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://www.niddk.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/)

Title: Planning Grants For Translational Research For The Prevention And Control Of Diabetes And Obesity (R34)

Announcement Type
This is a reissue of PAR-03-060 which was previously released January 22, 2003

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

This Funding Opportunity Announcement (FOA) must be read in conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply)

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 (R&R forms and Application Instruction Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

A registration process is necessary before submission and should be started at least two weeks in advance of the planned submission.

Program Announcement (PA) Number: PAR-06-358

Catalog of Federal Domestic Assistance Number
93.847

Key Dates
Release/Posted Date:  April 13, 2006
Opening Date:  May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  Not applicable
NOTE:  On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm   
Peer Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward  
Earliest Anticipated Start Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward  
Additional Information to Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 2, 2009 (now May 8, 2009 per NOT-OD-07-093)

Due Dates for E.O. 12372
N/A

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
   
Section II. Award Information
1. Mechanism 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Several large, controlled clinical trials have established "gold standard" approaches for treating type 1 and type 2 diabetes, and for preventing or delaying type 2 diabetes in individuals at high risk for developing the disorder.  Research is needed to translate the results of these trials into widespread practice.  Studies to develop effective, sustainable and cost effective methods to prevent and treat diabetes and obesity in clinical health care practice and other real world settings are appropriate targets for translational research.

The Diabetes Control and Complications Trial (DCCT), for type 1 diabetes, and the United Kingdom Prospective Diabetes Study (UKDPS), for type 2 diabetes, established the importance of intensive glycemic control in dramatically reducing the devastating complications of diabetes.

Unfortunately, the therapies proven to delay or prevent complications in these studies have not been widely incorporated into general health care practice. Prevention and treatment of long-term micro- and macrovascular complications remain a critical problem in the management of type 1 and type 2 diabetes mellitus. In the United States, diabetes is the leading cause of new blindness in working-age adults, of new cases of end stage renal disease and of non-traumatic lower leg amputations. In addition, cardiovascular complications are now the leading cause of diabetes-related morbidity and mortality, particularly among women and the elderly.  In adults with diabetes, the risk of cardiovascular disease (CVD) is two to four-fold greater than in nondiabetics. Comorbid conditions (hypertension, dyslipidemia and smoking) combine with hyperglycemia to contribute to accelerated atherosclerosis. Clinical trial data has established unequivocal benefit of rigorous control of glycemia and blood pressure in preventing both micro- and macrovascular complications of diabetes. Smoking cessation, aspirin therapy and lipid control have also been shown to prevent morbidity. Despite clear-cut evidence of benefit, recently available data demonstrate that patients with diabetes are not achieving recommended levels of glycemic, blood pressure or lipid control or adherence to other accepted treatment guidelines.

The difficulties inherent in achieving good glucose control and preventing diabetes complications make prevention a compelling strategy. This is particularly true for type 2 diabetes, which is clearly linked to modifiable risk factors – e.g., overweight or obesity and a sedentary lifestyle. The Diabetes Prevention Program (DPP) tested strategies to prevent or delay the development of  type 2 diabetes in individuals at high risk for its development by virtue of their having impaired glucose tolerance (IGT).  The DPP demonstrated that intensified lifestyle or drug intervention in individuals with IGT prevented or delayed the onset of type 2 diabetes.  Lifestyle intervention, leading to moderate weight loss and increased exercise, reduced diabetes incidence by 58% and the drug metformin by 31% compared with placebo.  The effects were similar for men and women and for all racial and ethnic groups.  Similar effects of lifestyle intervention were seen in another study conducted in Finland. Cost-effective strategies for promoting lifestyle modification leading to weight loss in these high-risk individuals, outside the setting of a controlled, clinical trial, need to be established. In addition, while behavioral treatment of obesity in adults leads to clinically significant weight loss, prevention of weight regain remains an elusive goal for many.

Overweight in childhood, the prevalence of which has more than doubled in the past two decades, is a major risk factor for type 2 diabetes. Indeed, the increase in overweight children has been linked to a rise in type 2 diabetes in the pediatric population. Family-based behavioral interventions have been shown to have a long-term impact on degree of overweight. However, cost-effective interventions in primary care and community-based settings are needed.

