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)

Announcement Type
 New

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

Title: Summer Institute Program to Increase Diversity in Health-Related Research

Request for Applications (RFA) Number: RFA-HL-04-035

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates
Release Date: March 4, 2005
Letters Of Intent Receipt Date(s): August 14, 2005
Application Receipt Dates(s): September 14, 2005
Peer Review Date(s): February 2006
Council Review Date(s): August 2006
Earliest Anticipated Start Date: August 1, 2006
Expiration Date: September 15, 2005

Due Dates for E.O. 12372
Not applicable

Executive Summary

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 and 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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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. Program Objectives

This program will fund summer institutes to enable faculty and scientists from under-represented racial and ethnic groups and faculty and scientists with disabilities to further develop their research skills and knowledge, enhancing their career development as faculty members or scientists. The primary goal of this program is to encourage scientists and research-oriented faculty to develop research skills and gain experience in advanced methods and experimental approaches in basic and applied sciences relevant to heart, lung, blood, and sleep (HLBS) disorders, so that they may compete for external funding for scientific research in the biomedical and behavioral sciences.

The primary outcome of this program is to increase the number of scientists and research-oriented faculty who are from under-represented racial and ethnic groups and those with disabilities who successfully compete for external funding for scientific research in the biomedical and behavioral sciences in heart, lung, blood, and sleep (HLBS) disorders. This Request for Applications (RFA) invites senior faculty, established researchers, and experienced mentors to apply to be Program Directors and Co-Directors for Summer Institute Program for Increasing Diversity (SIPID) awards in order to mentor promising candidates.

Background

The National Heart, Lung, and Blood Institute (NHLBI) recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NHLBI expects efforts to diversify the workforce to lead to:

Although the NHLBI currently provides various opportunities to develop careers and to participate in research for individuals from groups with low representation in the biomedical and behavioral sciences through traditional research programs and special initiatives, reports from the National Science Foundation ( see http://www.nsf.gov/sbe/srs/women/start.htm) and others provide strong evidence that diversity remains an important challenge that the entire research enterprise must actively address.

Abundant evidence exists that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the concept that diversity enhances the quality of education in multiple settings. Studies have suggested that racially concordant scientific staff is more successful in recruiting individuals from minority groups into clinical studies. Racially similar physician-patient dyads have been shown to be related to greater patient satisfaction in ways that may also enhance communication and participation in a clinical research setting. The need for a diverse workforce permeates all aspects of the nation's health-related research effort.

Moreover, minorities suffer a disproportionate burden of morbidity and mortality associated with HLBS disorders, and there is a critical need to increase the number of investigators conducting research on health disparities in HLBS disorders, such as sickle cell disease, hypertension, diabetes, coronary artery disease, congestive heart failure, and sleep apnea.

This RFA describes a summer institute program designed to increase the participation of faculty and scientists currently underrepresented in the biomedical, clinical, behavioral, and social sciences in obtaining external research funding. These groups are:

Components of the Summer Institute Program

In response to this initiative, each SIPID applicant should propose to design, organize, implement, and evaluate a summer institute for scientific career development of selected candidates. The goal of the summer institute program will be to enhance and develop research careers, skill in designing research on HLBS studies, skill and strategies in preparing research grants, and success at obtaining external funding of the mentees in research related to HLBS disorders.

The topic area of each SIPID application may be either: 1) a broad scientific discipline, 2) a broad disease area relevant to HLBS disorders, or 3) a multidisciplinary approach to an HLBS disorder. Applicants should propose topics that are relevant to mentees from multiple underrepresented ethnic and racial groups. Each summer institute program should focus on only one of the above three areas and should address the scientific career development needs of selected mentees. Some examples of topics are:

The specifics of the program will be left to the applicants, but we envision a program consisting of three components:

The first component will be an initial summer session lasting from 10-28 days in duration. The first summer program may be divided into more than one session, and mentees may attend multiple sessions. Training may involve both classroom and laboratory/field research activities. Rather than provide an in-depth basic course in any HLBS subject or field, the program should provide an introduction to some basics of the HLBS field(s) chosen; its methods; new developments in the field(s); and research examples from HLBS studies, particularly those relevant to underrepresented groups. The program should also include instruction on unique issues faced by mentees in conducting research and obtaining funding, from an instructor who has been successful in a similar environment(s). For example, a summer institute in prevention and behavioral medicine could include didactic short courses on topics such as cardiovascular disease mechanisms, randomized controlled trials, observational studies, recruiting/retaining/conducting research in communities (especially in minority communities), health disparities, the latest methodological and/or analytical innovations, networking/career development/survival, and grantsmanship.

