Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

NHLBI Career Transition Award (K22)

Activity Code

K22 Career Transition Award

Announcement Type

Reissue of PAR-09-102

Related Notices

  • July 30, 2014 - This PAR has been reissued as PAR-14-302.
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • 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

PAR-12-137

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 purpose of the NHLBI Career Transition Award (K22) program is to provide highly qualified postdoctoral fellows with an opportunity to receive mentored research experience in the NHLBI Division of Intramural Research and then to provide them with funding to facilitate the transition of their research programs as new investigators to extramural institutions. To achieve these objectives, the NHLBI Career Transition Award will support two phases of research: a mentored intramural phase (two years) and an extramural phase (three years), for a total of five years of combined support. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardees research program as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.

Key Dates
Posted Date

March 23, 2012

Open Date (Earliest Submission Date)

May 12, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

Now July 31, 2014, reissued as PAR-4-302. (Originally, September 8, 2015)

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.


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the NHLBI Career Transition Award (K22) program is to enable outstanding postdoctoral individuals to obtain research training experience in the NHLBI Division of Intramural Research and to facilitate their successful transition to an extramural environment as independent researchers. Eligible applicants must agree to be supported by the NHLBI laboratory or branch for the intramural phase of the program. Applicants must contact the NHLBI program staff (Section VII.) for guidance and additional information. Following the intramural phase support, eligible organizations for the extramural phase of the program are listed under Eligible Applicants in Section III.

To achieve these objectives, the NHLBI Career Transition Award will support two phases of research. The award will provide up to two years of support for mentored research training in an NHLBI intramural laboratory followed by three years of support for an independent research project in an extramural institution. It is anticipated that awardees will subsequently obtain research project grants such as the R01 to support the continuation of their work.

Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.

The extramural institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research.  Supplemental funds from the extramural institution for equipment and supplies (and if necessary, salary) are encouraged.

Awardees approved to proceed with the second phase of support will receive notification of approval in writing from the NHLBI. An application from the extramural institution on behalf of the candidate will be required for the NHLBI to process the second phase of the K22.

Acceptance into the NHLBI Career Transition Award Program does not convey any commitment or intent of the NHLBI to consider the awardee for a tenure track position within the NHLBI. The NHLBI Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, the NHLBI K22 awardees are not explicitly precluded from applying for available tenure track positions at the NIH. If an awardee obtains an NIH position, the NHLBI Career Transition Award will be terminated.

NHLBI DIVISION OF INTRAMURAL RESEARCH

The Division of Intramural Research conducts clinical research on the normal and pathophysiologic functioning of the cardiac, pulmonary, blood, and endocrine systems and basic research on normal and abnormal cellular behavior at the molecular level. The research activities of the laboratories and branches range from structural organic chemistry to cardiology.

Major areas of interest include:

Mechanisms of gene regulation, viral-mediated gene transfer and gene therapy, the molecular basis of lipoprotein dysfunctions and the atherogenic process, the molecular basis of diseases of the alveolar structures of the lung and the design of new therapeutic modalities, the cellular and molecular events underlying ischemic heart disease and myocardial hypertrophy, biochemical events associated with aging and certain pathologic processes, molecular, structural, and developmental aspects of muscle and nonmuscle contractile systems, cell and organelle movement, molecular and cellular processes for the conversion of metabolic energy into useful work, mechanisms of cardiac development, the molecular basis of transmembrane signaling, the pathophysiology of renal function at the cellular and molecular levels, the biochemistry of trace nutrients, enzyme kinetics, metabolic regulation and protein chemistry, the cellular and molecular basis of toxicities induced by drugs and other foreign compounds, molecular immunology and cytokines, hematopoietic stem cell biology and bone marrow transplantation, pathophysiology of vascular diseases with emphasis on molecular genetic interventions, cardiac imaging through ultrasound and magnetic resonance imaging, as well as some aspects of cardiovascular devices, computational biophysics, and mass and optical spectroscopy. Animal medicine and surgery support is provided to both clinical and basic science by full-time NHLBI staff.  Potential candidates are urged to visit the web site for the Division of Intramural Research at NHLBI: https://intramural.nhlbi.nih.gov/default.aspx

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

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.

Award Budget

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

Award Project Period

The total period of support is five years (two years intramural, plus three years extramural). Awards are not renewable.

