Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

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

Title:  Targeted Approaches to Weight Control for Young Adults (U01)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-HL-08-007

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates
Release/Posted Date:  April 8, 2008
Letters of Intent Receipt Date(s): September 10, 2008
Application Due Date(s):  October 10, 2008
Peer Review Date(s): February-March 2009 
Council Review Date(s): May 2009
Earliest Anticipated Start Date(s): June 2009  
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: October 11, 2008

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 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. 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. Submitting an Application Electronically to the NIH
    C. Application Processing   
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 Contacts
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

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) invites applications for cooperative agreements (U01) to conduct two-phase clinical research studies to develop, refine, and test innovative behavioral and/or environmental approaches for weight control in young adults at high risk for weight gain.  Weight control interventions can address weight loss, prevention of weight gain, or prevention of excessive weight gain during pregnancy.  The first phase will consist of formative research to refine the proposed intervention, recruitment, retention, and adherence strategies targeted to young adults.  The second phase will consist of a randomized controlled trial to test the efficacy of the intervention.  For the purpose of this FOA, young adults are defined as 18-35 years of age.

Background

After many years of declining coronary heart disease (CHD) mortality rates, recent national age-specific data suggest a possible increase in the CHD death rate among young adults.  While CHD and its risk factors have been rare at age 20, these new data suggest that these conditions may be increasing, and recent successes in reducing CHD mortality may be reversed in future years.  Data from the Coronary Artery Risk Development in Young Adults (CARDIA) Study suggest that excess weight gain in early adulthood adversely impacts development of multiple CHD risk factors, such as hypertension, dyslipidemia, and diabetes.  Mean CHD risk factor levels remained relatively unchanged in adults, initially aged 18-30, who maintained a stable weight over 15 years even if already overweight at baseline, whereas risk factor levels steadily increased in weight gainers.  These data suggest that if further weight gain is avoided early in adulthood, risk factor progression may be reduced or prevented and more adults will enter middle age at low CVD risk.  Low CVD risk status in middle age is linked to lower CVD morbidity and mortality, lower health care costs, increased life expectancy, and higher quality of later life. 

Yet, young adults are at higher risk for weight gain than older adults.  In the US, adults ages 25-74, major weight gain over 10 years (BMI gain = 5 kg/m2) was highest at ages 25-34.  The prevalence of overweight and obesity is already high by age 18-30, and is higher among minorities.  Overweight and obesity in US 18-30 year olds was more prevalent among Mexican Americans (58%) and African Americans (59%) than whites (49%).  In CARDIA, peak aging-related weight gain over 15 years was highest in the early 20s (~3 lb/year).  Overall mean 20-year weight change was over 30 pounds, and was higher among African-American women (45 lb) and men (38 lb) than whites (27-30 lb).   Despite this high risk for weight gain, few weight control studies have focused on young adults.  The few studies on young adults tend to be small or conducted in primarily white adults, limiting their generalizability. 

Proven weight loss strategies in older adults may be effective in young adults, although they have generally not been tested in this age group.  In adult weight loss studies with broad age ranges, only a small percent of young adults usually enroll and many dropout.  Investigators suggest that the attrition is due to the broad age range of the intervention groups.  However, other factors may be important too, requiring that intervention, recruitment, retention, and adherence strategies be targeted to young adults.  To do this, a better understanding of influences and barriers for young adults is pivotal in developing interventions that will appeal to this age group.  Influences on obesity-related behaviors—particularly dietary intake and physical activity—are multi-factorial, including physiology, family, peers, community, culture, and the environment.  Such influences may differ in their importance to young adults.  For example, this age group may be more sensitive to peer pressure than older adults.  Retention and adherence to interventions also may be affected by having fewer economic resources at this age.  Young adults may be less motivated to adopt and maintain healthy behaviors because they perceive health consequences to be distal, as most will not have developed CVD risk factors by this age.  Barriers to successful interventions also may arise from the transitional nature of this life stage, characterized by increased independence from families, high mobility, entry into the work force, marriage, and parenthood.  Further, there may be unique influences and barriers related to being both a young adult and an ethnic minority. 

Objectives and Scope

The purpose of this FOA is to fund two-phase clinical research studies to develop, refine, and test innovative behavioral and/or environmental approaches for weight control in young adults.  Ethnically- and socioeconomically-diverse adults, ages 18-35, at high risk of weight gain (e.g., having an overweight parent, postpartum women, becoming a parent) will be targeted.  Weight control interventions can address weight loss, prevention of weight gain, or prevention of excessive weight gain during pregnancy.  It is anticipated that each study would focus on a specific subset of this target population depending upon the research question(s).  Programmatic balance among funded studies is desired with respect to ethnicity, age, intervention settings, and research questions. 

