additional funding may be requested with strong justification. 

    For short-term trainees, the NIH awarding component may provide grant funds to cover the costs of trainee travel, including attendance at scientific meetings, which the organization determines is necessary to the individual's training. Trainees must be appointed to the training grant at the time of the actual travel for this to be an allowable cost.

    Training Related Expenses
     
     

    NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. The most recent levels of training related expenses are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

    Indirect Costs

    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    Governments

    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • U.S. Territory or Possession

    Other

    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations

    To be eligible for this FOA, applicant institutions must (1) have an institutional mission focused on serving students and diverse communities that are underrepresented  in NHLBI-funded research, or legislation recognizing such efforts, (2) serve high concentrations of students from disadvantaged backgrounds (a college or university where 20% or more of the student population receive Pell grants will be accepted as an indicator of concentrated student disadvantage), and (3) have a demonstrated need for research capacity development in cardiovascular disease (including associated conditions, e.g., obesity), lung, and blood diseases and sleep disorders, as defined below.

    To be eligible for this FOA, independent medical and graduate schools must (1) provide health care-related services to disadvantaged and underserved communities, and (2) have a need for research capacity development in cardiovascular disease (including associated conditions e.g., obesity), lung, and blood diseases. An institution where 20% or more of the institution's graduates provide health-related care to disadvantaged and underserved communities will be accepted as an indicator of service to these communities.

    To demonstrate need for research capacity development in heart, lung, and blood diseases and sleep disorders, applicant institutions should not have received over $1,515,000 in NIH funding (direct costs) from the NHLBI per year in any of the previous five years for research training (e.g., T, F, K) and education (e.g., R25) grants in the above NHLBI mission areas.

    Institutions meeting these eligibility criteria can assist NIH in its efforts to train and recruit the most talented researchers from all groups; to 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 sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

    The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

    Foreign Institutions

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

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

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (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.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) 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 SF 424 (R&R) Application Guide.

    The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is programmatically 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).
    Preceptors/Mentors

    Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program.  Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission.  Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

    Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors. In addition, if applicable, to complement expertise or broaden training experience, PD(s)/PI(s) are encouraged to leverage mentors/co-mentors from other institutional programs (e.g., Clinical and Translational Science Awards, CTSA). Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award.

    Trainees

    The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement. Within the 40 hours per week training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.  The program is expected to provide research training opportunities in a manner that will result in the recruitment and the provision of research training to women and individuals from groups that have been shown to be nationally underrepresented in health-related research. See, Section 487(a)(4) of the Public Health Service Act and the NIH Notice of Interest in Diversity.

    All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

    Predoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

    Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following:  D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

    Trainees selected for short-term training are required to pursue research training for 2-3 months on a full-time basis devoting at least 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Within the full-time training period, trainees must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Successful trainees may be appointed for additional periods of short-term training or, if appropriate to their career level, they should be encouraged to apply for an extended period of full-time training supported by an NRSA training grant or fellowship, or an NIH career development award.

    Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training. Short-term positions should be requested at the time of application as described in the NIH Grants Policy Statement. Applicants for programs that include only short-term research training should apply to the T35 NRSA, which can be found in the NIH Training Kiosk.

    Short-term trainees must be medical students, dental students, students in other health-professional programs, or graduate students in the physical or quantitative sciences. To be eligible for short-term, predoctoral research training positions students must be enrolled, in good standing, and must have completed at least one quarter or semester in a program leading to a clinical doctorate or a doctorate in a physical or quantitative science such as physics, mathematics, or engineering before participating in the training program. Individuals already matriculated in a formal research degree program in the health sciences, or those holding a research doctorate, a master's degree, or a combined health-professional/research doctorate normally are not eligible for short-term training positions. Within schools of pharmacy, only individuals who are candidates for the PharmD degree are eligible for short-term, research training positions.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    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.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Training (T) 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.

    Letter of Intent

    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: NHLBIChiefReviewBranch@mail.nih.gov  

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    Follow all instructions provided in the SF424 (R&R) Application Guide. 

    SF424(R&R) Project/Performance Site Locations

    Follow all instructions provided in the SF424 (R&R) Application.

