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-08-015

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

Request for Applications (RFA) Number: RFA-HL-10-012

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: June 25, 2009
Opening Date: July 25, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 25, 2009
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):  August 25, 2009
Peer Review Date(s): February/March 2010 
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July1, 2010  
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: August 26, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan
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

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 diverse groups into clinical trials.  For example, 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 no question that the need for a diverse workforce permeates all aspects of the nation’s health-related research effort.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences.

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the NIH Mentored Research Scientist Development Award (K01) 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 non-modular budget format.

The candidate should follow the instructions for budget information described in Section IV. 6.F 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 awarding Institute or Center (IC).  Awards are not renewable and are not transferable from one PD/PI to another.

2. Funds Available

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.

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 IC(s) 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.

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:

Research and Development Costs: 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.

NIH Grants Policy: NIH grants policies as described in the 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 staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility..

Current and former recipients of K12 support may apply for the K01 provided that they have no more than three years of K12 support by the time the K01 award is issued. The combined total of K12 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.

Diversity Candidates

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

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262).  The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans or Blacks, Hispanic Americans or Lations, American Indians, Alaska Natives, Native Hawaiians or other Pacific Islanders.  In addition, it is recognized that under-representation 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. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low-income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

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, hematologic, and sleep disorders, 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 would 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: Applicants may only have one individual Career Development Award application pending peer review at any time.

Resubmission(s): Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

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

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

Candidates for the K01, under some circumstances, may have been 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 applicant may submit one application.

Special Requirements

A. 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.

B. 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. The Principal Investigator and an institutional official must provide a single, signed statement establishing the eligibility of the candidate for support under this program including information on citizenship, diverse background, the nature of the candidate's disability, or qualifications for re-entry.   

For Diversity applicants:  The statement must include candidate’s citizenship or description of candidate’s diverse background or nature of the candidate’s disability or disadvantage.  The statement must also include a clear description of how the appointment of the candidate will impact the composition of faculty and expand diversity within science nationally or at the grantee institution. Three sealed letters addressing the candidate's potential for a research career must also be submitted. (See IV.6.E.)

For Re-Entry applicants:  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 coursework). Three sealed letters addressing the candidate's potential for a research career must also be submitted. (See IV.6.E.)

C. Mentor: 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.

D. Concurrent Applications: Applicant 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.

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

The PD/PI 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

2. Organizational/Institutional Registration in the eRA Commons

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

The PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, the candidate should immediately check with his/her business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

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 301-435-0714; Email: GrantsInfo@nih.gov.

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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: July 25, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 25, 2009
Application Due Date(s): August 25, 2009
Peer Review Date(s): February/March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 1, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

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:

Chief, Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (for express mail: Bethesda, MD 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

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. 

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

3.C. Application Processing

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.

Once an application package has been successfully submitted through Grants.gov, any 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 application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete 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 their application status in the Commons.

The NIH 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 NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept resubmission(s) application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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 costs up to 90 days before the beginning date of the initial budget period 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 NIH Grants Policy Statement NIH Grants Policy Statement.

6. Other Submission Requirements

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements (see http://grants.nih.gov/grants/funding/424/index.htm):

PD/PI Credential (e.g., Agency Login): The NIH requires the PD/PI 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.

The following information must be included in the application in accordance with the Supplementary Instructions for Research Career Awards in the SF424 (R&R) Application Guide (See Part I.7.5).

PHS 398 Career Development Award Supplemental Form Component Sections: Items 2-5 (Candidate Information) and 10-13 (Research Plan) are limited to a total of 25 pages. While each section of the Candidate Information and Research Plan components needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Candidate Information component and the Research Plan 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. 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.

6.A. Candidate Information and Career Development Plan

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. The Principal Investigator and an institutional official must provide a signed statement establishing the eligibility of the candidate for support under this program including information on citizenship and the nature of the candidate's disability, diverse background, or re-entry status. The statement must include a clear description of how the appointment of the candidate will impact the composition of faculty and 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. 

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.

Research Career Development Plan:

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 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.

Duration and Effort:

The award is granted for three to five years depending on the needs of the candidate and the evaluation of 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 in Biomedical Research.

Training in the Responsible Conduct of Research:

Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Candidates must follow the application instructions found in PHS 398 Career Development Award Supplemental form Section 7.5.1, and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

6.B. 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.  The candidate should consult with the mentor(s) regarding the development of this section.

6.C. Statement 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):

6.D. Environment and Institutional Commitment to the Candidate

Description of Institutional Environment:

Institutional Commitment to Candidate’s Research Career Development:

6.E. 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.  Resubmission applications must include new letters of reference. 

Applications that are missing the required letters of reference may be delayed in the review process or not accepted.

6.F. Budget for the Entire Proposed Period of Support

Allowable costs for this career award program are not uniform throughout the participating Institutes and Centers; therefore the salary amounts as well as the research development costs vary.  See IC-specific information: Table of Institute and Center Contacts.

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 IC 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: Candidates 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 of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

6.G. Resource Sharing Plan(s)

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 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 (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

Applications that are complete and responsive to this FOA 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:

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

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration all of the following five core review criteria, and additional review criteria (as applicable for the project proposed). 

Core 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.  An application does not need to be strong in all categories to be judged likely to have major career-enhancing impact. 

The application does not need to be strong in all categories to receive a high priority score. These

criteria are listed in logical order and not in order of priority.

Candidate:

Career Development Plan:

Research Plan:

Mentor(s), Consultant(s), Collaborator(s):

Environment and Institutional Commitment to the Candidate:

2.A. 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 – Does the application identify and include biographical sketches for a committee composed of the candidate's mentor(s) and two or three other senior faculty members? Does the application describe the roles and scheduled meeting frequency of the Advisory Committee?

Training in the Responsible Conduct of Research (RCR):  Does the application include appropriate and adequate documentation in prior instruction, or plans for training in the responsible conduct of research?

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.

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.

2.B. 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.

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

Select Agent Research. Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

2.C. 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).

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. JIT includes, but is not limited to, updated salary information and confirmation, current Other Support as well as Human Subjects and Animal certifications.  Activation of the JIT link in the eRA Commons is not an indication of a request for Just in Time information.  The applicant organization will be contacted by NIH grants administration staff if this information is required. 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 awarding component 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 an 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:

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 re-budgeted.  The awarding component 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 NIH awarding component.

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 3 months.  For longer periods, prior written approval of the NIH funding component is required.   Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 NIH component Institute or Center 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 awarding component 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.

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 awarding IC 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.  Staff within the NIH funding component 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 NIH awarding office 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:

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 NIH awarding component 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

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 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 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 Prevention and Population Sciences
National Heart, Lung, and Blood Institute
Two Rockledge Center
6701 Rockledge Drive, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0709
Fax: (301) 480-1455
Email: silsbeeL@nhlbi.nih.gov

2. Peer Review Contact(s):

Chief, Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health

6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924  (for express mail: Bethesda, MD 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email:
nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial/Grants Management Contact(s):

Ms. Pat Reyes
Senior Grants Management Specialist
National Heart, Lung, and Blood Institute
Rockledge II, Room 7140
6701 Rockledge Drive
Bethesda, MD 20892-7140 (Express: 20817)
Telephone: (301) 435-0187
Fax: (301) 435-5462
Email: reyesp@nhlbi.nih.gov

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).

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-02-005.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 on-line journal articles. Publicly accessible on-line 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:
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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NIH Funding Opportunities and Notices


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