Site Specific Approaches to Prevention or Management of Pediatric Obesity

RFA Number: RFA-DK-04-013

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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov)
National Cancer Institute (NCI/NIH), (http://www.nci.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR/NIH), (http://obssr.od.nih.gov/)
Office of Disease Prevention (ODP/NIH), (http://odp.od.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)


Announcement Type
This is a new announcement

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

Catalog of Federal Domestic Assistance Number(s)
93.847, 93.399, 93.865

Key Dates
Release Date: October 26, 2004
Letters of Intent Receipt Date(s): December 23, 2004
Application Receipt Date(s): January 24, 2005
Peer Review Date(s): June-July 2005
Council Review Date(s) : September 2005
Earliest Anticipated Start Date: September 30, 2005
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 25, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this RFA is to invite qualified scientific investigators to submit applications designed to develop and test intervention approaches for the prevention or management of overweight in children and adolescents through age 20 years. The focus is on utilizing specific sites where children and adolescents can be reached through innovative overweight prevention or weight management interventions.

The participating ICs intend to commit approximately 5.8 million dollars in FY 2005 to fund 8-12 new grants in response to this RFA. This funding opportunity will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanisms. The total project period for an application in response to this RFA may not exceed the following durations: 2 years for the R21, and 5 years for the R01. Exploratory/developmental grant applications are highly encouraged.

Organizations that have any of the following characteristics may submit applications: For profit or non-profit, public or private institutions, such as universities, colleges, hospitals, and laboratories, units of State and local governments, domestic institutions/organizations, faith-based or community-based organizations.

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 programs.

Applicants may submit more than one application, providing there is no scientific or budgetary overlap. The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    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
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative 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. Award Criteria
    4. 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

Nature of the research opportunity

The purpose of this RFA is to encourage the development and empirical testing of intervention approaches to prevent or manage overweight in children and adolescents: capitalizing on the strengths of various sites in which such, interventions can be delivered. It is anticipated that responsive applications will generally be in the form of clinical trials, that is, prospective studies involving a behavioral or biomedical intervention in one or more groups of human subjects, with appropriate control or comparison groups. This RFA targets interventions that focus on behavioral or environmental modifications either individually or, where appropriate, in combination. Recognizing that previous studies done in isolation within various sites have shown limited efficacy, applications that examine approaches across two or more sites are encouraged. Research applications that include the home/family as a site are especially encouraged, emphasizing the influence of parents as role models, gatekeepers for food and beverage access, screen time, and physical activity opportunities. The goal is to test strategies that will foster energy balance to prevent inappropriate weight gain in children who are not overweight, to achieve age-appropriate body weight in those at risk of becoming overweight, or to reduce degree of overweight in those who are already overweight. In addition to efficacy trials, effectiveness studies for prevention or management of overweight that can be delivered in or across specific sites and that have compelling preliminary data also would be responsive to this announcement. Efficacy studies of targeted interventions are expected to contribute towards incremental knowledge in understanding how to better control continuing increases in overweight among youth at the various sites they frequent. These and related investigations are intended to pave the way for effectiveness studies that test the extent to which interventions can be generalized to other sites or populations. Priority studies include: 1) child care centers, pre-schools, and other sites for youth age 2 to 5 years; 2) community recreational centers and community organizations frequented by youth, which can create social systems that support behavioral action and maintenance; and 3) home/family.

Background on extent of overweight, prevention or management of overweight in children and adolescents, and sites in which relevant research may be conducted:

Among children ages 2 to 20 years, overweight is currently defined as a body mass index (BMI) greater than or equal to the ninety-fifth percentile of the 2000 CDC BMI-for-age growth charts. At risk-of-overweight is defined as BMI greater than or equal to the eighty-fifth and less than the ninety-fifth percentile. Children at higher levels of overweight (weight for a given stature in excess of age- and sex-specific BMI reference cutoff values) also may be obese (excess total body fat). Hence, at higher BMI levels the terms overweight and obese are often used interchangeably. Based on the most recent national survey data from NHANES, more than 20 percent of all U.S. children ages 2-5 years and more than 30 percent ages 6-19 years are at risk of overweight or are overweight (BMI greater than or equal to the eighty-fifth percentile). Among youth ages 6-19 years who are overweight (BMI greater than or equal to the ninety-fifth percentile) Mexican-American boys (25.5 percent) and non-Hispanic black girls (23.2 percent) are disproportionately affected.

