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:  Diabetes Research Centers (P30, P60)

Announcement Type
This is a reissue of RFA-DK-06-014.

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

Request For Applications (RFA) Number: RFA-DK-08-008

Catalog of Federal Domestic Assistance Number(s)
93.847

Key Dates
Release Date: February 23, 2009
Letters of Intent Receipt Date:  June 22, 2009
Application Receipt Date: July 15, 2009
Peer Review Date(s): October – November, 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 1, 2010
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: July 16, 2009

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 and Information

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Diabetes Center grants to support research in diabetes mellitus and its complications, and related areas of endocrinology and metabolism.

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. The mission of the Diabetes Centers is to serve as a key component of the NIDDK-supported research effort to develop new therapies and improve the health of Americans with, or at risk for, diabetes and related endocrine and metabolic disorders.  The Centers promote new discoveries and enhance scientific progress through support of cutting-edge basic and clinical research related to the etiology and complications of diabetes, with the goal of rapidly translating research findings into novel strategies for the prevention, treatment and cure of diabetes and related conditions. 

To accomplish this mission, the Diabetes Centers:

Center Structure and Activities

The NIDDK Diabetes Centers are part of an integrated program of research support designed to enhance multidisciplinary cutting-edge research in diabetes and in related areas of endocrinology and metabolism. Diabetes Centers are intended to improve the efficiency and collaborative nature of diabetes research by providing shared access to specialized technical resources and expertise. In addition, Centers enhance translational research by providing a framework for fostering synergy between basic scientists and clinical investigators, with the goal of promoting rapid progress toward a treatment or cure for diabetes and its complications. Diabetes Endocrinology Research Centers (DERCs) support three primary research-related activities: (1) Biomedical Research Cores that provide resources to enhance the efficiency, productivity, and multidisciplinary nature of research in designated topic areas; (2) a Pilot and Feasibility Program designed to foster the development of new investigators and to provide seed-support for innovative high-risk projects; and (3) an Enrichment Program to promote interdisciplinary interaction and training of investigators in areas of NIDDK interest.  A Diabetes Research and Training Center (DRTC) provides all three elements of a DERC, with an additional focus on support for diabetes prevention and control research through dedicated cores and Pilot & Feasibility awards.  

Institution and Research Base

A DERC or DRTC must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, Diabetes Center applications must be associated with an existing program of excellence in biomedical research in diabetes and in related areas of metabolism and endocrinology.  Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in diabetes and related research areas.  In the case of the DRTC, the research base must also include a substantial number of investigators with a proven track record of productivity and peer-reviewed funding in research focused on diabetes prevention and control.  A high level of integration and close collaboration among Center personnel from diverse scientific disciplines are important features of a successful Diabetes Cen ter. 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.

Diabetes research often requires the use of specialized technologies and resources to support a cohesive research effort. The goal of the Diabetes Center program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas.

Administrative Core

Diabetes Center 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, all Diabetes Centers 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.     

Biomedical Resource Cores

Diabetes Centers are designed around cores that provide shared specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by Center-affiliated investigators. In a Diabetes Center, cores are intended to facilitate basic, clinical and translational research in diabetes, endocrinology and metabolic diseases in order to accomplish the stated goals of the individual Center and of the NIDDK Centers program.   

Each biomedical research core should provide state-of-the art services 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. With a regional or national core, the Center will service a specific research base that is expanded beyond investigators at the Center-affiliated institution.  In addition, Diabetes Center applicants may propose to share core services or functions with other Centers in the Diabetes Center program in order to expand, enhance, or increase the cost-effectiveness of research activities at the Center institution.  Examples of biomedical cores that would be considered responsive to this Request for Applications include: 

These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities. In responding to this RFA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institution. Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Diabetes Center topic areas.  Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure. 

The need for core support from the Diabetes Center must be well justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support.  Participants in the Diabetes Center program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards supported by the National Institutes of Health (http://www.ctsaweb.org/) and other related NIH roadmap activities, existing NCRR-supported General Clinical Research Centers (GCRCs) at the institution (http://www.gcrconline.org/), and any related NIDDK-funded Center programs such as the Obesity/Nutrition Research Center Program http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/ObesityNutrition.htm).  Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the Diabetes Center and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.

