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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)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov)

Title: Type 1 Diabetes TrialNet: Clinical Centers (U01)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-DK-08-011

Catalog of Federal Domestic Assistance Number(s)
93.847, 93.855, 93.865 and 93.213

Key Dates
Release Date: December 24, 2008
Letters of Intent Receipt Date: February 10, 2009
Application Receipt Date: March 10, 2009
Peer Review Date(s): June-July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September, 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 11, 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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency 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 NIDDK is seeking applications for TrialNet Clinical Centers to participate in multi-center clinical research studies aimed at prevention, delay of progression, or remission of T1D. These Clinical Centers will also be responsible for the oversight of a network of TrialNet Affiliate Centers involved in TrialNet study recruitment and follow-up.

TrialNet seeks to continue to study therapies (such as immunotherapies) aimed at preventing or delaying the development of T1D in persons at risk. Depending upon available evidence, initial studies may be conducted in patients with recent onset of T1D and will be aimed at decreasing b-cell destruction and/or enhancing b-cell survival in persons with recently-diagnosed T1D and evidence of residual b-cell function. If such treatments are effective and safe, clinical trials to prevent development of T1D in at-risk individuals may be initiated.

Background:

In 1997, Congress provided funding to the NIH to increase efforts directed at: (1) understanding the pathogenesis of T1D, (2) the development of new therapies to prevent or slow progression of T1D. The NIDDK, in conjunction with several other NIH institutes, developed a series of clinical and basic research projects to accelerate this effort. Among these was Type 1 Diabetes TrialNet, a network of clinical centers with expertise in T1D research that would facilitate studies of the natural history of T1D and would conduct clinical trials of new therapies, particularly those aimed at modulation of the immune system.

In 2001, cooperative agreements (U01s) awards of 7 years duration were awarded to 14 TrialNet Clinical Centers, a TrialNet Biostatistics Coordinating Center, and a TrialNet Steering Committee Chairman’s Office. In 2008 the Clinical Centers entered no cost extensions and the TrialNet Coordinating Center was funded as a contract. With the recent extension of the T1D Special Appropriation through 2011, the NIDDK is now issuing this FOA to select approximately 14 TrialNet Clinical Centers to maintain TrialNet’s ongoing studies and to launch a number of promising new clinical trials aimed at prevention of and early intervention in T1D. The TrialNet Coordinating Center will continue to operate via a contract mechanism and will issue subcontracts to the TrialNet Chairman’s Office and the TrialNet Core Laboratories.

The ongoing studies to be completed by TrialNet include (but are not limited to):

Prevention Studies:

New-Onset Studies:

Oral Insulin

Rituximab

Nutritional Intervention to Prevent Type 1 Diabetes

Abatacept

It is anticipated that the following studies (and others to be determined) will be launched and in need of completion during the project period covered by this FOA:

Prevention Studies:

New-Onset Studies:

Validation Studies:

Glutamic Acid Decarboxylase

Glutamic Acid Decarboxylase

T Cell

Teplizumab (Anti-CD3)

Metabolic Control

TrialNet and the Immune Tolerance Network (ITN; http://www.immunetolerance.org) work together closely to provide an integrated approach to studies aimed at the amelioration of T1D through tolerance-inducing strategies. Many ITN T1D study subjects are recruited and followed at TrialNet sites, and the ITN assists TrialNet with the collection, processing, and analysis of mechanistic samples (samples that help to improve understanding of T1D pathophysiology).

Objectives and Scope

The overall objective of this solicitation is to invite sites to apply to become TrialNet Clinical Centers. TrialNet Clinical Centers participate in the development and implementation of TrialNet clinical research studies.

The current FOA is soliciting applications for TrialNet Clinical Centers to carry out the TrialNet Natural History Study as well as TrialNet prevention and new-onset intervention studies. Clinical Centers will also be responsible for the oversight of a network of Affiliate Centers, additional clinical sites that will recruit and follow individuals with T1D as well as those at risk for development of the disease.

The project period for applications solicited under this invitation will be five years. Three years will be awarded initially with funding for years four and five provided depending upon availability of funds.

