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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://nichd.nih.gov)
National Cancer Institute (NCI), (http://www.cancer.gov)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov)

Title: Systems-Oriented Pediatric Obesity Research and Training (SPORT) Center of Excellence (U54)

Announcement Type

New

Request For Applications (RFA) Number: RFA-HD-10-001

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.393, 93.394, 93.395, 93.396  

Key Dates
Release Date:  September 23, 2010
Letters of Intent Receipt Date(s): November 30, 2010  
Application Receipt Dates(s): December 30, 2010
Peer Review Date(s): March 2011
Council Review Date(s): May 2011 
Earliest Anticipated Start Date: July 2011
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 31, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Objectives 

The proposed initiative will create a specialized center of excellence for transdisciplinary, systems science-oriented research and training to understand, prevent, and control childhood obesity and obesity-related chronic diseases. The Center will encompass epidemiological research, evaluation or intervention research at the environmental or policy level, and systems science training as part of capacity-building. Basic science studies can be included, as appropriate.

Purpose and Rationale of the Initiative

The purpose of this initiative is to solicit applications for a specialized center of excellence on systems-oriented, multilevel research and training in childhood obesity. Systems-oriented research seeks to understand how socio-environmental factors enable or constrain obesity-related behaviors and how these behaviors are a function of the dynamic interplay of biology and the environment.  In addition, a systems-oriented approach is geared towards generating childhood obesity solutions that can be sustained by considering individual behaviors within the broader social, physical, and economic environment.  This initiative is designed to create the opportunity for “big science,” within which epidemiological research, basic science research, environmental and policy interventions, and systems science training can all be integrated.  This initiative also solicits a research resource core from each application that has the capability of setting up and maintaining a web-based, GIS-enhanced database platform with a rigorous metadata structure built in.  This effort is urgently needed to advance the science towards both effective and sustainable solutions for childhood obesity, a goal that is difficult to achieve based on existing research infrastructure and activities.    

The NICHD systems science agenda on childhood obesity research includes 6 key features (Huang & Glass, JAMA, 2008; Huang et al., PCD, 2009): 1) framing obesity as a complex systems problem, 2) setting cross-disciplinary, cross-level hypotheses at the outset of research, 3) testing and evaluating structural interventions at the environmental and policy levels, 4) capacity building including systems training, 5) developing and applying systems methodologies, and 6) maintaining a global perspective.  The current FOA aims to establish the kind of large-tent science within which all the goals of the systems agenda can be advanced.  The FOA will create the space, opportunity, and incentive for engaging in truly transdisciplinary (beyond multidisciplinary) collaboration, pushing the boundaries of intervention approaches, and laying the groundwork for a sustainable area of new science.  Transdisciplinary research and capacity building involve team members from different disciplines working collaboratively to address common problems using a shared conceptual framework and diverse methodologies that only integrate but cut across disciplinary perspectives.

A systems approach recognizes that individual dietary and physical activity behaviors occur not in isolation but as functions of both biological predisposition and the broader context, such that research requires the integration of systems biology and environmental and macrosocial systems, and the utilization of theories, frameworks, and methodologies from diverse disciplines (i.e., from genes to policy).  To date, research funded has not generated effective and sustainable solutions to the obesity epidemic, and increasingly, it is recognized that a whole-society approach is necessary to achieve that goal.

There are many possibilities for how macro-environmental factors interact with biological processes to impact dietary, physical activity, and obesity outcomes.  Fields such as neuroscience, epigenetics, stress research, behavioral economics, and the gut microbiome are emerging at an opportune time to help bridge biological and socio-environmental factors that regulate eating and activity patterns.  For example, the effect of food marketing can be examined in relation to reward and addiction pathways in the brain, which subsequently impact one’s susceptibility to consumption of certain foods.  Human imaging studies suggest that the brain has automatic approach responses to food compared to non-food objects and that these responses can be significantly influenced by product advertizing and pricing, which are in themselves a function of regulations and economic incentives.  

