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

NHLBI Research Career Development Programs in T4 Implementation Research (K12)

Activity Code

K12 Physician Scientist Award (Program) (PSA)

Announcement Type

New 

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-HL-17-016

Companion Funding Opportunity

None  

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

93.840, 93.837, 93.838, 93.839, 93.233  

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs that propose to support mentored research and career development experiences for scholars prepared to address the complex process of bridging research and practice in a variety of real-world settings with a focus on heart, lung, blood, and sleep (HLBS) diseases and conditions. The career development opportunity should lead to research independence in the area of late stage translation (T4) research. Scholars are expected to be supported, depending on needs, for up to 3 years on consecutive 12-month appointments. Candidates selected for support as scholars must hold a research or health-professional doctoral degree and commit a minimum of 9 person-months (equivalent to 75% of full-time professional effort) to conducting dissemination and implementation (D&I) research focused on HLBS disorders and career development activities associated with the proposed program.

Key Dates

 

Posted Date

June 29, 2016

Open Date (Earliest Submission Date)

September 13, 2016

Letter of Intent Due Date(s)

September 13, 2016  

Application Due Date(s)

October 13, 2016  , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

March 2017

Advisory Council Review

May 2017

Earliest Start Date

September 2017

Expiration Date

October 14, 2016

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.


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 Research Career Development 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. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Purpose and Background Information

In recent years, there has been particular interest in accelerating the pace at which proven effective clinical interventions move from the laboratory to practice settings and communities. The need to address this gap has been expressed by multiple groups including members of Congress, the public, as well as the biomedical community. Concerns have also been raised regarding the inadequate workforce to accelerate the pace of translation from science discoveries into practice.

This initiative will build and foster a sustainable and diverse research workforce with competencies to study delivery and implementation strategies for proven effective preventive and treatment interventions in real world practice and community settings. These types of studies are identified as T4 late-stage translation research. Specifically, T4 translation research is defined as research that identifies implementation strategies to enhance sustainable uptake of proven effective interventions into "real world" settings. T4 translation research primary outcomes include acceptability, affordability, appropriateness, cost, feasibility, fidelity, penetration, and sustainability of the intervention in the specific context. A need for this initiative is demonstrated by an NHLBI research training portfolio analysis that indicated a shortage of individuals in the NHLBI training pipeline with the requisite skill set to move science discoveries into practice.

The NHLBI recognizes the critical need to nurture and support a well-trained diverse T4 research workforce. The nature of research in D&I, which requires linkages with practice settings and across disciplines, also calls for the need to find mentors from diverse sectors to guide specific areas of the research, thus encouraging a team approach to mentoring as well as serving to increase mentor pool availability.

This initiative is anticipated to play a pivotal role in establishing the next generation of researchers that are investigating and applying T4 translational research state-of-the art methodologies. Developing a cadre of T4 researchers will require trans-disciplinary approaches that embrace complexity in real-world settings and will be pivotal to closing the gap between evidence-based interventions and their implementation in real world settings. This is particularly important to decrease the wide disparities in health status in underserved populations that suffer disproportionately from HLBS related diseases and conditions.

This FOA seeks applications that demonstrate effective collaboration between multiple stakeholders, across disciplines, and includes scholars with varied research competencies.  It is anticipated that applications will propose an iterative process that supports the flow of evidence from research to practice and from practice to research with the goal of enriching the theory and practice of promoting and improving health and health care. This FOA is intended to promote the development of independent HLBS-focused scholars prepared to address the complex process of bridging research and practice in a variety of real-world settings through education curricula and mentored research experiences conducted with a diverse range of stakeholders and partners.

Program Objective

The purpose of this funding opportunity announcement (FOA) is to encourage applications that propose creative and innovative career development programs to begin to build a critical sustainable HLBS T4 translation research workforce.  Programs are expected to prepare  and equip scholars to advance the science and lead the field through their scholarship as the next generation of D&I researchers in HLBS diseases and conditions.