Support for the intramural phase is provided by the candidate's NHLBI intramural laboratory or branch.

Support for the extramural phase will be provided to the extramural institution. Total direct costs for the extramural phase cannot exceed $249,000, including fringe benefits, per year. The total costs cannot exceed $747,000 for the three-year period.

Other Award Budget Information
Salary

Intramural Phase:

Support during the intramural phase will be based on the candidate's years of postdoctoral experience, commensurate with the NHLBI intramural salary structure and is provided by the candidate's laboratory or branch.

Extramural Phase:

Support for the extramural phase will be provided to the extramural institution and may not exceed three years in duration.  The total cost for the extramural phase may not exceed $249,000 per year.  This amount includes salary, fringe benefits, research support allowance and applicable facilities and administrative (F&A) costs (see “Indirect Costs” below). 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

Support for the extramural phase will be provided to the extramural institution and may not exceed three years in duration.  The total cost for the extramural phase may not exceed $249,000 per year.  This amount includes salary, fringe benefits, research support allowance and applicable facilities and administrative (F&A) costs (see “Indirect Costs” below).

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

For the extramural phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. F&A costs requested by consortium participants are included in the total cost limitation..

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.

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:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in theNIH Grants Policy Statement, are not allowed.

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(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.

Eligible Individuals (Program Director/Principal Investigator)

NHLBI postdoctoral fellows (or individuals who have been accepted to an intramural postdoctoral position) are invited to work with their mentors  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).

Candidates for this award must have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD., or equivalent doctoral degree), or a combined clinical and research doctoral degree. The candidate must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated. During the intramural phase of the award, the candidate will spend full time on research. The required research experience must be completed in an intramural NIH laboratory. 

To obtain support for the extramural phase, at the time of the award candidates must have a full time formal tenure-track (or equivalent) appointment offer 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 NHLBI staff prior to preparing an application to discuss their eligibility.

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Individuals are eligible for a K22 award if they have been, or currently are, the PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.

Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.

Special Requirements

Acceptance into the NHLBI Career Transition Award Program does not convey any commitment or intent of the NHLBI to consider the awardee for a tenure track position within the NHLBI. The NHLBI Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, the NHLBI K22 awardees are not explicitly precluded from applying for available tenure track positions at the NIH.

Once a K22 award is made, the awardee is expected to remain with the NHLBI Intramural Program for at least 18 months.  Exceptions may be reviewed on a case-by-case basis.

Intramural Phase:

Mentor(s): The candidate must name a primary sponsor/mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. The mentor must be an investigator at the NHLBI who is recognized as an accomplished investigator in the proposed research area and has a track record of success in training research scientists. Candidates may also nominate co-mentors as appropriate to the goals of the program. Co-mentors may be NIH investigators or may be full-time faculty at an extramural institution. 

Extramural Phase:(Provide this information only during the time of transition to Extramural Phase.)

Sponsoring Extramural Institution:  To obtain support for Extramural Phase, the Intramural Phase awardee must have a formal tenure-track (or equivalent) offer at the extramural institution.  The institution must demonstrate a commitment to the individual by providing protected research time and space needed to conduct the proposed research.

K22 award recipients are expected to apply for NIH or other independent research grant support during the extramural phase of the award. Recipients may hold concurrent research support and under certain circumstances salary support from the final two years of their K22 award and a competing NIH research project grant when recognized as the PD/PI or subproject Director of the research project grant. See NOT-OD-08-065.

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. Awardees must be able to commit a minimum of nine  person-months conducting research career development activities associated with this award. The remaining three person-months (can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K22 award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. 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(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The principal mentor should be an NHLBI Intramural 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, 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.

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.

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 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.

Page Limitations

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

Other Project Information Component

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

Project Summary/Abstract (Component of the Other Project Information Component)

This attachment must be uploaded via the Other Project Information Component, and must include a description of your current research and the research you propose to continue in the extramural phase.

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 (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)

Description of Institutional Environment (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. At least three but not more than five 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 theNIH Grants Policy Statement.

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

Intramural Phase:

Research expenses including personnel, consultants, equipment, supplies, and travel will be negotiated with the laboratory chief and will depend on the nature and scope of the research approved by peer review.

Extramural Phase:

Allowable research expenses include (1) research expenses, such as supplies, equipment, and technical personnel; (2) travel to research meetings or training; and (3) statistical services, including personnel and computer time. The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

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(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, NIH. Applications that are incomplete will not be reviewed.

