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

Mentored Career Award for Faculty at Institutions That Promote Diversity (K01)

Activity Code

K01 Research Scientist Development Award - Research & Training

Announcement Type

Reissue of RFA-HL-10-011.

Related Notices

  • May 2, 2012 - This RFA has been reissued as RFA-HL-13-018.
  • October 25, 2011 - See Notice NOT-OD-12-008. The purpose of this guide notice is to alert grant applicants that NIH and CDC are extending the deadline by one business day for all funding opportunities that require electronic application submission  that have due dates between Oct 25 and Oct 28, 2011.

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-029

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.233, 93.837, 93.838, 93.839

FOA Purpose

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups, to improve the quality of the educational and training environment, to balance and broaden the perspective in setting research priorities, 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 objectives of this Funding Opportunity Announcement (FOA) are to:  (1) advance the awardee’s career development trajectory by strengthening research capacity, publishing and other scholarly activities, (2) improve success and retention in a research career;

(3) promote scientific collaborations that lead to acquisition of new skills or research in other fields of scholarly interest; and (4) increase the number of highly trained investigators at institutions that promote diversity  whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary, and hematologic diseases in general and in populations that suffer disproportionately from these conditions.

This FOA invites applications from eligible faculty members to undertake special study and supervised research under a mentor who is an accomplished investigator in the research area proposed and has experience in developing independent investigators.  The FOA is a three-to-five-year non-renewable career development award to support faculty at a non-research intensive institution with an institutional mission focused on serving diverse communities that are not well represented in NIH-funded research, or identified federal legislation of same. The candidates must have research experience and be committed to developing into independent biomedical investigators in research areas relevant to the mission of the NHLBI (i.e., cardiovascular, pulmonary, hematologic, or sleep disorders research).

Key Dates
Posted Date

August 10, 2011

Open Date (Earliest Submission Date)

September 26, 2011

Letter of Intent Due Date

September 26, 2011

Application Due Date(s)

(New Date October 27, 2011 per NOT-OD-12-008) , Original Date October 26, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

(New Date October 28, 2011 per NOT-OD-12-008) , Original Date October 27, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series)  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

Overall Progam Objectives:

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists are 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.

The objectives of this Mentored Career Development Award are to:  (1) advance the awardee’s career development trajectory by strengthening research capacity, publishing and other scholarly activities; (2) improve success and retention in a research career; (3) promote scientific collaborations that lead to acquisition of new skills or research in other fields of scholarly interest; and (4) increase the number of highly trained investigators from diverse backgrounds whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary, and hematologic diseases in general and in populations that suffer disproportionately from these conditions.  The NHLBI Mentored Career Award for Faculty at Institutions That Promote Diversity (K01) will provide salary and research support for a sustained period of “protected time” (3-5 years) to meet the program goals and objectives. The expectation is that through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.  

Background:

Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF) (see http://www.nsf.gov/statistics/wmpd/) and others, provide strong evidence that diversity remains an important problem that the entire research enterprise must actively address. There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion.  Recent studies have supported the argument that diversity enhances the quality of education in multiple settings.  Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials.  Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings.  There is limited evidence that individuals who have participated in the NIH administrative supplement program preferentially conduct research in areas related to health disparities or minority health. Surveys have revealed that a diverse faculty is important to attract diverse students and has a positive impact on retention and career mentoring for diverse students.  Moreover, a diverse faculty can significantly contribute to a balanced research agenda that benefits all people.  Thus, a diverse research and teaching workforce provides a valuable and more comprehensive educational experience for faculty and students.

The NHLBI recognizes a critical need to address national and global health disparities that disproportionately burden racial and ethnic minorities, individuals with disabilities, and lower social economically disadvantaged populations. The Institute has a long history of supporting biomedical, behavioral, and clinical and social sciences research and training to address cardiovascular, lung, and blood diseases and sleep disorders. Significant progress has been made in health outcomes. Recent years have also brought improvements in health disparities, although racial and ethnic minorities still lag in many areas including overall life expectancy. The health disparity populations are more likely to suffer from a host of illnesses such as diabetes, heart disease, stroke, asthma, and kidney disease. Thus, health disparity gaps remain to be addressed in the NHLBI scientific mission areas.