Each proposed study will consist of two phases: (1) formative research to refine the proposed intervention, recruitment, retention, and adherence strategies; and (2) a randomized controlled trial (RCT) to test the feasibility and efficacy of the intervention.  Phase I is estimated to last 1-2 years, while Phase 2 is to test at least a 24-month intervention.  The total duration of the study should not exceed five years.

Phase 1

This formative phase consists of research to refine the intervention by better understanding influences and barriers to successful intervention implementation or recruitment, retention, and adherence among the targeted young adults.  While approaches should build on proven strategies in other age groups, they will need to be targeted to young adults.  The formative phase will provide empirical evidence with which to target interventions. Interventions should be innovative and appealing to young adults.  Priority will be placed on funding trials that test the efficacy of interventions which have the potential to be practical, cost-effective, sustainable, and easily disseminated on a broad-scale. 

Targeting of interventions to make them more attractive to young adults may use one or more approaches.  Interventions that incorporate media often used by this age group, such as internet, chat rooms, iPods, or cell phones are encouraged.  The use of these and other technologies may appeal to young adults, as well as reduce participant burden.  Environmental approaches using local media campaigns (e.g., posters, radio spots, public service announcements) may be considered, either alone or in combination with individually-based intervention strategies.  Successful or promising approaches for this age group aimed at changing other health-related behaviors, such as smoking, alcohol use, and illicit drug use may also be used.  Some promising approaches have capitalized on consumer marketing research, which has been highly successfully at reaching this age group.  For example, studies have shown that advertisements utilizing lifestyle or image appeals are generally preferred to product-oriented ones, and advertisements using animals, animated characters, celebrity endorsers, and youth-oriented music are appealing to youth.  Tobacco marketers employ messages that resonate with smokers’ needs and aspirations, which may be critical for this transitional life stage.  Social networks and other approaches that utilize peer influence might also be considered, e.g., peer-led groups or peer-peer counseling.  Multidisciplinary teams are encouraged to facilitate the exchange of methods and successes for this age group from a variety of fields.     

Methods appropriate for this phase may include further analysis of existing data, focus groups, small-scale surveys, and/or pilot testing.  Plans for Phase 1 research projects should be described in the application, and should lead to improved intervention, recruitment, retention, and adherence strategies.  Examples of topics to be addressed in Phase 1 include but are not limited to:  feasibility of internet interventions among targeted race-ethnic groups and genders; development and pilot testing of interactive software to provide the intervention; and small-scale surveys or focus groups to identify barriers to recruitment and retention.  Specific criteria and milestones for successful completion of Phase 1 should also be included.  Phase 1 could be optional or shortened for some applicants who already have sufficient Phase 1 information.  Such information should be presented in the application to support and justify the proposed components of the Phase 2 study.

Phase 2

During the second phase, each study will conduct at least a 24-month randomized controlled trial to test a behavioral and/or environmental intervention for weight loss or prevention of weight gain in young adults, ages 18-35, at high risk of weight gain (e.g., having an overweight parent, postpartum women, becoming a parent). 

Applicants must describe the proposed Phase 2 intervention in their application; some refinements may be anticipated based upon the formative research in Phase 1. The process for using formative research from Phase 1 to refine the Phase 2 intervention should be described. Applicants should present available background material and pilot data that are relevant to the proposed intervention, and describe and justify the innovative aspects of their intervention. Studies must be designed such that the intensity and frequency of the intervention are sufficient to effect change in outcome measures.   

Trials may use either an individual- or cluster-randomized design.  The design should include at least two randomized groups:  an intervention group and a comparison group.   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 secondary targets of the intervention (e.g., increased physical activity, improved dietary habits), and the statistical analyses to be conducted.   Proposed sample sizes with supporting power calculations should be described.  The clinical trials can be single or multi-site.  If interventions are environmental or involve an environmental component, collaborations and ties should be demonstrated with the community or institutions in which the intervention will be provided, including letters of support.

Change in weight or body mass index (BMI) since randomization must be the primary outcome.  Potential secondary outcome measures include, but are not limited to change in the following:  objective measures of physical activity (such as by accelerometer), dietary intake, cardiorespiratory fitness, and CHD risk factor levels (e.g., systolic blood pressure, lipids, fasting glucose, or composite measures, such as the metabolic syndrome).