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 for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field? Will the research experiences in the intramural phase prepare the candidate to implement successfully the extramural phase research project? Do the letters of reference from at least three well-established scientists address the candidate's potential for becoming an independent investigator? Given the candidate’s prior training, proposed career development plan, and the referees’ evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent position within the time period requested for the intramural phase of this award?

Career Development Plan/Career Goals & Objectives

To what extent are the plans for evaluating the awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the extramural phase of the award? Is the timeline planned for the transition to the extramural phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the phase of the award? 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

Is the proposed research project appropriate for the candidate’s stage of research development and as a vehicle for development of the research skills described in the career development plan? Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience? Is the proposed research relevant to stated career objectives?

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? Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project? Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate's project?

Environment & Institutional Commitment to the Candidate

INTRAMURAL PHASE

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.

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

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

Renewals

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(s), 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 be assigned to the NHLBI for peer review and potential funding.. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the NHLBI Advisory Council. The following will be considered in making funding decisions:

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.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NHLBI intramural program. The NHLBI will transmit to the successful candidate an approval letter that will include the terms and conditions of the NHLBI intramural K22 award, as well as expectations for the transition to the extramural phase of the award.

A formal Notice of Award (NoA) will be provided as part of the extramural phase of the K22 award conducted at a domestic, sponsoring extramural institution/organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page).

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.

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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

Transition to the Extramural Phase

Transition from the intramural phase to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program as determined by annual scientific reviews and by the evaluation of a research and career development plan to be carried out at the institution. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time, space and resources needed to conduct the proposed research project and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. The NHLBI will conduct a transition review no later than three months before the end of the intramural phase.

Candidates must provide a progress report using form PHS 2590, which should detail progress achieved on the specific aims of the Research Plan and on the pursuit of identified career and career development goals. Future goals for the research project and for further career development should also be indicated. The mentor of the intramural phase must provide a separate narrative of the research and career development of the candidate.

The extramural phase institution will submit an application on behalf of the candidate for the K22 award using the SF-424. These materials should be sent directly to the NHLBI (tm275a@nih.gov).  The original application plus one copy (preferably in a PDF format) are to be mailed to the Financial/Grants Management contact person of the NHLBI listed in this FOA. The SF-424 application must include the following:  

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.

Intramural Phase:

The awardee’s progress will be evaluated on an annual basis by the mentor, Laboratory Chief, and Scientific Director and continued support will be approved by the intramural administrative officer.

Extramural Phase:

The Progress Report must include Sections (A) through (F) as described in Section 2.2.6 (Progress Report Summary) in the general PHS form 2590 instructions, as well as sections G through J as described in Section 5 of the 2590 instructions. Evaluation of the awardee’s progress for transition will encompass the following:

A demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period.

A description of career development and research-related activities undertaken during the prior funding period.

A list of accomplishments such as publications (in press or submitted), scientific presentation, new collaborations, inventions, or project-generated resources made during the prior funding period.

A brief explanation of plans to address the specific aims during the next year of support.

A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities.

An annual evaluation statement of the candidate's progress by the sponsor (usually the department chair for K22 awardees in the extramural phase), as required in the PHS 2590 continuation application instructions (item J. Sponsor's Report).

List all applications submitted for investigator-initiated research grant support.

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. 

4. Evaluation

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

Section VII. Agency Contacts

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

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)

Direct your questions about intramural programmatic issues to:

Herbert M. Geller, Ph.D.
Director, Office of Education
Division of Intramural Research
National Heart, Lung, and Blood Institute (NHLBI)
10 Center Drive, Room 6N248, MSC 1754
Bethesda, MD  20892-1754
Telephone: 301-451-9440
Email: direducation@nhlbi.nih.gov

Direct your questions about extramural programmatic issues to:

Nara Gavini, Ph.D.
Office of Research Training and Minority Health
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 9184, MSC 7913
Bethesda, MD  20892-7913
Telephone: 301-451-5081
Email: gavininn@nhlbi.nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health
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

Financial/Grants Management Contact(s)

Mr. Mark Wilkison
Grants Management Specialist
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7133, MSC 7926
Bethesda, MD  20892-7926
Telephone: 301-435-0184
Email: wilkisonm@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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