Cardiovascular disease and type 2 diabetes ranked first, and sixth, respectively, among the leading causes of death and disability in the United States. Research indicates that African Americans and Latino/Hispanic-Americans have a higher risk of death and disability from heart disease and stroke than any other population group in the United States. African American men were 30 percent more likely to die from heart disease than non-Hispanic White males and compared with Whites, Mexican Americans experience higher rates of overweight and obesity, two of the leading risk factors for heart disease.  African Americans, Hispanic/Latino Americans, American Indians, Alaska Natives, some Asian-Americans, Native Hawaiians and other Pacific Islanders are at particularly high risk for the development of type 2 diabetes. Diabetes (risk factor for cardiovascular disease) prevalence rates among American Indians are two to five times those of Whites. On average, African American adults are 1.7 times as likely and Mexican-Americans and Puerto Ricans are twice as likely to have the disease as non-Hispanic Whites of similar age. Overall, underserved communities are disproportionately affected by these chronic conditions and efforts are needed across the research spectrum to address these and other conditions.  The NHLBI is committed to improving health for all through research, training, and education efforts that improve the Nation's capacity to address and eliminate health disparities relevant to heart, lung, blood, and sleep disorders.

There is a pressing need for enhancing the research infrastructure including faculty research capacity at institutions with a history of making substantial contributions to the education of students who go on to pursue research geared toward addressing health disparities in NHLBI’s mission areas.  These institutions are important not only because of their role in educating students, but they also have  unique access to and serve communities that are disproportionately burdened by health disparities.  The focus of this funding opportunity announcement, is on institutions that promote diversity (e.g., Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal Colleges and Universities (TCUs).  Faculty trained to conduct innovative biomedical and biobehavioral research with a high likelihood for promoting health in underserved populations and eliminating health disparities is an important goal of this program.

Institutions that promote diversity represent large and largely untapped talent pools of students from underrepresented groups in science and engineering. For example, currently 30% of all postsecondary degrees going to African Americans are earned at HBCUs. Moreover, students attending these schools are almost twice as likely to major in science and engineering fields as compared to minorities attending majority-White institutions. Consequently, 31% of bachelor’s degrees in science and engineering earned by African Americans are earned at HBCUs. The top ten producers of Black bachelor’s degree recipients in physics are all HBCUs. As discussed in a study conducted by the Educational Testing Service, minorities attending institutions that promote diversity generally graduate at higher rates than at majority-White institutions, find lower average tuitions, and are more likely to pursue post-baccalaureate degrees (see data at http://csma.aas.org/spectrum_files/spectrum_Jun02.pdf. Diversifying Our Profession: The Role of Minority Serving Institutions by Keivan Guadalupe Stassun). Students select these institutions for a variety of reasons and the student population has become more diverse over time. Highly trained research faculty at institutions that promote diversity to address problems related to cardiovascular, pulmonary, and hematologic is critically important to help recruit and retain science and engineering faculty and students and serve as research advisors and role models for students.

Important NHLBI program goals are to enhance the science infrastructure of eligible institutions by developing the research career and teaching skills of the candidate (Pub. L. 106-525, Minority Health and Health Disparities Research and Education Act of 2000, Section 2, Findings). By enhancing these capabilities, the candidate will be better able to prepare his/her students to pursue advanced degrees and ultimately careers in biomedical and behavioral research. Increasing the pool of well-trained biomedical and behavioral investigators institutions that promote diversity in cardiovascular, pulmonary, and hematologic diseases research will significantly contribute to the future research work force.  History has shown also that many healthcare researchers and future professionals who graduate from non-research intensive institutions are likely to devote their careers providing biomedical and behavioral services in minority communities. (Public Law 106-525; Allocating Federal Funds for Science and Technology, Supplement 4, http://www.nap.edu/html/fedfunds/.)

Receipt of the NIH Career development awards is often an important gateway to additional NIH peer-reviewed research grant funding (see data: An Evaluation of the NIH Program of Individual Mentored Career Development Awards: K01, K08, and K23 Awards, Fiscal Years 1990-2005 [Forthcoming Report]).  A recent analysis of the NHLBI funding characteristics by institution type indicated that in 2009 institutions that promote diversity represented one tenth of the total NHLBI-funded institutions.  Given the substantial need for physicians, physician scientists and others who will be involved in the care of vulnerable populations often located in communities that encompass institutions that promote diversity, more efforts are needed to increase the pipeline. Targeting individuals who are poised to become junior faculty members whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary, and hematologic diseases in general and in populations that suffer disproportionately from these conditions is an important need that this program seeks to address.

Listed below are key metrics to be used to determine whether the program goals or outcomes have been met in a future evaluation.  

Other suggested areas of program relevance are listed below, but may not be appropriate depending on the specific stage and timing of an individual’s career development.

