Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

NIDDK Program Projects (P01)

Activity Code

P01 Research Program Projects

Announcement Type
Reissue of PAR-11-043
Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-266

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847   

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites submission of investigator-initiated program project applications. The proposed programs should address scientific areas relevant to the NIDDK mission including diabetes, endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic and hematologic diseases, as well as new approaches to prevent, treat and cure these diseases, including clinical research. A description of NIDDK scientific program areas can be found at http://www2.niddk.nih.gov/Funding/default.htm.

Key Dates
Posted Date

July 8, 2013

Open Date (Earliest Submission Date)

August 25, 2013

Letter of Intent Due Date(s)

Six weeks before the application due date

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard AIDS dates apply

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

May 8, 2016

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

You will be sent to ASSIST to prepare and submit your application. Problems accessing or using ASSIST should be directed to the eRA Commons Help Desk.
Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

New biologic knowledge will come from both sole investigators following their vision and from teams of scientists sharing their expertise.  Some complex biomedical problems require a multidisciplinary vantage point to discover an innovative solution. The P01 program project award supports research that has multiple distinct but synergistic projects built around a unifying central theme relevant to the NIDDK.

A central theme or well-defined major objective is the foundation of a P01 program project. Compared to the more narrow thrust of a traditional R01 research project, a program project is directed toward a range of scientific questions that elucidate various aspects of the central theme.  The interrelationships of research projects and collaborations among investigators will yield synergy and results beyond those achievable if each research project were to be pursued independently.  In addition, one or more shared research cores are required.  More information on grant programs supported by NIDDK can be found at Types of Grants Funded by the NIDDK.  http://www2.niddk.nih.gov/Funding/Grants/GrantTypes

The project leaders and core leaders should be established investigators with strong records of innovative research and independent funding support.  The participation of experts in several disciplines or in several areas of one discipline will greatly enhance the goals of the program project. All investigators must contribute to, and share in, the responsibilities of fulfilling the program objectives. 

The research of the program projects should advance the mission of the NIDDK to gain new knowledge relevant to understanding diabetes, endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic and hematologic diseases, and to develop new approaches to prevent, treat and cure these diseases.

A program project requires:  a) a minimum of three projects that complement and contribute to its central theme; and b) at least one research core facility that provides services to at least two research projects.  Investigators are allowed to submit each research project as an R01 application and as part of the program project for review in the same review cycle. If such a project were to receive impact scores that merit funding of both the R01 and P01 applications, funding of the project in the program project will take precedence, and the R01 application will be inactivated administratively.

The NIDDK envisions that only rarely, if ever, will applications request less than $500,000 in direct costs per year for all years. Therefore, most, if not all, applications must obtain permission before submission of a new, renewal or resubmission application (See Section IV.6). Potential applicants are strongly encouraged to contact NIDDK while they are still in the process of developing conceptual plans for an application and at least 6 months before the due date to discuss a potential application. The discussion could include the choice of activity code, relevance of the topic to the NIDDK mission and the scope and approach of the project.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal - Only one subsequent renewal application is allowed for any application funded in FY 2011 or beyond.
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon the NIDDK budget and the number of highly meritorious applications.  A limited pool of funds for program projects and similar large grants makes these awards highly competitive.

Award Budget

Applications cannot request more than $6.25 million in direct costs over 5 years.  The indirect costs related to the subcontracts will be excluded from the requested direct cost levels prior to application of the cap.

Award Project Period

The maximum project period for these awards is 5 years.

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


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads and Core Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established research scientist who has the experience, ability, and time commitment to provide scientific leadership and to ensure quality control, effective administration and integration of all components of the program project. Each research project should be led by an experienced investigator with an established record of productivity and independent funding.

Minimum expected levels of effort for the overall P01 application are three person months for a single PD/PI or an aggregate of three months with multiple PDs/PIs and 1.2 person months for individual project leaders.  