As another example, urban design and neighborhood safety may impact physical activity patterns via influences on stress pathways.  Social structures and economic stress may impact sleep patterns, which have been shown to influence endocrine regulation and obesity.  Different environmental backgrounds may produce different compositions of gut microbiota, which can result in differential nutrient absorption and energy partitioning, and impact subsequent food intake.  While food economics and policies may seem distally removed from individual energy balance, these macro-level factors can, in fact, affect what foods are available to and accessible by individuals.  Studies funded by the NICHD and others have shown that maternal diets can result in epigenetic programming in the fetus leading to a greater propensity for obesity and chronic morbidities later in life.  Furthermore, foods consumed by mothers can shape the taste preference of offspring via changing flavors in the breast milk, possibly through changes in neural pathways involved in reward and cognition.

Many other hypotheses can be posed linking the environment to biology to help explain obesity-related behaviors and outcomes.  However, at the present, this type of cross-disciplinary work has not been well facilitated by the existing research infrastructure. Even less frequent are evaluative or intervention research that takes the complex systems of obesity into account.  Therefore, new opportunities are needed for innovation in childhood obesity research that can lead to effective and sustainable prevention and control strategies.

Scope and Structure

This initiative will create the infrastructure and scientific investment for a new generation of obesity and chronic disease research to 1) simultaneously examine the influence of a wide range of biological and socio-environmental factors on obesity behaviors and outcomes in children and their families, 2) evaluate the downstream impact of environmental or policy interventions, and 3) train a new cadre of systems-oriented scientists to address complex public health issues such as childhood obesity.

Prospective applicants will be research teams representing biological, clinical, social, behavioral, and methodological sciences and other relevant fields of study. Each applicant will be a U.S. institution in partnership with at least one international institution.  If more than one international partner is chosen, these partners should be based in different countries to maximize geographic diversity. Applicants should provide justification for why the partners are chosen and how the partnership advances the science based on a systems-oriented framework.  For instance, international partners may be chosen based on the contrast of childhood obesity rates or socio-environmental characteristics or other unique advantages for comparative evaluation or intervention research.  US partnerships with foreign sites can also increase the variance of macro-level variables (necessary for meaningful analyses), further understanding of disparities in the US through comparative studies, and broaden the range of potential interventions tested at the environmental and policy levels.

Epidemiologic and basic science studies. Each center will propose one primary transdisciplinary hypothesis bridging the multiple levels of factors (from biological to macrosocial) that affect obesity-related behaviors and outcomes.  A core set of measures will be applied to all sites.  Existing cohorts of children or families can be used as catchment samples and may be particularly cost-effective. Nevertheless, extensive collection of additional macro- and micro-level data will likely be necessary.  Where appropriate, basic science research can be proposed to help elucidate mechanisms of biological-microsocial connections that are under study within the epidemiological research framework.

Evaluation or intervention research.  Applicants can propose to evaluate an existing policy or environmental change, or propose a new intervention that aims to modify the food, physical, social, and/or economic environment via policies or environmental change.  Interventions should be designed to effect changes at the macro-level with downstream impact on communities and individuals.  Interventions can vary by site or be common across sites within an application, and can be either the testing of new protocols and/or the rigorous evaluation of policy change.  Changes in community processes and family- and individual-level behaviors and obesity will be the outcomes. Target samples should be children < 21 years, but a focus on young children is particularly encouraged.

The Center should also establish a “developmental research fund” to conduct opportunistic evaluation research to assess the effects of policy-level changes (“natural experiments”) affecting energy-balance behavior and childhood obesity.  The Center should scan regularly for policy changes that are appropriate for evaluation. Policy changes may occur at the federal, state, local or school district level, and need not be limited to the geography of the cohort samples for the epidemiologic and basic science studies.  The Center should define their “rapid response” process to gather baseline data, using Center expertise or via sub-contract from the “developmental research fund” in cases of collaboration with experts outside the original Center composition of personnel.  Outcomes of interest for this evaluation research may be proximal, such as diet, physical activity or consumer behavior, or distal, such as changes in BMI or biomarkers.

Systems science training. Systems science thinking requires training in integrated rather than reductionist modalities and methodologies. Systems science refers to a host of methodologies that focus analysis at the interrelationships among variables within a system, including non-linear relationships, and emergent and dynamic properties (see PAR-08-224).  In addition, there is a need for individuals to be trained as bridges between content experts and systems modelers, to oversee and manage the organizational process of systems modeling, pose systems-oriented questions, and to help translate model output into policy-relevant recommendations – we call these people “complex systems designers”.  Each Center will be required to propose a curriculum with both didactic and hands-on components for trainees at the predoctoral and/or postdoctoral level.  The curriculum should include training on several complementary methodologies as opposed to focusing on a single methodology.  Trainees should include students and fellows from both the U.S. and foreign sites.  Training across sites for each student is strongly encouraged. 

