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), (http://www2.niddk.nih.gov)

Title: NIDDK Centers for Diabetes Translation Research (P30)

Announcement Type

New

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

• June 11, 2015 - This RFA has been reissued as RFA-DK-15-003.
• November 5, 2010 - See Notice NOT-DK-11-001 Correction of Page Limitations.

Request For Applications (RFA) Number: RFA-DK-10-009

Catalog of Federal Domestic Assistance Number(s)

93.847

Key Dates
Release Date: August 24, 2010
Letters of Intent Receipt Date: October 18, 2010
Application Receipt Dates: November 17, 2010
Peer Review Date: March 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: July 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: November 18, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), encourages grant applications from institutions/organizations that propose to establish Centers for Diabetes Translation Research (CDTR) whose cores support and enhance diabetes type II translation research (e.g., bedside to practice and the community). All activities pursued by CDTRs should enhance the efficiency, productivity, effectiveness and multidisciplinary nature of diabetes translation research.
• Mechanism of Support. This FOA will utilize the P30 award mechanism.
• Funds Available and Anticipated Number of Awards. The total amount to be awarded under this RFA is up to $3 million for each of 5 years. The NIDDK anticipates awarding up to seven (7) Center grants under this FOA.
• Budget and Project Period. An applicant for a CDTR may request a project period of up to 5 years and a budget for direct costs up to $200K per year. Subcontracts to minority serving institutions will not count toward the cap. Additional funds exceeding the cap are available if the CDTR includes a pilot and feasibility program ($50K direct costs) and/or the CDTR includes a plan to provide core resources/services regionally or nationally ($100K direct costs).
• Application Research Strategy Length: The P30 Research Strategy section may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• 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.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
  Hearing Impaired. Telecommunications for the hearing impaired are 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 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
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

The prevalence of diabetes mellitus in the United States is reaching epidemic proportions and accounts for a huge national burden of morbidity, mortality, and health care expenditures. Several large, controlled clinical trials (e.g. DPP, DCCT, and UKPDS) have established "gold standard" approaches for treating type 1 and type 2 diabetes, and for preventing or delaying type 2 diabetes in individuals at high risk for developing the disorder. Despite these advances, the efficacious interventions from these trials are rarely translated into widespread practice. Closing this gap will require type II translation research (e.g. bedside to practice and the community) testing innovative adaptations of evidence based approaches to prevent and treat diabetes that can be disseminated and sustained in clinical health care practice and other settings outside of the traditional academic research setting.

For the purpose of this FOA, type II translation is defined as research focused on translating interventions/approaches that have clearly demonstrated efficacy into real world health care settings, communities, and populations at risk. Type II translational research is distinct from type I translational research. Type I translational research (bench to bedside) builds on basic science findings and focuses on early phase research to translate these findings into potential interventions or therapeutics that might ultimately be tested in clinical trials. While type I translational research is a critically important piece of the research continuum, it is not the focus of this announcement and should not be the focus of the CDTR. Type II translational research supported by a CDTR might include effectiveness, dissemination, implementation, and cost effectiveness research. The target of this type of the research can be varied to include individuals, families, healthcare practitioners or systems, communities, and/or policy makers. Examples of CDTR expertise that would be relevant to conducting diabetes translation research might include design and analysis issues in translational research (e.g. quasi-experimental designs, adaptive or practical clinical trials, modeling, analyses for complex designs and data systems, health economic analysis), methodologies such as community engagement or Community Based Participatory Research, measurement at various levels (e.g. individual, family, system, community, healthcare practitioner) and dissemination and implementation science. Topic level expertise might include such areas as adherence, health information technology, health disparities, health literacy and/or numeracy, technology based approached to intervention delivery or measurement, diabetes self management, lifestyle change, and health communication.

The mission of the CDTRs will be to serve as a key component of the NIDDK-supported research program to translate efficacious research findings into practice and the community to improve the health of Americans with, or at risk for, diabetes. CDTRs will enhance scientific progress and improve the uptake of research through support of rigorous translation research aimed at prevention and improved treatment of diabetes (type 1, type 2 and gestational) and related conditions. To meet these goals, CDTRs will provide core services and consultation locally, regionally, and nationally in areas relevant to the NIDDK translation research agenda. Activities supported by CDTRs should enhance the efficiency, productivity, effectiveness and multidisciplinary nature of diabetes translation research.