The second component will be mentoring and research or research career development related networking activities throughout the following academic year, which is expected to require a minimum commitment of 5% time for both mentees and mentors. Mentoring could be online, telephonic, and/or in-person. Mentoring activities could include areas such as assistance with career goals, research design and statistics, external funding, and proposal development. At least one midyear meeting should be held either during intervals between semesters, in conjunction with a conference, on a 3-day weekend during the winter, or at another appropriate time and location. At the midyear meeting, additional mentoring activities will occur, such as identification of appropriate grant mechanism and funding agencies and/or review and feedback on draft research concepts or applications. Mentoring activities may also include a visit to the laboratory or research site of a mentor during the academic year.

The third component of the program is the second summer session, which may be of a duration different than the first summer session. The second summer session could be held either at one location for all mentors and mentees, or each mentee could attend a summer session at the laboratory of their mentor(s). Activities could include developing and writing a grant application, holding a mock study section meeting, additional coursework on relevant topic areas, or focused mentoring.

Each year, awardees may matriculate up to 12 eligible candidates as mentees in their program, called a cohort. Each grantee will hold programs for three cohorts. Each mentee should be paired with at least one mentor. A mentor may have more than one mentee per year. Program Directors should recruit mentors nationally who are experts in their respective areas and who are exceptional mentors.

Applications are required to include specific plans for evaluation from both the mentees and mentors. The evaluation plan must include plans to assess the effectiveness of the program in terms of the mentees' perceptions of the curriculum and conduct of the program, as well as the longer-term impact, as measured by mentees' success in receipt of external funding from government agencies or private foundations. The desired outcome of the SIPID program is that each mentee would submit a grant application focusing on a HLBS disorder within two years of completing the program.

Grantee institutions must recruit doctoral-level or equivalent mentees who are faculty members or scientists and are either underrepresented minorities or have disabilities. Each grantee may focus on mentees who are early in their careers, changing their career focus, or trying to develop research skills if they are established clinicians, and faculty at non-research-intensive colleges/universities. Grantees are encouraged to consider the ramifications of these different categories of mentees on the design of their programs.

Applicants must provide a letter of support demonstrating mentors' and mentees' access to facilities, such as classrooms, research laboratories, computers, dormitories, food service, and some off-time activities as appropriate for the program being proposed. Applicants must describe in detail their plans for recruitment and selection of various under-represented minority groups and scientists with disabilities. Applicants' must also state that they will require prospective mentees to submit a letter stating their interest in pursuing research funding related to a HLBS disorder and a letter of support from their department chair or dean that would include some commitment to research time of 5% during the academic year and 33% during the summer and facilities as appropriate.

Time Line of the Project:

Grantees will develop their program during the winter of 2006-2007 and implement their program during the summers of 2007, 2008, 2009, and 2010 with appropriate modifications or refinements following each of the first two years.

Year 01: During the first four months of the award (August-November 2006), investigators should plan the research skills development and mentoring program. Grantees should recruit and select mentees who are underrepresented minorities and scientists with disabilities (December 2006-March 2006), with the initial summer institute for the first cohort of mentees occurring during the summer of 2007.

Year 02: From August 2007-March 2008, the investigators should: plan for the second summer, hold a midyear meeting of the first cohort, and recruit and select the second cohort. During the summer of 2008, the first cohort will return for their second summer institute, and the second cohort will attend their first summer institute.

Year 03: From August 2008-March 2009, the investigators should: plan for the third summer, hold a midyear meeting of the second cohort, and recruit and select the third cohort. During the summer of 2009, the second cohort will return for their second summer institute, and the third cohort will attend their first summer institute.

Year 04: From August 2009-March 2010, the investigators should: plan for the fourth summer and hold a midyear meeting of the third cohort. During the summer of 2010, the third cohort will return for their second summer institute. During the final two months of the program (July-August 2010), the program directors should complete their evaluation and final report.

Evaluation should be ongoing to permit evidence-based modification of the program or specific activities of the program (e.g., changing recruitment strategies). Annual evaluation data should be provided with the non-competing continuation application and a summary of the final evaluations should be provided to the NHLBI as part of the final report.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R25 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the 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

The NHLBI intends to commit approximately $960,000 in direct costs in FY05 to fund five to six new summer institute programs in response to this RFA. Each applicant may request a project period of four years and a budget for direct costs of up to $175,000 for the first year, $250,000 for the second year, $260,000 for the third year, and $210,000 for the fourth year. F&A costs are limited to 8% of direct costs for this RFA. A total of up to $4.860 million is anticipated to be available for direct costs over the four-year period for the project. The projects are expected to start in August 2006 and continue until July 30, 2010.

