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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI, (http://www.nhlbi.nih.gov)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)

Title: Childhood Obesity Prevention and Treatment Research Consortium (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-10-004

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.865

Key Dates
Release Date: February 2, 2009
Letters of Intent Receipt Date: September 8, 2009
Application Receipt Date: October 6, 2009
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (Url Activation Date):
FAQs http://www/funding/inits/faq-hl-10-004andhl-10-005.htm
Expiration Date: October 7, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This FOA, issued by the National Heart, Lung, and Blood Institute (NHLBI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), solicits cooperative agreement grant applications from institutions to conduct randomized controlled trials to test innovative interventions that address issues immediately germane to the childhood obesity epidemic and runs parallel with a separate Funding Opportunity Announcement (FOA) that solicits applications a Research Coordinating Unit (see RFA HL-10-005 (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10-005.html)). The goal of this Funding Opportunity Announcement (FOA) is to fund randomized trials testing intervention approaches to prevent excess weight gain in non-overweight youth and in those already overweight, and/or to reduce weight in obese and severely obese youth. For the purposes of this FOA (RFA-HL-10-004) and RFA-HL-10-005, prevention of obesity is defined as prevention of excess weight in non-overweight youth (primary prevention), as well as prevention of additional weight gain in those already overweight or obese. Treatment is defined as reduction of weight (including weight loss or weight maintenance during linear height growth) in those already obese or severely obese. The whole program is designed to promote collaboration, coordination and exchange of scientific information among institutions, and partnerships with local, state and national agencies. The ultimate goal is to improve children’s health by preventing obesity-related morbidity and mortality from cardiovascular and other chronic diseases. This FOA targets young children, pre-adolescents and adolescents and encourages novel interventions. Applications will be accepted from multi-disciplinary research teams, networks or collaborative groups that are already established or will be formed to conduct high-quality, transdisciplinary research in childhood obesity prevention and treatment. The ultimate goal is to improve children’s health by preventing obesity-related morbidity and mortality from cardiovascular and other chronic diseases.

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
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

This FOA requests outstanding and novel grant applications for randomized controlled trials that would test innovative interventions to prevent overweight and obesity in youth and to treat existing overweight, obesity, and severe obesity in youth. There is also a Research Coordinating Unit (RCU) for the childhood obesity prevention and treatment research consortium (See RFA-HL-10-005), which runs in parallel to this FOA.

For the purposes of this FOA, prevention of overweight and obesity is defined as prevention of excess weight in non-overweight youth (primary prevention), as well as prevention of additional weight gain in those already overweight or obese. Treatment is defined as reduction of weight (including weight loss or weight maintenance during linear height growth) in those already overweight, obese or severely obese. Prevention and treatment are considered a continuum. Because of this continuum, communication and collaboration to strengthen the integration between prevention and treatment approaches are needed.

This FOA focuses particularly on young children, pre-adolescents, and adolescents. In particular, for obesity prevention, studies are encouraged to target pre-schoolers and pre-adolescents. For obesity treatment, studies are encouraged to target overweight, obese, or severely obese pre-adolescents and adolescents with one or more elevated risk factor levels (e.g., with type 2 diabetes, high blood pressure, or dyslipidemia).

Applications will be accepted from multi-disciplinary research teams, networks or collaborative groups that are already established or will be formed to respond to this FOA to conduct high-quality, transdisciplinary research in childhood obesity prevention and treatment. Such collaborative groups and teams must have the infrastructure to foster communication across the studies funded, and to translate successful interventions into community and clinical practice. The teams should propose innovative, high-quality research in prevention or treatment or both, if justified, of pediatric overweight and obesity germane to clinical practice and community programs.

This FOA encourages novel interventions that would improve children’s health by preventing overweight and obesity-related morbidity and mortality. The intervention must be innovative, must have multiple components and levels and must be conducted in combinations of settings and/or levels (e.g., individual-, family- and community-based; individual-, clinic- and family-based; clinic- and community-based; individual, community and neighborhood levels). Applicants must be familiar with previous intervention studies in childhood obesity prevention and treatment and must draw from existing successes and failures of previous research or from other fields (e.g., substance abuse) to improve the scientific rigor in childhood overweight and obesity prevention and treatment research.

