Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Mentored Career Development Award to Promote Faculty Diversity/Re-Entry in Biomedical Research (K01)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-HL-10-012

Update: The following update relating to this announcement has been issued:

• August 25, 2011 - This RFA has been reissued as RFA-HL-12-030.
• August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Request for Applications (RFA) Number: RFA-HL-11-022

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.233, 93.837, 93.838, 93.839

Key Dates
Release/Posted Date: July 9, 2010
Opening Date: September 1, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 1, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): October 1, 2010
Peer Review Date(s): February/March 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): June 1, 2011
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: October 2, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The overall goal of NIH-supported career development programs is to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs.

• Purpose. The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation s capacity to address and eliminate health disparities. This FOA issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), solicits applications to increase the number of highly trained investigators, from diverse backgrounds or who have experienced an interruption in their research careers. It is targeted toward individuals 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 the general and health disparities populations.
• Mechanism of Support. This FOA will utilize the K01 award mechanism and is a continuation of the program named Mentored Career Development Award to Promote Faculty Diversity/Re-Entry in Biomedical Research (K01) (RFA-HL-10-012).
• Funds Available and Anticipated Number of Awards. The estimated annual funds (total costs) available for the entire program are expected to be approximately $1.2 million. The actual amount may vary, depending on the response to the FOA and availability of funds. Eight to ten new awards are anticipated.
• Budget and Project Period. The total project period for an application submitted in response to this FOA must be at least three but not more than five years. Direct costs are limited to a maximum salary for recipients of $75,000 per year plus commensurate fringe benefits for 9-12 person months (equivalent to 75 to 100%) full-time professional effort, and a maximum of $30,000 for research and development costs.
• PHS 398 Career Development Award Supplemental Form Component Sections Length: Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined total of 12 pages, including tables, graphs, figures, diagrams, and charts. See http://grants1.nih.gov/grants/funding/funding_program.htm.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). This program supports faculty members from diverse backgrounds or who have experienced an interruption in their research careers. Also referred to as the Candidates, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution/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.
• Number of PDs/PIs. Only one PD/PI may be designated on the application.
• Number of Applications. Candidates may only have one individual Career Development Award application pending peer review at any time.
• Resubmissions. Resubmission applications are not permitted in response to this FOA.
• Renewals. Awards are not renewable and are not transferable from one PD/PI to another.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
• Application Materials. See Section IV.1 for application materials.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Career Objectives

Background

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

The NHLBI also recognizes that researchers sometimes experience an interruption in their careers due to non-academic issues. Examples of interruptions include starting and/or raising a family, an incapacitating illness or injury, caring for an ill member of the candidate’s immediate family (spouse, child, parent), pursuing non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree, or performing military service. Because of the rapid pace of research, these researchers are often lost to the scientific workforce. Therefore, there is a need to ensure a pathway for re-entry into academics for these individuals who because of these interruptions may have unique perspectives on problem solving, adaptability to new situations, and ability to bring innovative insights into the academic research environment that can make a significant contribution to the scientific workforce.

Purpose

The purpose of the Mentored Career Development Award to Promote Faculty Diversity/Re-Entry in Biomedical Research is to provide an intensive, mentored research experience to individuals and therefore significantly enhance research skills and abilities through a three-to-five-year award to support faculty members from diverse backgrounds who are currently underrepresented on faculty at academic institutions in health-related research. The objective of this award is to increase the number of highly trained investigators from diverse backgrounds whose basic and clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary,and hematologic diseases in the general and health disparities populations.

This program provides research development opportunities for non-tenured science faculty from diverse backgrounds and for non-tenured re-entry science faculty with varying levels of research experience. The research development program of the candidate should be based on the candidate’s scholastic background, previous research experience, past achievements, and potential to develop into an independent research investigator.

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.

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

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. However, primary pulmonary diseases (i.e., COPD, IPF, TB) are clearly associated with an increased risk of developing malignancies. Studies that address the mechanistic correlation between cancer (i.e. lung cancer) and these pulmonary diseases may be considered responsive to the NHLBI. Applications on vaccine development and respiratory pathogens, unless focused on the host cellular and immune response, will be considered non-responsive. 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 its appropriateness for this FOA and the mission of the NHLBI.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Mentored Research Scientist Development (K01) award mechanism. The Project Director/Principal Investigator (PD/PI; also referred to as the Candidate) and his/her mentor will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.

The candidate should follow the instructions for budget information described in Section IV, as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and budget justification information.