It is anticipated that T4 Implementation Research program applications will consist of:

  • A strong foundation in dissemination and implementation research employing theories, models, and frameworks, and analytic techniques to reduce research practice gaps and improve implementation outcomes.
  • The enhancement of the scholar's ability to conceptualize and think through D&I research problems and employ novel approaches (e.g., systems science and simulation modeling) to improve implementation outcomes with increasing independence.
  • Experience conducting research using state-of-the-art D&I methods as well as presenting findings at national meetings and publishing in scholarly journals.
  • Innovative research and career development preparation at the forefront of D&I science that will accelerate innovation in the field of implementation research and inform real-world sustainable improvement in HLBS health care.
  • An opportunity to collaborate with members of the community that deliver interventions and with diverse communities to enhance the scholar's understanding of the importance of context-sensitive research designs in the successful implementation of evidence-based practices.
  • Career development opportunities that leverage and build capacity to improve the connectivity of T4 translation research and research conducted in the earlier stages of translation (T0-T3).
  • Opportunities to create new or utilize existing community structures to enhance implementation research efficiencies to improve HLBS diseases and conditions.  

The program should represent a diverse cadre of scholars and be able to accommodate their preparation in different disciplines and varying levels of research experience, if needed. The scholars can receive up to 3 years of career development support. Candidates with prior D&I related courses  may need little didactic training, thus 2 years of K12 support may be appropriate to develop a research program that is competitive for individual funding. However, a prospective research scholar with less experience in the D&I research field may require a more structured program, which includes some didactic training in addition to a mentored research experience. Thus, the scholar may require 3 years of K12 support in order to be competitive for individual funding.

This FOA is intended to support applications that include a plan for each scholar that is designed to develop a significant research project, which, before the end of the scholar’s support, will enable preparation and submission of an individual career development or research grant application.  The ultimate objective is to empower the scholar to become an independent researcher prepared to address the complexities of bridging research and practice in a variety of real-world settings with a focus on HLBS diseases and conditions.

Program Considerations

The NHLBI Research Career Development Programs in T4 Implementation Research K12 program’s goal is to recruit scholars from diverse disciplinary and demographic backgrounds.  Because implementation science draws from and is applicable to a broad range of clinical, population, and translational science disciplines, this program provides a unique opportunity for scholars (trained at different stages of the translation research spectrum) to gain formal skills development and mentorship in D&I research, an area not commonly incorporated into traditional medical and graduate training programs. Scholars must express an interest in obtaining the necessary experience to specifically accelerate the delivery and implementation of proven evidence-based interventions from research to practice and community settings to improve health and health care for HLBS diseases and conditions, and particularly racial and ethnic health disparities conditions (e.g., asthma, hypertension, heart disease).

This is a new trans-disciplinary career development paradigm that differs from the typical basic and clinical career development programs. Unique features can include but are not limited to training content (going beyond discipline-based concepts and methods), crossing disciplinary boundaries (e.g., social sciences, epidemiology, systems science, and big data science, etc.), diverse mentor/faculty expertise, context specificity, community engagement, and collaborations across diverse and non-academic institutions and organizations.

Dependent on the proposed career development program, resident scientific and community expertise, and other personnel skill sets identified, applicant institutions may choose to identify and collaborate with partners to meet the objectives of this program. Partners may work in a variety of organizational settings, as long as their experience is germane to the proposed research projects.  For the purpose of this FOA, a broad definition of partners is used; they may be academic institutions, program implementers, educators, community based-organizations or others working in the nonprofit and private sectors, whether health-care related or not, to help meet the scholar’s career development needs and ensure exposure to broad experiential research opportunities. The partner(s) may contribute to the program in various ways based on the needs of the applicant institution (e.g., contribution to collaborative research venture, provide tools and strategies to effectively link implementation research to action at the community level, provide joint career development experiences in diverse settings, including opportunities to work with organizations, communities, health systems, and policy makers) to build a strong knowledge exchange D&I career development network.

If applicable, grantee organizations may provide career development opportunities for scholars located at other institutions through a partner or consortium structure. This FOA will support well-justified consortia created to enhance the goals and objectives of the program. Consortium partners will be identified by the applicant organization, and each partner institution must identify faculty at their location who have agreed to serve as mentors.
 

To increase the probability of achieving the program goals and objectives and to create maximum efficiencies for the program, a one year planning period is anticipated. The objective of this initial year is to maximize the productivity of the program by putting into place the mentoring teams and an advisory committee; curriculum planning; finalization of the didactic training components and syllabus; establishment and implementation of a new HLBS T4 translation career development platform that could potentially include diverse practice settings analyses, multi-level program designs, and analyses; and collaborative research projects that provide insight on the formulation, implementation, scale-up, and adoption (and de-adoption) of interventions.  Overall, the one-year planning period is intended to prepare for the scholars' career development experiences that will begin in the second year of the award.