One of the most striking features about BMI in children and adolescents is that it tends to track over time and especially with increasing age it becomes predictive of weight status in young adult years and beyond. A fairly comprehensive scientific literature indicates that overweight status is associated with numerous adverse health outcomes that are associated with premature morbidity and mortality, and through overweight prevention or management this can be ameliorated.

Prevention and management encompass various levels of age-appropriate weight status based on the 2000 CDC BMI-for-age growth charts for boys or girls:

Primary prevention: prevention of inappropriate weight gain in youths currently at a healthy weight (BMI less than the eighty-fifth percentile).

Secondary prevention: prevention of further weight gain in youths currently at risk of overweight (BMI greater than or equal to the eighty-fifth percentile to less than the ninety-fifth percentile).

Tertiary prevention: in youths already overweight (BMI greater than or equal to the ninety-fifth percentile),

a) Prevention of further weight gain (i.e., weight maintenance),

b) Prevention of weight regain among those who have lost weight.

Secondary and tertiary prevention are consistent with interventions for the management of overweight.

Site-specific intervention approaches that include weight loss in overweight children or adolescents are considered a part of overweight management and therefore, would be responsive to this RFA.

For the purpose of this RFA, the various sites can be defined as places where children and adolescents through age 20 years spend the majority of their time and where they can be reached through overweight prevention or weight management interventions. The primary care provider (PCP) alone as a site is specifically excluded because this has been addressed in a separate targeted initiative (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-020.html). However, community health care settings, e.g., the role of WIC clinics in public health departments, or school-based health care settings that utilize school health professionals (e.g., health educators, physical educators, school health nurses, school health councils) or use of coordinated school health and/or school-based health centers will be considered, as will approaches that include the PCP in combination with one or more other sites to facilitate or enhance a trans-community approach.

Examples of sites include, but are not limited to the following:

  1. Home/family: A site where intervention research is dedicated to the role and mechanism of families in the initiation, support, and reinforcement of fundamental food and beverage consumption, physical activity practices, and sedentary behaviors, or behavioral determinants associated with these practices.
  2. School: A site where intervention research can be conducted to increase knowledge, influence attitudes and dietary and physical activity behaviors, and leverage the role of peer influence.
  3. Community: a) Institutional (e.g., daycare/preschool, after-school care, faith-based, community/recreational centers, YMCA, summer camp, etc.) and b) Environmental (e.g., playgrounds, walk/bike paths, shopping malls, etc.)
  4. Integrated trans-community: A more comprehensive approach to prevent or control childhood obesity might be one that integrates two or more of the various individual community sites, school, home/family, and other key influential entities that constitute the community.
  5. Innovative collaborations and modalities (e.g., Internet, media, industry as a site/partner)

There is considerable evidence that the nature of energy imbalance is primarily influenced by excessive energy intake, insufficient energy expenditure, and the associated behaviors that influence dietary energy intake, energy output through volitional physical activity, as well as sedentary behaviors that all may contribute to retention of excess stored energy in body fat depots. Energy intake and energy expenditure in children occur across the spectrum of sites in which they typically spend the majority of their waking hours. Therefore, it is essential to develop and test intervention approaches that address energy balance influences within the context of sites that are part of the dynamic contemporary environment in which children and adolescents routinely live, learn, play, and engage in social interactions that often revolve around energy intake and expenditure.