Applicants are asked to propose one study aimed at either: (1) the analysis of data and/or samples being collected by TrialNet as part of the Natural History Study, or (2) intervention in individuals at-risk for T1D or with newly-diagnosed T1D. Proposals will be used in the review of potential Centers and may be considered for implementation once the network and Steering Committee have been re-established.

Network Components

Radial Diagram

Radial Diagram

1. Clinical Centers

Approximately 14 awards will be made to Clinical Centers. These Centers will be responsible for the completion of ongoing TrialNet studies and for the development and implementation of new TrialNet studies. Each Clinical Center will also be responsible for the oversight of a network of TrialNet Affiliate Centers, including training and supervision of clinical studies, quality control, and administrative support.

All TrialNet studies are conducted in accordance with guidelines developed by the investigators and are overseen by the network Steering Committee in conjunction with the TrialNet Coordinating Center. Oversight is also provided by Data Safety and Monitoring and External Evaluation Committees established by the NIH. Clinical Centers will be required to submit data and samples as required by protocols for testing and storage to the Coordinating Center or appropriate laboratories. The Clinical Centers must work in concert with the Coordinating Center to implement procedures for uniform data collection, handling and transmittal of data, as well as data audits and other data quality control procedures, as has been established by the study protocols.

TrialNet investigators will conduct analyses and will prepare manuscripts relating to data generated by TrialNet studies. TrialNet investigators will have exclusive access to data generated during the course of TrialNet studies for a period of time determined by the TrialNet Steering Committee in accordance with NIDDK procedures and policies. The network will eventually be required to share data and patient specimens derived from collaborative studies with investigators outside the network under policies and procedures to be determined by the NIDDK with input from the Steering Committee. The Steering Committee has determined policies under which ancillary research projects (studies proposed by any interested party to complement the objectives of TrialNet) may be conducted through the auspices of the TrialNet network.

2. Coordinating Center

The TrialNet Coordinating Center is responsible for the collection, management and analysis of TrialNet laboratory and clinical data. In addition, the Coordinating Center plans and organizes research activities across TrialNet components, manages meetings and communications, develops procedures for ensuring research participants confidentiality and safety, develops procedures for quality control, training and certification, participates in protocol development, develops and updates the manual of operations, oversees implementation and adherence to TrialNet protocols and assures quality of the data collected. In addition to funds awarded directly to the Clinical Centers through cooperative agreement awards, the Coordinating Center will provide capitated reimbursement to the Clinical Centers for specified protocol activities.

The TrialNet Coordinating Center coordinates transfer of biologic specimens from the Clinical Centers to central laboratories for analysis and to the NIDDK Repository where samples are stored for future analyses. The Coordinating Center maintains the system for identification of samples and linkage of samples to a central clinical database and also coordinates with the NIDDK Repository to prepare the collected data for eventual archiving.

The Coordinating Center provides appropriate biostatistical, data management, and coordination and analytic expertise and generates appropriately detailed reports to the Steering Committee, Data Safety and Monitoring Board, External Evaluation Board, and the NIDDK staff at regular intervals. The Coordinating Center is also responsible for the logistics and planning of the meetings of the Steering Committee and its subcommittees, the Data and Safety Monitoring Board, and the External Evaluation Board.

3. Steering Committee

The Steering Committee is the primary governing body of the TrialNet network. This group considers proposed studies, and recommends which should be performed by the TrialNet study group. The TrialNet Steering Committee, comprised of the Steering Committee Chairperson, the Principal Investigator and a Co-Investigator from each Clinical Center, the Principal Investigator from the Coordinating Center and each Core Laboratory, and representatives from the NIDDK, NIAID, NICHD, and Juvenile Diabetes Research Foundation (JDRF), meets 2-3 times yearly to evaluate proposed and ongoing protocols and to reach consensus on TrialNet activities.

The Steering Committee will continue to develop policies and procedures for the consortium, including procedures for modification of study design, for use of study samples and data, for approval of ancillary studies, for publication and presentation of results, and for monitoring study progress, completeness and quality of data collection, and other performance measures.

4. Project Scientist

The NIDDK Project Scientist assists the Steering Committee in considering proposed studies and carrying out studies selected for implementation, including protocol development, quality control, interim data monitoring, final data analysis and interpretation, preparation of publications, and overall performance monitoring.