This FOA is intended to support applications that propose no more than 5 scholars in a 3-year period and allows scholars to enter the program only in years 2, 3, and 4 of the award. It is anticipated that each period of scholar support will be continuous and will not allow for sabbatical leave. The PD(s)/PI(s) should consider involving scholars across institutions in order to build collaborative teams with various perspectives and skill sets shared through knowledge transfer and exposure to diverse settings. 

Program faculty/mentors will have direct involvement in the one year planning phase providing direction to the development and operation of the program.  During this time, it is anticipated that mentors will assist the PD(s)/PI(s) in the design and evaluation of the didactic coursework needed, propose multi-level research projects using T4 translation research trans-disciplinary approaches, as well as help identify academic and non-academic partners with diverse skill sets that will lead to a state-of-the-art implementation research preparation program. 

The FOA specifically seeks applications that propose program faculty mentoring responsibilities for scholars during years 2-5 of the program that include:

  • Aiding in implementation research skill development for research projects and more broadly
  • Providing tailored advice on the scholars didactic training needs
  • Providing career development and networking opportunities
  • Providing support in making presentations, preparing research publications, and assisting in preparing grant applications 
  • Helping identify future implementation research opportunities for scholars
  • Assisting in overall program evaluation.
Specific Interests

Specific areas of programmatic interest include, but are not limited to the following:

  • Development of competencies that address testing or refinement of intervention and evaluation models appropriate for T4 translation research that address HLBS-related diseases and conditions.
  • Strategies that lead to the understanding of the context and complexity of health interventions, including those with multiple components, those for low resource settings, and for populations traditionally underrepresented in research.
  • Development and/or use of measures and analyses related to the T4 translation research models/frameworks (addressing HLBS-related health inequities) with the goal of moving science to practice, and practice to policy.
  • Competency development as related to T4 translation research projects to assess issues of resources expended, programs costs, cost-effectiveness or other economic outcomes.
  • Incorporation of stakeholder relevant outcomes of research (including relevant outcomes for patients, families, providers, administrators, policymakers).
  • Fluency across diverse institutions and with a range of stakeholders and individuals (both traditional and non-traditional) to achieve effective implementation of evidence-based interventions and improved HLBS health outcomes.
  • Effective mentoring of scholars and evaluation of the program mapping curricula, career development, and research project objectives to measurable performance metrics.
  • Extend program benefits to the broader field through lessons learned, thereby enhancing the scale up of D&I career development.
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
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NHLBI intends to commit total costs up to $372,000 in FY2017, $1,821,000 in FY2018, $3,121,000 in FY2019, $3,121,000 in FY2020 and $1,298,000 in FY2021.

Up to 3 awards are intended to be funded in total.

Award Budget

Application budgets may not exceed direct costs of $344,444 in FY2017, $1,686,111 in FY2018, $2,889,815 in FY2019, $2,889,815 in FY2020 and $1,201,852 in FY2021.

Award Project Period

The maximum project period allowed is 5 years. 

Other Award Budget Information
Personnel Costs

Program Director/Principal Investigator (PD/PI): Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

Limited program-related administrative 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 they are in accordance with applicable cost principles.  For institutions covered by OMB Circular A-21, this type of training program may qualify as a “major project” where administrative salaries are allowable as a direct cost.  When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.  

A minimum of 10% but not to exceed 15% of the PD/PI's salary and fringes may be requested for the year one start-up phase, and up to 10% per year thereafter. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. If a multiple PD/PI model is proposed, effort can be combined but must not exceed 15% for the multiple PD/PI salaries and fringes for the year one start-up phase and 10% per year thereafter throughout the duration of the project period.

Program Faculty/Mentors: Up to 5% of Program Faculty members’ salary and fringes may be requested for the latter 9-month period of the one year start-up phase, and up to 5% per year thereafter.

Ancillary Personnel Support: Up to 6 person-months effort may be budgeted for an administrative assistant in the first year of the start-up planning phase and 4 person-months effort thereafter.  

Advisory Committee:  The Advisory Committee Chair and members may be paid a maximum of $2,000 per year to defray costs for their participation in the program.

Other Program Related Expenses

Scholars Costs

Consultant costs, equipment, supplies, travel for key persons (including the Advisory Committee), and other program-related expenses must be justified as specifically required by the proposed program and must not duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Sections C, D, and F, as appropriate.