Research Resource Core (RRC). The RRC has responsibility over a web-based, GIS-enhanced database platform with a rigorous metadata structure (use available technology if appropriate).  The RRC is responsible for data quality control and assists in data retrieval and pooled data analysis across sites.  Specifically, the RRC will develop standards and protocols for the acquisition, analysis, and sharing of geospatial data in addition to individual-level data.  Included in this work should be procedures for determining measurement error in geospatial data when used to describe the physical activity and food environments. This work could also include: 1) defining necessary basic geospatial data layers for core measures of the physical activity and food environments, 2) developing and demonstrating a process for data collection and harmonization to create common data elements in compatible electronic formats with specifications for metadata, 3) developing a standard process for validating geospatial data layers in the database, 4) developing an open-access framework and general user interface to facilitate data sharing, 5) developing applications to facilitate data merging and complex data analysis, 6) developing strategies for ongoing maintenance, communication and dissemination of geospatial data/open-access framework. Included in this work could be procedures for determining measurement error in geospatial data when used to describe the physical activity and food environments. Output of the grant award will include publishable documentation of these processes and standards with the intent that such information can be made publicly available.

The RRC should also include systems modeling expertise (e.g., system dynamics modeling, agent-based modeling, integration of macro-micro simulations etc.) that can be applied to the epidemiological, basic science, and intervention evaluation components of research.  It is expected that systems-based simulation modeling, in addition to statistical methodologies, will be necessary to fully capture the dynamic inter-relationships across biological and macrosocial contributors to childhood obesity.  This expertise should also be intergrated into the training curriculum to equip trainees with requisite skills for the application of systems science to public health research. 

Selected research examples and areas of focus, include but are not limited to those listed below:

Epidemiological and basic science research in this FOA is designed to elucidate the dynamic interplay of structural, socio-environmental, and biological factors that contribute to the development of childhood obesity.  Current data offer pieces of information that partially explains the complexity map of childhood obesity.  However, no one study has been able to construct and quantify a complete picture of the myriad etiologies of childhood obesity.  The evidence base is particular poor in terms of knowledge of how macrosocial factors are relevant to the physiology and behaviors of energy balance, and consequently to obesity, rendering the effort to support environmental and policy changes quite tenuous.  Furthermore, little research to date has uncovered the dynamic feedback loops at the societal and physiological levels that may significantly impact both the overall population trend of childhood obesity rates as well as disparities across population segments.  Therefore, the epidemiological component (and auxiliary basic science studies, as appropriate) of this FOA is aimed at filling these knowledge gaps, with research foci and approaches that may include, but are not limited to, the following: 

Intervention research in this FOA refers to either the testing of new protocols or the evaluation of existing or impending programs and policies.  The application in response to this FOA should contain an original intervention or evaluation study, independent of future proposals submitted to the “developmental research fund” that the Center will administer. Studies considered responsive would be interventions or evaluations that include active intervention modalities beyond individual-level behavior modification and involves the modification of aspects of the social, built, economic or policy environment that are implicated in childhood obesity. Studies should be at the community level beyond specific institutions, such as schools, for which the NIH has issued FOAs elsewhere. Some examples that would be considered responsive include, but are not limited to, the following. Sites within a Center may choose to follow the same protocol or not for this component of the FOA.

Note that depending on the intervention, program or policy chosen for study, appropriate primary outcomes may be community and behavioral changes with adiposity changes at the individual level serving as secondary outcomes.  A minimum of 24-month follow-up from baseline is required for outcome measures.