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 cooperative agreement (U01) 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).

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

This FOA is a one-time solicitation. At this time, it has not been determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

The estimated amount of funds available for support of approximately 14 Clinical Centers awarded as a result of this announcement is $5.4 million for fiscal year 2009. Future year amounts will depend on annual appropriations. The total project period for applications submitted in response to the present FOA should be 5 years.

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 located in North America 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. Applications may be submitted by investigators from institutions in North America (United States and Canada) only. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

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

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5939.

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.

RFA-DK-08-011 Type 1 Diabetes TrialNet (U01)

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

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: February 10, 2009
Application Receipt Date: March 10, 2009
Peer Review Date(s): June-July 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September, 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room Number 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]

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
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room Number 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]

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 and Information

Each applicant should submit an application that includes the following:

(1) A proposal to conduct a study aimed at:

(a) Understanding the pathogenesis and progression of T1D through analysis of data and/or samples being collected by TrialNet as part of the Natural History Study and/or an ongoing or approved TrialNet intervention protocol (http://www.diabetestrialnet.org/researchers/sample.htm)

(b) Establishing safety and efficacy of an intervention to slow disease progression in individuals at-risk for T1D, or with newly-diagnosed T1D.

The Center’s proposed protocol, including study rationale, study design, number of subjects required, projected time for completion, power analysis, projected mechanistic studies to be done in conjunction with the trial, and a projected budget should be included in the application. Studies proposed by successful applicants from this FOA may be considered for implementation by the TrialNet Steering Committee pending review and prioritization.

(2) A detailed description of the Center’s prior experience in the performance of T1D clinical research studies as well as data supporting the Center’s past and present ability to recruit T1D patients for treatment studies. The Center must demonstrate access to a population of T1D patients and family members at high risk for developing T1D. The application should provide a detailed accounting of the Center’s recruitment and retention goals, and its plans to accomplish these, for each type of study that TrialNet conducts: new onset T1D, prevention, and natural history.

For Centers that have participated in TrialNet, a detailed recruitment report, generated by the Coordinating Center, should be included in the application. For Centers that have not participated in TrialNet, a report detailing the Center’s experience in the conduct of T1D clinical research studies should be included. In addition, Centers that have not participated in TrialNet should include a recruitment plan specific to TrialNet’s ongoing and planned studies (http://www.diabetestrialnet.org/patientinfo/studies.htm).

This plan should contain details of past accomplishments and available resources that will enable the site to become an effective and productive TrialNet Clinical Center.

(3) A description of available facilities at the Center for the conduct of TrialNet studies. This should include details regarding the availability of extended and weekend hours to accommodate patients and available support services, such as research centers, to assist TrialNet in the conduct of study-related drug administration (including infusions) and testing (such as Oral and IV Glucose Tolerance Testing and Mixed Meal Tolerance Testing).

(4) A description of experience (if any) that the Center has had in managing one or more affiliate sites as well as a plan for recruiting and maintaining a productive network of TrialNet Affiliate Centers.

Applications should include a Principal Investigator with demonstrable experience in the conduct of T1D clinical research as well as a Co-Investigator with significant expertise in the area of T1D immunology. If the Principal Investigator is a T1D immunologist rather than an endocrinologist, the Co-Investigator should be a pediatric or adult endocrinologist with expertise in the area of T1D clinical research. The experience of both of these individuals should be described in detail in the application.

Research Plan Page Limitations

The complete application may exceed the 25 page limit to a maximum of 45 pages. The research proposal portion of the application should be no more than 25 pages in length and the recruitment/retention plan portion should be no more than 10 pages in length.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only, and 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: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

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

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

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

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

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

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

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

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

Merit of the proposed project and actions to implement it as well as the extent to which overall goals and objectives of the FOA are addressed;

Qualifications, experience, and responsibilities of the Principal Investigators, Co-Investigators, and key support personnel;

For Centers that have participated in TrialNet, progress during the previous funding period in developing appropriate infrastructure and meeting study goals;

For Centers that have not participated in TrialNet, (1) a report detailing experience that the Center has had in the conduct of T1D clinical research studies, and (2) a comprehensive recruitment plan for ongoing and planned TrialNet studies including a detailed description of available resources that will enable the site to become a productive TrialNet Clinical Center;