This program will complement and enhance a strong ongoing diabetes prevention and control program at NIDDK including translational research project awards such as those supported by the theR18 FOA (http://grants.nih.gov/grants/guide/pa-files/PAR-09-176.html). To learn more about the NIDDK type II translation research priorities in diabetes, please see the Clinical Research to Practice: Translational Research chapter in the current draft of the Advances and Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the DMICC: http://www2.niddk.nih.gov/AboutNIDDK/ReportsAndStrategicPlanning/DiabetesPlan/PlanPosting.htm.

To accomplish this mission, the Centers for Diabetes Translation Research will:

• Create an environment that supports important and innovative type II translation research;
• Raise awareness of and interest in type II translational diabetes research at their institutions as well as locally, regionally, and nationally;
• Enhance translational diabetes research education and training opportunities for patients, students, scientists, and clinicians;
• Attract and retain new and junior investigators;
• Develop cores that enhance and leverage other funding resources such as grants and other NIH Centers
• Provide core services based on skills, knowledge, and expertise that are unique to type II translational research;
• Foster interdisciplinary collaborations required to advance type II translational research;
• Promote the translation of scientific discoveries from bedside to practice and the community to improve public health.

Center Structure and Activities

The goal of the NIDDK Centers for Diabetes Translation Research is to improve prevention and treatment of diabetes by promoting research that supports rapid dissemination, implementation, and sustained use of effective interventions/approaches. CDTRs are part of an integrated program of research support designed to enhance multidisciplinary cutting-edge research in diabetes. The CDTRs should improve the efficiency and collaborative nature of type II translational research in diabetes by providing shared access to specialized technical resources and expertise and a framework for fostering synergy between disciplines relevant to translating evidence based approaches to real world adoption and practice. Centers for Diabetes Translation Research (CDTRs) should enhance the efficiency, productivity, and multidisciplinary nature of research in their designated cores/topic areas.

Institution and Research Base

A CDTR must be an identifiable unit within a single institution such as a university medical center or a consortium of cooperating institutions. CDTR applications must demonstrate a strong base of successful external research funding (NIH or non-NIH) that is related to type II translational research in diabetes. Program excellence is measured through a consistent and outstanding record of publications and peer-reviewed research funding in areas related to is an important feature of a successful CDTR. Multi-disciplinary collaborations are also encouraged. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Center applicants should identify one or more central themes or focus areas that link Center investigators and their research programs.

Translational research (e.g. effectiveness, dissemination, and implementation research) often requires unique scientific expertise. Core resources in a CDTR might include expertise in translational research designs, measurement that is practical as well as accurate, community engagement methodologies, health information technology, technological approaches to intervention, and cost-benefit/cast effectiveness analyses. Where possible and applicable, CDTRS are encouraged to leverage relevant skills and collaborations with other institutions (e.g., academic, health departments, healthcare systems, and community organizations) or NIH funded centers (e.g., Diabetes Research Centers, Nutrition Obesity Research Centers, and Clinical and Translational Science Awards). The goal of the Diabetes Center program is to make type II translational science resources readily accessible to a broad spectrum of investigators who are pursuing research in relevant topic areas.

Administrative Core

CDTRs applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. In addition, CDTRs will be required to maintain a Center website, with the administrative core taking primary responsibility for its curation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website. The Core Center Director should provide at least 10% effort on the Administrative Core and a total of 20% effort distributed among the Administrative and other components of the Center. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed. Again, where possible and applicable, CDTRS are encouraged to leverage resources in other NIH funded centers (e.g. Diabetes Research Centers, Nutrition Obesity Research Centers, and Clinical and Translational Science Awards).