Training in systems science thinking and methodologies is critical to the capacity building of systems science in public health.  The current FOA requires that each Center applicant propose a didactic and hands-on curriculum to equip trainees at the U.S. and foreign sites with the critical thinking, knowledge, and skills necessary to develop systems-oriented solutions for real world problems.  Training should include sufficient exposure to systems thinking and methodologies.  Some trainees may go on to become systems researchers or public health modelers; others may serve well as complex systems designers that oversee or manage complex systems modeling initiatives in public health.  Trainees may be at the predoctoral and/or postdoctoral level.  Applicants should demonstrate that the training program can be institutionally sustained in a meaningful way.  Institutional commitment is necessary.  Candidates for the training program can be drawn from any field of study (e.g., public health, medicine, business, engineering, computer science, economics, political science, sociology, geography etc.), many of which may be beyond the traditional domains of medicine and public health, as long as it can be demonstrated that their expertise and interest are relevant to problems in the public health arena and that they intend to apply the skills learned to problems in public health. 

The proposed curriculum should include:

Training can also include the application of systems-oriented research to the implementation, dissementation, and scale-up of obesity prevention or intervention programs across communities.  

Programs can be designed to be either intensive or spread across a degree or fellowship program.  However, applicants should propose reasonable benchmarks to ensure that students achieve adequate competencies in the substantive and methodological aspects of systems science as applied to public health problems.

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

Section II. Award Information


1.    Mechanism of Support

This funding opportunity will use the U54 award mechanism.

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

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

 This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".  

2. Funds Available

The estimated amount of funds available from the NICHD, NCI, and OBSSR for support of 1 project awarded as a result of this announcement is $4.25M in total costs for fiscal year 2011. Future year amounts will depend on annual appropriations.  Each application can request up to five years of funding.

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.

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

NIH grants policies as described in the http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm).

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

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

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

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

Section IV. Application and Submission Information


1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

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

The exceptions from the standard PHS398 Instructions and detailed information on the application structure and components are provided in Section IV.6. Other Submission Requirements: All applicants must follow the specific instructions in that section.

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.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s): November 30, 2010
Application Receipt Date(s): December 30, 2010
Peer Review Date(s): March 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July 2011

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:

Layla Esposito, Ph.D.
Child Development & Behavior Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B05F, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6888 
Email: espositl@mail.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:

Sherry Dupere, Ph.D.
Chief, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service; non-UPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: duperes@mail.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

SPORT Center of Excellence (U54) applicants must demonstrate in the application their ability to meet:

For the SPORT Center of Excellence applications submitted in response to this FOA, the standard PHS 398 Research instructions for application preparation are altered as follows:

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to replace standard sub-sections of Section 3 “Research Strategy” of the PHS 398 Research Plan with the following new sub-sections A-H:

A.  Overview of the Proposed SPORT Center of Excellence and Its Areas of Focus

B.  Administrative Core, Including Center Organization and Research Team and Capabilities

C.  Epidemiological Research Project

D.  Intervention Research Project

E.  Basic Science Project

F.  Rapid-Response Pilot Grants  to Evaluate Environmental or Policy Interventions (Pilot Project Core)

G. Education and Training Core

H. Research Resource Core

Budget (PHS 398 Form Pages 4 and 5): Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form page 4) and the entire proposed project period (Form page 5). Include appropriate budget pages for any sub-contractual arrangements proposed.

Core resources should be budgeted to include centralized data collection and archive across sites within a center.

Use additional Form Pages 4 and 5 to provide detailed separate budget information (first year and cumulative budgets for the entire project period) for the following individual application components:

RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:

Other sections of the PHS398 Research Plan remain unmodified and should be completed following standard instructions:

A. Overview of the Proposed SPORT Center of Excellence and Its Areas of Focus (up to 6 pages)

Present the overall vision for the proposed SPORT Center including the following segments:

B. Administrative Core, Including Center Organization and Research Team and Capabilities (up to 12 pages).

In this section, describe the following aspects of the proposed SPORT Center.

Note: The SPORT awardee will be expected to apply proper process management methods for planning, monitoring, and managing the workload over the award period and will be expected to share specific details of these aspects with NICHD Program Staff members upon request.

C. Epidemiological Research Project (up to 12 pages).

Describe the research project in sufficient detail to enable reviewers to judge its scientific merit.

The description must contain the following elements:

a.     Significance
b.    Innovation
c.     Preliminary Studies
d.    Approach

D. Basic Science Research Project (up to 12 pages)

This component is not required but can be added to elucidate mechanisms of the interaction of environmental or macroscoial factors with biological pathways to influence childhood obesity or obesity-related behaviors, corresponding to the aims of the Epidemiology Research Project in C. above. 