Commitment to conduct ongoing TrialNet studies and to implement new TrialNet studies;

Availability of adequate resources for the ongoing and proposed research in terms of space, equipment and personnel;

Adequacy of preparation and ability of the senior leader to oversee TrialNet projects; and

Adequacy of the provision for protection of human subjects, and provision for inclusion of women and minorities in clinical studies as applicable

2.A. Additional Review Criteria:

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

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

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

Data Sharing Plan. (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm)

Sharing Model Organisms. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html)

Genome Wide Association Studies (GWAS). (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-088.html)

3. Anticipated Announcement and Award Dates

Applicants should expect to hear about the outcome of their application no later than September 2009.

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).

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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigators at the TrialNet Clinical Centers will have primary responsibility for all aspects of development and implementation of the protocols at their site and at their Affiliate sites, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. Modifications of protocols will be approved by the Steering Committee. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

TrialNet is a clinical studies network which depends upon active and timely collaboration among investigators in the network and at affiliate institutions. The collaborative protocol and governance policies will call for the continued submission of data centrally to the Coordinating Center for a collaborative database, the submission of copies of the collaborative data sets to each Principal Investigator upon completion of the study, procedures for data analysis, reporting and publication and procedures to protect and ensure the privacy of medical and genetic data (if any) and records of individuals. The NIDDK Project Scientist, on behalf of the NIDDK, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee. The NIDDK expects that biologic samples and associated clinical data will be made available to the broader scientific community at an appropriate juncture to support further studies related to the prevention of and early intervention in T1D. The consortium will be expected to put all study materials and procedures manuals in the public domain and/or make them available to other investigators. Awardees are encouraged to publish and to publicly release and disseminate results, data and other products of the study, concordant with the study protocols and governance and the approved plan for making data and materials available to the scientific community and the NIDDK and other co-sponsors. However, following completion of the individual project or following conclusion of a network funding period of NIDDK support, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the Steering Committee and the NIDDK.

Support or other involvement of industry or any other third party in any study performed by the consortium may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to, and concurrence by NIDDK.

The NIDDK has established Central Biosample and Data Repositories for the archival and storage of data and biosamples. All samples and data transferred to the repositories will be under the custodianship of the NIDDK, although the study’s Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. The Clinical Centers will submit the samples and data to the NIDDK repository via the Coordinating Center and the study is expected to put all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approval plan for making data and materials available to the scientific community and the NIDDK for the conduct of research at no charge other than the costs of reproduction and distribution.

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

2. A.2. NIH Responsibilities

The NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIDDK Project Scientist will have one vote on the Steering Committee and on all key study group subcommittees. Representatives of other Institutes, Centers and some outside organizations (profit or non-profit) supporting and sponsoring the network will also have one vote each on the Steering Committee (including NIAID, NICHD, and JDRF). The Project Scientists will have substantial scientific-programmatic involvement in quality control, interim data analysis, safety monitoring, and final data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The dominant role and prime responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the Project Scientists.

The NIDDK reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIDDK cannot concur, (d) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (e) human subject ethical issues that may dictate a premature termination.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities (optional)

Proposals considered by TrialNet for performance by the network are submitted by either an individual investigator or by a group of investigators. These proposals come from members of the TrialNet Steering Committee or from individuals or groups that have had no previous involvement with TrialNet. Once received, proposals are initially reviewed by the following TrialNet committees: (1) the Scientific Review Committee; (2) the Clinical Feasibility Committee; (3) the Ethics Committee; (4) the Safety Review Committee; and (5) the Infectious Disease Committee. The submitted protocol and the reports from these committees are then reviewed by the Intervention Strategies and Prioritization Committee. This group determines whether this study is a priority to TrialNet and then makes a recommendation to the TrialNet Steering Committee (the governing body of TrialNet). Prior to Steering Committee action, the TrialNet Executive Committee (consisting of the principal representatives from the NIDDK, the NIAID, the TrialNet Chairman’s Office, and the TrialNet Coordinating Center) and the NIDDK provide input. If the study advances to the Steering Committee and then the Steering Committee approves the protocol to be conducted by TrialNet (a 2/3 majority vote is required), a Protocol Development Committee is formed to expedite protocol development. This committee consists of the protocol Principal Investigator (generally the submitting investigator) and TrialNet’s standing Protocol Development Team (consisting of key members of the Executive Committee).