Although the financial plans of the IC 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. Fiscal and administrative costs are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to receive grants under this solicitation, and domestic applications may not include international components.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed summer institute program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

The Program Director for each application is expected to possess certain essential qualifications as described below:

The Program Director and any Program Co-Director of the SIPID grant will, taken together, have scientific leadership and background in HLBS topic areas, as documented by scientific publications and a record of peer-reviewed scientific support, as well as experience and leadership in mentoring. For example, a Program Director with strong scientific experience and expertise could have a Program Co-Director with mentorship experience and leadership, or vice versa. It is expected that the Program Director and Program Co-Director(s) combined will provide approximately 15-20% full- time equivalent (FTE) during the academic year and 80-100% FTE during the summer.

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/grants/policy/nihgps_2001/part_i_1.htm.

3. Other-Special Eligibility Criteria
Each applicant organization may submit only one application in response to this RFA.

Section IV. Application Submission Instructions

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. For further assistance contact GrantsInfo, Telephone (301) 710-0267, 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 PHS 398 research grant application instructions and forms. Applications must have a Dun and Bradstreet (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.

See Section VI.2 Administrative and National Policy Requirements for additional information.

The title and number of this funding opportunity 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.
This solicitation has only one submission date: September 14, 2005. Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters Of Intent Receipt Date(s): August 14, 2005
Application Receipt Dates(s): September 14, 2005
Peer Review Date(s): February 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: August 2006

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
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express Mail Zip Code: 20817)
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 PHS 398 research grant application instructions and forms as described above. 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)

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

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express Mail Zip Code: 20817)
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 listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

The NIH will not accept any application in response to this funding opportunity 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 funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity 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.

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

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 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 (See also Section VI.3. Reporting)

6. Other Submission Requirements

Supplementary Application Instructions

1. Application face page: Item number two on this page must include the RFA number and the title, Summer Institute Program to Increase Diversity (SIPID) (R25).

2. Description, Performance Sites, and Key Personnel (Form Page 2): Under Performance Sites include "Consortium/Contractual Arrangements," and a list of collaborating sites. If multiple sites are to be used, the applicant institution must be one of those sites. A justification must be included if any other sites will be used.

3. Resources (Resources Format Page): Describe the scientific, research, and mentoring environment; include a description of the facilities, laboratories, research samples, participating departments, computer services, and any other resources to be used in the conduct of the proposed SIPID program, including related resources such as dormitories and food service. Describe how these facilities will be available for the program. Use continuation pages, as necessary.

4. Research Plan: Part "c" of this section should be re-titled "Preliminary Data and Activities" and included if applicable. This section should contain information on steps that have led to the proposed SIPID program, including collaborations to date.

5. Research Plan: Part "d" of this section should be re-titled "Scientific and Research Training Program Plan" and should contain material organized under the following subheadings, as appropriate to the specific program:

a) Program Direction: Describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in mentoring, research, and/or teaching, and can organize and administer the program. Describe the qualifications and mentoring, scientific, research, and training experience of the proposed SIPID Program Director and Co-Program Director(s). Provide evidence of institutional commitment and support for the proposed program. Include a description of plans for collaborating with other institutions for purposes of outreach. Include a statement that the applicant is willing to collaborate with NHLBI staff's participation as program faculty in didactic sessions on grants, grantsmanship, and grants review. Provide a biosketch for the Program Director and Co-Program Director.

b) Program Faculty/Mentors: Describe the characteristics and responsibilities of the faculty/mentors; provide evidence that participating faculty/mentors are actively engaged in mentoring, research, or other scholarly activities related to HLBS disorders or health, and in other disciplines relevant to the proposed program. Describe plans for effective program administration and coordination among faculty/mentors. Provide a biosketch and a letter of cooperation from each faculty/mentor who has agreed to participate in the program and indicate the exact role of each faculty/mentor in the didactic portion of the summer institute and in the mentoring portion. Faculty/mentors may be recruited from across the country.

c) Proposed Scientific and Research Training Program: Describe the appropriate HLBS research area selected, including a justification for the area selected. Describe the didactic and research training program, each component of the program, and each activity within each component. Describe plans for providing mentees with appropriate mentoring experiences. Describe plans to provide information to mentees regarding the responsible conduct of research; if human subjects will participate, the use of human subjects in research; and if animals will be used, the use of animals in research. See the Required Federal Citations section of this RFA.

d) Recruitment and Selection of Program Mentees: Provide details about the proposed methods for the recruitment and selection of mentees for each cohort, including the ability to recruit and matriculate mentees from underrepresented racial and ethnic groups and individuals with disabilities. Include a statement that the mentee applicants will apply directly to the grantee rather than to the NHLBI, a statement that the applicant will require the mentee applicant to submit a letter of support from his/her department chair or dean, or other appropriate supervisor, and a statement that the applicant will require a letter from the mentee applicant stating they are interested in pursuing research funding related to a HLBS disorder.

e) Evaluation Plan: Describe the plans and methods for monitoring mentee progress. Describe plans for evaluating the short- (2-year) and long-term (5-year) effectiveness of the SIPID program. Describe plans for mentee and mentor evaluation of the program. Provide a biosketch and letter of commitment for evaluation staff. Please note that applications that do not have an adequate evaluation plan will be considered non-responsive to this RFA. The inclusion of evaluation instruments in an appendix is encouraged.