Prevention and Control Core (P60 DRTC proposals only)

Diabetes Research and Training Center (DRTC) proposals must direct a minimum of 20-25% of Center direct costs to support dedicated core(s) and Pilot & Feasibility projects in topic areas related to diabetes prevention and control research.  Prevention & Control (P&C) 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. Prevention and Control Cores should address how they may support and foster activities pursued under other ongoing NIDDK translational research programs (e.g. http://grants.nih.gov/grants/guide/pa-files/PAR-06-532.html; http://grants.nih.gov/grants/guide/pa-files/PAR-06-358.html).  In addition, applicants are encouraged to focus on underserved populations that may be disproportionately affected by diabetes.  P&C cores will also be expected to establish a Prevention & Control webpage within the context of the Center website that will be used to support networking to and from other P&C Core sites within the Diabetes Center Program.  P&C Core directors should indicate willingness to facilitate adoption of a unified presence for P&C activities supported by the Diabetes Center Program at-large.    

Pilot and Feasibility Program

The Diabetes Center Pilot and Feasibility (P&F) program provides seed support for new and innovative research projects directed at basic biomedical, clinical and translational research questions relevant to diabetes and its complications. To be considered a viable P&F program, the Center must support a minimum of two pilot projects, and typically at least 20-25% of the Center direct costs, exclusive of equipment, should be for support of P&F projects.  In addition, DRTC applicants will be expected to include and provide for a substantial focus on prevention and control projects in the DRTC P&F program.  

Funding and Duration of Support: It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the majority of approved P&F projects. However, a limited number of proposals may be selected for support as enhanced P&F awards with prior NIDDK approval. Enhanced P&F awards will be selected from worthy proposals in the following three project categories: clinical and translational research awards, clinical and basic research innovative partnership awards, or technology research and development awards. These enhanced awards may be funded at up to $100,000 direct costs per year and for up to 3 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 research. Established diabetes investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the Diabetes Center P&F program.  P&F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships between basic scientists and clinical researchers.  While the distribution of P&F funds to be used in each award category is ultimately at the discretion of the Center P&F committee, it is expected that the Center P&F program will, where possible, place particular emphasis on funding innovative clinical and translational research projects.

Enrichment Program

The Diabetes Center enrichment program should be designed to advance translational research in diabetes, endocrinology and metabolism and promote scientific exchange among investigators with research interests in these topic areas, 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.  Applicants should describe any training opportunities afforded by the Diabetes Center for Center participants, and document ways the Center may 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 the Diabetes Center 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 to conduct research in diabetes is 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.  Just as in the case of funding for individual research projects, 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.   

Additional Features  

Cooperation, Coordination and Integration:  Applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ctsaweb.org/) or a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources (http://www.gcrconline.org/) are strongly encouraged to utilize the CTSA or GCRC as a resource for enhancing clinical research programs within the Diabetes Center. In such cases, appropriate letters of support from the CTSA or GCRC program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the Diabetes Center and CTSA or GCRC activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of Diabetes Center activities through cooperation with other NIH supported core facilities at the applicant institution.  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 Diabetes Center.

The Diabetes Center must provide support for enrichment activities to foster multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research.  While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might operate on a regional or national level and involve multiple Diabetes Research Centers.  The application should include a statement regarding willingness to participate in such activities.

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

Core access and Cost Recovery: Core resources must precisely define issues regarding access to core services, including investigator eligibility requirements for services, 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 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 cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. 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.

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 NIH Center Core Grant (P30) and NIH Comprehensive Center (P60) award mechanisms.

