Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI), (

Title: Community-Responsive Interventions to Reduce Cardiovascular Risk in American Indians and Alaska Natives

Announcement Type
This is a reissue and modification of RFA-HL-04-023, which was previously released April 28, 2004.

Request For Applications (RFA) Number: RFA-HL-06-002

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release Date: December 6, 2005
Letters of Intent Receipt Date(s): February 10, 2006
Application Receipt Dates(s): March 10, 2006
Peer Review Date(s): June-July 2006
Council Review Date(s): August 2006
Earliest Anticipated Start Date: September 1, 2006
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: March 11, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research 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
      3. Anticipated Announcement and Award Dates

    D. Sharing Research Resources
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. Research Objectives

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

The National Heart, Lung, and Blood Institute (NHLBI) invites applications for cooperative agreements to conduct five-year studies in American Indian/Alaskan Native (AI/AN) communities to test the effectiveness of behavioral interventions to promote the adoption of healthy lifestyles and/or improve behaviors related to cardiovascular (CV) risk, such as weight reduction, regular physical activity, and smoking cessation. These behaviors and lifestyles are known to affect biological cardiovascular risk factors, such as hypertension, dyslipidemia, obesity, glucose intolerance, and diabetes. A central feature of this project is to develop and test culturally appropriate interventions that could be incorporated into clinical programs of the community health care systems or delivered through public-health approaches in Native communities. The interventions tested should be sustainable and capable of being disseminated to other Native communities after termination of research support.

The concept for this RFA was developed in consultation with AI/AN Tribes, recognizing the government-to-government relationship between AI/AN Tribes and the United States, and incorporates recommendations of a working group of AI/AN health experts. The long-term goal of this RFA is to reduce cardiovascular disease mortality and morbidity in AI/AN. This initiative focuses on primary and primordial prevention, important approaches that can contribute to that goal.

A. Background

1. Burden of Disease in AI/AN Communities. Observational studies have shown that many AI/AN communities bear a heavy burden of cardiovascular disease (CVD) and cardiovascular risk factors (e.g., obesity, diabetes) that could be reduced through effective interventions on modifiable risk factors. The high burden of disease will worsen unless behaviors and lifestyles affecting CVD risk can be changed. Widespread concern exists among AI/AN communities and health organizations that despite extensive documentation of these problems in observational studies, few intervention studies have been launched to test effective solutions in their environment. Tribal leaders and AI/AN working group members have urged that health research in their communities focus on the most serious health issues they face, and they have identified CVD, obesity, and diabetes as being among these issues.

Prevalence of obesity in AI/AN communities is about 50% higher than in the U.S. general population--in which obesity is often described as being of epidemic proportions. In some AI/AN communities, cigarette smoking, sedentary lifestyle, and stress augment the adverse effects of obesity. AI/AN are particularly vulnerable to Type II diabetes, a problem exacerbated by high rates of obesity. Diabetes prevalence is 3-20 fold higher among AI/AN than in the general U.S. population. It is an important cause of coronary heart disease, cardiomyopathy end-stage renal disease, non-traumatic amputation, and vision impairment. Lipid abnormalities also are common in Type II diabetics, particularly high triglycerides and low HDL-cholesterol levels. Dyslipidemia and blood pressure can be improved by appropriate changes in diet and by increased exercise. CVD risk is also substantially improved by smoking cessation. In addition, attention to high stress levels, sleep loss, and depression may be warranted because of evidence that they may influence the health behaviors of interest in this RFA. For example, poorer diet, higher smoking rates, and physical inactivity are more prominent in those with high stress, sleep disorders, or depression. These psychosocial factors also are associated with CVD progression in observational epidemiologic studies, and there is evidence from smaller clinical studies they may affect mechanisms leading to CVD. The purpose of this RFA, however, is not to focus on these factors, but only to address them if they affect the targeted behaviors in the population of interest.