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent, preferably electronically via e-mail, to:

Michele Barnard, PhD
Deputy Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 751
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8898
Email: barnardm@mail.nih.gov

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Admin Core

6

Core (Use for Research Cores)

6

Project

12

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Under the Facilities and Other Resources section, describe the features of the institutional environment that would facilitate effective implementation of the program project. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographic distribution of space and personnel, and consultative resources. If the projects are not at the same location, describe the plans for communication and sharing of biologic material.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Minimum expected levels of effort for the overall P01 application are three person months for a single PD/PI or an aggregate of three months with multiple PDs/PIs and 1.2 person months for individual project leaders. 

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan          (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims of the overall program project. Outline how the individual cores and projects will contribute to these aims.

Research Strategy: The overall research strategy includes:

A. Program Introduction and Statement of Objectives: Present the background, rationale and hypotheses of the central scientific theme and the strategies to address specific questions and problems related to the central theme. Explain the strategy for achieving the objectives of the overall program.

B. Organization and Synergy of the Program Project: Describe the relationships among the projects and cores and their contribution to the overall strategy. Describe the unique advantages that would be gained by the proposed program project, the synergy among the projects and the means by which the projects collectively will achieve the stated objectives of the proposed research. Include in this description, the role of the research cores in promoting the collaboration among the projects.  For new (Type 1) applications, this section should indicate any prior successful collaboration among investigators in the group and include peer-reviewed publications that resulted from the collaboration.  For renewal (Type 2) applications, a description of the collaboration among the projects and cores during the previous funding period must be included.  A justification for adding new projects or cores or for deleting components previously should also be included.

C. Relation of the Program Project to the Applicant Institution: Describe the relationships between the proposed program project and other existing research units at the applicant institution. List all NIDDK-supported Centers and Program Projects at the applicant institution and the relationship, if any, with the proposed Program Project. Indicate if any of the proposed cores will expand cores already existing at the institution.

Progress Report Publication List:  For renewal (Type 2) applications, include a table of publications that directly resulted from the Program Project since it was last reviewed.   The table should list the publications and note which Project(s) and Core(s) were directly involved in the research for each publication.

Protection of Human Subjects: Please specify which Projects and Cores will utilize human subjects.

Vertebrate Animals: Please specify which Projects and Cores will utilize vertebrate animals.

Multiple PD/PI Leadership Plan:  If the Program Project will be directed by multiple PDs/PIs, a leadership plan must be included.

Letters of Support: Attach letters of support relevant to the program project as a whole e.g., letters of institutional support.  Letters of support relevant to specific projects or cores should be attached in their respective Research Plan forms.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administrative Core (optional)

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.  The Administrative Core should not involve Human Subject research.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.  The Administrative Core should not involve Vertebrate Animal research.

Project Narrative:  Do not complete; it is not required for the Administrative Core.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Administrative Core)

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The Administrative Core may include limited funds for program enrichment activities such as seminars and research workshops, if they are directly related to the goals of the program project.  The funds cannot be used for general departmental activities.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan          (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the specific aims of the Administrative Core

Research Strategy: An administrative core is not required for a program project. The research strategy should provide a strong justification for the inclusion of an administrative core and its benefit to the program project.   If an administrative core is included, it could provide a support structure for activities such as:  coordinate the research mission, monitor timeline for achieving research milestones, coordinate and integrate program project activities, implement a plan for regular evaluation of scientific progress.  

Letters of Support: Attach letters of support relevant to the Administrative Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Research Core

When preparing your application in ASSIST, use Component Type ‘Core’.

At least one Research Core, utilized by a minimum of two Research Projects, is required for a Program Project. 

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Follow the standard SF424 instructions for project narratives.

Project /Performance Site Location(s) (Research Core)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Research Core)

Budget (Research Core)

Budget forms appropriate for the specific component will be included in the application package.