If this component is included, describe the research project in sufficient detail to enable reviewers to judge its scientific merit.  The description must contain the following elements:

a.     Significance
b.    Innovation
c.     Preliminary Studies
d.    Approach

E. Intervention Research Project (up to 12 pages).

Describe the research project in sufficient detail to enable reviewers to judge its scientific merit.

The description must contain the following elements:

a.   Significance
b.   Innovation
c.   Preliminary Studies
d.   Approach

F. Rapid-Response Pilot Project Core (up to 6 pages)

Outline your vision on strategies and mechanisms for developing and administering rapid-response pilot projects and their evaluation/approval using the “Developmental Research Fund”. Pilot projects must be opportune investigations of existing or impending environmental or policy interventions (“natural experiments”), and need not be limited to the geography related to the epidemiological cohort.  They can be used to collect baseline data in order to increase the competitiveness for ancillary NIH funding.  (As specific pilot projects will be developed and selected post-award, no such specific projects are to be listed in the application).  It is anticipated that up to $500,000 a year in direct cost can be set aside for this Fund, but applicants will need to balance this with other components of the project. Applicants should justify the dollar amount requested based on the number of pilot projects anticipated and the size of the award for each pilot project.  The description of the core should also include:

G. Education and Training Core (up to 12 pages)

The education and training core will design, implement and monitor systems science training across sites within each SPORT Center:

H. Research Resource Core (up to 12 pages)

In this section, describe the following:

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

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

Other Requirements

Awardees must agree to the award administration information detailed in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award.”

Site Visits and Semi-Annual SPORT Scientific Meetings.  Because of the complexity of SPORT, NICHD and/or other NIH program staff members will conduct at least one administrative site visit per year.  SPORT applicants must agree to participate in this process and should plan for appropriate budgets, including travel for collaborators and other necessary costs.  Applicants must plan appropriate travel funds for the PD(s)/PI(s) and team leaders to participate in the semiannual SPORT scientific meetings. They should also plan such funds for travel of key administrative staff, and of new/junior investigators of their institutions to these meetings.

Appendix Materials

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

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

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should 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 NIH Guide NOT-OD-04-042.

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

For purposes of this FOA, peer review of scientific and technical merit focuses on three areas: (1) review of the individual Research Project components; (2) review of the individual Core units; (3) review of the U54 program as an integrated collection of research projects and cores oriented around a central theme, and the overall merit of the program.

Review Criteria for Individual Research Projects

The following standard review criteria will be used for the evaluation of the individual Research Project components:

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria. 

Scored Review Criteria

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?  How will the research project contribute to the overall mission of the Center and add to the capacity in the field for systems-oriented research?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the transdisciplinarity of the research team comprehensive and sufficient to undertake all activities within the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice and training paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the research questions, hypotheses, methods, and training curriculum transdisciplinary and novel?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Is the application of GIS and systems modeling appropriate and adequate for the research aims?  Are potential problems, alternative strategies, and benchmarks for success presented?   If aspects of the project are in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is there a sound plan for benchmarking the success of the project in accordance with the mission of the overall Center? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

Review Criteria for Cores

Reviewers will assign an impact/priority score based on the assessment of each Core unit independently in terms of the factors listed below.

Overall Impact

Review Criteria for the Center as an Integrated Effort

The overall U54 application will be evaluated as an integrated research effort focused on a central theme.  The relationship and contributions of each Research Project and Core to the overall theme of the program project will be discussed and evaluated.  Reviewers will assign an impact/priority score based on assessment of the scientific and technical merit of the overall program project. The assessment will take into consideration all proposed Research Projects and Cores, including any with poor ratings

The review will assess the merit of the U54 Center as an integrated program, including the following considerations:

Overall Impact

Additional Review Criteria

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

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

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.  For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.  For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

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

Resubmission Applications.   Not applicable.

Renewal Applications.  Not applicable.

Revision Applications.  Not applicable.

Additional Review Considerations

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

Applications from Foreign Organizations.   Foreign organizations are not applicable for this FOA.

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

In addition, NIH considers the following in evaluating Center grant applications:

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 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 Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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.

