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-12-029
Related Notices	November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
Funding Opportunity Announcement (FOA) Number	RFA-HL-13-018
Companion Funding Opportunity	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
Funding Opportunity 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 minority and other health disparity populations into clinical research protocols, and to improve the Nation s capacity to address and eliminate health disparities. This funding opportunity announcement seeks to provide support for faculty in institutions that promote diversity. Such institutions train substantial numbers of students from disadvantaged backgrounds, receive modest research support from NHLBI and provide health-related services and education to minority and other health disparity populations not well represented in NHLBI-funded research. Opportunities for mentored research career development for faculty at these institutions will enhance the educational experience for all students attending these instutions, and will improve outreach to underserved communities in NHLBI focus areas. 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 faculty at eligible institutions 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. An award made to a successful applicant to this FOA will be 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 institutions that have been identified by federal legislation as having specially focused institutional missions. 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).

Posted Date	May 2, 2012
Open Date (Earliest Submission Date)	June 9, 2012
Letter of Intent Due Date	June 9, 2012; January 7, 2013; January 7, 2014
Application Due Date(s)	July 9, 2012; February 7, 2013; February 7, 2014, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	October/November 2012, June/July 2013, June/July 2014
Advisory Council Review	January 2013, October 2013, October 2014
Earliest Start Date(s)	April 1, 2013; December 1, 2013; December 1, 2014
Expiration Date	February 8, 2014
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, including 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The 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.

The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide faculty with salary and research support for a sustained period of protected time (3-5 years) to engage in intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral or clinical sciences that leads to research independence. 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.

There is a pressing need for enhancing faculty research capacity at institutions with a history of making substantial contributions to the education of students from diverse backgrounds, underrepresented in research areas of interest to the NHLBI. 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) and other institutions with similar missions to educate students from diverse backgrounds underrepresented in research areas of interest to NHLBI. Training of faculty that 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.

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.

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, faculty awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

Background:

The NHLBI recognizes a critical need to address national and global health disparities that disproportionately burden racial and ethnic minorities, individuals with disabilities, and those from 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. Health disparities have decreased in recent years, 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 are 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-American subpopulations, 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.

Institutions that promote diversity represent large and largely untapped talent pools of students. For example, currently 30% of all post-secondary degrees awarded 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 schools awarding bachelor’s degrees to Black recipients in physics are all HBCUs. As discussed in a study conducted by the Educational Testing Service, minorities attending Minority Serving Institutions, when compared to those attending majority-White institutions, generally graduate at higher rates, have 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 may also be instrumental in programs designed to help underserved communities to understand and address problems related to cardiovascular, pulmonary diseases. They are critically important to help recruit and retain students and serve as future research advisors and role models for students from disadvantaged backgrounds who may not otherwise have access to such individuals.

Important NHLBI program goals are to enhance the science and human resource infrastructure of eligible institutions by developing the research career and teaching skills of the candidate. 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 faculty investigators in institutions that promote diversity in cardiovascular, pulmonary, and hematologic diseases research will significantly contribute to the future research work force in these areas. 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 and other underserved communities.

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 [http://grants.nih.gov/training/K_Awards_Evaluation_FinalReport_20110901.pdf].). 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 faculty who are 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 capacity of these institutions. Targeting institutions that promote diversity and their prospective and 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.

See Section VI. Award Administration Information, 4. Evaluation for key metrics to be used to help determine whether the program goals or outcomes have been met in a future evaluation.

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. 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), and the Academic Research Enhancement Award (AREA, R15), and candidates may be eligible for support from 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 minority and other health disparity populations or with federal recognition of the same. The faculty member must hold a PhD, MD, DVM, DO, 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.

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	NHLBI intends to fund two to three new awards in FY 2013, 2014, and 2015, corresponding to a total of $300,000 for new grants per fiscal year.
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.

Salary	NIH will contribute $75,000 plus fringe benefits per year toward the salary of the career award recipient. 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	NIH 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, secretarial and administrative assistants, etc. 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 grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

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

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

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

The Institution must be a domestic college or university with an institutional mission focused on serving minority and other health disparity populations underrepresented in scientific research, or institutions that have been identified by federal legislation as having specifically focused institutional missions.

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.

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 theNIH Grants Policy Statement, are not allowed.

http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 4-6 weeks prior to the application due date.

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). Individuals on temporary or student visas are not eligible.

Former and current PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), FIRST Awards (R29), sub-projects of program project (P01), sub-projects of center grants (P50), 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), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. 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. 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.

However, 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.

Awardees must have a research or health-professional doctoral degree or equivalent, 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. The award will enable suitable faculty members holding doctoral degrees, such as the PhD, MD, DO, DVM, 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.