Any travel costs proposed for national meetings should be reasonable to support scholars' activities and enhancement of their skills. However, during Year 3 of the program, travel costs should be planned and proposed for the PD/PI and active scholars to attend the grantees' meeting in Bethesda, MD.

Scholars may also attend an additional scientific meeting per year. Funds may be requested in the budget for this purpose but may not exceed $3,889 per traveler.

Items that may NOT be supported with K12 funds include:

  • Travel of the PD/PI or program mentors to scientific meetings other than the annual K12 meeting in Bethesda, MD.
  • Alterations and renovations.

The NHLBI salary contribution toward the K12 scholar's salary is capped at $100,000.  The total salary requested for scholars must be based on a full-time, 12-month staff appointment and requires scholars to devote a minimum of 9 person-months of full-time professional effort to conducti career development and health-related research with the remaining effort devoted to activities related to the development of a successful research career. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived.

Scholar costs per year should not exceed the following:  Up to $30,000 per individual scholar may be provided for the following types of expenses; (a) research expenses, such as supplies, equipment, and technical personnel, including expenses generated in the laboratories/research settings of an individual who serves as Program Faculty/Mentor; (b) tuition and fees related to required career development courses and activities; (c) travel to scientific meetings or training; and (d) statistical services including personnel and computer time. Research costs cannot be pooled and used for other programs unrelated or only indirectly related to the research activities of individual scholars or used for Program advertising or recruiting.

NOTE: The K12 award will provide up to three years of funding for each scholar. Each applicant should not propose more than 5 scholars in a 3-year period and scholars may only enter the program in years 2, 3 and 4 of the award. No new candidates shall begin after year 4 unless prior approval from the NHLBI Grants Officer is obtained.

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 in response to 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

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 access to the requisite faculty, staff, potential scholars and facilities to conduct the proposed institutional program. Due to the interdisciplinary nature of implementation research, collaborations/partnerships beyond the applicant institution may be necessary. 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.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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 Career Development Program 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 PD(s)/PI(s), 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. Multiple PD/PIs have equal responsibility for the scientific and technical direction of the training program, as well as accountability and leadership for ensuring an effective career development structure and interactions of the mentoring and research teams.

The PD/PI should be an established researcher 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. Individuals from diverse disciplinary and demographic backgrounds are encouraged to apply.  Applicants may hold academic appointments or positions in applied research firms or community organizations. PDs/PIs are expected to have engagement  with a pertinent community-based group or with collaborators who have/or can build community relationships to identify and understand the relevant public health needs, develop methods of effective community dialogue and research, ensure health information is widely available, and provide information and access to research studies. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI's responsibilities throughout the award include program coordination, leadership, outreach, and recruitment of scholars, development of innovative methods, tools, and career development models, and dissemination of curricula and career development models. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee and using their recommendations to help ensure the career development program goals and objectives are accomplished. If the PD/PI has experiencein mentoring, organizing and implementing research training or career development programs other than those that are NIH-funded,  they are encouraged to consult with a PD/PI who is well versed in providing oversight for  NIH research training programs (e.g., T32 or CTSA clinical research training program).

The PD(s)/PI(s) are expected to have ongoing independent peer reviewed research grant support.

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).
Program Faculty/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.

Program faculty/mentors should include researchers with varied skill sets such as clinicians; intervention developers who bring expertise in their programs; researchers who bring expertise in service settings; methodologist researchers who bring modeling and conceptual frameworks and expertise for the multi-level strategies required to change systems, organizations, communities, and providers; health policy researchers who bring the formulation and promotion of health policies and practices that improve the access to high quality care and reduce health disparities; and other individuals such as implementers and service delivery stakeholders, who are particularly critical in advancing successful implementation strategies.

Program faculty/mentors researchers should have strong research records in their field, and recent publications and successful competition for research support in the area of the proposed research mentoring program.  Mentors should have a record of mentoring or research training, including mentoring individuals from diverse backgrounds. Mentors will interact closely with the scholar, and should be individuals with expertise and experience relevant to the proposed career development program.

Mentors must be committed to continue their involvement throughout the total period of the Scholar’s career development under this award. 

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Scholars may not be or have been a PD/PI on an R01, R29, U01/U10, subproject of a Program Project (P01), Center (P50, P60, U54) grant, or individual mentored or non-mentored career development award (e.g., K01, K08, K22, K23, K25, K99/R00).  

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

Applicants must obtain 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.