2. Need for Community Involvement. An important consideration of working with AI/AN communities is that interventions should be developed with direct community involvement and in a way that approaches proven to be beneficial are sustainable after the study is completed (Department of Health and Human Services. Consultation with American Indians and Alaska Natives. A report on the continuing dialogue between the Department of Health and Human Services and American Indian and Alaska Native leaders. January 2001). NHLBI convened an AI/AN Intervention Working Group that included representatives from each Indian Health Service Area and from major AI/AN organizations. The Working Group recommended community involvement from the initiation of planning, with Tribal consultation as the initial step. Based on these recommendations, NHLBI consulted elected representatives of AI/AN communities during the development of this initiative and also participated in discussions with AI/AN health professionals. The consultation process identified several diseases that are within the mission of NHLBI, including CVD and many of its risk factors--high blood pressure, diabetes, and obesity, as well as many behaviors and lifestyles that affect CVD risk, such as diet high in saturated fat and salt, lack of physical activity, and cigarette smoking--as major public health threats that are common to many of these communities. The consultation process also recommended aggressive CVD risk factor management as a viable and sustainable intervention strategy, and identified interventions for the above CVD risk factors. The consultation results were reviewed with the AI/AN Intervention Working Group, which made recommendations to the NHLBI on some parameters for this initiative. (The minutes of the three Working Group meetings are available at the following web site:

Reducing significant and worsening health issues among AI/AN communities and individuals may be fostered by greater understanding of how to enhance their strengths and resiliencies. Although American Indian communities have relied on health research and medical science to reduce health disparities, they also have relied on their own medical, psychological, organizational, and cultural assets and strengths to survive major harms and disruptions over the centuries, and to rebound from insults to health. (For research about resiliencies, see This RFA attempts to harness the synergy that can come from the interaction of these two important contributors to health in AI/AN communities by promoting active and substantial participation by the community in the development, implementation, and dissemination of intervention research.

B. Objectives and Scope

1. Research Questions. The purpose of this initiative is to test the effectiveness of behavioral interventions to promote the adoption of healthy lifestyles and/or adoption of behaviors related to CVD risk, such as healthy diet, regular physical activity, and smoking cessation that are known to affect biological cardiovascular risk factors, such as hypertension, dyslipidemia, obesity, glucose intolerance, and diabetes. The primary research question to be addressed in these studies is: Can a culturally appropriate behavior change program in AI/AN participants lead to sustained favorable changes in health behaviors and lifestyles, which are known to improve CVD risk factors? The research plan should be developed consistent with community attitudes and readiness for change. The intervention program should be designed so that it could be sustained within the entire community within existing resources, and, if successful, disseminated elsewhere.

2. Eligibility. The target population is adult and/or children AI/AN at high risk for CVD, but free of clinical (or previously diagnosed) CVD. Each applicant should provide his or her own definition of high risk and criteria for ascertainment of whether or not potential participants have CVD. Applicants may propose a primary prevention program, that is, improving CVD risk factor(s) in those who possess a risk factor (e.g., already obese or hypertensive), and/or a primordial prevention program, that is, preventing the occurrence of the risk factor (e.g., preventing obesity or hypertension). Although the interventions tested must be directed toward behaviors, CVD risk factors used to identify eligibility may be either behavioral or biological. Examples of potential eligibility criteria include smoking, obesity, sedentary lifestyle, glucose intolerance, diabetes, hypertension, dyslipidemia. Applicants should propose objective measures for eligibility, and identify eligibility criteria and provide support for their choices in terms of the availability of the target population, the prevalence of the condition(s), and suitability for the proposed intervention.

3. Design. Applicants should propose either an experimental design with either an individually or family randomized design, or alternatively, a quasi-experimental design with community or school randomization. Applicants proposing a group- or family-based study must include at least two schools or communities in the intensive intervention condition and at least two schools or communities in the comparison condition. Applicants who propose an individually randomized study, but who propose to include family members or significant others in the intervention to increase structure and social support, should discuss how this approach may affect plans for informed consent, randomization procedures, data collection, and statistical analyses.

The design should include at least two randomized groups: an intensive intervention group and a comparison group. Many communities will not participate in the research unless they receive some form of intervention; therefore, instead of a control group, participants enrolled in the comparison group may receive a less intensive intervention, such as education and advice, or an alternate intervention, such as injury prevention. Participants in both the intensive intervention group and the comparison group will continue to receive medical care from their usual source of care.

Each application should identify the specific research question to be addressed; the intervention(s) to be delivered; the expected effects of the intervention (including magnitude of change); the statistical analyses to be conducted (for experimental designs); and, if successful, plans to disseminate the intervention. Applicants should describe the characteristics of their populations and proposed sample sizes with supporting power calculations (for experimental designs).