The studies must be well designed. Either individual or group randomization can be proposed. The research must be hypotheses driven, must use appropriate statistical analyses, and must have clearly stated primary and secondary outcome measures as well as identified mediating and moderating variables.

Background

The growing epidemic of childhood obesity requires urgent attention. In 2003-2004, 33.6% of children aged 2 to 19 years were at or above the 85th percentile of body mass index (BMI). The prevalence of overweight or at risk of overweight is particularly high among Mexican American and African American youth 2-19 years of age (37.0% and 35.1%, respectively), and even higher among American Indians (up to 59% in some tribes). Children from families of low socio-economic status or who live in rural areas are disproportionately affected. Some experts predict that a continuing childhood obesity epidemic may reverse the steady increases in life expectancy substantially because of possible increases in obesity-related cardiovascular deaths.

Observational epidemiologic studies have examined development and consequences of obesity in children and adolescents. Studies such as the Bogalusa Heart Study and the NHLBI Growth and Health Study (NGHS) have measured energy and nutrient intakes, physical activity levels and patterns, psychosocial factors, blood pressure, blood lipids and glucose, fasting insulin and carotid IMT during critical periods of growth. Much have been learned from these studies: obesity during childhood is associated with numerous adverse effects including hypertension, dyslipidemia, left ventricular hypertrophy, atherosclerosis, metabolic syndrome, type 2 diabetes, sleep disorders, and non-alcoholic fatty liver disease as well as psychological effects such as stigmatization, discrimination, depression and emotional trauma. Obesity in childhood substantially increases the risk of being an obese adult; adults who were overweight or obese during childhood have higher risks of developing hypertension, dyslipidemia, metabolic syndrome, diabetes, and coronary heart disease than those who were not overweight or obese during childhood. In addition, these studies have identified important factors associated with development of obesity, such as cultural norms, body image, dietary patterns, and fast-food consumption information that can be drawn upon to develop overweight and obesity reduction intervention approaches.

A limited number of intervention studies in childhood overweight and obesity prevention and treatment have provided a sound basis, background and lessons learned for future scientific rigor in childhood overweight and obesity research. A synthesis of current evidence suggests that successful prevention and treatment of childhood overweight and obesity must address multiple etiological factors that shape daily diet and physical activity behaviors. These factors are biological and physiological (e.g., genetic predisposition, appetite and satiety mechanisms and regulation), personal (e.g., physical activity patterns, taste preferences, and dietary composition), environmental (e.g., homes, schools, community, food availability and cost, built environment), as well as societal (e.g., cultural norms, TV advertising of foods, social network) and healthcare-related (e.g., primary pediatric care provider).

A recent Cochrane review of 22 obesity prevention intervention studies (including school-based studies such as PATHWAYS, Planet Health and Project SPARK) identified only two prevention trials where the tested interventions significantly lowered BMI. In 18 obesity treatment trials from another Cochrane review, the sample sizes were too small to have adequate power to detect treatment effects, and the studies were not generalizable because the settings were mostly hospital-based. Problems in research design and methods were identified for both the prevention and treatment studies, including use of inappropriate statistical methods, small sample sizes that could miss treatment effects, low participation rates that could compromise internal validity, insufficient potency of interventions, low adherence rates, limited use of theoretical frameworks to design the intervention, and short duration of studies (a majority less than 12 months). Obesity prevention studies in children have been limited in size and in intervention duration, breadth, and intensity. Obesity treatment trials have been particularly few in number, mostly hospital-based, and have been limited in size, duration, population diversity, and in intervention scope and modalities.

Furthermore, intervention designs have not considered the multiple factors associated with overweight and obesity. Although there is strong justification from the observation that multiple factors influence weight (e.g., individual behaviors; peer influences; home, family and school environments; and healthcare settings), there are sparse data on the effectiveness of interventions that are multi-component and intervene on multiple factors that affect body weight. To increase the evidence base for efficacious prevention and treatment methods, research is needed that is rigorous in methodology and builds on previous childhood obesity research to test promising intervention approaches.

The next generation of research studies should also take advantage of recent advances in our knowledge of environmental influences on energy balance, including physical environments and psychosocial environments such as social networks, and biological factors including genetics, neuroendocrine mechanisms, and appetite regulation. Further, there is a need for adequate methodological rigor that addresses various intervention components including duration and intensity in multiple settings. Data on mediating and moderating variables (e.g., social/peer support and self-efficacy for diet and physical activity behaviors) that are hypothesized as important determinants of changes in behavior are also needed, as is population-based research that intervenes within two or more settings or levels (e.g., individual, community, societal) for childhood overweight and obesity prevention and treatment.