2. Content and Form of Application Submission

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

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

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
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.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:

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars, and intended scholars outcomes.

Other Attachments. An Advisory Committee is a required component of this career development program, and will monitor progress, provide recommendations on a periodic basis and help evaluate the overall effectiveness of the research career development program. Provide a plan for the appointment of an Advisory Committee; 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 provide recommendations on a periodic basis and 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. The filename “Advisory_Committee.pdf” should be used for this attachment.

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.

Research and Related (R&R) 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. Also include proposed salary costs for planned scholars.
  • Do not complete the section on Participant/Trainee Support Costs.
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

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

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Training Program

Program Plan

Program Administration. Institutions with existing institutional training or career development programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Describe plans for administering the overall program including the proposed strategy and structure for monitoring the program. Year one should be a planning phase. The objective of this initial year is to maximize the productivity of the program by putting into place:

  • the mentoring teams and an advisory committee
  • curriculum planning
  • finalization of the didactic training components and syllabus
  • establishment and implementation of a new HLBS T4 translation career development platform that could potentially include diverse practice settings analyses, multi-level program designs, and analyses
  • concept development for collaborative research projects that provide insight on the formulation, implementation, scale-up, and adoption (and de-adoption) of interventions. 

Overall, the one-year planning period is intended to prepare for the scholar's training and career development experiences that will begin in the second year of the award.

If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the “Multiple PD/PI Leadership Plan” section of the application. Clearly identify the integrative, multi-disciplinary, and the expertise (e.g., scientific, academic, and practitioner) required of the program leadership team. Advancing implementation science will require deliberate and strategic efforts to facilitate collaboration, communication, and relationship-building among researchers, implementers, and policy-makers.  If applicable, grantee organizations may provide career development opportunities for scholars located at other institutions through a partner or consortium structure. Describe formal collaborations with any relevant entity and if applicable, describe how the scholar or mentor from the partner or consortium institution will be integrated in the overall K12 program at the applicant institution.

Proposed Career Development. Outline the objectives of the program and describe the program activities (years 2 through 5) that will be used to meet these objectives.  Describe the following:

  • Immediate and long-term objectives of the program.
  • How qualified scholars will be prepared for successful careers as researchers with increased capacity to close the gap between evidence-based health interventions and actual practice in health service and community settings.
  • Intended scholars for whom the training program is proposed, including the training level(s) of the scholars and the academic and research background needed to pursue the proposed training
  • Planned courses, seminars, workshops, tutorials, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed career development.  Include information on frequency of mentoring
  • Plans to accommodate differences in didactic training needs and the research skill set preparation among scholars
  • Plans for providing an integrated multidisciplinary team approach with effective collaboration among clinicians, researchers, implementers, policy-makers, and health service delivery as well as other relevant stakeholders, to increase the program's chance of success. If multiple sites are participating, provide justification in terms of career development and research experiences.  
  • Strategies for determining individual professional development plans for each scholar including skills and career guidance, instruction and training in writing applications for research funding in order to apply successfully for future career development support (e.g., mentored K awards) as well as independent research support such as R01 grants
  • Appropriate timelines for career progression and transition to independence (career development plan). Include plans for creating research milestones for scholars during the K12 period and for the transition from K12 support. Scholars are expected to transition from K12 training to individual career development awards (K awards or equivalent) or independent NIH research funding by the end of the K12 training.

Each scholar must have a primary research mentor, as well as access to other scientists/methodologists, clinicians, intervention developers, and health service delivery stakeholders and others with relevant expertise (as dictated by the research project) who can contribute to the scholar's research career development.

Program faculty mentoring responsibilities for scholars during years 2-5 of the program must include:

  • Aiding in implementation research skill development for research projects and more broadly
  • Providing tailored advice on the scholars didactic training needs
  • Providing career development and networking opportunities
  • Providing support in making presentations, preparing research publications, and assisting in preparation of grant applications
  • Helping identify future implementation research opportunities for scholars
  • Assisting in overall program evaluation.

Faculty, Trainees, and Training Record

Describe how the faculty will:

  • Develop, update, enhance, evaluate, and revise relevant curricula and innovative teaching methods and tools;
  • Work with the scholars to conceptualize, design, collect, analyze, and interpret their study data to help ensure research productivity;
  • Work in conjunction with the PD/PI to provide for scholars regular career development opportunities, such as journal clubs and other forums to facilitate the exchange of ideas and assist in writing grant applications, as well as manuscripts and journal reviews with other senior-level scientists in a team approach;
  • Assist in program evaluation; and identify specific opportunities for scholars, particularly women and underrepresented scholars, to take advantage of that facilitate future access with appropriate administrators or colleagues that foster successful attainment of career goals, such as informal and formal networks or associations.