Special Requirements

The Program Director and any Program Co-Director(s) of the SIPID grant will, taken together, have scientific leadership and background in HLBS topic areas, as documented by scientific publications and a record of peer-reviewed scientific support, as well as experience and leadership in mentoring. For example, a Program Director with strong scientific experience and expertise could have a Program Co-Director with mentorship experience and leadership, or vice versa.

Allowable Costs

Applications should contain four budget periods of 12 months each. Applicants should provide adequate written budget justification for all applicable direct and F&A costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and justified for the SIPID program. Grant funds may not be used to supplant funds otherwise available at the applicant institution.

Personnel Costs - individuals participating in the design, implementation, and evaluation of the SIPID program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program (should not?) exceed 50% of the total direct cost over the four years of the program (not including consultant fees). Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated maximum, which is $180,000 in fiscal year 2005

Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Equipment, supplies, and other program related expenses must be justified as specifically required by the program proposed and should not duplicate items generally available for programs at the host institution.

Applicants may request funds to pay offset participation costs of mentors/faculty members as consultants. Travel funds may be requested for up to 12 mentees per cohort for transportation, room, board, and some research or research career development related group activities outside the classroom for their initial and follow-up summer institutes and for the midyear meeting in between and for a visit to the mentor's laboratory or research site, if proposed. Travel funds may also be requested for mentors for these activities. Travel funds should be requested for the Program Director and Co-Program Director to travel to Bethesda, MD, each year for an annual meeting of the Program Directors and NHLBI staff. Grantee institutions are strongly encouraged to provide facilities such as dormitories and food service for the mentees and mentors. Evidence of institutional commitment to the program by the applicant institutions or other organizations for costs is strongly encouraged. Programs should be structured such that Mentee Applicants will apply directly to the grantee program (rather than to the NHLBI) and Mentee Applicants should, as a part of their application process to the grantee program, submit a letter stating that (s)he intend to pursue research related to heart, lung, blood, or sleep disorders. The Program Director should be willing to collaborate with the NHLBI staff in participation as program faculty on topics related to grant funding and grantsmanship.

Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," will be reimbursed at a rate of 8% of modified total direct costs for the applicant organization and any approved subcontract. Funds for the evaluation plan are not expected to exceed 5% of the total direct cost, except during the fourth year of the grant.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

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 nonresponsive 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 goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Scientific and Research Training Program

Program Infrastructure

Program Leadership

Evaluation Plan

Institutional Commitment and Resources

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

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
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will 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/grants/policy/nihgps_2003/NIHGPS_part4.htm.

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

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.

Notice of Award will be sent to the Sponsored Projects Office of the applicant institution by e-mail.

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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm.

Support from the SIPID grant may not be used to circumvent National Research Service Award (NRSA) training mechanisms or supplement NRSA stipends.

Each grantee must recruit and matriculate members from each underrepresented minority group and from persons with disabilities into their summer institute program.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable

3. Reporting

Awardees will be required to submit the 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.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Direct inquiries regarding scientific/mentoring issues to:

Jared B. Jobe, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8120, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0407
FAX: (301) 480-1773
Email: JobeJ@mail.nih.gov

Patrice Desvigne-Nickens, M.D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 9158
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Telephone: (301) 435-0494
FAX: (301) 480-1336
Email: DesvignP@mail.nih.gov

Carl E. Hunt, M.D.
National Center on Sleep Disorders Research
National Heart, Lung, and Blood Institute
Rockledge I, Suite 6022
6705 Rockledge Drive
Bethesda, MD 20892- 7993
Telephone: (301) 435-0199
FAX: (301) 480-3451
Email: huntc@mail.nih.gov

Sri Ram, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 10206
6701 Rockledge Drive, MSC 7952
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: rams@mail.nih.gov

Ellen M. Werner, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Room 10156
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0061
FAX: (301) 480-0868
Email: wernere@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Ms. Tanya McCoy
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7132, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0183
FAX: (301) 480-0422
Email: McCoyT@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 (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.

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 that is available at 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 (see 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 PA 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 PA 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:
(Be sure to cite any additional appropriate authorizations, regulations or policies below)
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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