The K01 program must be tailored to meet the individual needs of the candidate. Candidates may request 3 to 5 years of support. The actual duration of the award will depend upon the number of years of prior research experience, the demonstrated need for additional mentored experience to achieve research independence, and the policy of the NHLBI. Awards are not renewable and are not transferable from one PD/PI to another.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

The estimated amount of funds available for support of eight to ten new projects awarded as a result of this announcement is $1.2 million. The actual amount may vary, depending on the response to the FOA and availability of funds. Future year amounts will depend on annual appropriations.

• The total project period for an application submitted in response to this FOA must be at least three but not more than five years.
• Loan Repayment Program (LRP): Awardees under this program may be eligible to apply for the NIH Extramural Loan Repayment Program. Information regarding the eligibility requirements and benefits for the program may be obtained through the LRP website at http://www.lrp.nih.gov/.
  

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

2.A. Allowable Costs

Salary: Individual compensation is based on the institution's salary scale for individuals at an equivalent experience level. The maximum salary for recipients of NHLBI K01 Career Awards is $75,000 per year plus commensurate fringe benefits for 9-12 person-months (equivalent to 75 to 100%) full-time professional effort. The NHLBI Research Career Development Award Programs require the recipients to devote a minimum of 9 person months (equivalent to 75%) full-time professional effort to the research plan being supported by the career development award; the remaining 25% effort should be devoted to research and research-related activities such as teaching, patient care, or other research-related activities. If 100% effort is to be devoted to the research program during the "summer months," the percent effort for the remainder of the year may be reduced provided that the effort over the course of the year is at least 75%. NIH permits supplementation of salary from non-federal sources.

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. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary.

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 K01 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

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

• The K01 award recipient must be the PD/PI (or one of the named PD/PIs, if following the multiple-PD/PI model) on a competing NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, etc. or an equivalent application from another Federal agency).
• The K01 award must be active when the competing research grant application is submitted.
• The K01 award must be in its final two years before the reduction in effort to 6 person-months (50% full-time professional effort) is permitted. When the effort is reduced, the salary will be reduced accordingly.

Research Development Support: A maximum of $30,000 per year may be requested for research project requirements and related support (e.g., technical personnel costs, supplies, equipment, candidate travel, publication costs, and tuition) for necessary courses.

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

Indirect Costs: These costs, also known as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Other(s):
  • Eligible Agencies of the Federal Government

Some institutions provide unique opportunities for access to students and faculty from diverse backgrounds. These institutions can assist NIH in its efforts to recruit the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities. Accordingly, NIH strongly encourages applications from the following institutions: Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-Serving Institutions, and Alaska Native and Native Hawaiian Serving Institutions.

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH support.

Project Director/Principal Investigator (PD/PI): Also referred to as the Candidates, individuals with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities are invited to work with their mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

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

Degree and Research: To receive an award under this program, individuals must have been awarded a doctoral degree, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent degree at least two years prior to the award and have a full-time non-tenured faculty appointment (such as instructor or assistant professor) at an accredited college or university at the time of award.

Level of Effort: Candidates must be able to commit a minimum of 9 person-months (75% of full-time professional effort) conducting research career development activities associated with this award. The remaining 3 months (25% effort) can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K01 award, i.e., the candidate’s development into an independent investigator. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056.

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 NHLBI staff contact for this RFA prior to preparing an application to discuss their eligibility.

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.

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

Candidates from Diverse Backgrounds

NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis.. The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be included in the recruitment and retention plan.

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

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds.

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

Recruitment and retention plans related to a disadvantaged background (C1 and 2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

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

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

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

Re-Entry Candidates

Eligible candidates have experienced an interruption in their research careers. Applicants must demonstrate potential for a career as an independent investigator in basic or clinical research. The candidate must have a doctoral degree in a basic or clinical area related to cardiovascular, pulmonary, and hematologic diseases, and at least two years of postdoctoral research experience in basic and/or clinical science. The candidate must have interrupted his or her career for a period of at least three years but not more than eight years. Examples of appropriate interruptions include starting and/or raising a family, an incapacitating illness or injury, caring for an ill member of the candidate s immediate family (spouse, child, parent), pursuing non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree, or performing military service.

The program is not intended to support additional graduate training and is not intended to support career changes from non-research to research careers for individuals without prior research training. Generally, at the time of application, a candidate should not be engaged in full-time paid research activities.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Candidates may only have one individual Career Development Award application pending peer review at any time.

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.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Awards are not renewable and are not transferable from one PD/PI to another.

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

Each candidate may submit one application.

