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 Award For Faculty At Minority Institutions (KO1)

Announcement Type
This is a continuation of the program named “Mentored Career Award for Faculty at Minority Institutions (KO1)” (RFA-HL-04-026) which was previously released April 14, 2004.

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

Request For Applications (RFA) Number: RFA-HL-05-016

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

Key Dates
Release Date: April 20, 2005
Letters of Intent Receipt Date(s): June 21, 2005; June 21, 2006; June 21, 2007
Application Receipt Date(s): July 19, 2005; July 19, 2006; July 19, 2007
Peer Review Date(s): October/November 2005: October/November 2006; October/November 2007
Council Review Date(s): January 2006; January 2007; January 2008
Earliest Anticipated Start Date: April 1, 2006; April 1, 2007; April 1, 2008
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 3, 2008

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The Mentored Career Award for Faculty at Minority Institutions (K01) is a three-to-five-year non-renewable career development award made to faculty at a minority institution. The candidates are faculty members at a minority institution, must have research experience (length of time may vary), and be committed to developing into independent biomedical investigators in research areas relevant to the mission of the NHLBI (i.e, cardiovascular, pulmonary, hematologic, or sleep disorders research). The award will enable suitable faculty members holding doctoral degrees, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent degree, 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. Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 Section II. Award Information
   1. Mechanism(s) 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. Address to 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. Sending an Application 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. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

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

 Section VII. Agency Contact(s)
   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 Objectives

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

Section II. Award Information

1. Mechanism(s) of Support

This RFA will use the KO1 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. An unsuccessful application to this RFA for one receipt date may be submitted as a new application on subsequent receipt dates for this RFA.

This RFA uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). Refer to Section III of PHS 398 application instructions. A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Funds will be provided for the reimbursement of facilities and administrative costs at a rate of 8% of the total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign institutions are not eligible to apply.

The Institution must be a domestic college or university with student enrollment drawn substantially from minority racial and ethnic groups (such as African Americans/Blacks, Hispanics, American Indians, Alaska Natives, and non-Asian Pacific Islanders) currently underrepresented in biomedical and behavioral research. Ongoing staff and facilities must be available for the proposed program. 1.B. Eligible Individuals

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

To receive an award under this program, individuals must have been awarded a doctoral degree, 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 faculty appointment at an accredited college or university at the time of award. A minimum of 75% effort must be devoted to the research program. Candidates for this award must be either citizens or non-citizen nationals of the United States or have been admitted lawfully to the United States for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551, or some other legal verification of such status) by the time of the award. Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). An individual admitted lawfully for permanent residence must submit with the application a notarized statement indicating possession of the Alien Registration Receipt Card I-551. Individuals on temporary or student visas are not eligible.

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 (RO1), comparable career development awards (e.g. KO7, KO8, K22, K23), subprojects of program project (PO1) or center grants (P50), and the equivalent, such as VA Merit 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 minority supplement is eligible to apply. Current and former recipients of K12 support may apply for the KO1 provided that they have no more than three years of K12 support by the time the KO1 award is issued. The combined total of K12 plus KO1 support must not exceed 6 years. A candidate for the KO1 may not concurrently apply for or have an award pending for any other NIH career development award.

Guidelines for Special Leave: K01 Award recipients may take leave to train at another institution, take a leave of absence during the award period, or train at a lower level of effort for a longer period of time. K01 Award recipients should review a document describing the Special Leave Guidelines for Recipients of Mentored Career Awards at http://www.nhlbi.nih.gov/funding/training/redbook/sl_guide.htm, which summarizes NIH and NHLBI policies for these situations.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Special Requirements

Applicant Institution: Applications will be accepted from a domestic college or university with student enrollment drawn substantially from minority racial and ethnic groups (such as African Americans/Blacks, Hispanics, American Indians, Alaska Natives, and Native Hawaiians and Pacific Islanders) currently underrepresented in biomedical and behavioral research. 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.

Mentor: Each candidate must also identify and complete arrangements with a mentor (at the same institution or at a collaborating research center) who is recognized as an accomplished investigator in the proposed research area and who will provide guidance for the candidate's career development and research plan.

Arrangements with mentors at institutions at a distance from the applicant institution will be considered, but approaches for ensuring close and active involvement of a distant mentor must be clearly outlined in the application. Plans for intensive training of the candidate during the summer period (2 - 3 months) and during the academic year should be developed with the mentor. The establishment of a viable mentoring plan is essential to the success of the candidate. The commitment to both the summer and academic year training periods must be documented in the application by the mentor and the mentor's department chair. A mentoring plan describing the candidate's interaction with the mentor, how it will enhance the candidate's research capabilities and teaching skills, and steps to assist the candidate in advancing his/her career goals must be delineated in the application. The mentor must provide an annual evaluation of the candidate's career development. This evaluation is to be included as part of the annual progress report if an award is made.

Concurrent Applications: Applicant must be aware of the NIH policies associated with other federally sponsored support. The Mentored Career Award for Faculty at Minority Institutions may not be submitted or awarded concurrently with other NIH applications, such as the NIH research project grants (RO1), comparable career development awards (e.g. KO7, KO8, K22, K23), subprojects of program project (PO1) or center grants (P50), and the equivalent, such as VA Merit Awards.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. Refer to Section III of PHS 398 application instructions. 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this RFA must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date(s): June 21, 2005; June 21, 2006; June 21, 2007
Application Receipt Date(s): July 19, 2005; July 19, 2006; July 19, 2007
Peer Review Date(s): October/November 2005; October/November 2006; October/November 2007
Council Review Date(s): January 2006; January 2007; January 2008
Earliest Anticipated Start Date(s): April 1, 2006; April 1, 2007; April 1, 2008

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 at the beginning of this document.