One third of people with type 2 diabetes are undiagnosed. In addition a significant proportion of patients are diagnosed with diabetes only when they present with diabetic retinopathy or neuropathy.  Epidemiologic data has shown that the risk for complications increases with duration of diabetes. Thus early diagnosis and treatment likely decreases the risk for complications. Population-based, as well as generalizable, clinic-based strategies are needed to establish cost-effective programs to  identify individuals at risk for diabetes or who have diabetes who could benefit from prevention or treatment programs.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through this FOA seeks to foster the development of cost effective and sustainable translational research studies to prevent and treat obesity and diabetes.  The interventions designed should have the potential to be disseminated to clinical practice, individuals or communities at risk. Studies submitted to this program should focus on developing preliminary data demonstrating that the proposed approach is feasible and will improve weight control or glycemia.  It is not the intent of this FOA to support the development of initial efficacy trials.  Rather, it is for the translation of interventions that have previously been shown to be efficacious in the research setting.  Proposed studies must address issues of sustainability, cost effectiveness and dissemination. Studies addressing minority populations at disproportionate risk for obesity, diabetes and diabetes complications are encouraged. Study design and its accompanying analysis plan must be linked to the research question.  The general goal is to select a design that maximizes generalizability and minimizes bias.  Relevant topics include but are not limited to:

Of particular interest are studies to improve self-management and enhance health care delivery to underserved and minority populations. Such studies may seek to improve outcomes in populations (with either type 1 or type 2 diabetes) that historically have had poor glycemic, blood pressure, and other risk factor control, or promote effective prevention strategies in minority populations known to be at high risk for the development of type 2 diabetes and/or its complications.

These studies will provide pilot and feasibility data to be used in developing full-scale studies that would be submitted as research demonstration and dissemination projects (R18) under PA-02-153  (http://grants.nih.gov/grants/guide/pa-files/PA-02-153.html).  The R34 submitted in response to this FOA should be designed to develop convincing preliminary data that demonstrate feasibility and provide pilot data indicating that the intervention can result in weight loss, prevention of inappropriate weight gain, or improved glycemia.  It is recommended that investigators review the guidance regarding requirements for the R18 to help understand the long-terms goals of the R34 project. An outline of the key features of the subsequent full-scale study being piloted, including biostatistical considerations should be included together with a discussion of how the R34 will lead to a subsequent R18 proposal.  Applicants who do not require support for a feasibility study may apply for an R18 directly under PA-02-153.  It is also recommended that applicants review the contents of the translational research meeting report URL at http://www.niddk.nih.gov/fund/other/Diabetes-Translation/conf-publication.pdf The rationale for the future large-scale intervention should be described. Applicants should provide a description of key elements of the design of that study, including the population to be studied, the setting for delivery of the intervention, primary and secondary outcomes to be assessed, the duration of follow-up, and the statistical analysis to be employed. Investigators must also address how cost effectiveness and sustainability will be assessed during the R18.  

For the project to be supported under the R34, applicants should provide a detailed description of the target population to be studied, with justification, including a definition of the cohort by age, gender, sex and race/ethnicity The applicant’s experience in recruiting this target population and the methods to be used should be described.  Sample size needs required to pilot the proposed study and assumptions made to estimate an appropriate pilot sample size should be detailed by presenting the analysis plan to be used.  Applicants must state their plans for reporting accrual by gender, race and ethnicity and for the reporting of results that examine differences in treatment effects across these subgroups (see below, "Inclusion of Women and Minorities in Research Involving Human Subjects"). Methods for assuring privacy and maintaining confidentiality should be included.  A data and safety monitoring plan must be included. 

Studies may utilize methodology from the fields of biomedical, social or behavioral sciences, epidemiology, clinical trials, and health services and dissemination research. The primary outcome should include glycemia or weight.  An intervention aimed at producing a behavioral change should be grounded in behavior change theory, which should be incorporated into the intervention. The application will be strengthened by the inclusion of a process evaluation – i.e., an evaluation of whether the intervention is actually delivered as intended.

Investigators should provide detailed evidence that the research team has the experience and expertise to conduct the research study.  Most translational research will require a multidisciplinary research team.  Thus, a variety of researchers may be required for these studies, including, but not limited to, endocrinologists, public health physicians, primary care physicians, epidemiologists, statisticians, psychologists, health educators, sociologists, nurses, nutritionists and other health related professionals. The interdisciplinary nature of the research team should be fully described and justified.

Brief descriptions, as appropriate, of the process for biologic sample collection, storage and handling; the laboratory tests that are needed; physical facilities, data management and computer resources, and facilities for data retrieval and storage; and a plan for randomization of patients or settings for delivery of interventions into protocols should be provided.  