3.A. Special Requirements

Applicant Institution: Applications will be accepted from domestic colleges or universities, medical schools, or comparable institutions. 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.

Candidate: The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of program that is appropriate. Also, please provide a signed statement establishing the eligibility of the candidate for support under this program including information on diverse background (see Section III.1.B. Eligible Individuals ) or re-entry status. The statement must include a clear description of how the appointment of the candidate will expand diversity within science nationally or at the grantee institution. For re-entry candidates, the statement must describe how the award will promote the candidate’s potential for independent research. Please include in 2. Career Development Award Attachments; Candidate Information. The statement must also contain a certification regarding the citizenship of the candidate. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

For Applications from Diverse Backgrounds: For the purpose of this announcement, institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The strength of an institution’s description and justification for the appointment of an identified candidate will be judged along with all other aspects of the proposed experience. Three letters addressing the candidate's potential for a research career must also be submitted. (See IV.6. Statements of Support.)

For Re-Entry candidates: The statement must include: candidate s citizenship, research objectives and career goals, research experience prior to onset of hiatus, period and length of career hiatus, reason for career hiatus, description of how the candidate has kept current or attempted to keep current in her/his field, identification of any steps already taken toward re-entry (if any, such as attending scientific meetings, training or course work). Three letters addressing the candidate's potential for a research career must also be submitted. (See IV.6. Statements of Support.)

Mentor(s): Each candidate must identify a mentor(s) who is an accomplished investigator in the proposed research area and has experience in developing independent investigators. The mentor is not required to be affiliated with the applicant institution. If the mentor is affiliated with another institution, appropriate documentation must be provided concerning the relationship of the applicant institution and the mentor's institution, as well as a clear delineation of the arrangements proposed for the research development program at a location distinct from the applicant institution.

Concurrent Applications: Candidates must be aware of the NIH policies associated with other federally sponsored support. The Mentored Career Development Award to Promote Faculty Diversity/Re-Entry in Biomedical Research applications may not be submitted or awarded concurrently with other NIH applications, such as the NIH research project grants (R01), Academic Career Awards (K07), comparable career development awards (e.g., K08, K22, K23), Pathway to Independence Award (K99/R00), subprojects of program project (P01) or center grants (P50), or non-NIH equivalent grants/awards.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp)
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1. Organizational/Institutional Registration in Grants.gov/Get Registered

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2. Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

3. Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. The candidate should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Candidates must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

• Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
  
  For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].
  
  Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist
SF424 (R&R) Detailed Budget

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Application Due Date(s): October 1, 2010
Peer Review Date(s): February/March 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): June 1, 2011

3.A.1. Letter of Intent

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

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 NHLBI staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

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, MSC7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

In order to expedite the review, applicants are requested to notify the NHLBI Review Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

• All registrations must be complete prior to the submission deadline.
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two-day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NHLBI will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NHLBI will not accept any application that is essentially the same as one already reviewed.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Citizenship: Candidates must meet the citizenship requirements as described in the Eligibility section of this announcement (see Section III) at the time of award.

Concurrent Awards: Candidates must be aware of the NIH policies associated with other federally sponsored support (see: NOT-OD-08-065).

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department.

NIH policy allows NIH mentored career development award recipients in the final two years of their award to receive salary support from both their K award and a research grant from any Federal agency (see NOT-OD-08-065). The K-award recipient must be a named PD/PI of a competing research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). See the Notice for full details.

Research Development Support: The research development support costs allowed for this program 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. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

Pre-Award Costs: Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover allowable costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: (1) are necessary to conduct the project, and (2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement).

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Cover Letter:

The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution.

PHS398 Career Development Award Supplemental Form Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide (See Supplementary Instructions for Research Career Awards, Part I.7.5) are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Specific Aims is limited to 1 page.
• Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined total of 12 pages, including tables, graphs, figures, diagrams, and charts.
• While each section of the Candidate Information and Research Strategy components needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Candidate Information component and the Research Strategy component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.

Candidate Information and Career Development Plan

Candidate s Background:

• Describe the candidate's commitment to a health-related research career. Include a description of all the candidate's professional responsibilities in the grantee institution and elsewhere and show their relation to the proposed activities on the career award.
• Describe prior training and how it relates to the objectives and long-term career plans of the candidate.
• Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
• Provide evidence of the candidate's potential to develop into an independent investigator.
• Include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the career development program and related career development activities.
• The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of program that is appropriate. Also please provide a signed statement establishing the eligibility of the candidate for support under this program including information on diverse background (see Section III.1.B. Eligible Individuals ), or re-entry status. The statement must include a clear description of how the appointment of the candidate will expand diversity within science nationally or at the grantee institution. For re-entry candidates, the statement must describe how the award will promote the candidate’s potential for independent research. The statement must also contain a certification regarding the citizenship of the candidate. Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.

