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 Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)

Title: National Institute of Biomedical Imaging and Bioengineering Program Project (P01) Applications

Announcement Type

New

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-233

Catalog of Federal Domestic Assistance Number(s)
93.286

Key Dates
Release Date:  July 20, 2010
Letters of Intent Receipt Date(s): 30 days before the receipt date.   
Application Submission Dates(s): Standard dates apply; please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply; please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: May 26, 2013

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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and 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
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

This Funding Opportunity Announcement (FOA), issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), encourages grant applications for investigator-initiated Program Project Grants (P01) in all areas of biomedical imaging and bioengineering supported by the Institute (see  http://www.nibib1.nih.gov/Research/ProgramAreas for a description of NIBIB’s scientific research programs)

Areas include but are not limited to: Biomaterials, Biomedical Informatics, Drug and Gene Delivery Systems and Devices, Image-Guided Interventions, Image Processing, Visual Perception and Display, Magnetic, Biomagnetic and Bioelectric Devices, Magnetic Resonance Imaging and Spectroscopy, Mathematical Modeling, Simulation and Analysis, Medical Devices and Implant Science, Micro-biomechanics, Micro- and Nano-Systems, Platform Technologies, Molecular Imaging, Nanotechnology, Nuclear Medicine, Optical Imaging and Spectroscopy, Rehabilitation Engineering, Sensors, Structural Biology, Surgical Tools, Techniques and Systems, Telehealth, Tissue Engineering, Ultrasound (diagnostic and interventional), and X-ray, Electron, and Ion Beam Technologies.

The program project mechanism is designed to support integrated, multiproject research programs involving a number of independent investigators who share knowledge and common resources while working towards a unifying overall goal. Basic, translational, early-stage clinical, and/or population-based studies are appropriate. The P01 is a highly competitive grant and the NIBIB funds very few of these grants each year.

Successful NIBIB program projects generally bring together investigators in engineering, mathematics, informatics, and the physical and life sciences to apply complementary approaches to a common theme.  The leader of the overall P01 is called the Principal Investigator (PI); the leaders of the subprojects in a P01 are called subproject leaders.  The PI of the P01 must devote a minimum of 3.0 person months (25% effort) to the grant. The PIs of the subprojects must devote a minimum of 2.4 person months (20% effort) to the subproject(s) for which they serve as leader.  If multiple principal investigators or co-leaders are used then each must devote a minimum of 1.2 person months (10% effort) to the subproject. A P01 requires a minimum of three research subprojects led by three independent subproject leaders or co-leaders.  One of the subprojects must be led by the P01 Principal Investigator. There can only be one overall PI but subprojects are allowed to have co-leaders (multiple subproject leaders on a single subproject).  Collectively, these subprojects should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than would occur if each subproject were pursued individually. 

Each individual subproject should reflect a self-standing, scientifically meritorious, research effort  (individual subprojects of the P01 can also be submitted as R01 applications); however, the individual subprojects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.

In addition to individual research subprojects, applicants may propose one or more Shared Resource Core if needed for the proposed research.  Each Shared Resource Core must provide support for at least two of the proposed research subprojects.  The Cores should consist of some service, technique, or instrumentation that will enhance the research endeavors, consolidate manpower effort, and contribute to cost effectiveness and quality.  Administrative Cores are also allowed.  Core support may include personnel, equipment, supplies, services, and facilities required for the integration of the subprojects toward their central research focus. 

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the Program Project (P01) grant award mechanism.  The applicant will be solely responsible for planning, directing, and executing the proposed project. 

This FOA uses “Just-in Time” information concepts.  It also uses non-modular budget formats described in the PHS398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

Program Project Grants in the NIBIB compete for funding with all other grant mechanisms.  There is no set-aside budget for P01s. Budgets for direct costs per year will depend upon specific project requirements, and a project duration of up to five years may be requested.  The expected direct cost for program project awards is $1.2-1.4 million per year for most studies within the scope of this FOA. Under certain circumstances, with the advanced concurrence of NIBIB staff, additional funds may be requested and provided for major pieces of equipment.