Concerned about the public health burdens, along with a dearth of evidence-based approaches for obesity prevention and treatment, the NHLBI along with other NIH Institutes convened a Working Group to provide recommendations for future research in childhood obesity prevention and treatment. Attendees included scientists and leaders in clinical trial design, epidemiology, biostatistics, physical activity and nutrition, pediatrics, genetics, and bariatric surgery. The goal was to obtain advice on research priorities to prevent excess weight in youth and to treat overweight and obese children and adolescents. The Working Group report is available at http://www.nhlbi.nih.gov/meetings/workshops/child-obesity/index.htm. This initiative draws upon these recommendations and those from the literature (e.g., Cochrane reviews) that more successful research will be achieved within a multidisciplinary collaborative framework (e.g., consisting of methodologists, statisticians, pediatricians, nutritionists, physical activity specialists, health-care practitioners, neurobiologists, and geneticists).

Research Focus

To address the growing public-health burden of childhood overweight and obesity and based on the Working Group’s recommendations, this initiative proposes taking bold action to dramatically improve the evidence-base for pediatric overweight and obesity prevention and treatment.

Applications are sought from multi-disciplinary research teams, networks or collaborative groups that have already been formed or will be formed to respond to this FOA. New or existing infrastructures such as the Clinical and Translational Science Awards (CTSA), Practice-based Research Networks, Clinical Research Networks, Obesity or Nutrition Research Centers, and Clinical Nutrition Research Units, Research Centers in Minority Institutions , Institutional Development Award programs, or other collaborative entities that can form or that have the infrastructure to conduct high-quality, transdisciplinary research on childhood obesity prevention and treatment, as well as translation of successful interventions into community programs and clinical practice are encouraged to apply.

The teams should propose innovative, high-quality research in prevention or treatment of pediatric overweight and obesity germane to clinical and community practice. Each team can address either prevention or treatment; they may address both prevention and treatment if well justified. The program as a whole will (1) address the multiple research questions related to childhood overweight and obesity prevention and treatment; (2) foster collaboration between prevention and treatment researchers; (3) promote rapid implementation of study protocols; (4) implement both short and long-term studies and enable accrual of large sample sizes and diverse populations; (5) foster most effective use of time, money and effort; and (6) provide an infrastructure for dissemination and translation into clinical practice and community programs when applicable.

Infrastructure requirements

To meet the goals of the FOA, applicant institutions and teams must harness the skills and resources of a number of agencies and existing infrastructures to meet or exceed the following requirements:

Relevant to this FOA are both shorter-term studies as well as longer-term studies, smaller and larger sample sizes, depending on the specific research question and hypotheses for the proposed trial. This issue on sample sizes is especially important for prevention studies where small effects on body weight are applicable and appropriate, but detection of small effects requires large sample sizes and resources.

The program as a whole is intended to be a coordinated and rigorous multi-disciplinary program in randomized trials testing childhood overweight and obesity prevention and treatment approaches. The program infrastructure and collaborations could also facilitate translation of successful interventions into clinical and community practice.

Scope

The foci of the studies for overweight and obesity prevention or treatment in youth are envisioned as follows:

Obesity Prevention: design and conduct randomized trials to test innovative interventions for preventing excess weight gain in non-overweight youth and/or additional weight gain in those who are already overweight. Because of the focus on primary prevention, the most important groups are envisioned to be young children (e.g., 1-2, 2-5 and/or 6-10 years old). The goal is to test various promising intervention approaches including combinations of family- and community-based, and family- and clinic-based approaches, at the individual, community and societal levels.

Obesity Treatment: design and conduct randomized trials to test innovative interventions aimed at weight management (including reduction in weight) in obese/severely obese youth or in overweight youth with elevated cardiovascular disease risk factor levels (e.g., type 2 diabetes, hypertension, dyslipidemia). Because the focus is on youth already experiencing adverse consequences of elevated weight, the most important groups are envisioned to be pre-adolescents and adolescents. The goal is to test various intervention approaches alone or in combination including pharmacotherapy, meal replacement, and intensive behavioral intervention coupled with family-based and/or community-based interventions, at individual and clinic, community, and/or societal levels.