    SF424 (R&R) Other Project Information

    Follow all instructions provided in the SF424 (R&R) Application, with the following additional modifications:

    Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term faculty), and intended trainee outcomes.

    Other Attachments

    Advisory Committee: An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period.  Please name your file "Advisory_Committee.pdf".

    If applicable, the NHLBI encourages the inclusion on an Advisory Committee of an individual(s) with a history of obtaining and managing NIH-institutional training programs (e.g., T32 pre-/postdoctoral trainees).

    Certification Letter: Applicants are required to attach a letter certifying the institution's eligibility for this program. The Certification Letter must be on institutional letterhead and scanned so that an institutional official's signature is visible. Name the PDF formatted letter "Diversity_Eligibility_Ltr.pdf".

    Training Plan Letter: If a collaborating institution is involved, written commitment to the training plan signed by the collaborating site PD/PI, and countersigned by the site signing official, must be part of the application. Name the PDF formatted letter "Training_Plan_Ltr.pdf".

    The filename provided for each "Other Attachment" will be the name used for the bookmark in the electronic application in eRA Commons.

    SF424(R&R) Senior/Key Person Profile Expanded

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Cover Page Supplement

    Follow all instructions provided in the SF424 (R&R) Application.

    PHS 398 Training Subaward Budget Attachment(s)

    Follow all instructions provided in the SF424 (R&R) Application Guide.

    Training Budget

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff
    PHS 398 Research Training Program Plan

    The PHS 398 Research Training Program Plan Form is comprised of the following sections:

    • Training Program
    • Faculty, Trainees, and Training Record
    • Other Training Program Sections
    • Appendix Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

    Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

    Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

    Training Program

    Program Plan

    In addition to the instructions in the Application Guide, include the following:

    Program Faculty

    The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.

    Proposed Training

    Describe how trainees will be educated in the human health- and disease-related aspects of their research training.

    The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in laboratory and project management. The PD/PI should describe how trainees appointed to the training program will have the opportunity to carry out state-of-the-art supervised biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career. Also, if providing research training at the postdoctoral level, PD/PI must describe plans to emphasize specialized training to meet national research priorities in the biomedical, behavioral, or clinical sciences that are with the scientific purview of the NHLBI. 

    Dependent on the proposed training program, resident scientific resources and personnel, the institutions that promote diversity may describe how they may choose to identify and collaborate with a research center (medical school or comparable institution) that has strong, well-established cardiovascular, pulmonary, or hematologic diseases research and research training programs to help meet research training needs. Include a description of how this arrangement will provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, hematologic diseases or sleep disorders research and who will assist the research advisor at the applicant institution with the trainee's development and research plan. Provide plans for the student and advisor at the trainee's home institution in collaboration with the mentor at the research center to develop both the summer training as well as academic year training. Plans should include explanation of how the mentor(s) will guide the trainee through the initial training period and continue this interaction throughout the award in order to develop a strong mentoring relationship essential to the success of the trainees and the program.

    If the applicant institution chooses to collaborate with an established cardiovascular, pulmonary, hematologic diseases or sleep disorders research center(s), arrangements must be completed before submitting an application, clearly outline the arrangements between the participating institutions for the recruitment of trainees and joint selection of trainers for the provision of training, and for ongoing cooperation and collaboration between the institutions in the implementation of the program.

    For programs that propose short-term training, any didactic training must be well structured and appropriately justified for the duration of the training experience. Short-term trainees must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career.

    For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program. 

    Institutional Environment and Commitment to the Program.

    The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for trainees (9 person months, equivalent to 75%) selected for the program.

    Eligible applicant institutions must provide information that demonstrates that they:

    1. have an institutional mission focused on serving students and diverse communities that are not well-represented in NHLBI-funded research, or legislation recognizing such efforts;

    2. serve high concentrations of students from disadvantaged backgrounds (a college or university where 20% or more of the student population receive Pell grants will be accepted as an indicator of concentrated student disadvantage); and

    3. have a demonstrated need for research capacity development in cardiovascular disease (including associated conditions, e.g., obesity), lung, and blood diseases and sleep disorders.