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 NIDDK intends to commit up to 5.0 million dollars in FY 2010 to fund three (3) new and/or competing continuation grants in response to this FOA.   An applicant for a DERC may request a project period of up to 5 years and a budget for direct costs up to 1.0 million dollars per year. An applicant for a DRTC may request a project period of up to 5 years and a budget for direct costs up to 1.25 million dollars per year. These budget limits are exclusive of: (a)  first year equipment costs, (b) direct costs on subcontracts to historically black colleges and universities (HBCUs), health departments, community health centers or other agencies that focus on underserved populations for the purpose of establishing collaborations and providing access to the research infrastructure to investigators at these institutions to foster health disparities research in populations disproportionately affected by diabetes, and (c) F&A costs on consortium and subcontract arrangements.

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:

1.B. Eligible Individuals

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

Because a Diabetes Center has a large and complex administrative structure, the principal investigator must have strong leadership abilities and demonstrated proficiency in managing a large, multi-component project.

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.  Institutions may submit one Diabetes Center application in response to this FOA.

Resubmissions. Applicants may submit a resubmission application, but such application must  include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. 

Renewals. Renewal applications are permitted in response to this FOA.

Research Base: Successful Diabetes Center applications require an existing program of excellence in biomedical research in the area of diabetes, its complications, and in related research in endocrine and metabolic diseases. To justify Center support, the DERC or DRTC must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support.  The research base of the DRTC 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 Diabetes Research Centers (http://www.niddk.nih.gov/fund/other/guidelines.pdf). 

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

Page limits for the narrative, non-tabular sections of proposals will be strictly enforced. These limits will be 120 pages for the DERC (P30) proposals, and 140 pages for the DRTC (P60) proposals. Failure to abide by these page limits may result in return of the application without review.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: June 22, 2009
Application Receipt Date: July 15, 2009
Peer Review Date(s): October – November 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 1, 2010

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 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, Rm. 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.  Resubmissions from RFA-DK-06-014 are allowed, but they must include an Introduction.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

Research Plan Page Limitations

The Research Plan in Diabetes Center applications (Items A-D; PHS 398) shall be limited to 120 (P30 DERC) or 140 (P60 DRTC) pages exclusive of form pages, tabular information and appendices. Content and order of information to be provided should be presented in the form and format as described in the Diabetes Center administrative guidelines (http://www.niddk.nih.gov/fund/other/guidelines.pdf) with adjustments as indicated in this RFA.  An overview of the structure of a responsive Center application is provided below, with all non-formatted pages that will be subject to the page limitations marked (*).  Every effort should be made to provide information in tabular or chart form where indicated in the guidelines to facilitate application preparation and review.  Failure to comply with these instructions may result in return of the application without review.

The sections of the Research Plan include:

SECTION 1: OVERVIEW

SECTION 2:  ADMINISTRATIVE COMPONENT

SECTION 3:  BIOMEDICAL RESEARCH COMPONENT

SECTION 4: CENTER-RELATED INFORMATION

SECTION 1:  OVERVIEW

                        1.  Detailed Budget for Initial Budget Period (398- Form Page 4)

                        2.  Budget for Entire Proposed Project Period (398- Form Page 5)

                        3.  Consolidated budget for first year of requested support (Budgets for each individual Core should immediately precede the narrative for each Core)

SECTION 2:  ADMINISTRATIVE COMPONENT

SECTION 3:  BIOMEDICAL RESEARCH COMPONENT

                        1. Description (PHS 398- Form Page 2)

                        2. Key Personnel (PHS 398- Form Page 2-cont’d)

                        3. Budget with justifications (PHS 398- Form Page 4)

                        4. Biographical sketches: Core Director and key personnel (PHS 398- Form Page)

                        5. Objectives of the core*

                        6. Core function, including quality control*

                        7. Benefits from core*

                        8. Proposed developmental research or training*

                        9. Funded investigators who will use the core and proposed extent of use (see Guidelines Illustration V). For Renewals: Core Use during the last grant period (see                         Guidelines Illustration V)*

                        10. For renewals:  Core progress and productivity (include literature citations, grant awards, and 2-3 key advances supported by core activity)*

                        11. For renewals: if applicable, describe any recharge system that may be in place to allow investigators to utilize a core.*