4. Interventions. Applicants are strongly encouraged to propose intervention designs that are of maximum duration within the time limits and budget of this initiative. We envision that interventions can be up to two years in duration (including any booster or maintenance intervention), because sustained behavior change is needed to reduce risk of disease. Because the targeted health behaviors tend to cluster, applicants are strongly encouraged to propose intervention components targeted at two or more behaviors (e.g., dietary change and increased physical activity). Targeted behaviors include: increasing regular physical activity, smoking cessation, reducing or preventing overweight and obesity, and improving diet.

Applicants may wish to consider adding specific components to their intervention programs to further promote self-management of CVD risk reduction. For example, intervention(s) could include approaches to improve self-management of CVD risk factors and provide education on how to interact with health-care providers (e.g., health-care seeking, keeping appointments, and adhering to health-care recommendations).

The behavioral interventions to be tested will be consistent with community values and may include traditional health, medical, and/or cultural practices. Examples of possible intervention strategies include the following or combinations of the following. However, applicants are not limited to these strategies:

Environmental approaches to behavioral change may also be considered as interventions as they affect the targeted health behaviors. Examples include:

The interventions should be delivered by individuals (e.g., behavioral professionals, community health workers, counselors, nutritionists, nurse practitioners, physician assistants, traditional healers) drawn from the community to the greatest extent possible.

5. Collaboration. The studies supported by this initiative will not use a common study protocol. However, whenever possible, investigators should collaborate and report in a standardized manner when they are measuring key common variables, such as diet, blood pressure, physical activity, height and weight, and smoking status and rates. Investigators may also use different methods of measuring similar outcome variables when justified. Investigators may also collaborate in the development of formative assessment measures, such as survey instruments and focus group guidelines. Investigators are encouraged to collaborate for data archiving, such as selecting a single archive and archiving format. Investigators should indicate in their application their willingness to collaborate on the development and use of standardized measurement protocols, data archiving, and coordination of formative assessment and possibly of intervention approaches, and their willingness to collaborate with NHLBI scientists in all aspects of the study.

6. Outcome Measures. Because the research objectives are to change behaviors that affect CVD risk, the primary outcome measures should be objective measures of the behaviors that the intervention targets. In some cases these may be measures of CVD risk factors that the behaviors affect. Potential outcome measures include, but are not limited to:

Adherence to the behavioral recommendations, such as engaging in physical activity, following dietary recommendations, smoking cessation, and participating in stress reduction and health education programs, and improved quality of life, are of interest as indicators of success of the program(s) and acceptability. In addition to specifying the primary outcome, applicants should propose and justify secondary outcome measures. Although an extensive cost analysis is beyond the scope of this initiative, applicants must include a cost-effectiveness analysis.

7. Recruitment of Individuals and Communities. Applicants may propose to include one or more AI/AN communities to achieve the necessary sample size or otherwise enhance the scientific value of the study sample, within the strict budgetary constraints of this RFA. Applicants should provide preliminary evidence of community support and of their ability to recruit participants in each community involved in the study, to implement measurement and intervention protocols in the target population, to provide appropriate oversight, and to maintain high rates of follow-up throughout the intervention.

Individuals recruited as part of a pre-existing study that is not an intervention study may be proposed for inclusion in the proposed study. However, applicants must provide evidence that recruitment from an existing cohort will not unduly interfere with the goals of the existing study or that the cohort is no longer being studied. In addition, the application should include a justification for including such participants for the proposed protocol. Applicants including participants from an extant study must submit, prior to the review, a letter from the principal investigator or steering committee of the parent study approving their participation.

8. Quality Control and Data Management. Applicants must describe their procedures for quality control of measurements and intervention delivery and provide preliminary evidence of their ability to achieve adequate quality control. They must also describe their data management procedures.

9. Collaborations. Tribes, communities, and organizations that do not have research experience are strongly encouraged to develop collaborations with research organizations. Involvement of Native researchers and other appropriate professionals also is strongly encouraged. Applicants are strongly encouraged to include a Native researcher as a co-investigator on this project in their application. After the award, grantees may also submit an application for a minority supplement award for funding one or more AI/AN training positions; however, these awards are competitive and funding is not guaranteed. Guidelines for the minority supplement program can be found at:

10. Awareness of Strain on Existing Resources. Investigators should be aware of the need to conduct this study without creating excessive strain on existing resources that are often functioning at, or above, capacity. These existing resources include medical facilities, personnel, and equipment, as well as community infrastructure. Applicants should propose using facilities or systems for which they have tribal, community, or Indian Health Service approval, as appropriate, and provide written evidence thereof.