PHS 398 Research Plan          (Research Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the specific aims of the Research Core

Research Strategy:  Describe the core and the various services it would provide, as well as the personnel, facilities, management, and any special arrangements such as cooperation with other cores. The research strategy should also include a clear delineation of procedures, techniques, and quality control, and how core usage would be prioritized. If applicable, describe in detail statistical analyses and data management.  Describe the role of the leaders of the Research Cores in developing the research directions of the Program Project.  The research strategy could also include plans for the development of new methods and innovative procedures essential to advancing the research goals of the Program Project.

Research Core resources should not simply duplicate resources already available at the institution.  The Research Core could be available to investigators outside the Program Project, but procedures for prioritization and funding for the outside users should be described. 

For renewal (Type 2) applications, discuss progress in the Research Core during the prior funding period and the rationale for any changes. 

Progress Report Publication List:  For renewal (Type 2) applications, include a list of publications that directly resulted from the Research Core during the prior funding period.

Letters of Support: Attach letters of support relevant to the Research Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Project

When preparing your application in ASSIST, use Component Type ‘Project’.

The application must consist of a minimum of three projects that complement and contribute to the central theme of the Program Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Follow the standard SF424 instructions for project narratives.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Project)

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Minimum expected levels of effort for the overall P01 application are three person months for a single PD/PI or an aggregate of three months with multiple PDs/PIs and 1.2 person months for individual project leaders. 

PHS 398 Research Plan          (Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:  Describe the specific aims of the Project.

Research Strategy: Describe the research strategy of the Project in the same detail and format as required for an investigator-initiated R01 grant application. Even though three or more Projects are required for a Program Project and the Projects need to be synergistic, this section should focus on the specific Project and not the potential synergy between this Project and the other Projects and Cores.  Impact scores will be assigned to individual research projects as well as to the program project as a whole. Thus, the description of each Project should be explicit enough to enable peer reviewers to understand and evaluate each Project independently.  For renewal (Type 2) applications, discuss progress in the Project during the prior funding period. 

Progress Report Publication List:  For renewal (Type 2) applications, include a list of publications that directly resulted from the Project during the prior funding period.

Letters of Support: Attach letters of support relevant to the Project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must submit a written request at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Although a written, pre-approval request is due at least 6 weeks prior to the application due date, NIDDK strongly encourages investigators to submit the pre-approval request much earlier (eq., 6 months prior to the application due date).  Early discussions with program staff and submission of the pre-approval request can significantly aid the investigators in the subsequent development of the application.  NIDDK reviews pre-approval requests on a rolling basis and typically will inform investigators within 4 weeks of submission of the pre-approval request whether they will be allowed to submit an application.  The following information will help staff in this consideration:  1) a description of the central theme, including its significance and impact; 2) the specific aims of the individual projects and cores and the synergy among the projects and cores; 3) the importance and relevance to NIDDK; 4) the need for a P01 program project, as opposed to another activity code; 5) biosketches for all key personnel; and 6) first year budget (indicate whether direct costs will exceed $1M in any year).  The request can be sent as a single attachment (PDF) to an e-mail (preferred method) or by regular mail to the appropriate NIDDK program staff (listed under their area of interest http://www2.niddk.nih.gov/Funding/default.htm).   

The following criteria will be used in the administrative staff review of these requests:

A. Relevance to the NIDDK: Importance of the unifying central theme to the NIDDK mission.

B. Programmatic priority: Will the proposed research significantly advance the mission of NIDDK?

C. Programmatic balance: How does the proposed research relate to currently funded research in the NIDDK and by the investigative team?

D. Activity Code: Is the proposed work appropriate for the P01 activity code?  Are there at least three discrete projects and a core that serves at least two projects?

If the NIDDK agrees to accept an application, a cover letter should be included with the application that identifies the NIDDK program staff who agreed to accept assignment of the application to the NIDDK. The NIDDK will also notify the NIH Division of Receipt and Referral of their willingness to accept the application. 

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the overall Program Project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the overall Program Project proposed).