Career Goals and Objectives:

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

Career Development/Training Activities:

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful. The sponsor/mentor may form an advisory committee to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
• Describe the professional responsibilities/activities (including other research projects) beyond the minimum required 75% effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• All research development programs should be carefully tailored to meet the candidate's needs and must include a mentor(s) who will provide appropriate research guidance. All candidates must provide a full description of the research and career development plan for the period of the award. The proposed plan must include hands-on research experience, with either a clinical or a basic science focus, for the entire three-to-five-year period.
• 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.
• If the candidate has already acquired research experience, as might be obtained through a research fellowship, but needs further development under the guidance of an appropriate mentor(s), the candidate may propose a three-to-five-year program encompassing an advanced research experience focusing on a specific research project. Such a candidate may take additional courses or engage in special instruction in research techniques in other laboratories for a reasonable period of time if needed. During the latter phases of the award, the relationship of the mentor and candidate may more closely resemble that of collaborators.

Mentor(s):

The mentor must submit a written plan for the development of the candidate and provide guidance during the preparation of the research project. A secondary mentor may also be proposed, but the primary mentor must continue to be involved throughout the award period. In some cases candidates may choose to have both a basic or clinical research mentor and a career development mentor. The primary mentor must submit a report each year on the candidate's progress, which should be included in the annual progress report.

A biographical sketch with relevant publications and a list of current research support must be included for all mentors. Mentors should also include a list of current and past research trainees (not more than the past 10 years) with information on their current positions.

Advisory Committee:

A committee composed of the candidate's mentor(s) and two or three other senior faculty members should be identified and their biographical sketches submitted with the application. This Advisory Committee should meet with the candidate to review the research development plan and research project to evaluate the awardee's progress and to provide guidance for scientific career development. The roles and scheduled meeting frequency of the Advisory Committee should be described in the application. Please use 2. Career Development Award Attachments; 7. Statements by Mentor, Co-Mentors, Consultants, Contributors

Duration and Effort:

The award is granted for three to five years depending on the needs of the candidate and the evaluation by the initial review group and the National Heart, Lung, and Blood Advisory Council. It is not renewable, and all funds must be used on behalf of the original candidate. Substitution of another mentor and/or a change of institution may be permitted with the prior approval of the NHLBI. A minimum of 9 person- months (equivalent to 75%) full-time professional effort must be devoted to the research program. The remainder may be devoted to other clinical and teaching pursuits that are consistent with the program goals; i.e., the candidate's development into an independent biomedical scientist or the maintenance of the teaching and/or clinical skills needed for an academic research career.

The candidate must have a full-time appointment at the applicant institution. In general, candidates who have Veteran's Administration (VA) appointments may not consider that appointment as part of the VA effort toward satisfying the "full-time" requirement at the applicant institution. However, it is permissible for part or all of the research program to be conducted in a VA laboratory, for example, if the mentor has a VA appointment, so long as the above conditions are satisfied as they apply to the Mentored Career Development Award to Promote Faculty Diversity/Re-Entry in Biomedical Research.

Training in the Responsible Conduct of Research:

• Applications must include a plan to obtain instruction in the responsible conduct of research.
• This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research.
• Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019.
• The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.
• The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.
• The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

Research Plan

The research plan should follow instructions outlined in PHS 398 Career Development Award Supplemental form, including sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods, and Research Strategy. The candidate should consult with the mentor(s) regarding the development of this section.

• 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 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.
• Data and Safety Monitoring (when applicable): Candidates proposing to conduct clinical trials should consult with NHLBI staff. Plans for data and safety monitoring must be included in research plans involving Phase I or Phase II clinical trials (see Federal Citations in Section VIII): Generally, this requirement may be satisfied in the submitted application by providing documentation that the sponsoring institution has an approved plan in place and providing a brief description of the key elements of the plan.

Statements of Support

Statement by Mentor, Co-Mentors, Consultants, Contributors (All statements/letters should be appended to each other and uploaded as a single pdf document):

• The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research supervisor; (2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; (3) a plan for career progression for the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award; and (4) a plan for monitoring the candidate’s research, publications, and progression towards independence.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are 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 each consultant/collaborator 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 must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report, PHS 2590 (see Section VI.3. Reporting).

Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

• 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 how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to Candidate’s Research Career Development:

• 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 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.
• Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

Letters of Reference

Electronic submission of reference letters is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons and do not use Grants.gov. Therefore, candidates must follow the Supplemental Instructions in the SF424 R&R Application Guide for Research Career Awards (Instructions, Part 7.3) (see http://grants.nih.gov/grants/funding/424/index.htm).

Letters of reference are an important component of the application for the mentored career award. Candidates for this career award must arrange to have at least three (but no more than five) letters of reference submitted on their behalf to the NIH eRA Commons Web site at https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new. The letters should be from well-established scientists (referees) addressing the qualities of the candidate as well as their potential for becoming an independent investigator. These letters should be from individuals not directly involved in the application, but who are familiar with the candidate’s qualifications, training, and interests, including advisory committee members (if applicable).

The mentor/co-mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters.

Applications that are missing the required letters of reference will not be reviewed.

Budget for the Entire Proposed Period of Support

Budget Component (Section 4.7): Use the SF424 (R&R) Detailed Budget component and review the instructions found in Part I.4.7(R&R Budget Component) of the Application Guide. However for K applications only limited budget information is required; therefore, candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) (Supplemental Instructions for Career Development Awards), noting the special instructions that modify Section 4.7. In budget section A (Senior/Key Persons) include base salary, person-months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on NHLBI policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/).

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHLBI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

• 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 impact/priority score.
• Receive a written critique.
• Receive a second level of review by the NHLBI Advisory Council.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.

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 above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?
• Is the candidate’s prior training and research experience appropriate for this award?

Career Development Plan.

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
• Is 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?
• Are the goals and scope of the plan when considered in the context of prior training/research experience and the stated training and research objectives, appropriate?
• Are the content and duration of the proposed didactic research activities during the proposed award period clearly described and made pertinent to the goals that the candidate has for achieving independence?
• Are there adequate plans for 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?
• Is the plan for developing/enhancing the candidate’s research skills appropriate and adequate?
• Is the proposed research within the realm of expertise of the mentor and yet sufficiently distinct to allow the candidate to develop long-term independence?
• Is there evidence of long-term viability of the proposed research plan?
• Does the project address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?
• If applicable, are there adequate plans for data and safety monitoring of clinical trials?

Mentor(s), Consultant(s), Collaborator(s).

• Are the mentor's research qualifications in the area of the proposed research appropriate?
• Do 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 focusing on research?
• 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 and Institutional Commitment to the Candidate.

• Is there clear commitment of the sponsoring institution to ensure that a minimum of 75% 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?
• Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? If the institution of the mentor(s) is different from that of the applicant, are the quality and extent of interaction of the faculty in the basic and clinical sciences and the quality of the research and research training programs at the mentor s institution adequate for the development of the candidate?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. Not Applicable.

Renewal Applications. Not Applicable.

Revision Applications. Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, and Frequency of instruction as detailed in NOT-OD-10-019). Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.

Select Agents 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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); (2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and(3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period of Support. Reviewers will consider whether the budget and the requested period of career development support are fully justified and reasonable in relation to the proposed research and career development needs of the candidate. The impact/priority score should not be affected by the evaluation of the budget.

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific merit of the proposed research career development program as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant 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 NHLBI to the grantee business official.

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. See Section IV.5., Funding Restrictions.

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.

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

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

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

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

• The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
• The funds may be used for health-related research purposes.
• The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

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

C. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NHLBI is required. Details on the process for submission of prior approval requests can be found in the NIHGPS, Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.

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

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

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

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

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

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

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

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

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

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

• A relinquishing statement and final invention statement are submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NHLBI.
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
• All conditions of the award are met at the new institution.
• The period of support requested is no more than the time remaining within the existing award.

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

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. (Note that the instructions for Research Career Development applications must be followed for this program).

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 will encompass the following:

• A demonstration of scientific progress toward achieving 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, 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 mentor, as required in the PHS 2590 continuation application instructions (item J. Mentor’s Report).

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Lorraine M. Silsbee, M.H.S.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
MSC7936
Bethesda, MD 20892-7936 (Express mail zip: 20817)
Telephone: (301) 435-0709
FAX: (301) 480-1455
Email: [email protected]

2. Peer Review Contact(s):

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: [email protected]

3. Financial/Grants Management Contact(s):

Ms. Pat Reyes
Senior Grants Management Specialist
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7140, MSC7926
Bethesda, MD 20892-7926 (Express mail zip: 20817)
Telephone: (301) 435-0187
FAX: 301-435-5462
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, state and federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible online journal articles. Publicly accessible online journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs (LRP):
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40-hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

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