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. 

Participating Faculty Biosketches

 Highlight the relevant experiences of the proposed program faculty in clinical, population, or translational research, multi-disciplinary expertise, ‘real world’ implementation research and activities, other scholarly activities relevant to implementation science in which the program faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). In particular, highlight current relevant research or implementation activities that seek to close the gap between evidence-based health interventions and actual practice in health service and community settings.

Data Tables

Particular attention must be given to the required Training Data Tables for New Applications - New Postdoctoral Training: Tables 1, 2, 3, 4, 5B, 6B, and 8C.

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.  

 
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.

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

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.

The following types of applications are outside the purpose of this FOA, will be considered non-responsive, and will not proceed to review:

  • Applications that do not focus on implementation science rcareer development with the goal of closing the gap between evidence-based health interventions and actual practice in health service and community settings.
  • Applications that do not identify topic area(s) of research that meet the scientific mission(s) of NHLBI.

In order to expedite review, applicants are requested to notify the NHLBI Referral Office by email at nhlbichiefreviewbranch@nhlbi.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

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.

Career Development Program and Environment

  • Does the proposed program clearly outline a plan to recruit and develop well-qualified scholars for successful careers as researchers with increased capacity to close the gap between evidence-based health interventions and actual practice in health service and community settings?
  • Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
  • Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?
  • Are appropriate timelines indicated for career progression and transition to independence?
  • Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
  • Does the proposed career development program benefit from multi-disciplinary expertise and unique features of the scientific and training environments, subject populations, partnerships or employ useful collaborative arrangements that increase the program’s chance of success?
  • Is the institutional commitment to the proposed program appropriate?
  • If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided?
  • Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
  • When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

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

  • Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
  • Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
  • Are the research qualifications, scientific stature, previous leadership and mentoring experience, and research track record of funding (including NIH funding) appropriate for the proposed career development program?
  • Are the PD(s)/PI(s) currently engaged in research or related activities relevant to the scientific area of the proposed program?
  • Does the PD/PI have relevant training or experience to successfully implement   an NIH career development  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?

Mentors

  • Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training?
  • Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research or implementation activities that seek to close the gap between evidence-based health interventions and actual practice in health service and community settings?

Scholars

  • Is a recruitment plan proposed with strategies likely to attract high quality scholars?
  • Are there well-defined and well justified recruitment and selection strategies?
  • Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?  
  • Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholars?
  • What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
  • Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Training Record

  • Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?
  • Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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).  Taking into account the specific characteristics of the career development program, the level of scholars experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development 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?  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? 

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 the 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council . The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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
  • 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 scholar 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 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. Evaluation results should be included as part of the final Progress Report.

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.

The NHLBI will assess the program’s overall outcomes, gauge its effectiveness in meeting program goals and objectives. Subsequently,  the NHLBI will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

For programs involving post doctorates and early career investigators:

Short-Term Metrics include:

  • Enhanced methodological training skill sets to conduct rigorous T4 research through didactic
  • training, direct application to research proposal design and execution, as well as access to basic clinical trials training.
  • Documented collaborations (e.g., practice linkages) resulting in trans-disciplinary scholarly products and presentations.
  • Establish key components of practice linkages and mentorship teams needed to maximally achieve the goal of moving evidence to practice.
  • Subsequent authorship of scientific publications in a T4 translation research HLBS-related field.
  • Evidence of active pursuit of extramural grants and contracts to support future research goals.

Long-Term Metrics include:

  • Evidence of additional institutional support for the training program: facilities and resources available to the program enhancing the quality of T4 translation research training at the institutional level.
  • Increased numbers of postdoctoral students and junior faculty conducting T4 translation research.
  • Subsequent employment of K12 trainees in a HLBS T4 translation research field.
  • Evidence of academic advancement and promotion based on research and related accomplishments.
  • Subsequent independent T4 translation research grant/contract support from the NHLBI or another funding 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: https://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: 301-710-0267

Scientific/Research Contact(s)

Helena Mishoe, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-5081
Email: mishoeh@nhlbi.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)

Hubert Walters
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: waltersh@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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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