The Steering Committee, composed of each of the Principal Investigators and designated mechanistic Co-Investigators from each Clinical Center, the Principal Investigator of the Coordinating Center, the NIDDK Project Scientist, the Chairman of the Steering Committee, the Principal Investigator from each Core Laboratory, and representatives (one each) from NIAID, NICHD, and JDRF, will be the main governing board of the network. Project Scientists from other Institutes and Centers will serve as voting and ex officio members of the Steering Committee. This committee will have primary responsibility for approval of the common protocols, facilitating the conduct of participant follow-up, monitoring completeness of data collection and timely transmission of data to the Coordinating Center, and reporting the study results. It will also be responsible for establishing study policies in such areas as access to patient data, ancillary studies, publications and presentations, and performance standards. Each member of the Steering Committee will have one vote and all major scientific decisions will be determined by a 2/3 majority vote of the Steering Committee. Subcommittees will be established for specific purposes as needed, such as for ancillary studies, publications and presentations, clinical monitoring, and safety monitoring among others.

Each consortium Clinical Center awardee agrees to the governance of the study through the Steering Committee. Meetings of the Steering Committee will ordinarily be held face-to-face approximately twice yearly.

The NIDDK Project Scientist (and the other cited NIH scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., to address issues of recruitment, intervention, follow-up, quality control, standards and methods, adherence to protocol, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment or retention. Regardless of the number of NIDDK staff participating in technical advisory roles, the NIDDK will be limited to one vote on the Steering Committee.

The TrialNet Publications, Presentations, and Communications Committee (PPCC), a committee appointed by and reporting directly to the Executive Committee), is the primary body overseeing publication and release of TrialNet information. The PPCC manages TrialNet publications policy, monitors/facilitates the timely publication of results, and mediates disputes. Upon completion of a study, the Lead Author (designated by the PPCC) is charged with coordinating the preparation of the planned presentation and/or publication. The Lead Author is charged with making the draft available to all co-authors and is responsible for responding to comments. The Lead Author works closely with the PPCC Chair, the Steering Committee Chair, and senior Coordinating Center staff to address issues of authorship and selection of appropriate venues for presentation/publication. All TrialNet publications of principal outcomes are prepared under the overall direction of the PPCC. An individual Center may not repot the data collected from its center alone. All presentations and publications using TrialNet study data must protect the main objectives of the trial. Six months after the completion of primary outcome analyses and acceptance of the final paper for publication, de-identified data will be shared with TrialNet study investigators. At that time, investigators are free to conduct additional analyses of the study data that are not addressed in the primary results paper or in other papers under development.

An independent Data Safety and Monitoring Board and an External Evaluation Board will be convened by the NIDDK and will be composed of experts in relevant medical, psychological, statistical, operational, and bioethical fields who are not otherwise involved in the study. They will periodically review the progress of the study. The committees will oversee participant safety, evaluate study progress and results, monitor data quality, and provide operational and policy advice to the Steering Committee and the NIDDK regarding the status of the study. The Principal Investigator of the Coordinating Center, the NIDDK Project Scientist, and the Director of the Division of Diabetes, Endocrinology and Metabolism may participate as ex-officio, non-voting members of these Committees. Committee members will be appointed by the Director, NIDDK. The NIDDK named Project Coordinator will serve as executive secretary of the Data Safety Monitoring Board and of the External Advisory Board.

Each member of the Steering Committee will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Ellen W. Leschek, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
Division of Diabetes, Endocrinology and Metabolic Diseases
Room 603, MSC 5450
6707 Democracy Boulevard
Bethesda, MD 20892-5450
Telephone: (301) 402-8291
FAX: (301) 480-3503
Email: [email protected]

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room Number 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: [email protected]

3. Financial or Grants Management Contacts:

Diana O Donovan
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room Number 708, MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8868
FAX: (301) 594-9523
Email: [email protected]

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 public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (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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