This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

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: Short-Term Training Program to Increase Diversity in Health-Related Research (R25)

Announcement Type
This was formerly named NHLBI Short-Term Training for Minority Students Program T35 (RFA-HL-03-014) which was previously released March 17, 2003.

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

Request For Applications (RFA) Number: RFA-HL-05-018

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

Key Dates
Release Date: April 22, 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: September 18, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

(1) Students appointed to the program may or may not be from the applicant institution.

(2) The only requirement for student selection is that they fulfill the referenced eligibility requirements.

(3) Student appointments will be determined by the institution and carried out in a manner that will include the recruitment of individuals from disadvantaged backgrounds, racial and ethnic minorities, and others who are underrepresented in biomedical and behavioral research (e.g., individuals with disabilities).

Institutions may request support for at least 4 but not more than 24 students per budget period, based on a full-time, three-month appointment. A student may be appointed for a minimum of two months and a maximum of three months during a budget period; however, institutions are encouraged to appoint a student for more than one budget period, i.e., two or more successive summer research experiences. All research training and education must be full-time during the specific sequence.

Suggested Guidance on Appointing Individuals from Disadvantaged Backgrounds: Individuals who come from a family with an annual income below established income thresholds according to family size published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index, and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. The institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial need.

Individuals from disadvantaged backgrounds which are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Eligibility related to a disadvantaged background as defined under this section 2 is applicable to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

C. Other:

The application form is available at:
http://grants.nih.gov/grants/funding/phs398/phs398.html.

Only one application per health professional school may be submitted for a given receipt date. Although a university may have more than one Short-Term Research Training Program to Increase Diversity in Health-Related Research, they may not be in the same school.

Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research 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. 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. Research Objectives

Although the number of individuals from diverse backgrounds (such as African Americans, Hispanics, Native Americans) pursuing advanced degrees in the biomedical and behavioral sciences increased over the past 25 years, the representation in these fields remains disproportionately low.

This program is intended to: (1) provide opportunities for undergraduate and health professional students from diverse backgrounds (e.g., disadvantaged backgrounds and racial and ethnic minorities) and individuals with disabilities to participate in activities leading to research careers in areas relevant to cardiovascular, pulmonary, hematologic, and sleep disorders, and (2) increase the short supply of qualified investigators from diverse backgrounds (e.g., disadvantaged backgrounds and racial and ethnic minorities) and individuals with disabilities.

NHLBI encourages research areas crossing disciplinary boundaries (examples; biophysics, biostatistics, bioinformatics, bioengineering) to develop a new interdisciplinary workforce.

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences research work force. The NIH expects efforts to diversify the work force to lead to:

The recruitment of the most talented researchers from all groups.

An improvement in the quality of the educational and research environment.

A balanced perspective in the determination of research priorities.

An improved capacity to recruit subjects from diverse backgrounds into clinical research protocols.

An improved capacity to address and eliminate health disparities.

Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF), (see http://www.nsf.gov/sbe/srs/women/start.htm) and others provide strong evidence that diversity remains an important problem that the entire research enterprise must actively address.

There is abundant evidence that the biomedical and educational enterprise will directly benefit from broader inclusion. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have suggested that racially and culturally concordant scientific staff may be more successful in recruiting individuals from minority groups into clinical trials. Racially similar physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. There is no question that the need for a diverse work force permeates all aspects of the nation's health-related research effort.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences. This announcement describes programs designed to stimulate the participation of individuals from the following groups:

A. individuals from underrepresented racial and ethnic groups.

B. individuals with disabilities

C. individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

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 R25 award mechanism. As a Principal Investigator, 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. 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 estimated annual funds (total costs) available for the program is expected to be $750,000. The actual amount may vary annually, depending on the response to the RFA and availability of funds.

Up to eight new awards per year are anticipated.

The total project period for an application submitted in response to this RFA may not exceed five years.

The anticipated award date for the first receipt date is April 1, 2006; for the second, it is April 1, 2007; and for the third, it is April 1, 2008.

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

The Notice of Grant Award will provide facilities and administrative costs based on 8% of total direct costs exclusive of tuition and fees.

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:

For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Units of state government
Units of local government
Eligible agencies of the federal government
Domestic Institutions
Faith-based or community-based organizations
Foreign institutions are not eligible to apply.

The applicant institution must have a strong research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program.

1.B. Eligible Individuals

Eligibility and Requirements for Principal Investigators

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research program as Principal Investigator i’s 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 research Principal Investigator at the institution will be responsible for the selection and appointment of students to the research grant and for the overall direction, management, and administration of the program.

This announcement program is designed to stimulate the participation of individuals from the following groups:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting, and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution are eligible for support under this program.

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

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Eligibility related to a disadvantaged background as defined under this section 2 is applicable to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

Awards under this program are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of an Alien Registration Receipt Card or some other legal evidence of admission for permanent residence at the time of application).

Eligibility and Requirements for Students

Educational background: Undergraduate students must (1) have successfully completed at least one undergraduate year at an accredited school or university (including baccalaureate schools of nursing); or (2) be attending community or junior colleges provided they are enrolled in at least three courses per academic term. Health professionals should have successfully completed one semester at a school of medicine, optometry, osteopathy, dentistry, veterinary medicine, pharmacy, or public health.