The studies must also meet the following minimum requirements:

In addition, a Research Coordinating Unit will be funded to coordinate activities between the various studies funded as part of this FOA (see RFA-HL-10-005).

See below for additional information.

Phases of the Research Program

There will be three phases in this 7-year award:

Phase 1 (1-2 years)

This phase will consist of protocol development, planning, formative research and pilot testing. Formative research obtains information to help guide intervention development; it consists of, for example, focus groups with the children, their family members, stakeholders, and community agencies, and/or in-depth interviews with pediatric health care providers. Investigators may include short-term studies, evidentiary studies or pilot studies based on novel theoretical frameworks during this phase; however, there should be a sound basis for proposing such phase 1 studies. Although formative research is part of the funding period, investigators must propose specific interventions in their applications with sound justification. The proposed interventions may be adjusted based on results from the formative research phase. Applicants who do not propose to include this phase in their study should provide justification for not doing so. Administrative review (by an NHLBI-appointed DSMB) of the studies will occur at the end of this phase prior to phase 2.

Phase 2 (4 years)

Applicants will conduct randomized controlled trials, including recruitment, baseline measures, randomization, implementation of the interventions, process and outcome measurements, and follow-up. Interventions should be at least 36 months. Intermediate outcomes will also be assessed, and applicants should demonstrate their ability to sustain the intervention during this phase. Annual administrative review and evaluation by one or more NHLBI-appointed DSMBs will take place during this phase.

Phase 3 (1 year)

This phase will focus primarily on data analyses and dissemination of study results. Successful interventions and materials could also be disseminated into clinical practice and community programs.

New/Underrepresented Investigators

Future national work in childhood overweight and obesity prevention and treatment research requires new or young investigators or investigators from underrepresented racial/ethnic groups to have the necessary skills to carry on future studies. Thus, applicants must include in their application, funds to support new/young investigators or those from underrepresented racial/ethnic groups for up to two years. These new investigators will be encouraged to propose ancillary studies, and apply for additional or later NIH training or research grants to support future research in childhood overweight and obesity prevention and treatment. (For the definition of new investigator, see http://grants.nih.gov/grants/new_investigators/resources.htm#definition.)

Program Infrastructure:

Steering Committee: Principal investigators from each research team, the Research Coordinating Unit Principal Investigator, and the NIH staff will comprise this committee. The committee will establish policies and procedures for the RFA program such as approaches to coordination of protocol development, selection of common measures, monitoring and development of new investigators, selection and approval of ancillary studies, and establishment of a dissemination plan.

Investigators meetings: Biannual meetings of investigators from all funded studies will be held to enable sharing and collaborative problem solving. Applicants should budget for key investigators to attend two-day biannual meetings in the Bethesda area. In addition, applicants are required to participate in monthly conference calls for scientific exchange.

Ancillary studies: As resources and programs develop in each network team, it is anticipated that new research opportunities will arise. Ancillary studies can be proposed and submitted to NIH and other funding sources for peer-reviewed research project grants.

Program Organization and Coordination

The clinical trials supported by this FOA will not use a common study protocol. However, after awards are made and whenever possible, investigators must collaborate to develop and report standardized measures of key common variables, such as height, weight, waist circumference, percent body fat, and other characteristics. This FOA strongly encourages the use of common study variables, criteria, and measurement protocols to facilitate meta-analysis of the studies when possible.

Research Coordinating Unit (RCU)

Please refer to FOA RFA-HL-10-005 for RCU functions and information on applying as a RCU. Applicants can propose to perform the research coordination functions alone or conduct the clinical trial alone. The PI/PD for the clinical trial must not be the same PI/PD for the RCU. However, the PI/PD for the clinical trial can come from the same institution as the PI/PD for the RCU.

NHLBI Data and Safety Monitoring Committee: One or more NHLBI-appointed DSMBs will review study protocols and provide oversight of recruitment progress, data quality and completeness, efficacy monitoring, and participant safety. The DSMB will report to the NHLBI. Applicants are required to include a data and safety monitoring plan in their application but the DSMB will be appointed by the NHLBI.