Based on the historical small number of awards for this program each year, and to ensure an adequate cohort size for evaluation, an administrative review (using outside experts) will be convened to evaluate the program during year eight after the completion of the initial awards made in FY2012. The evaluation will utilize the identified evaluation criteria. The expert panel will recommend to the NHLBI’s leadership and Council future program direction, duration, or discontinuation.

NHLBI encourages research training and career development crossing disciplinary boundaries (examples: biophysics, biostatistics, bioinformatics, bioengineering) to develop a new interdisciplinary work force.

Specific Programmatic Objectives for Submitted Applications:

The research proposed must 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. Therefore, 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.

Each candidate may submit one application. However, more than one candidate from each institution may apply. A Mentored Career Award for Faculty at Institutions That Promote Diversity (K01) prepares the faculty member to apply for other types of NIH support such as the Research Project Grant (R01), Academic Research Enhancement Award (AREA, R15), Exploratory/Development Grant (R21) or the Minority Biomedical Research Support Program.

Scientists and physicians with some research experience who need guided course work and supervised laboratory experiences, as well as faculty who need an intensive research experience under the guidance of an established scientist, are eligible to apply.

The Mentored Career Award for Faculty at Institutions That Promote Diversity (K01) is a three-to-five-year non-renewable career development award to support faculty at an eligible institution with an institutional mission focused on serving diverse communities or with federal recognition of the same. The faculty member must hold a Ph.D., M.D., D.V.M., D.O., or equivalent professional degree and wish to develop research capabilities in research areas relevant to the mission of the NHLBI. The candidate or the awardee is in the career stage that will benefit from a mentor who is an accomplished investigator, either at the same institution or at a collaborating research center.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
The OER Glossary and the SF 424 (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.

NIH intends to fund an estimate of two to three new awards, corresponding to a total of $300,000, for fiscal year 2012. Future year amounts will depend on annual appropriations.

The total project period for an application submitted in response to this FOA must be at least three but not more than five years.RFA with multiple ICs/components (choice 1, preferred):

Loan Repayment Program (LRP): Awardees under this program may be eligible to apply for the NIH Extramural Loan Repayment Program. Information regarding the eligibility requirements and benefits for the program may be obtained through the LRP website at http://www.lrp.nih.gov/.

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.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

The total project period may not exceed 5 years.

Other Award Budget Information
Salary

NHLBI will contribute $75,000 plus fringe benefits for full-time professional effort (i.e., equivalent to 9 to 12 person months) per year toward the salary of the career award recipient. Individual compensation is based on the institution's salary scale for individuals at an equivalent experience level. The salary must be consistent with both the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

The NHLBI Research Career Development Award Programs require the recipients to devote a minimum of 9 person-months (equivalent to 75%) full-time professional effort to the research plan being supported by the career development award; the remaining 25% effort should be devoted to research and research-related activities such as teaching, patient care, or other research-related activities. If 100% effort is to be devoted to the research program during the "summer months," the percent effort for the remainder of the year may be reduced provided that the effort over the course of the year is at least 75%. The NIH permits supplementation of salary from non-federal sources.

K01 award recipients are encouraged to obtain funding from the NIH or other federal sources either as a named PD/PI on a competing research grant award or cooperative agreement or as sub-project director on a competing multi-project award (see NOT-OD-08-065).  At the time the research grant is awarded, the effort required on the K01 award may be reduced to no less than 6 person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at 9 person-months (75% full-time professional effort) or more for the duration of the K01 award.  To be eligible for salary support from peer-reviewed research awards from any Federal agency:

The K01 award recipient must be the PD/PI (or one of the named PD/PIs, if following the multiple-PD/PI model) on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).

The K01 award must be active when the competing research grant application is submitted.

The K01 award must be in its final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted.  When the effort is reduced, the salary will be reduced accordingly.

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

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. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NHLBI will contribute $36,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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:

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

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

Foreign (non-U.S.) components of U.S. Organizations are not allowed.

The Institution must be a domestic college or university with an institutional mission focused on serving diverse communities or with federal recognition of the same.

These institutions can assist NIH in its efforts to train and recruit the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; 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. Accordingly, NIH strongly encourages applications from the following institutions: Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-Serving Institutions, and Alaska Native and Native Hawaiian Serving Institutions.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple Principal Investigators are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; 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.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.  Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Former PDs/PIs on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K–awards), or the equivalent are not eligible. Former principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

Candidates for this award must have a research or health-professional doctoral degree or equivalent.