Student Selection:

1. Students appointed to the program may or may not be from the applicant institution.

2. The only requirement for student selection is that they fulfill the referenced eligibility requirements.

3. Student appointments will be determined by the institution and carried out in a manner that will include the recruitment of individuals from disadvantaged backgrounds, racial and ethnic minorities, and those who are underrepresented in biomedical and behavioral research (e.g., individuals with disabilities).

4. The overall goal of the program is to provide research opportunities to individuals that will significantly contribute to a diverse research workforce in the future.

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_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Special Requirements

Provisions of the Award

Institutions may request support for at least 4 but not more than 24 students per budget period, based on a full-time, three-month appointment. A student may be appointed for a minimum of two months and a maximum of three months during a budget period; however, institutions are encouraged to appoint a student for more than one budget period, i.e., two or more successive summer research experiences. A student may be appointed, in special circumstances, to more than one 3-month period during a budget period, provided prior approval is obtained from the staff of the NHLBI. All research training and education must be full-time during the specific sequence. It is expected that most programs will be designed to provide a summer research experience, but other innovative program designs and time schedules will be considered. The requested number of short-term students must be justified in the application.

Only one application per health professional school may be submitted for a given receipt date. Although a university may have more than one Short-Term Research Training Program to Increase Diversity in Health-Related Research, they may not be in the same school. The applicant institution must have the available research facilities, personnel, and support for the program in the areas of cardiovascular, pulmonary, hematologic diseases, or sleep disorders. Institutions with adequate staff and resources in these areas are encouraged to apply. These grants will support research experiences of consecutive two to three months duration for undergraduate students and students in health professional schools. The grantee institution will be responsible for the selection and appointment of students.

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. 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 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). Submisstion 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:

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this RFA

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

The letter of intent is to be sent by the date listed 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.

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

The application should provide a summary of the research program including its objectives, the types of research activities available, the faculty who will participate, the geographical area to be included in the recruitment, a mentoring plan, and any special activities or experiences to be provided to the students. It should also describe the administrative structure of the program and the distribution of responsibilities within it, plans for recruiting, selecting, and assigning students to research activities; duration of research training and months in which it will occur; description of a typical student program including percent time to be spent in various activities; and additional support or services to be provided by the applicant institution.

Applicants for competitive renewal applications are required to provide information concerning past students in the program, the accomplishments of the program, student publications, and whether students supported by the program have pursued research careers. This information should also be included in the non-competing renewal application. Therefore, it is important that the applicant includes plans for tracking students who participated in the program.

Information on suggested tabular formats for presenting the data required for peer review of the Short-Term Training Program to Increase Diversity in Health Related Research, (R25) application can be obtained from the Office of Minority Health Affairs, NHLBI by contacting 301-451-5081. While not required, these specific formats will facilitate peer review and may also be useful as a framework for the narrative sections. It is strongly encouraged that the tables be included in the main application (will not be counted toward the page limitation) rather than in the Appendix.

Funds may be requested for:

Student participation expenses: The expenses of the students should be consistent with the NHLBI Research Supplements to Promote Diversity in Health-Related Research guidelines found at http://www.nhlbi.nih.gov/funding/training/guid-app.htm (Section B - Summary Table. See URS for undergraduates and GRS for health professional students). Exceptions to these requirements may be considered, depending on the circumstances of the applicant and the specific request. This amount may be supplemented from non-federal funds.

Facilities and Administrative Costs: The Notice of Grant Award will provide facilities and administrative costs based on 8% of total direct costs

Reasonable Accommodations for Individuals with Disabilities: As a part of this award, funds may be requested to make changes or adjustments in the research setting that will make it possible for an otherwise qualified employee with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under this award include specialized equipment, assistive devices and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested must be reasonable and documentation of the disability should be included with the application. These additional funds are in excess of the Stipend, Research Training and Education-Related Expenses, and Travel expenses.

An unsuccessful application to this RFA for one receipt date may be submitted as a new application at the next receipt date if this RFA is reissued. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and availability of funds.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

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:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique.

Receive a second level of review by the National Heart, Lung, and Blood Advisory Council.

Review Criteria

The following criteria will be considered when assessing the merits of the proposed Short-Term Training Program to Increase Diversity in Health-Related Research:

1. Program Design: Design of the proposed research program.

2. Principal Investigator and Participating Faculty: Qualifications, dedication, and previous student recruitment record of the Principal Investigator and all participating faculty, particularly with regard to prior experience with similar programs.

3. Recruitment and Retention Plans for Students: Recruitment and selection plans for students and the availability of high-quality candidates; methods for retaining promising students in the program and methods for tracking students.

4. Environment: Adequacy of facilities, environment, and resources for the proposed research program; commitment of the institution and participating faculty to the goals of the research program.

5. Program Evaluation: Procedures for evaluation of the effectiveness of the program and impact of the program on the students involved.

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.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

Following initial review, the NHLBI Advisory Council provides a second level review. The Council will consider the assessment of the scientific and educational merit of the research grant application.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

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/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 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 e-mail enabled, a hard copy of the NGA 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/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).

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 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:

Michael Commarato, Ph.D.
Division of Heart and Vascular Diseases (responding for all NHLBI programmatic Divisions)
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7940
Bethesda, MD 20892-7940
Telephone: (301) 435-0527
FAX: (301) 480-1330
Email: commaram@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. Beckie Chamberlin
Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7144, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0174
FAX: (301) 451-5462
Email: chamberr@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).

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/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.

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