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.

The 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 or sleep disorders).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 person-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.

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

To be eligible for this FOA, applicant institutions with an undergraduate student body must demonstrate that they (1) have an institutional mission focused on serving students and diverse communities that are not well represented in NHLBI funded research, or legislation recognizing such efforts, (2) serve high concentrations of students from disadvantaged backgrounds (a college or university where 20% or more of the student population receive Pell Grants will be accepted as an indicator of concentrated student disadvantage), and (3) have a demonstrated need for faculty research capacity development in cardiovascular disease (including associated conditions, e.g., obesity), lung, and blood diseases.

To be eligible for this FOA, independent medical and graduate schools must demonstrate that they (1) provide health care-related services to disadvantaged and underserved communities, and (2) have a need for research capacity development in cardiovascular disease (including associated conditions e.g., obesity), lung, and blood diseases. An institution where 20 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 NIH funding (direct costs) from the NHLBI per year in any of the previous five years for research training (e.g., T, F, K) and education (e.g., R25) grants in the above NHLBI mission areas.

Certification Letter

Applicants are required to attach a letter certifying the institution’s as well as the applicant’s eligibility for this program. The Certification Letter must be on institutional letterhead and scanned so that an institutional official’s signature is visible. The Certification Letter (titled: Diversity_Eligibility_Ltr) from the institution certifying eligibility of the institution and the applicant for the program. The Certification Letter must be on institutional letterhead and scanned so that an institutional official signature is visible. Attach this letter to SF 424 (R&R) Section 4.4 Other Project Information Component Item 12. Other Attachments.

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.

Applications that do not meet these eligibility requirements will be considered non-responsive.

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 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.

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.

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.

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 description of the career development plan 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. 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.

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

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

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

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

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

Descriptive title of proposed 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

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 submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

Candidate’s Background (Component of Candidate Information)

• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.

Career Goals and Objectives (Component of Candidate Information)

• Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur; (2) justifies the need for further career development to become an independent investigator; and (3) utilizes the relevant research and educational resources of the institution.

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

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The candidate and sponsor may propose a mentoring team (or an Advisory Committee). The roles and scheduled meeting frequency of the Advisory Committee should be described in the application.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent research career.
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• For candidates with some research experience, the research development program may be designed to begin with a creative and detailed scientific learning experience and progress to an intensive research activity under the guidance of an appropriate mentor(s). The first year or two of the program may incorporate any needed course work, seminars and other educational experiences necessary to prepare the candidate for the subsequent research program, but must include a hands-on research experience. The remainder of the development plan could include an intensive, fully-described research program and research projects that can be reasonably completed within the planned period. During this latter phase, the program should provide for progressive development of the individual into an independent investigator.

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.

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

• The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The mentor(s) should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Each mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
• Signed statements must be provided by all consultants/collaborators confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

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

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.

Describe the sponsoring institution s scientific environment including the resources and facilities that will be available to the candidate.

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

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
• Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist, e.g., clinic responsibilities, teaching and administration, and/or additional research activities.
• Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.

Research Strategy (Component of Research Plan)

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the proposed research.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described.

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.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). Applications lacking the appropriate required reference letters will not be reviewed. 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.

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.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

Applications must be submitted electronically following the instructions described in the 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(s)/PI(s) 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 the 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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

Reviewers 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.

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 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

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?

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.

Mentoring Team/Advisory Committee

If a Mentoring Team or Advisory Committee is proposed, what are the qualifications of the members, 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.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NHLBI, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

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

Applications will be assigned to the NHLBI. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

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

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

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 sub awards 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 sub awards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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

• Subsequent participation in research or employment in a STEM field.
• Refereed articles in top-level journals as measured by citations and other indicators of recognition.
• Presentations at national and/or international meetings that help enhance the reputation of the awardee’s research program and the NHLBI relevant area of research.
• Evidence of active pursuit of extramural grants and contracts to support future research goals.
• Evidence of academic advancement and promotion based on research and related accomplishments.

Depending on the individual’s career stage, additional evidence of research career development may include:

• Demonstrated evidence of the acquisition of new skills or the pursuit of secondary fields of scholarly interest.
• Evidence of other scholarly activities such as the publication of book chapters or review articles.
• Participation in an internal institutional leadership role; serving as an officer in a professional scientific association; organizing sessions at professional meetings; serving as paper discussant at professional meetings.
• Serving as a non-supervisory member on PhD dissertation and Master's theses committees, if opportunities are available.

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

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 301-710-0267
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

Henry Chang, MD
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

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.

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

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.