Project Director/Principal Investigator (PD/PI): Also referred to as Candidate, must have research experience (length of time may vary) and be committed to developing into independent biomedical investigators in research areas relevant to the mission of the NHLBI (i.e., cardiovascular, pulmonary, and hematologic diseases). Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

Candidates for the K01, under some circumstances, may have been PDs/PIs on NIH research or career development awards, provided the research experience proposed in the K01 application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Candidates are therefore strongly encouraged to contact the NHLBI staff person listed under Section VII of this FOA prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.

Citizenship and Residency: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible.

Degree and Research: The award will enable suitable faculty members holding doctoral degrees, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent, to undertake special study and supervised research under a mentor who is an accomplished investigator in the research area proposed and has experience in developing independent investigators. To receive an award under this program, individuals must have been awarded a doctoral degree, at least two years prior to the award and have a full-time faculty appointment at an accredited college or university at the time of award.

Level of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award.  The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K01 award, i.e., the candidate’s development into an independent investigator.

It is envisioned that most candidates for this award will hold non-tenured faculty appointments (such as instructor or assistant professor). In some instances other individuals may be eligible to apply (such as individuals due to be appointed to a faculty position or individuals with tenured faculty positions). Candidates must hold a faculty appointment at the time of award. The faculty appointment must not be contingent on receipt of the award.

Current and former recipients of K12/KL2 support may apply for the K01 provided that they have no more than three years of K12/KL2 support by the time the K01 award is issued. The combined total of K12/KL2 plus K01 support must not exceed six years. A candidate for the K01 may not concurrently apply for or have an award pending for any other NIH career development award.

The candidates must have research experience (length of time may vary) and be committed to developing into independent biomedical investigators in research areas relevant to the mission of the NHLBI. The award will enable suitable faculty members holding doctoral degrees, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent, to undertake special study and supervised research under a mentor who is an accomplished investigator in the research area proposed and has experience in developing independent investigators.

Although candidates due to be appointed on faculty are eligible to apply, candidates must hold non-tenured faculty appointments (such as instructor or assistant professor) before the award is made. The faculty appointment must not be contingent on receipt of the award.

Ineligible individuals include current and former PDs/PIs  on NIH research project grants (R01), Academic Career Awards (K07), comparable career development awards (e.g., K08, K22, K23), Pathway to Independence Award (K99/R00), subprojects of program project (P01) or center grants (P50), or non-NIH equivalent grants/awards. An individual who has previously received support from the Minority Access to Research Careers (MARC), Minority Biomedical Research Support (MBRS) Program, Academic Research Enhancement Award (AREA), or a diversity supplement is eligible to apply.

Former or current PDs/PIs of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) are eligible for this award.

Eligibility Requirements

To be eligible for this FOA, applicant institutions with an undergraduate student body must demonstrate that they (1) serve high concentrations of disadvantaged students and (2) have a need for research capacity development in cardiovascular disease (including associated conditions e.g., obesity), lung, and blood diseases.  A college or university where 20 percent or more of the student population receive Pell grants will be accepted as an indicator of institutional disadvantage. 

To be eligible for this FOA,  independent medical and graduate schools, must demonstrate that they (1) provide health care related services to economically disadvantaged 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 percent or more of the institution’s graduates provide health related care to disadvantaged and underserved communities will be accepted as an indicator of institutional disadvantage.

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 funding (direct costs) from the NHLBI per year in each of the previous five years for research training and education (e.g., R25) grants in the above NHLBI mission areas.

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 scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications pending review concurrently.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI  on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

A candidate for an NIH K01 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K07, K08, K22, K23) or any PHS or award that duplicates any of the provisions of the K01 award. Current principal investigators on NIH career awards are not eligible.

Candidates for the K01, under some circumstances, may have been a PD/PI on NIH research or career development awards, provided the research experience proposed in the K01 application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Candidates are therefore strongly encouraged to contact the NHLBI staff person listed under Section VII prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.

Applicant Institution: The application must include a plan that identifies personnel and other resources to be devoted to the candidate. In addition, evidence of institutional commitment to the candidate's research development and level of effort should be included in a statement from the institution. The statement should also address the institution's plans for the candidate during and following the tenure of the award. The statement should be signed by an institutional official (e.g., a dean) and the candidate's department chair.

Level of Effort

At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036

Mentor

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
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 or Bethesda, MD 20817 (for express mail)
Telephone: 301-435-0270
Email:nhlbichiefreviewbranch@nhlbi.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) to determine which components are required.