Because young adults are largely asymptomatic and often do not seek medical attention, interventions must be developed so that they can be implemented in settings frequented by young adults, if effective.  Universities, colleges, and trade schools provide a venue for intervention for many young adults.  Pregnant women and new parents might be open to interventions that could additionally have positive effects on their children’s health; thus, possible settings include pediatric or obstetrics practices, well-baby clinics/programs, WIC, and parenting classes.  Interventions should take advantage of these and other important life events that may provide opportune settings or strong motivations for behavioral and environmental changes. 

Some examples of research questions appropriate for this FOA include, but are not limited to, the following:

Applicants should provide preliminary evidence of their ability to recruit participants, to provide appropriate oversight of participants, and to maintain high rates of participant follow-up throughout the intervention. Studies should incorporate quality control procedures for measurements, data collection, and data management, as well as for assuring fidelity to intervention delivery.

The NHLBI Clinical Research Guide at http://www.nhlbi.nih.gov/crg/index.php, provides helpful information for preparation of clinical study applications.

Areas of research that will not be considered responsive to the FOA include: formative research only and study populations that include participants outside the young adult age range (i.e., 18-30). 

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 should collaborate on developing and reporting standardized measures of key common variables, such as height, weight, dietary intake, blood pressure, physical activity, smoking status, and population characteristics.  Investigators may also collaborate in the development of formative assessment measures, such as survey instruments and focus group guidelines.  The use of common study variables, criteria, and protocols to facilitate meta-analysis of the studies when possible is highly encouraged. 

Investigators should indicate in their application their willingness to collaborate on the development and use of standardized measurement protocols, identification of eligibility criteria, formative assessment methods, data analysis, and their willingness to collaborate with NHLBI scientists in all aspects of the study.  The cooperative agreement mechanism will be used and a Steering Committee formed to facilitate collaboration (see Section VI.2.A , Cooperative Agreement Terms and Condition of Award.)

Each awardee is responsible for refining and finalizing their protocols and for conducting the research.  Awardees should oversee implementation of their interventions and adherence to their protocols, and assure appropriate quality control procedures are in place.  Each awardee will be responsible for training and certification of their personnel.

The NHLBI will be substantially involved with the awardees in a partnership.  The NHLBI Program Scientist will monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and assure adherence to NHLBI policies.  NHLBI will appoint a Data and Safety Monitoring Board (DSMB) and appoint a chairperson of the Steering Committee among Principal Investigators.

A Steering Committee will be an important body for this project.  The Steering Committee is composed of the Principal Investigators of the RCTs and the NHLBI Program Scientist, each of whom will have one vote.  The Steering Committee will meet in-person three times a year for the first year and twice per year thereafter.  The Committee will meet by teleconference on at least a monthly basis.

A DSMB will be established to monitor data and oversee participant safety in all of the studies supported by this initiative.  At the first meeting, the DSMB will review the awardees’ protocols.  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 twice each year.  At least one of the meetings each year will be in person.

A DSMB will be responsible for monitoring the funded projects and will report to the Director of the NHLBI.  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 review committee that will evaluate the applications for scientific merit. 

In addition to the DSMB meetings, each awardee will be required to attend Steering Committee meetings in which study plans, findings, and issues of common interests and concerns will be shared and discussed.   Each applicant should include in their budgets funds for attending these meetings.  For budgeting purposes, the applicants should assume that in addition to DSMB meetings, in-person meetings will be convened three times during the first funding year and twice a year for each funding year thereafter.  Applicants should assume for budgeting purposes that the meetings will be for two days in the Washington, DC, metro area and will require the attendance of the Principal Investigator and one other person. 

To facilitate coordination of research activities between awardees, this FOA will also support the costs of a Resource and Coordination Unit (RCU) by one of the awardees for this FOA.  In consultation with the awardees and NIH, the RCU will be responsible for conducting a number of tasks, including the following:

Applicants should propose to perform the resource and coordination functions in addition to conducting their own study.   Applicants should submit a separate budget for the RCU, including the cost of meeting rooms and equipment for in-person meetings (see Section II.2).  The evaluation of the RCU will be separate from the overall review of the scientific merit of the application (see Section IV. 2.B).  

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

Section II. Award Information


1. Mechanism of Support

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 an NIH cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) 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 PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

At this time, it is not known if this FOA will be reissued.