Metrics to Evaluate Success of Proposed Program

Metrics will be established by the Steering Committee after award. Examples of metrics include:

Selected Research Examples

The following are examples of areas of research that would be responsive to this FOA. However, applicants will design and implement their own research and are not limited to the following examples:

Examples of research recommendations are also available at http://www.nhlbi.nih.gov/meetings/workshops/child-obesity/index.htm. As recommended by the recent Cochrane review on childhood obesity prevention studies, interventions must be accompanied by the following: careful evaluation design that explore what is working or not and for whom, be generalizable and have high impact and promise for sustainability, include stakeholders (families, school and environments) in decision making, use qualitative methods to inform intervention design, report on the developmental and design stages of interventions, and include process measures, cost-effectiveness analysis and appropriate statistical analyses.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Research Project Cooperative Agreement (U01) grant mechanism. The applicant institution’s Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) 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."

2. Funds Available

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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Faith-based or Community-based Organizations

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The PD/PI must have the necessary expertise to lead this effort. He or she must be an experienced investigator in childhood obesity research, be able to lead a collaborative effort and must establish and/or nurture existing and ongoing partnerships.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement. However, third party in-kind matching contributions could be proposed to promote participation of a diverse group of multidisciplinary teams and to encourage partnerships with agencies. Applicants who propose matching or in-kind financial contributions will be held to the requirement financially and must provide evidence (e.g., letter of support) of such contribution.

3. Other-Special Eligibility Criteria

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct and from different principal investigators.

Awards for a Clinical/Field Center and a Research Coordinating Unit (RCU) will not be made to the same Principal Investigator to ensure that pooled data analyses and data acquisition are performed independently.

An institution may submit an application for both a RCU and a Clinical/Field Center, but each must have a different PD/PI.

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 funding opportunity must be typed in item (box) 2 only of the face page of the application form, and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. The PDs/PIs must devote at least 2.4 calendar months/year (not less than 20% effort/year) to the study.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

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
Letters of Intent Receipt Date: September 8, 2009
Application Receipt Date: October 6, 2009
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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 copies of the appendix material must be sent to:

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

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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 NIH Grants Policy Statement.

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 award if such costs: (1) are necessary to conduct the project, and (2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new 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 and Information

Additional information or answers to questions on submission requirements are at: http://www/funding/inits/faq-hl-10-004andhl-10-005.htm

For cooperative agreements, awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A "Award Administration Information."

Research Plan Page Limitations

The research plan may not exceed 25-pages.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by National Heart, Lung, and Blood Institute (NHLBI) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project? Does the PD/PI devote enough time (at least 20% effort or 2.4 calendar months) for the research? Are there well established collaboration and partnerships with other agencies? Are the infrastructure requirements adequately developed? Is there evidence of partnerships with community/local, state and national organizations, or professional societies? Is there evidence of a multidisciplinary and diverse team of investigators? Is there a new/young investigator or an investigator from underrepresented racial/ethnic group included in the team of investigators? Is there evidence that the PD/PI and investigative team will participate in DSMB, bi-annual and monthly meetings?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Is the intervention novel? For example: Does the intervention build on successes and failures of previous childhood obesity prevention and treatment research and propose new areas of investigation?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the applicant acknowledge the successes and failures of past research in the literature and use such knowledge to design and implement the study? Is the study likely to have high participation and/or adherence rates? Are the proposed recruitment and retention strategies adequate?

Is the sample size adequate and is the study adequately powered to detect intervention effects? Is there sufficient evidence and justification that the effect size can be achieved through the proposed intervention in the allotted time in the proposed study population? Are the statistical analyses appropriate for the design and unit of randomization selected?

Does the study intervene on a combination of multiple factors, levels (e.g., individual and environment) and settings (e.g., home and school, family and clinic)? Are mediating and/or moderating variables assessed?

Is the research proposed in Phase I of the project appropriate for the aims of the clinical trial proposed in Phase II of the project? Is the process or plan for using formative research from Phase I to refine the Phase II intervention adequately described? Are clear, objective criteria and milestones proposed to ascertain the success of Phase I to warrant progression to the Phase II trial?

Are the informed consent procedures, data collection, quality control, and data management appropriate?

For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

2.A. Additional Review Criteria:

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

2.B. Additional Review Considerations

Please see FOA HL-10-005 for review considerations pertinent to the Research Coordinating Unit.