A variety of intervention trials have been conducted in various sites where children can be reached, notably the school site. Various school-based studies have actually achieved moderate levels of change in dietary and physical activity knowledge, attitudes, and even behaviors. However, the impact on measured BMI, body weight, and body composition or other variables such as blood pressure, or blood lipids, blood glucose or insulin, or the conditions associated with these biomarkers has been limited. A common finding in some studies indicates that family involvement and parent modeling emerged as a crucial component across the various studies. Recognizing that approximately 2/3 of all calories are still consumed at home, the role of the home site as a major source of energy intake may be considered. Another common theme, which emerges from previous research, is that an individual level focus is important, but environmental level factors may be considered as well.

School based or other site-specific studies conducted in isolation may not be sufficient to achieve either short term or sustained prevention or management of overweight. The continuity, reinforcement, and synergy gained from trans-site approaches that integrate the concepts, behaviors, and the means to achieve them may benefit from sites that are connected. For example, linkages between the school site, after school sites, community sites, and the home site are avenues for further exploration of connected intervention approaches. School-based interventions that are conducted in combination with one or more other sites would be responsive to this announcement.

Examples of research that would be considered responsive to this RFA include, but are not limited to, the following:

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

Section II. Award Information

1. Mechanism(s) of Support


This funding opportunity will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.


2. Funds Available

The participating IC(s) NIDDK, NCI, OBSSR, ODP, and NICHD intends to commit approximately 5 million dollars in FY 2005 to fund 8-12 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 2 years for R21 applications and 5 years for R01 applications and a budget for direct costs up to 275,000 dollars over 2 years for R21 applications and up to 500,000 dollars direct costs per year for R01 applications .

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 and the receipt of a sufficient number of meritorious applications. Fiscal and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-04-040.

Section III. Eligibility Information

1. Eligible Applicants


1.A. Eligible Institutions

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

1.B. Eligible Individuals

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

Interaction is encouraged between NIH-funded investigators and investigators at CDC Prevention Research Centers, a national network of 28 academic research centers that engage communities as participants in research on preventing chronic diseases such as cancer, heart disease, and arthritis. Information about CDC Prevention Research Centers may be found at: http://www.cdc.gov/nccdphp/bb_prc/index.htm.

2. Cost Sharing
Cost sharing is not required for this RFA.

3. Other-Special Eligibility Criteria

Applicants should include plans to assess the feasibility of the intervention for long-term use by the target population. This process evaluation should address adherence, acceptability, and ease of delivery of the intervention. It is anticipated that some interventions may be ongoing up to the point of assessment, whereas others may include a brief, defined intervention with post-intervention follow-up at a later time.

Full-scale trials supported by the R01 mechanism should include preliminary data. The primary outcome must be a measure of obesity appropriate for children, such as comparison of change in BMI between randomized groups, change in BMI percentile or BMI z-score (SD units), and/or measures of body composition. Regardless of the duration of intervention, outcomes at 2 years post-randomization should be assessed. Secondary outcomes relating to health, independent of weight loss or weight maintenance are encouraged, and should be assessed where feasible. These outcomes may include assessment of factors such as insulin resistance, blood pressure, lipids, fitness, quality of life, economic impact, and psychosocial status. Applicants also may evaluate the effects of intervention on other factors such as body composition (e.g., percent body fat, bone density, visceral adiposity).

For exploratory/developmental studies [R21's], preliminary data are not required but may be included if available; measurements must be made at the end of the intervention period and a minimum of six months post-randomization. Outcome measurements at 12 months post-randomization are encouraged, if feasible. For R21 pilot studies objective primary outcome measures of behavior change that would be expected to lead to prevention of weight gain are acceptable (for example, showing increased walking as measured by accelerometry, increase in percentage of children walking to school, or decreased television viewing measured by a tracking device). In the case of pilot studies, change in weight or body fat, if not the primary outcome, should be measured as a secondary outcome wherever feasible.

Regardless of funding mechanism (i.e., R21 or R01) the study should include a comparison group or control intervention with adequate justification of the active intervention-control comparison. With the exception of R21 pilot studies, sample size calculation should be included. Eligibility criteria as well as recruitment and retention strategies should be well specified.

