EXPIRED
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)
Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
Office of Behavioral and Social
Sciences Research (OBSSR), (http://obssr.od.nih.gov)
Title: Translational Research for the Prevention and Control of
Diabetes and Obesity (R18)
Announcement
Type
This Funding Opportunity Announcement
(FOA) is a reissue of PAR-06-532.
Program
Announcement (PA) Number: PAR-09-176
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
Research and Related (R&R) forms and the SF424 (R&R) Application
Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This 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).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.847, 93.865
Key Dates
Release/Posted Date: April
28, 2009
Opening Date: June
1, 2009 (Earliest date
an application may be submitted to Grants.gov)
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 Due Date(s): July 1, 2009,
November 2, 2009, March 1, 2010, July 1, 2010, November 1, 2010, March 1, 2011,
July 1, 2011, November 1, 2011, March 1, 2012
AIDS Application
Due Date(s): Not
applicable
Peer Review
Date(s): October
2009, March 2010, July 2010, October 2010, March 2011, July 2011, October 2011,
March 2012, July 2012.
Council Review
Date(s): January
2010, May 2010, October 2010, January 2011, May 2011, October 2011, January
2012, May 2012, October 2012.
Earliest Anticipated Start Date(s): April
1, 2010
Additional Information To Be Available
Date (Activation Date): Not Applicable
Expiration Date: March 2, 2012
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 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. Submitting an Application
Electronically 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
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 Contacts
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 (e.g. DPP, DCCT, and UKPDS) have established "gold standard" approaches for treating type 1 and type 2 diabetes, and for preventing or delaying type 2 diabetes in individuals at high risk for developing the disorder. Large controlled trials have also consistently demonstrated success in achieving weight loss though lifestyle approaches, although maintenance remains a challenge. Despite these advances, the efficacious interventions from these trials are rarely translated into widespread practice. Research is needed to test innovative adaptations of evidence based approaches to prevent and treat diabetes and obesity that can be disseminated and sustained in clinical health care practice and other settings beyond the research environment.
The R18 submitted in response to this FOA should be designed to maximize generalizability and minimize bias in testing interventions for weight loss, prevention of inappropriate weight gain, or improved glycemic control. Relevant topics include but are not limited to:
The primary outcomes must include glycemia and/or weight change expressed as BMI, weight, percent body fat, etc. Behavior change (such as changes in diet and/or physical activity patterns or behaviors) or knowledge acquisition may be included as secondary or intermediate outcomes but applications will not be considered appropirate if objective clinical measures are not included as primary outcomes.
It is not the intent of this FOA to support the development of initial efficacy trials or the development or distribution of programs for diabetes control or weight loss. Rather, it is for translation of interventions that have previously been shown to be efficacious.
Proposed studies must address issues of cost in relation to implementation, sustainability, dissemination, and clinical outcomes. Researchers should address the capacity of the tested approach for wide dissemination, the sustainability of the approach once the research is concluded, and include an evaluation of the implementation costs in relation to the health benefit achieved. Applications will be strengthened by the inclusion of a process evaluation i.e., an evaluation of whether the intervention is actually delivered as intended.
Studies addressing minority populations at disproportionate risk for obesity, diabetes and diabetes complications are encouraged but the research must have generalizability across a reasonably large segment of the at risk population. It is not the intent of this FOA to support research applications that propose to simply replicate efficacious intervention trials in a different group of people (e.g., different age, gender, race/ethnic, disability, SES, or other groups). Proposals in which the main focus is on development and validation of culturally appropriate materials are not considered appropirate.
Study design and the accompanying analysis plan must be linked to a research question. The research designs employed should emphasize generalizability while maximizing scientific rigor (reducing threats to external validity while preserving internal validity).
Applicants who have received R34 awards in response to PAR-06-358 or PAR-09-177 (Planning Grants for Translational Research for the Prevention and Control of Diabetes and Obesity) must clearly identify how the pilot and feasibility data generated in the Planning Grant has led to and supports the full scale R18 proposal. Investigators who require a planning and pilot data collection phase should utilize the R34 prior to submission of an R18 proposal PAR-09-177.
All R18 applicants must provide the rationale for the large-scale intervention and provide a full description of the setting for delivery of the intervention, primary and secondary outcomes for the research, duration of follow-up, sample size requirements, and the statistical analysis to be employed. For the project to be supported under the R18, applicants must also 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 applicants experience in recruiting this target population and methodology should be described. 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 must also be included along with a data and safety monitoring plan. Applicants may wish to review the contents of the translational research meeting report URL at http://www.niddk.nih.gov/fund/other/Diabetes-Translation/conf-publication.pdf.
Studies may use methodology from the fields of biomedical, social or behavioral sciences, epidemiology, clinical trials, and health services and dissemination research. Interventions aimed at producing behavioral change should be based on behavior change theory(ies) which should be described in the application.
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 or 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 are also encouraged to use various existing practice based research centers and networks.
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
This FOA will use the R18 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
2.
Funds Available
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.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost
Sharing or Matching
This
program does not require cost sharing as defined in the current NIH Grants
Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement), See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Renewals will be allowed for this FOA.
Section IV. Application and Submission Information
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or 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:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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.
Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 organization/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 the 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 301-710-0267, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover
component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget,
as appropriate (See Section IV.6., Special Instructions, regarding appropriate
required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review
and Anticipated Start Dates
Opening
Date:June 1, 2009 (Earliest date an
application may be submitted to Grants.gov)
Application Due
Date(s): July 1, 2009, November 2, 2009, March 1,
2010, July 1, 2010, November 1, 2010, March 1, 2011, July 1, 2011, November 1,
2011, March 1, 2012
Peer
Review Date(s): October 2009, March
2010, July 2010, October 2010, March 2011, July 2011,
October 2011, March 2012, July 2012.
Council
Review Date(s): January 2010, May 2010, October 2010, January 2011, May
2011, October 2011, January 2012, May 2012, October 2012.
Earliest Anticipated Start Date(s): April 1, 2010
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp 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 due date(s). (See Section
IV.3.A. for
all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.