Translational Resource Cores

Cores should focus on activities supporting research designed to enhance translation of research advances into clinical or community practice. Services should support research into identification of barriers to widespread adoption of new practices, and into development and testing of interventions to overcome these barriers under real world conditions. Cores should address how they will support and foster NIDDK translational research (e.g., http://grants.nih.gov/grants/guide/pa-files/PAR-09-176.html, http://grants.nih.gov/grants/guide/pa-files/PAR-09-177.html, and http://grants.nih.gov/grants/guide/pa-files/PAR-10-038.html). Cores should be designed to provide shared specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by Center-affiliated investigators. In addition, applicants are encouraged to focus on underserved populations that may be disproportionately affected by diabetes. Center directors should indicate willingness to collaborate and facilitate the adoption of a unified presence for NIDDK funded CDTRs.

Each research core should provide state-of-the art expertise to multiple funded research projects. A Center may support research at a single or set of cooperating institutions through an Institutional Core, or may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core (see below for more information). With a regional or national core, the Center will service a specific research base that is expanded beyond investigators at the Center-affiliated institution. If relevant, applicants should consider and propose opportunities to share core services or functions with other NIH funded Centers in order to expand, enhance, or increase the cost-effectiveness of research activities of the Center.

Since type II translational research often requires collaborative research efforts, applicants should demonstrate the existing or new partnerships that will leverage skills and resources at other institutions to enhance the CDTR’s capacity to advance and support translational science. Demonstrating collaborations might include linkages between disciplines, other institutions, community partners and health departments.

Applicants are encouraged to propose cores that address specific objectives based on the unique skills and expertise of investigators at the applicant institution. Particular emphasis should be placed on services that support and foster interdisciplinary translational approaches to research.

The need for support of each core in a CDTR must be well justified, with clear documentation of the potential for a broad user base of NIDDK-funded investigators pursuing diabetes related translational research. Participants in the CDTR are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Centers within their institutional setting. Applicants should provide information on other institutional programs or centers supporting related resources and clearly describe and opportunities for synergy and integration between the CDTR and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Enrichment Program

The CDTR enrichment program should be designed to advance type II translational diabetes research, promote scientific exchange among investigators with related research interests, and to enhance interactions between diabetes researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Where applicable, coordination with enrichment programs supported by other institutional Centers should be detailed. Applicants should describe any training opportunities afforded by the CDTR and document ways these facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on related NIDDK T32 programs at the Center institution(s), and describe how, if relevant, the CDTR will help to integrate, facilitate and enhance activities of T32-supported trainees. A letter from the PI of any related NIDDK-funded T32 at the Center institution should be included that acknowledges and details how the PI of the T32 intends to promote cohesive interactions between the two programs.

Training postdoctoral fellows or junior investigators to conduct type II translational research in diabetes can be an associated activity of a Center. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training. Funding for fellowships should be sought from NIH NRSA institutional training grants (e.g. T32, T35) and individual fellowships (e.g. F30, F32), and other sources such as private foundations, and commercial companies.

Regional or National Resource

Funding and Duration of Support: Up to $100,000 in direct costs per year may be available to CDTRs that propose to serve as a regional or national resource.

Eligibility: Centers must partner with institutions, regionally or nationally, that are not already strongly affiliated with the Center institution or develop a plan to serve a consultative/advisory role to those outside of the Center institution. Services or resources shared with an already associated institution, such as an affiliated teaching hospital, are encouraged but would not be a justification for additional funds. Applicants must demonstrate how resources will be shared and how these services or partnerships will be documented. Activities might include opening core use and the pilot and feasibility program to investigators outside the institution or plans to reach and advise/consult with researchers beyond the CDTR institution. Centers must define and provide a rationale for which institutions will be eligible for services and/or support from the Center.

Partnerships with Minority Serving Institutions

Funding and Duration of Support: Centers may exceed the direct cost cap of $200,000 by the amount of the subcontract if the applications include a subcontract to a minority serving institution.

Eligibility: Applicants must clearly document the ways in which the subcontract institution supports a significant base of minorities. Qualifying institutions might be universities whose student population is largely made up of racial or ethnic minorities or a research focused healthcare intuition who serves a large minority patient population.

Pilot and Feasibility Program

Additional funds are available if the CDTR includes a Pilot and Feasibility (P&F) program to provide seed support for research relevant to diabetes translational research. To be considered a viable P&F program, the Center must support a minimum of two pilot projects.

Funding and Duration of Support: Up to $50,000 in direct costs per year is available to support P&F programs. The majority of approved P&F projects are expected to last 1-2 years. Efforts to increase the number of P&F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged.