The letter of intent should be sent to:

Chief, Review Branch
Division of Extramural Affairs, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all five collated sets of the appendix material must be sent to:

Chief, Review Branch
Division of Extramural Affairs, NHLBI
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form, and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHLBI . Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Citizenship: Applicants must meet the citizen requirements as described in the Eligibility section of this announcement prior to award (Section III).

During the last two years of the KO1 award, with prior approval from NIH, the percent effort required may be reduced to no less than 50 percent and replaced by effort on a subsequent research award so that the total level of research commitment remains at 75 percent or more for the duration of the KO1 award. Please refer to the NIH Guide Notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html

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 of a new or competing continuation award if such costs: are necessary to conduct the project, and 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 of a new or competing continuation award.

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 http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III) the following information must be included in the application:

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

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 and pending 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. This information should be provided for the co-mentor, if relevant.

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 75% 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 the entire 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 Award for Faculty at Minority Institutions.

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 full-time professional effort (i.e., 75% to 100%). The salary must be consistent with both the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The NHLBI Research Career Development Award Programs require the recipients to devote a minimum of 75% 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.

Research and Development Costs - A maximum of $36,000 per year may be requested for research project requirements and related support (e.g., technical personnel costs, supplies, equipment, candidate travel, telephone charges, publication costs, and tuition for necessary courses).

If the mentor hosts the candidate supported by this program in their laboratories, a limited level of support (up to $6,000 per annum) may be requested to be used in support of research activities directly related to the research and career development needs of the candidate. If funds are to be transferred to the mentor's institution, arrangements for the transfer of funds and the conduct of activities should be formalized in a subcontract agreement with the mentor's institution.

Facilities and Administrative (F & A) Costs - F & A costs will be provided at a rate of 8% of the total direct costs of each award, exclusive of equipment. The F & A cost rate on an agreement with the mentor's institution may not exceed 8%.

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 regard the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Plan for Sharing Research Data
Not Applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this RFA should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

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

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

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHLBI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The following will be considered in making funding decisions:

Review Criteria

The following criteria will be considered when assessing the merits of the proposed Mentored Career Award for Faculty at Minority Institutions:

(1) Candidate - The candidate's overall qualification as demonstrated by academic record and research performance, potential for a career as an independent researcher, and commitment toward pursuit of an academic research career and toward the enhancement of the scientific program at the minority institution.

(2) Candidate's Career Development Plan - The quality of the research career development plan, based on the candidate's past research experience, training, and career goals, as demonstrated by such things as relevance of the proposed didactic training, structure of interaction with mentor, attendance at scientific meetings, and participation in journal clubs and research seminars.

(3) Research Project - Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's research skills.

(4) Mentor(s) and Co-Mentor(s) - The mentor's accomplishments in the scientific research area(s) proposed, experience and record in training investigators, and commitment for the duration of a candidate's research development. A biographical sketch with relevant publications and a list of current and pending research support must be included for all mentors. Mentors should also include a list of current and past research trainees (not more than the last 10 years) with information on their current positions. This information should be provided for the co-mentor, if relevant .

(5) 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. The roles and scheduled meeting frequency of the Advisory Committee should be described in the application.

(6) Environment and Institutional Commitment - The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the development of the candidate. If the mentor(s)' institution is different from the applicant, 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 will be considered.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research and career development activities. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research (RCR): NIH initial review groups will assess quality of the proposed training in the responsible conduct of research.

2.C. Sharing Research Data
Not Applicable

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this RFA should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
The anticipated award dates are April 1, 2006; April 1, 2007; April 1, 2008

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face page). If a grantee is not email enabled, a hard copy of the Notice of Grant award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also 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 notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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 begin requesting 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; and 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 or research training 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. Special Leave:

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 NIH funding institute or center is required.  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 NIH awarding institute or center 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 KO1 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 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.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent.  Such requests will be considered on a case-by-case basis during the award period.  In no case will it be permissible to work at less than 50 percent effort.  The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission to reduce the level of effort will not be approved to accommodate other sources of funding, 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.

D. Termination or Change of Institution: 

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Grant Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH 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 therefore, the effective date, and the right to appeal the decision.  If the grantee is moving to another eligible institution, career award support may be continued provided:

A relinquishing statement is 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 NIH awarding institute. 

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 sponsor 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 period. 

A change of grantee request 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 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.

E. Changes in Research Program:

Individual awards are made for career development at a specific institution 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.  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 NIH component institute 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.

3. Reporting

Awardees, in conjunction with their mentor(s), will be required to submit a detailed PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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.

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

Section VII. Agency Contacts

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

1. Scientific/Research Contact:

Traci Heath Mondoro, Ph.D.
Division of Blood Diseases and Resources (responding for all NHLBI programmatic Divisions)
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0052
FAX: (301) 480-1060
Email: mondorot@nhlbi.nih.gov

2. Peer Review Contact:

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

3. Financial or Grants Management Contact:

Ms. Patricia Reyes
Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7140, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0187
FAX: (301) 480-1948
Email: reyespc@mail.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 (45CFR46) 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 IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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.

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 new PHS Form 398, 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. Applications that do not provide this information will be returned without review.

Public 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 public 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 RFA 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.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 RFA 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 or Health Systems Agency review. 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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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