Applicants are encouraged to collaborate with one or more groups or organizations that will participate in the development and/or implementation of the overweight prevention or management intervention (including but not limited to schools, faith-based or community organizations, health care sites, parks and recreation centers, health clubs or exercise facilities). A letter of intent to collaborate from this organization should be included with the application, describing the proposed collaboration in detail.

Although an applicant may submit more than one application, there must be no scientific or budgetary overlap in multiple application submissions.

If the application includes a clinical trial with human subjects, then the application must also include a data and safety monitoring plan. Each application for a clinical trial should address data and safety monitoring at least in general terms. A detailed data and safety monitoring plan, if not included in the application must be approved by program staff for all clinical trials prior to issuance of an unrestricted award.

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. 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 PHS 398 research grant application instructions and forms (rev. 5/2001). 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 line 2 of the face page of the application form and the YES box must be checked.


3. Submission Dates
Applications must be mailed on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: December 23, 2004
Application Receipt Date(s): January 24, 2005
Peer Review Date: January 24, 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 30, 2005


3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:


Robert J. Kuczmarski, Dr.P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 673
Bethesda, MD 20892-5450
Telephone: (301) 451-8354
FAX: (301) 480-8300
Email: kuczmarskir@extra.niddk.nih.gov


3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five 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)

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.


4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Award Criteria).

6. Other Submission Requirements

This RFA is a one-time solicitation. Future unsolicited, competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Applications that are not funded in the competition described in this RFA may be resubmitted as new investigator-initiated applications using the standard receipt dates for new applications described in the instructions for the PHS 398 application.

The Exploratory/Developmental (R21) grant mechanism is used to support exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. Applications submitted under this mechanism should be exploratory and novel. Preliminary data are not required but may be included if available. More information about the R21 mechanism can be obtained at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

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

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria
This announcement does not require cost sharing

2. Review and Selection Process

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

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

3. Merit Review Criteria

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

1. Significance . Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. 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?

3. 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?

4. Investigators . Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment . Does the scientific environment 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?

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).


3.B. Additional Review Considerations

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

3.C. Sharing Research Data

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

3.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Award Criteria.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

2. Administrative Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Robert J. Kuczmarski, Dr.P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 673
Bethesda, MD 20892
Telephone: (301) 451-8354
FAX: (301) 480-8300
Email: kuczmarskir@extra.niddk.nih.gov

Amy Lazarus Yaroch, Ph.D.
Health Promotion Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd / EPN 4074
Bethesda, MD 20892-7335
Telephone: 301-402-8425
FAX: 301-480-2087
Email: yarocha@mail.nih.gov

Deborah H. Olster, Ph.D.
Office of Behavioral and Social Sciences Research
National Institutes of Health
One Center Drive, 1/256
Bethesda, MD 20892-0183
Telephone: (301) 451-4286
FAX: (301) 402-1150
Email: olsterd@od.nih.gov

Martina Vogel-Taylor
Office of Disease Prevention
National Institutes of Health
Bldg. 31, Room 1B-03
Bethesda, MD 20892-2082
Telephone: 301-496-6614
FAX: 301-480-9654
Email: vogelm@od31eml.od.nih.gov

Lynne Haverkos, MD, MPH
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B05G
Bethesda, MD 20892-7510
Telephone: 301-435-6881
FAX: 301-480-0230
Email: haverkol@mail.nih.gov

2. Peer Review Contacts:
Not Applicable

3. Financial or Grants Management Contacts:

Florence Danshes
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 734
Bethesda, MD 20892
Telephone: (301) 594-8861
Email: danshesf@mail.nih.gov

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd., Suite 243
Bethesda, MD 20892
Telephone:(301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@gab.nci.nih.gov

Lisa Moeller
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., 8A17
Bethesda, MD 20892-7510
Telephone: 301-496-5482
FAX: 301-402-0915
Email: moellerl2@mail.nih.gov

Section VIII. Other Information

Required Federal Citations


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

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.

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

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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