Eligibility: The P&F program is particularly directed at new investigators and established investigators new to diabetes translational research. Established diabetes investigators pursuing timely or highly significant projects are also eligible for support under the CDTR P&F program but this should be the exception rather than the primary focus of the P & F program. P&F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new scientific partnerships and collaborations.

Additional Features

Cooperation, Coordination and Integration: Applicants from institutions with an NIH Clinical and Translational Science Award (CTSA) program (http://www.ctsaweb.org/) funded by the NIH National Center for Research Resources or an NIDDK funded Center such as a Diabetes Research Center or Nutritional Obesity Research Center, are strongly encouraged to partner with these Centers to maximize resources for enhancing translational research programs within the CDTR. In such cases, appropriate letters of support from the NIH funded Center or CTSA principal investigator should be included with the application detailing plans for appropriate integration and synergy with the CDTR activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of CDTR activities through cooperation with other NIH supported core facilities at the applicant institution. Applicants are encouraged to suggest coordinated efforts, such as educational activities, enrichment programs or pilot and feasibility programs, that might operate on a regional or national level and involve CTSAs or NIH funded Centers. The application should include a statement regarding willingness to participate in such activities.

Other NIH-supported Centers and associated cores at the institution should be identified and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the CDTR.

The proposed budget should include travel for the Principal Investigator and Associate Center Director, or other key personnel, to attend an annual CDTR meeting. The application should include a statement of willingness to attend this annual meeting of CDTR Directors.

Core access and Cost Recovery: Core resources must precisely define issues regarding access to core services/consultation, including investigator eligibility requirements and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations, such as calculations that justify investment of funds in core services (e.g. comparative costs of other sources of proposed core services), and policies for cost recovery from investigators for use of services should also be included.

Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing research needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of core services provided by the research institution. Cores should address the issue of allocation of resources that includes how these will be prioritized, documented and tracked for success. Success should be measures in terms of support for new translational research grants, peer reviewed publications, or development of new methods, measures, analytic approached, or methodologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.

Research Base: Successful CDTR applications require an existing program of excellence in type II translational research either in diabetes or in areas directly related to diabetes. To justify Center support, the CDTR must serve a large research base of NIH-funded investigators pursuing research activities in Center topic areas. The research base of the CDTR must also include investigators with an established track record of productivity and funding support in prevention and control research that is directed toward translating current diabetes research findings into clinical and/or community practice). Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK Centers for Diabetes Translation Research http://www2.niddk.nih.gov/research/centers/centerprograms/#diabetes.

Applications that propose cores to significantly support type I translation research (bench to bedside), or biomedical, behavioral or clinical research other than research to practice translation (type II translational research), are not responsive to this FOA.

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 P30 award mechanism(s). 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).

2. Funds Available

The estimated amount of funds available for support of up to seven CDTRs awarded as a result of this announcement is $3,000,000 for fiscal year 2011. Future year amounts will depend on annual appropriations. An applicant may request a project period of up to 5 years and a budget for direct costs up to $200,000 per year. CDTRs can exceed the direct cost cap by the amount of a subcontract to a minority serving institutions. Additional funds are available if the CDTR includes a pilot and feasibility program ($50K direct costs) and/or the CDTR includes a plan to provide core resources/services regionally or nationally ($100K direct costs).

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• For-Profit Organizations (Other than Small Businesses)
• State Governments

1.B. Eligible Individuals

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

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

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

The CDTR Director, who is the Principal Investigator on the P30 application and Director of the Administrative Core, must be a scientist who can provide effective administrative and scientific leadership and who has demonstrated proficiency in managing a large, multi-component project. The Director will be responsible for the organization and operation of the CDTR and for communication with the NIDDK on scientific and operational matters. Center Directors are required, and their administrators are strongly encouraged, to attend Center Director's meetings to be held at a location to be determined by the NIDDK. Funds for travel to this meeting should be included in the budget of the Administrative Core of the Center.

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) 710-0267, 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.