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm);

2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

3. Anticipated Announcement and Award Dates

Earliest Anticipated Announcement and Award Date: June/July 2010.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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 12 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

The FOA uses the cooperative agreement (U01) grant mechanism.

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 (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).

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 following 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.

The administrative and funding instrument used for this program will be the cooperative agreement 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 below.

2. A.1. Awardee Rights and Responsibilities

The awardee (s) will have the primary and lead responsibilities for the project as a whole, including, for example, research design and protocol development, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, as well as collaboration with other awardees, and with assistance from the NIH Project Scientists.

Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and governance. Within three years of the end of the period of NIH support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance and with 2.A.2, paragraph 3 below. In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NIH immediately upon completion of the three year period following the end of the period of NIH support.

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.2. NIH Responsibilities

The NIH Project Scientists have substantial scientific and/or programmatic involvement during conduct of this activity, through scientific and technical assistance, advice and coordination above and beyond the levels required normally for program stewardship of grants, as described below:

The NIH Project Scientist will serve on the Steering committee; he/she or other NIH scientists may serve on other study committees, when appropriate. The NIH Project Scientist (and other NIH scientists) may work with awardees on issues coming before the Steering Committee and DSMB, and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

The NIH reserves the right to phase out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of the protocol, major change in scope, or substantive changes in the agreed-upon protocol with which NIH cannot concur; (d) attainment of a major study endpoint before schedule with persuasive statistical significance; or (e) human subject ethical issues that may dictate a premature termination.

Partnerships with community agencies, clinics, industry are encouraged in this FOA and may be advantageous and appropriate.

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 assigned program director may also serve as an NIH Project Scientist.

2.A.3. Collaborative Responsibilities

A Steering Committee, composed of the principal investigator(s) of each field site, the principal investigator of the Research Coordinating Unit, and the NIH Project Scientists will be the main governing board of the study and will have primary responsibility for facilitating the conduct and monitoring of studies, and reporting study results. The Steering Committee will establish subcommittees, and members of the Steering Committee including the Project Scientist will serve on subcommittees as they deem appropriate.

Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the principal investigators (i.e., cooperative agreement awardees) including a Chairperson selected by the Steering Committee, and the principal investigator from the Research Coordinating Unit, and the NIH Project Scientist. Meetings of the Steering Committee will ordinarily be held by telephone conference call or face-to-face in the Bethesda/Washington, D.C. Metro Area.

Each full member of the Steering Committee will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

A Data and Safety Monitoring Board will be appointed by the Director, NHLBI, to provide overall monitoring of interim data and safety issues; the Steering Committee will nominate members for this Board but the final decision on membership will be made by the NHLBI. Meetings of the Data and Safety Monitoring Board will ordinarily be held in Bethesda/Washington, D.C. Metro Area. An NIH scientist other than the NIH Project Scientist shall serve as Executive Secretary to the Board. An independent Protocol Review Committee, established by the NIH, will provide peer review for each protocol. Because the Board serves as an independent group advisory to the NHLBI, study investigators will not communicate with Board members regarding study issues, except as authorized by the Board’s Executive Secretary.

Each awardee designs and implements his/her own protocol and analyzes own data. However, for analysis of data that are common for all studies, collaborative protocols (e.g., manuscripts from two or more sites), and governance policies will call for the continued submission of data centrally to the Coordinating Unit for a collaborative database; the submittal of copies of the collaborative datasets to the RCU upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NIH Project Scientist, on behalf of the NIH, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.

Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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.

Procedures for resolving disagreements between grantee and the Steering Committee (e.g., policies related to collaborative activities (e.g., use of common measures) will be resolved through a similar arbitration panel.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

We encourage 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:

Charlotte A. Pratt, PhD, RD
Program Director
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
MSC 7936, Room 10018
Bethesda, MD 20892
Tel.: (301) 435-0382
Fax: (301) 480-5158
E-mail: prattc@nhlbi.nih.gov

Terry T-K Huang, PhD, MPH
Director, Obesity Research Strategic Core
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B11
Bethesda, MD 20892-7510 (regular mail)
Rockville, MD 20852-7510 (courier)
Telephone: (301) 594-1846
Fax: (301) 480-9791
Email: huangter@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Ms. Kim Stanton
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge II, Room 7167
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0159
FAX: (301) 480-1948
Email: stantonk@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40-hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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