                        12. Future directions and plans to ensure continuing evolution & relevance of the core*

                        1. Description Abstract (PHS 398- Form Page 2)

                        2. Key Personnel (PHS 398- Form Page 2-cont’d)

                        3. Budget with justifications (PHS 398- Form Page 4)

                        4. Biographical sketches: Core Director and key personnel (PHS 398- Form Page)

                        5. Objectives of the core*

                        6. Core function, including quality control*

                        7. Benefits from core*

                        8. Proposed developmental research or training*

                        9. Funded investigators who will use the core and proposed extent of use (see Guidelines Illustration V). For Renewals: Core Use during the last grant period (see                         Guidelines Illustration V)*

                        10. Core progress and productivity (include literature citations, grant awards, and 2-3 key advances supported by core activity)*

                        11. Future directions and plans to ensure continuing evolution & relevance of the core*

                        1. Overview*

                        2. Key Personnel (PHS 398- Form Page 2-cont’d)

                        3. Composite budget with budgetary justifications for future years

                        4. Biographical sketches: Program Director and Committee (PHS 398- Form Page)

                        5. Management of the pilot and feasibility program*

                        6. Program progress and productivity (include publications with PMCID numbers as available, grant awards, and 2-3 key advances supported by the P&F program)*

                        7. Future directions and plans*

In initial applications include: eligibility requirements, selection process, abstracts of proposed P&F awards, and justification for core usage by P&F awards* 

For competing renewal applications include: Total number and titles of all P&F submissions received during the prior project period, selection process and funding success rate, single paragraph synopses of Pilot and Feasibility studies awarded during the last project period and productivity associated with each (publications with PMCID numbers, presentations, grant awards)*

                        1. Description (PHS 398- Form Page 2)

                        2. Key Personnel (PHS 398- Form Page 2-contd)

                        3. Budget with justifications (PHS 398- Form Page 4)

                        4. Biographical sketches: Program director and key personnel (PHS 398- Form Page)

                        5. New applications: Describe plans for the enrichment program*

                        6. Renewal applications: Describe the enrichment program and indicate the program’s value to Center members.  Indicate how the program has grown or been                                      adapted to better serve Center members' needs during the past funding period.*

                        7. Future directions and plans to ensure continuing evolution and relevance of the enrichment program*

                        8. Other considerations (include plans to enhance interactions with relevant NIDDK supported T32 training programs; letters of acknowledgment and support from                          T32 PIs should be provided)*

SECTION 4: CENTER-RELATED INFORMATION

1. Biographical Sketches for all Center participants (Non-key personnel) in alphabetical order (PHS 398- Form Pages)

2. Distribution of Professional Effort (see Guidelines Illustration II)

3. Summary of total current and pending support of all Center participants including person months.  List support related to diabetes first, followed by non-Center related research support (see Guidelines Illustration III).

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: 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

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 NIDDK and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

The following will be considered in making funding decisions:

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

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

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

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

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

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?   

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

The following additional review considerations apply to all new and competing continuation Diabetes Research Center applications.  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 present in the diabetes research community, and will they provide services that would otherwise be unavailable, or be 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?  Do the existing Centers show clear evidence of successful implementation of a recharge structure to support expanded and/or evolving Center activities?  Do the new proposals document a clear intent to implement a recharge structure to support expanded and/or evolving Center activities?

The following evaluation criteria will be used to assess the progress of competing continuation Diabetes Center applications. Competing applications should demonstrate productivity as following:

Research Base:

Biomedical Cores:  

Pilot & Feasibility Program:

NIH considers the following in evaluating Center grant applications:

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

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

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

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

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

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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.

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 score.

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

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

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

3. Anticipated Announcement and Award Dates

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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:

James F. Hyde, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 789
Bethesda, MD  20892-5460
Telephone: (301) 594-7692 
FAX: (301) 480-3503
Email: James.Hyde@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
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov  

3. Financial or Grants Management Contacts:

Todd Le
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 726
Bethesda, MD 20892-5456
Telephone: (301) 594-7794
FAX: (301) 594-9523
Email:  ToddLe@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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


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