    Independent medical and eligible graduate schools must provide information that demonstrates that they:

    1.  provide health care-related services to disadvantaged and underserved communities; and

    2.  have a need for research capacity development in cardiovascular disease (including associated conditions e.g., obesity), lung, and blood diseases. An institution where 20% or more of the institution's graduates provide health-related care to disadvantaged and underserved communities will be accepted as an indicator of service to these communities of institutional disadvantage.

    Plan for Instruction in the Responsible Conduct of Research

    Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide. 

    Appendix

    Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.  

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit 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.

    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 (SAM). 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.

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

    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.

    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

    Training Program and Environment

    • Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?
    • Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
    • Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
    • Does the program provide appropriate inter- or multidisciplinary research training opportunities?
    • Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers? 
    • Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
    • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
    • Are the facilities, environment, and resources for the proposed research training at the institution that promotes diversity adequate and appropriate?
    • If a partnership arrangement is proposed, are the facilities, environment, and resources for the proposed research training, collectively at the institution that promotes diversity and collaborating research center adequate and appropriate?
    • Is a collaborative effort in training and management evident where partnering institutions are involved?
    • For applications that request short-term research training positions: Is this aspect of the program well designed and, where appropriate, integrated with other aspects of the training program? Are the numbers of short-term positions appropriate? Does the program include features to encourage short-term trainees to consider careers in health-related research?

    Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

    • Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
    • Does the PD/PI plan to commit sufficient effort to ensure the program's success?
    • Is sufficient administrative and research training support provided for the program?
    • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
    • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

    Preceptors/Mentors

    • Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
    • Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
    • Do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
    • If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

    Trainees

    • Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program?
    • Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?
    • Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?
    • For applications that request short-term research training positions: Does the program have access to and the ability to recruit high quality, short-term trainees?

    Training Record

    • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program?
    • Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
    • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
    • To what extent do trainees' subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?
    • Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?
    • For applications that request short-term research training positions, is there a record of retaining health professional trainees in research training or other research activities for at least two years? What is the success in attracting students back for multiple appointments? What is the effect of the short-term component on the overall training program?
    Additional Review Criteria

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

    Protections for Human Subjects

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

    Inclusion of Women, Minorities, and Children 

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Vertebrate Animals

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Biohazards

    Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program's accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. 

    Recruitment Plan to Enhance Diversity

    Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Considering the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction?  For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application?  4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years? 

    For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

    Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

    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).

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 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 NHLBI 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.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date 

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the 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.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see 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 https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.

    The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.

    As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; and more details are in the Frequently Asked Questions. Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation should be discussed.

    Inventions and Copyrights

    Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

    Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

    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. 

    Other Reporting Requirements
    • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
    • Additionally, a completed Payback Agreement Form (PHS Form 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support.
    • A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
    • Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each trainee appointed for eight weeks or more. Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

    A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement

    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.

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

    Within ten years of making awards under this program, NIH will assess the program's overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

    The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

    For programs involving graduate students:

    • Successful completion of a STEM graduate program
    • Subsequent participation in a formal research training or career development program in a STEM field
    • Subsequent participation in research or employment in a STEM field
    • Authorship of scientific publications in a STEM field
    • Subsequent independent research grant support from NIH or another source

    For programs involving postdoctorates and early career investigators:

    • Subsequent participation in a formal research training or career development program in a STEM field
    • Subsequent participation in research or employment in a STEM field
    • The number of trainees who have received initial research training at the institution and who have presented their research projects at national meetings
    • Authorship of scientific publications in a STEM field
    • Evidence of academic advancement and promotion based on research and related accomplishments
    • Subsequent independent research grant support from NIH or another source
    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA 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)
    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: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Henry Chang, MD
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-827-8263
    Email: Henry.Chang@nih.gov

    Peer Review Contact(s)

    Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0270
    Email: NHLBIChiefReviewBranch@nhlbi.nih.gov

    Financial/Grants Management Contact(s)

    Reggie Brown
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0166
    Email: brownreg@nhlbi.nih.gov 

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.

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