Investigators located at existing Diabetes Research and Training Centers (DRTC) or proposing to collaborate with a DRTC should include a complete description of how the proposal in response to this PAR will utilize the core facilities funded through the DRTC. Investigators who are not directly affiliated with a DRTC may, if feasible, form collaborations with such centers in order to utilize the core resources. A list of DRTCs can be found at http://www.niddk.nih.gov/fund/other/centers.htm.

Investigators located at existing CDC-DDT supported "Translating Research into Action for Diabetes (TRIAD)" sites should include a full description of how the TRIAD sites will be advantageously utilized. TRIAD investigators should also describe how they will integrate the TRIAD sites and cohort without adversely affecting or overlapping the current and future multicenter collaborative goals of the TRIAD Study (e.g., primary hypotheses, cohort follow-up). The testing of interventions to prevent or treat disease among individuals from the TRIAD cohort is encouraged.

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

Applicants may be interested in the messages and resources already developed by the National Diabetes Advisory Board (NDEP) and available on the NDEP web site at http://www.ndep.nih.gov/.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the National Institutes of Health (NIH) clinical trial planning grant (R34) award mechanism, which will provide up to $150,000 in direct costs per year. The total project period for an application submitted in response to this FOA may not exceed 2 years.  Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. These grants may not be renewed. It is anticipated that the data collected using these grants will provide the basis for a full-

Scale study, which would be submitted as a research demonstration and dissemination project (R18) under PA 02-153.

This funding opportunity will use the R34 award mechanism. R34 grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/policy.htm#gps). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium F&A costs), use the Modular Budget Component provided in the SF424 (R&R) Application Package and Instructions Guide (See specifically the Modular Budget Component). 

2. Funds Available

 Total amount of funding that your agency/IC expects to award through this announcement:

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign Institutions are not eligible

1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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
 
There is no limit on the number of applications an applicant may submit under this announcement provided that they are scientifically distinct.

Section IV. Application and Submission Information


Registration and Instructions for Submission via Grants.gov


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations. 

1.Request Application Information

Applicants must download the SF424 (R &R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R &R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R &R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Project Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget                                                                                                                               

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s) http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically
PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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.

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: are necessary to conduct the project, and 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 the NIH Grants Policy Statement

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R34 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

R34 appendix materials should be limited, as is consistent with the exploratory nature of the R34 mechanism. The following materials may be included in the appendix:

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

Sharing Research Resources

N/A

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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

As part of the initial merit 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 high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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?

Translation:  Does the intervention strategy proposed have the ability to be translated into primary care, community, family or other patient care/support settings and address issues of sustainability and dissemination? Does the intervention have the potential to lead to a cost effective intervention that can be sustained in real world settings?

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 priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods.

2.C. Sharing Research Data

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

3. Anticipated Announcement and Award Dates

N/A

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/her Summary Statement (written critique) via the NIH 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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

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

3. Reporting

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Sanford Garfield, Ph.D (for behavioral research)
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK
6707 Democracy Boulevard, Rm. 685
Bethesda, MD 20892-5460
Telephone:  (301) 594-8803
FAX:  (301) 480-3503
E-mail:  sg50o@nih.gov

Barbara Linder, M.D., Ph.D. (for pediatric medical research)
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK
6707 Democracy Boulevard, Rm. 699
Bethesda, MD 20892-5460
Telephone:  (301) 594-0021
FAX:  (301) 480-3503
E-mail:  bl99n@nih.gov

Myrlene Staten, M.D. (for adult medical research)
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK
6707 Democracy Boulevard, Rm. 6107
Bethesda, MD 20892-5460
Telephone:  (301) 402-7886
FAX:  (301) 480-3503
E-mail:  ms808k@nih.gov

Robert Kuczmarski (for obesity research)
Division of Digestive Diseases and Nutrition
NIDDK
6707 Democracy Boulevard, Rm. 673
Bethesda, MD 20892-5460
Telephone:  (301) 451-8354
FAX:  (301) 480-8300
E-mail:  rk191r@nih.gov

Ronald P. Abeles, Ph.D.
Special Assistant to the Director
Office of Behavioral and Social Research
Office of the Director
National Institutes of Health
Gateway Building, Room 2C234, MSC 92057201 Wisconsin Avenu
Bethesda, MD 20892-9205  USA
Tel: 1-301-496-7859     Fax: 1-301-435-8779
E-mail: abeles@nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Diana O’Donovan
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 726
6707 Democracy Boulevard
Bethesda, Maryland 20892-5456
Telephone:  (301) 594-8868
Fax:  (301) 480-3504
Email:  do66k@nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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.

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 SF424 (R&R); 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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

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

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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