C. Dissemination Plan

A critical feature of this project is the development of interventions with the potential to be incorporated into the medical care systems, public-health system, and/or community structure of AI/AN communities, if the results demonstrate clinical effectiveness. Intervention programs resulting in positive study outcomes may be disseminated to the communities in which the study was conducted, as well as other Native communities, and to NHLBI at the completion of the research. The application must include a dissemination plan that includes dissemination of study results as well as dissemination of intervention approaches and materials. The dissemination plan should identify a target audience, describe methods to be used, and discuss how the intervention will be made translatable. The dissemination plan should be updated at the end of the study when the results are known. A budget not to exceed 5% of the total project budget may be proposed to implement the dissemination plan.

D. Study Components

Grantee organizations will be tribes, communities, research organizations, or institutions that are actively involved in the recruitment, evaluation, and treatment of study participants. Proposed studies may involve several tribes, communities, or sites. Partnerships with tribes and/or communities are mandatory, if the tribe or community is not the grantee organization.

Each awardee will have primary responsibility for collecting, editing, storing, and analyzing their data. Awardees should oversee implementation of their interventions and adherence to their protocols, and assure that appropriate quality control procedures are in place. Each awardee will be responsible for training and certification of their personnel.

A Data and Safety Monitoring Board (DSMB) will be established to monitor data and oversee participant safety in each study supported by this initiative. At the first meeting, the DSMB will review the awardee’s protocol. Subsequently, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and overall awardee performance. It has the responsibility to review interim data and final data, and recommend whether the protocol should be modified, and whether the study should be continued or should be terminated early. Thus, its ethical responsibilities to the participants, as well as to the integrity of the study, are of paramount importance to the NHLBI. The DSMB will meet at least twice annually, with at least one of the meetings being in person.

The funding agencies will appoint a single DSMB for monitoring all of the funded projects. Therefore, applicants should not appoint DSMB members in advance of the peer review, or even inquire about the interest of possible DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer reviewer committee that will evaluate the applications for scientific merit.

In addition to the semi-annual DSMB meetings, a meeting will be held with the Project Officers from the funding organizations and the investigators from each site at least annually. The investigators may form committees that would meet periodically by conference calls as needed. Annual meetings will be held in the Washington, D.C., area.

E. Time Line of the Project

The timeline for this initiative does not allow time for initial tribal and/or community protocol approval or approval of facilities after each study has begun. All such approvals must be submitted with the application. IRB approvals must be submitted prior to the award.

The duration of the grants resulting from this RFA will be five years. The time line after the awards are made is planned as follows, but may be modified as needed. Any modifications should be included in the grant application with justification.

In Year 01 the grantees will focus on: 1) conducting formative assessment measures through surveys, interviews, and focus groups to determine recruitment strategies and intervention methods to ensure community responsiveness to the study; 2) pilot testing screening and measurement procedures and data collection instruments; 3) training assessors and interventionists; and 4) submitting any protocol modifications for community and IRB approval.

In Year 02 the grantees will focus on: 1) recruiting and screening potential participants, 2) baseline measurements, 3) randomization of eligible participants, and 4) implementing the interventions.

In Years 03 and 04 the grantees will continue the two-year interventions and conduct follow-up assessment beginning in Year 04.

In Year 05 the grantees will complete follow-up assessment during the first part of Year 05; during the second part of Year 05, grantees will conduct data analyses, and present and publish results from the study. After approval by the NHLBI, dissemination plans will be implemented, which may be during a no-cost extension.

F. Community Support Collaborations

Applications must include evidence of 1) strong scientific capabilities and 2) evidence of community involvement and support. Applications that represent a partnership between a tribe or community and a research organization should include a resolution from the tribal or community government specifying that the community or tribe agrees to participate as a partner in the project and will strongly support the project for its entire duration. Applications that include more than one tribe or community should include a resolution of support from each participating tribe and community. If the application includes a consortium of tribes or communities, applicants must provide a resolution of support from each tribe or community of the consortium. If the applicant is a tribally sanctioned non-profit tribal organization, specific tribal resolution(s) of support will not be required if the current tribal resolution(s) under which the organization operates encompasses activities proposed in the application. A copy of the current operational resolution(s) should be submitted with the application. Each AI/AN organization that participates in the project should also submit such a letter of support.