2. Funds Available

The NHLBI intends to commit up to $3.6 million in FY09 to fund 3 to 4 applications in response to this FOA.  For the two-phase research component, each applicant may request a project period of five years and a budget for direct costs of up to $3,000,000 over the five year period, including direct costs of up to $500,000 for the first year, $650,000 for the second year, $650,000 for the third year, $650,000 for the fourth year, and $550,000 for the fifth year. One of the awards will serve additionally as a Resource and Coordination Unit (RCU) to facilitate cross-study activities.  It is anticipated that the maximum award for the RCU will be approximately $675,000 in direct costs, including direct costs of up to $150,000 for the first year, $125,000 for the second year, $125,000 for the third year, $125,000 for the fourth year, and $150,000 for the fifth year.  The RCU costs are in addition to the two-phase research component costs.  A total of up to $18.85 million is available from NHLBI over the five-year period for the program.     

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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.

Facilities and Administrative (F&A) 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:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 (i.e., 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 and 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 electronic Research Administration (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 grant 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 the multiple PD/PI option, 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on lines 1 and 2 of the face page of the application form, and the YES box must be checked.

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. 

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. Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: September 10, 2008
Application Due Date: October 10, 2008
Peer Review Date(s): February-March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: June 2009

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 mail zip code: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 mail zip code: 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 or competing renewal 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 or competing renewal 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 the NIH Grants Policy Statement).

6. Other Submission Requirements and Information

Applications must include the following:

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Research Plan Page Limitations

N/A

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008, and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008, may voluntarily provide the appendix on five identical CDs; if submitting CDs, it is not necessary to include a paper appendix.  (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 comply with 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 and further the advancement of the 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 the 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 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 (e.g., 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 (go to 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 this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the 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:

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

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, and weighted 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 meritorious 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 advance? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

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? 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? Are the proposed intervention, recruitment, and retention strategies adequately targeted to young adults?  Is the Phase 1 research appropriate to the aims of the Phase 2 trial?  Is the process/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 1 to warrant progression to the Phase 2 trial?  Are the informed consent procedures, randomization procedures, intervention approaches, data collection, quality control, data management, and statistical analyses appropriate for the design and unit of randomization selected?  Are the sample size and statistical power adequate?  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? 

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 PD(s)/PI(s) and other key personnel 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? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Does the research team have sufficient formative research and clinical trial experience? Does at least one member of the research team have appropriate experience with targeting interventions to minorities if appropriate?  

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  If interventions are environmental or involve an environmental component, are collaborations and ties with the community/institutions to host the intervention sufficiently demonstrated, e.g., in letters of support?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating

Collaboration:   Have the investigators stated their willingness to collaborate with NHLBI staff and staff from other grants supported by this initiative?  Is there evidence that the applicant is willing to collaborate on the development of key common measures and measurement protocols, such as height, weight, CHD risk factors?

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 rating:

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 “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
 
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

Resource and Coordination Unit (RCU): The adequacy of the plan for the Resource and Coordination Unit (RCU) will be assessed by the reviewers.  However, reviewers will not factor the proposed RCU plan into the determination of scientific merit or the priority score.   Each plan will receive a secondary priority score specific to the RCU which is separate from the primary priority score of the parent application.  The following review criteria will be used:

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

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

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 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 (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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for:
The awardee(s) will have lead responsibilities in 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, unless otherwise provided for in these terms or by recommendation  of the Steering Committee.

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 DHHS, PHS, and NIH policies.

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.

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, 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 terminate 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 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.

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 NIH 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 NIH.

Additionally, an agency program official or NIH 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 

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), the NIH Project Scientist, and the Chairperson. Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the metropolitan Washington Area.

A Data and Safety Monitoring Board will be appointed by the Director, NIH to provide overall monitoring of interim data and safety issues; the Steering Committee will nominate members for this Board.  Meetings of the Data and Safety Monitoring Board will ordinarily be held in Bethesda.  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 NIH, study investigators will not communicate with Board members regarding study issues, except as authorized by the Board’s Executive Secretary.

The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating center for a collaborative database; the submittal of copies of the collaborative datasets to each principal investigator 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.

Each full member will have one vote. 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Catherine (Cay) Loria, Ph.D., M.S.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10118, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0702
Fax: (301) 480-5158
Email: loriac@nhlbi.nih.gov

2. Peer Review Contact(s):

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/Grants Management Contact(s):

Craig E. Bagdon, MPA
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7129, MSC 7926
Bethesda, MD 20892-7926
Telephone: (301) 435-0480
Fax: (301) 451-5462
Email: bagdonc@nhlbi.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) 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 institutional review board (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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 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 Part 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 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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