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted. The PD/PI(s) assume(s) responsibility and accountability to the awardee organization and to the NICHD for the performance and proper conduct of SPORT research and training activities in accordance with terms and conditions of the award.

The PD(s)/PI(s) of the SPORT Center of Excellence will have the primary responsibility for:

Lead PD/PIs responsible for the SPORT Center of Excellence will have, as appropriate, the following additional responsibilities:

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

2. A.2. NIH Responsibilities

A designated NICHD Program Director, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond normal stewardship role in awards, as described below. The NICHD Project Scientist may invite, as needed, additional NIH scientific staff as members with relevant expertise to have substantial involvement in the conduct of the SPORT scientific activities.

All NIH staff members who may be involved in the scientific activities of SPORT, including the Project Scientist, will not attend peer review meetings and/or supplemental applications. If such participation is essential, these individuals will seek NICHD waiver according to the NICHD procedures for management of conflict interest.

Additionally, one NICHD Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice.

Main NICHD responsibilities to SPORT awardee(s) include:

The NICHD reserves the right to adjust funding, withhold, suspend, or terminate the support to those SPORT awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

The NICHD staff members will coordinate an external evaluation of the SPORT Program.

2.A.3. Collaborative Responsibilities

The SPORT Steering Committee will serve as the main governing board for the SPORT initiative.

The committee will consist of the following voting members:

Additional NIH staff members may participate in Steering Committee meeting as non-voting members.

The SPORT Steering Committee will meet two times per year (in person at the semiannual scientific PD/PI meetings). One co-chair of the SPORT Steering Committee will be selected for every 12 months by the committee to coordinate its operation alongside the NICHD Project Scientist who will serve as the permanent co-chair. The SPORT Steering Committee co-chair will meet with the NICHD Project Scientist  one to two times per month by telephone conference.

In addition, the designated NICHD Program Official will participate in the activities of the SPORT Steering Committee as a non-voting member. Additional non-voting members to serve in an advisory capacity may be added to the SPORT Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NICHD and NIH Program Staff members and/or Program Staff members from other Federal agencies.

The SPORT Steering Committee will have primary responsibility for:

The SPORT Steering Committee will establish a scientific advisory panel (a subcommittee) to serve the SPORT Steering Committee and the SPORT awardees. The Advisory Panel Subcommittee will comprise scientific experts from outside the SPORT initiative and will be charged with the following activities:

The SPORT Steering Committee may also consider forming topic-specific working groups, which will be a resource of cross-SPORT expertise. Representatives from the NICHD, as well as other NIH institutes or other Federal agencies, will participate in working groups as appropriate (but will not serve as chairs of these working groups).

Members of the SPORT initiative will be required to accept and implement policies approved by the SPORT 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. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Terry T-K Huang, PhD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B11
Bethesda, MD 20892-7510
Rockville, MD 20852 (for courier service)
Telephone: (301) 792-1690
Email: huangter@mail.nih.gov

Layla Esposito, Ph.D.
Child Development & Behavior Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B05F, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6888 
Email: espositl@mail.nih.gov

Robin McKinnon, PhD, MPA
National Cancer Institute
6130 Executive Boulevard, EPN 4005
Bethesda, MD 20892-7344
Rockville, MD 20852 (for courier service)
Telephone: (301) 594-3599
Email: mckinnonr@mail.nih.gov

Heather Bowles, PhD
National Cancer Institute
6130 Executive Boulevard, EPN 4005
Bethesda, MD 20892-7344
Rockville, MD 20852 (for courier service)
Telephone: (301) 435-2845
Email: bowleshr@mail.nih.gov

Deborah Olster, PhD
Office of Behavioral and Social Sciences Research
31 Center Drive, B1C19
Bethesda, MD 20892-2027
Telephone: (301) 402-1147
Email: Deborah.olster@nih.gov

2. Peer Review Contacts:

Sherry Dupere, PhD
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard
Bethesda, MD 20892
Rockville, MD 20852 (for courier Service)
Telephone: (301) 496-5541
Email:duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Bryan S. Clark, M.B.A.
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8A01, MSC 7510
Bethesda, MD 20892
Rockville, MD  20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: clarkb1@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.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.

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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