Letters of support and/or resolutions should be placed in the grant application after the Literature Cited in section h. or section i., clearly labeled, and referenced in the body of the application, where the organizational structure is discussed.

Tribal/community resolutions of support must explicitly stipulate that they agree to respond expeditiously to requests for approval of protocol modifications, approval of abstracts for presentations to scientific meetings, and approval of manuscripts submitted for publication in scientific journals. The time required for approving each of these (protocol, abstracts, manuscripts): (1) must be proposed and stated within the resolution of support, (2) may differ for each of these activities; (3) may be modified by study investigators only in consultation with the tribal/community leadership; and (4) should identify an individual or entity within the tribe or community to whom a request for waiver of the time requirement can be directed if circumstances arise. In the absence of a written waiver, study investigators may assume passive approval only after the established time interval has expired. Disapprovals must specify the reasons for disapproval explicitly, and describe the steps necessary for obtaining approval.

Applications that represent a collaboration between a tribe or community and a research organization should describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The application should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects.

Applicants are strongly encouraged to provide work opportunities for AI/AN/FN undergraduate, graduate, and postdoctoral students in behavioral and biomedical research.

Applicants should obtain necessary clearance for their research protocols through all applicable Institutional Review Boards (IRBs), including their institutional IRB, the tribal or community IRB(s), if applicable, and the local and national Indian Health Service IRB if their research involves Indian Health Service facilities or personnel. Applicants are requested to include in their clearance package descriptions of all intervention components for both the intensive intervention group(s) and the comparison group and descriptions of all measurements. All required IRB approvals must be submitted to the NHLBI prior to the award of the grant.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the cooperative agreement (U01) award mechanism. This RFA is a one-time solicitation. Any future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 15, 2006. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application.

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 (see A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

Plans to continue funding beyond the current funding opportunity are indefinite.

2. Funds Available

The NHLBI intends to commit up to $1.8m in Fiscal Year 2006 to fund up to three new Field Centers in response to this RFA. Each applicant may request a project period of five years and a budget for direct costs of up to $275,000 for the first year, $450,000 for the second year, $475,000 for the third year, $500,000 for the fourth year, and $300,000 for the fifth year. A total of approximately $8.8 m is available from NIH over the five-year period for the project.

The anticipated start date for these awards is September 1, 2006.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible for awards under this announcement. Applications that do not meet the eligibility criteria will be returned without review. This funding opportunity is for new applications. Applicants who previously submitted to RFA HL-04-023 should submit a new application for this announcement.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 Principal Investigator for each application is expected to possess certain essential qualifications: 1) strong scientific expertise in behavioral intervention studies, biobehavioral research, and/or biomedical research; 2) scientific leadership experience and a strong academic and scientific background, as exemplified by scientific publications and a record of peer-reviewed scientific support; 3) history of mutually beneficial and productive collaborations with the AI/AN communities participating in the proposed research and, if applicable, with the partners or subcontractors of the proposed study; 4) extensive supervisory experience; 5) knowledge of NIH grant and research policies, including those concerning human participants in research, human biological material, data management, and data privacy; and 6) knowledge of tribal/community processes for review and approval of research and research publications.

This RFA may be of interest to researchers with expertise in the areas of behavioral sciences, prevention research, dietary and nutritional sciences, exercise science, minority health, epidemiology, biostatistics, and cardiology. Experience with controlled community studies is desirable, but not required.

2. Cost Sharing or Matching

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

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

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at 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:

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 10, 2006
Application Receipt Date(s): March 10, 2006
Peer Review Date: June-July 2006
Council Review Date: August 2006
Earliest Anticipated Start Date: September 1, 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

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

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

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:

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. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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.

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

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

6. Other Submission Requirements

6.A. Data and Safety Monitoring Board (DSMB) and Annual Meetings

Applicants should budget for semi-annual DSMB meetings, including travel, meeting rooms, and honoraria for DSMB members, and also for an annual meeting in the Washington, D.C. area with the NHLBI Project Officers and the investigators from each site. Applicants should estimate the number of meetings and conference calls that may be needed and budget for them.