Page Limitations

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

PHS 398 Career Development Award Supplemental Form

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

Candidate’s Background (Component of Candidate Information)

Career Goals and Objectives (Component of Candidate Information)

Career Development/Training Activities During Award Period (Component of Candidate Information)

Training in the Responsible Conduct of Research 

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

Research Strategy (Component of Research Plan)

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.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted.  Applications lacking the appropriate required reference letters will not be reviewed (more details in the Notice). This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHLBI. Applications that are incomplete and/or nonresponsive will not be reviewed.

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-10-115.

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 should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

Does the candidate have the potential to develop as an independent and productive researcher? Is the candidate’s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in (patient-oriented) research? Do the letters of reference from at least three well-established scientists address the candidate’s potential for becoming an independent investigator?   

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Are the candidate's prior training and research experience appropriate for this award? Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

Research Plan

Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan? If applicable, are there adequate plans for data and safety monitoring of clinical trials?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is active/pending support for the proposed research project appropriate and adequate?  Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence? 

Environment & Institutional Commitment to the Candidate

Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality? Is there assurance that the institution intends the candidate to be an integral part of its research program? If the mentor(s) institution is different from the candidate's institution, are the quality and extent of interaction of the faculty in the basic and clinical sciences and the quality of the research and research training programs at the mentor's institution adequate for the development of the candidate?   

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/priority score, but will not give separate scores for these items.

Advisory Committee

What are the quality of the Advisory Committee, the quality of the planned roles for advice and the adequacy of scheduled meeting frequency of the Advisory Committee with the Candidate? 

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate:

(1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care;

(4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

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/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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).

Resource Sharing Plans

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

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 convened by the NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria.  Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 NHLB Advisory Council.

The following will be considered in making funding decisions:

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

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 business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.      

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.

The following related administrative policies apply to NIH Research Career Award (“K”) programs:

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient.  Such fees must be assigned to the grantee institution for disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation.  Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury.  Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892.  Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH supported research grant or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted.  The NHLBI will give consideration to approval for the use of released funds only under unusual circumstances.  Any proposed retention of funds released as a result of a career award must receive prior written approval of the NHLBI.

Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award.  Only local institutional approval is required if such leave does not exceed three months.  For longer periods, prior written approval of the NHLBI is required.   Details on the process for submission of prior approval requests can be found in the NIH Grants Policy Statement, Requests for Prior Approval.

 A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made.  Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior written approval of the NHLBI and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support.  Such leave does not reduce the total number of months of program support for which an individual is eligible.

Percent Effort Policies: Under certain circumstances, an awardee may submit a written request to the NHLBI requesting a reduction in professional effort below 9 person-months (equivalent to 75 percent).  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 6 person-months (equivalent to 50 percent effort).  The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability.  Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.  In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee.  In addition, the awardee must submit assurance of his/her intention to return to at least 9 person-months effort as soon as possible.  During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. See: NOT-OD-09-036.

Changes in Research or Career Development Program: Consultation with the NHLBI Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development in a specific research program:  A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH Institute or Center.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the NHLBI to ensure that the plan remains within the scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the PD/PI’s continued career development.  The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program.   NHLBI staff will review the request and will notify the institution of the results of the evaluation.

Change of Institution or Termination: Consultation with the applicable NIH funding Institute or Center program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.

A change of grantee institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds.  In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project.  A change may be made without peer review, provided the PD/PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project.  If these conditions or other programmatic or administrative requirements are not met, the NHLBI may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the K awardee is moving to another eligible institution, career award support may be continued provided:

A relinquishing statement and final invention statement are submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NHLBI. 

The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.

All conditions of the award are met at the new institution.

The period of support requested is no more than the time remaining within the existing award.

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.  The Director of the NHLBI may terminate an award upon determination that the purpose or terms of the award are not being fulfilled.  In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons, the effective date, and the right to appeal the decision.

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. Accordingly, recipients are hereby notified that they 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed.  The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Henry Chang, M.D.
Division of Blood Diseases and Resources (responding for all NHLBI programmatic Divisions)
6701 Rockledge Drive, Room 9176, MSC 7950
Bethesda, MD 20892-7950 (Express mail zip: 20817)
Phone: (301) 435-0067
Email: changh@nih.gov

Peer Review Contact(s)

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 (Express mail zip: 20817)
Telephone: (301) 435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Ms. Renee Livshin
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute 
6701 Rockledge Drive, Room 7169
Bethesda, MD 20892-7926 (Express mail zip: 20817)
Telephone: (301) 435-0174
Email: LivshinR@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 Parts 74 and 92.


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