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: October 18, 2010
Application Receipt Date: November 17, 2010
Peer Review Date: March 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: July 1, 2011

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@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:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

The CDTR must be an identifiable organizational unit within an eligible institution (see section III, 1.A.) such as a single university, medical school, or a consortium of cooperating institutions. To qualify for a CDTR grant, just as with all other P30 grants, the applicant institution must already have a significant base of ongoing, independently supported, peer-reviewed research projects related to diabetes type II translational.

The research base must exist prior to the submission of an application and it is a critical element considered during the peer review process. This currently funded research base provides the major support for a group of investigators who would benefit from shared resources. The body of research described as the research base may include only currently funded, peer reviewed research grants awarded to the applicant institution/consortium. These may be federally or privately funded awards. Training grants and fellowship awards are not considered part of the research base. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considered in judging the adequacy of the research base. Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.

Additional application instructions are available in the Center for Diabetes Translational Research Guidelines available on the internet at http://www2.niddk.nih.gov/research/centers/centerprograms/#diabetes or from the Program Director listed below under Scientific/Research Contacts (Section VII.1).

Page Limits

In accordance with the NIH Enhancing Peer Review initiative, page limits will be imposed on these CDTR P30 applications as listed below.

Background and Overview 6 pages: Explain the scientific background for the P30; the central focus(s) or theme(s) of the P30; the administrative structure of the P30, including internal and external administrative and advisory committees; and the criteria for designating an investigator as a CDTR member.

Research Base 3 page introduction + 1 page per research investigator in the research base to discuss their research program and grants.

Pilot and Feasibility Program, if included 3 page discussion of P&F program

Enrichment program 3 pages

Plan to serve as Regional or National Resource, if proposed 3 pages

Cores - 6 pages per core

PHS398 Research Plan Sections

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

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to requirements given in Section IV, 6 above.

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).

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 Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year 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 the National Institute of Diabetes and Digestive and Kidney Diseases 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
• Receive a written critique.
• Receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC).

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

Overall Impact

Reviewers will provide an overall impact/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, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the proposed CDTR resources and expertise enhance and advance diabetes type II translational research? What is the likelihood that the CDTR will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective?

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? Are the center investigators willing to interact with each other and contribute to the overall objectives of the CDTR? What are the scientific and administrative leadership abilities of the proposed center leadership? Do they demonstrate commitment and ability to devote adequate time to the effective management of the program?

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

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

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? Is there evidence of institutional commitment to the program, including lines of accountability, regarding management of the center grant and the institution's contribution to the management capabilities of the center?

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.

Centers for Diabetes Translational Research (CDTR). Foremost, does the research base to be supported by the Center show evidence of a strong and consistent record of productivity and peer-reviewed funding in Center-related research areas? Do the proposed cores fill a need in the diabetes type II translation research community, and will they provide services that would otherwise be scarce or are more cost-effective to conduct centrally? Is the necessary technical and analytical expertise available? Does the application demonstrate ability to monitor use and utility of the cores, and provide approaches to ensure continuing development and evolution of services as needs of the community change? Does the application document a clear intent to implement a recharge structure to support expanded and/or evolving Center activities? Do the training opportunities proposed enhance the capacity (e.g., skills and capabilities) for type II translational research and, if applicable, are they integrated with other NIH funded training at the Institution such as T32s?

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

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

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

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

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. Revisions are not allowed for this FOA.

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 allowed for this FOA.

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

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:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of the proposed project to program priorities

NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program;
• The qualifications and experience of the center director and other key personnel;
• The statutory and program purposes to be accomplished;
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
• The extent to which the center's activities would be coordinated with similar efforts by other organizations;
• The administrative and managerial capability of the applicant; and
• Other factors which the awarding IC considers appropriate in light of its particular statutory mission

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/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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:

Christine Hunter, Ph.D., ABPP
Director of Behavioral Research
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes & Digestive & Kidney Diseases
6707 Democracy Boulevard, Room 605
Bethesda, Maryland 20892-5460
Phone: 301-594-4728
Fax: 301-480-3503
Email: hunterchristine@niddk.nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3. Financial or Grants Management Contacts:

Elizabeth Gutierrez
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 712B
6707 Democracy Boulevard
Bethesda, Maryland 20892-5456
Telephone: (301) 594-8844
Fax: (301) 480-3504
Email: gutierrezel@niddk.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/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.