6.B. Checklist of What Each Application Should Include


Population, Recruitment, and Retention

Study Design and Intervention


Quality Control Methods




Partnerships and Approvals



6.C. Budget and Related Issues

Applications should contain five budget periods of 12 months each. Applicants should provide adequate written budget justification and include all applicable direct and F&A costs. Applications must include estimates of staffing needs, including the principal investigator and other professional and support staff. Applications must include estimates of travel costs for annual investigator meetings, and two annual DSMB meetings (at least one must be in person in Bethesda, MD) to review the study progress, as detailed under the section on Special Requirements, along with statements indicating willingness to participate in these meetings. Applications must include budget for staff to conduct data entry at their centers, for any equipment needed for data collection and intervention delivery, and for conference calls.

Applications must include a plan to hire community members, when available, for appropriate roles on the project. Each applicant is strongly encouraged, but not required, to include at least one AI/AN co-investigator on the study team, preferably a current or former community member or an enrolled tribal member. Other appropriate roles for community members include, but are not limited to, research coordinators, recruiters, interventionists, assessors, and research assistants. Without regard to the number of AI/AN staff members and investigators hired by the study, additional scientist positions possibly can be added through the NIH Minority Supplement process (

6.D. Plan for Sharing Research Data

All applicants must include a plan for disseminating research data in their application, as described in Section I.1.C.

The reasonableness of the dissemination plan or the rationale for not sharing research data will be assessed by the reviewers and will factor the proposed dissemination plan into the determination of scientific merit or the priority score.

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

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 the 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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does this study address an important problem? If the aims of the application are achieved, could the project yield behavioral interventions that would impact cardiovascular mortality and morbidity in AI/AN? Is the underlying rationale for the study strong?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the informed consent procedures, randomization procedures, data collection, quality control, data management, and statistical analyses appropriate for the design and unit of randomization selected (individual, family, school, or community)? Are the proposed outcome measure(s) objective measures of behaviors that the intervention targets? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Do the investigators have previous experience of prior effective partnerships with AI/AN communities?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies take advantage of unique features of the scientific and cultural environment or employ useful collaborative arrangements? Is there evidence of institutional support? Have the investigators stated their willingness to collaborate with staff from the NHLBI?

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:

Dissemination Plans: The plans for the initial dissemination of successful intervention materials and interventions to AI/AN health care providers and communities.

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).

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.

2.C. Sharing Research Data
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Announcements about awards from this solicitation will be made by September 1, 2006.

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA 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 NoA 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 NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program will be the cooperative agreement (U01, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above. The terms and conditions below elaborate on these actions and responsibilities, and the awardee agrees to these collaborative actions with the NHLBI Project Scientist toward achieving the project objectives. It is anticipated that these terms and conditions will enhance the relationship between the NIH staff and the Principal Investigator(s), and will facilitate the successful conduct and completion of the study. These agreements will be in addition to, and not in lieu of, the relevant NIH procedures for grants administration. The terms will be as follows:

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators.

Awardees are required to publish and to publicly release and disseminate results, data, and other products of the study. However, during or within three years beyond the end date of the project period of NHLBI support, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the study Principal Investigator(s). As part of the dissemination plan, at the end of the project, each awardee will provide a copy of the protocol and intervention materials to the NHLBI for use in dissemination.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. An NHLBI Project Scientist may serve as a member of subcommittees on the project. The NHLBI Project Scientist (and other NHLBI scientists as needed) may work with awardees on issues such as recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study, potential changes in the protocols, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to any major problems such as insufficient participant enrollment. The final protocol and consent forms will be negotiated between the Principal Investigator and the NHLBI Project Scientist, and must be approved by the NHLBI based on recommendations from the DSMB. Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NHLBI reserves the right to terminate or curtail the studies (or an individual award) in the event of

(1) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol; (2) substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (3) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination.

2.A.3. Collaborative Responsibilities

Awardees will retain custody of and have primary rights to their data developed under these awards, subject to government rights of access consistent with current Department of Health and Human Services (DHHS), Public Health Service (PHS), and NIH policies. The NHLBI Project Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the data as the other members of the project team.

Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NHLBI support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI.

These special terms of award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( 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:

Jared B. Jobe, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8122, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0407
FAX: (301) 480-1773

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 code: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730

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) 435-0166
FAX: (301) 480-3310

Section VIII. Other Information

Required Federal Citations

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 (

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,

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at 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 (

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at and view the Policy or other Resources and Tools including the Authors' Manual (

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 ( 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

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

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at 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

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:

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