Scored Review Criteria - Overall

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

Significance

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the overall Program Project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Do(es) the overall Program Project PD/PI(s) have: (a) track record(s) of consistently producing highly significant research publications in one or more of the research areas proposed for the program project; (b) track record(s) demonstrating the ability to effectively and productively manage a large, interdisciplinary project in the proposed research area?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the overall Program Project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the overall Program Project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

Are the approaches proposed in the individual projects and cores complementary? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria - Overall

As applicable for the overall Program Project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Synergy

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program project to exert a sustained, powerful influence on the research field(s) involved.

The relationship and contributions of each research component and core to the overall theme of the program project will be discussed and evaluated. In assigning the impact score for the application as a whole, the assessment of scientific synergy (i.e., the extent to which the potential for scientific impact of the proposed program project as a whole is deemed likely to be greater than the sum of its component research projects and cores) should contribute significantly to the overall score. This will include the following:

Scientific merit of the program as a whole, as well as that of individual projects, and its potential impact on the field;

Scientific gain of combining the component parts into a program project (beyond that achievable if each project were to be pursued separately);

Cohesiveness and multidisciplinary scope of the program and the coordination and interrelationship of all individual research projects and cores to the common theme;

Leadership and scientific ability of the PD(s)/PI(s) and his or her commitment and ability to develop a well-defined central research focus (request of support for sufficient effort to provide effective oversight and administration of the program should be considered); and past accomplishments of the program or a demonstrated ability in mounting similar programs.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed program project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the Program Project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Applicants should include:

Progress and achievements specific to this program project during the past funding period and the evidence through publications, conferences, etc., that collaboration has occurred;

Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of ongoing work;

Previous performance and estimated use of the core(s); and

Justification for adding new projects or cores or for deleting components previously supported.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the overall Program Project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

As applicable for the overall Program Project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Review Criteria for Individual Research Projects

It is important that each project fits and contributes to the theme of the overall program project, but this factor should be judged separately and have no bearing on a project's individual impact score. Instead, these considerations are addressed with respect to the merit of the overall program project.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Scored Review Criteria

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment, in which the work will be done, contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Review Criteria for Administrative Core

The review criteria for the individual cores are given below (cores receive merit descriptors rather than numeric scores; individual criterion scores are not provided):

Utility of the core to the program project;

Quality of the facilities or services provided by this core (administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program, and replacement of the principal investigator/program director if required on an interim or permanent basis);

Qualifications, experience, and commitment of the personnel involved in the core; and

Appropriateness of the core in relation to the scope of the proposed administrative support.

Review Criteria for Individual Research Cores

The review criteria for the individual cores are given below (cores receive merit descriptors rather than numeric scores; individual criterion scores are not provided):

Utility of the core to the program project; each core must provide essential facilities or service for two or more projects

Quality of the facilities or services provided by this core (including procedures, techniques, and quality control) and criteria for prioritization of usage;

Qualifications, experience, and commitment of the personnel involved in the core; and

Appropriateness of the core in relation to the scope of the proposed research support.

If human subjects, vertebrate animals, or biohazards are to be used in the core, the adequacy of these sections must be assessed and will be considered in determining the descriptor of the individual core.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Mr. Louis Martey
Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301- 594-7733
Fax: 301-435-6047
Email: marteyl@mail.nih.gov

Michael J. Grey, Ph.D.
Division of Digestive Diseases and Nutrition (DDN)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3759
Fax: 301-480-8300
Email: greymj@mail.nih.gov

Chris Mullins, Ph.D.
Director of Basic Cell Biology Programs
Division of Kidney, Urologic and Hematologic Diseases (KUH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4902
Fax: 301-480-3510
Email: mullinsC@extra.niddk.nih.gov

Peer Review Contact(s)

Michele Barnard, Ph.D.
Deputy Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: barnardm@mail.nih.gov

Financial/Grants Management Contact(s)

Mr. Robert Pike
Chief, Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8854
Email:pikera@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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