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 NIBIB provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. A Principal Investigator may not submit more than one application for a given receipt date.   

Personnel: The Program Project PI must devote a minimum of 3.0 person months (25% effort) to the program including serving as the leader of a component subprojects.  Component subproject leaders must devote a minimum of 2.4 person months (20% effort) to their subproject.  If the subproject uses multiple leaders (equivalent to multiple PIs on an R01), the minimum effort devoted by each multiple PI must be at least 1.2 person months (10% effort). 

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are 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. Applicants may submit a renewal application.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398.

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

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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

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

Additional information is available in the PHS 398 grant application instructions.

Supplemental Instructions for the Preparation of Multi-Project Applications.

For all P01 applications submitted in response to this FOA, the standard PHS 398 instructions are modified as summarized below.  These additional instructions are required because the PHS Form 398 is designed primarily for individual freestanding research project grant applications, and does not have specific instructions for multi-project applications.

Form Page 1 - Face Page: Include the number and title of this FOA in item/line 2 of the PHS 398 application face page.

Form Page 2 - Description, Performance Sites, and Key Personnel: Under Description, state the proposed programs broad, long-term objectives, specific aims, and the significance to the field of Biomedical Imaging and/or Bioengineering.  Define the relevance of each proposed subproject and shared resource core to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors for the entire P01, beginning with the PI/PD and then listing all other Key Personnel alphabetically. Include all project and core leaders, co-leaders, co-investigators, and consultants and consortium collaborators (if applicable and if these individuals will devote measurable effort to the project).

Form Page 3 - Table of Contents: Modify the PHS 398 Form Page 3 to enable reviewers to find each component of the application easily.

Form Pages 4 and 5 Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. Prepare detailed and summary budgets for individual subprojects and shared cores as well.  If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions).

Biographical Sketches: Compile all biographical sketches after the Overall Budget, starting with the PD(s)/PI(s) followed by all other investigators in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.

Program Overview:

The Program Overview section should summarize the overall research plan for the multi-project P01 application.  Page limits for each section are given below. The sections of the Program Overview are as follows:

Summarize the overall research strategy, including the unifying, central theme to which each component subproject relates and research investigator contributes. Describe the overall goals, significance, innovation, approaches, preliminary studies and progress (for competing renewal applications) of the program as a whole.  Examples of previous collaborations that may have led to the goals of the proposed work should be presented.  Also include subsections on:

The following table summarizes the page limits for the various sections of the Program Overview:

Program Overview Section

Page Limit

Introduction to the Overall Application (for resubmission applications only).

1

Overall Program Goals and Specific Aims

1

Overall Research Strategy

12


Individual Research Subprojects:

Each P01 program project application must include at least three individual (albeit connected) research subprojects each of which is pertinent to the central theme of the program.  There is no requirement that the component subprojects be located at a single institution, however, it is incumbent upon the applicant to make clear how component subprojects and cores would function across institutions.  Subproject leaders are expected to devote at least 2.4 person months (20% effort) to each subproject for which they serve as leader.  If multiple principal investigators are used, each must devote a minimum of 1.2 person months (10% effort).  It is expected that most of the subproject leaders will be investigators with significant research experience and fully established at their institutions.

Each research subproject should be prepared according to the standard PHS 398 instructions as modified below. The overall format and page limits for an R01 application apply to each subproject.  However, instead of the standard PHS 398 face page for each subproject, create a title page that lists the subproject number, the name of the subproject, and the name of the subproject leader(s). Do not repeat biographical sketches included at the beginning of the application. For each individual subproject, page limits are 1 page for the Introduction in Resubmission or Revision applications, if applicable, 1 page for Specific Aims and 12 pages for the Research Strategy portion.  Each subproject must have a designated subproject PI or multiple PIs. Each individual subproject of a program project grant should represent both an independent and an interdependent research effort.  Subprojects may be technology development or hypothesis-driven basic, translational or applied research or a combination of technology development and hypothesis-driven research.  The subprojects must include the following:

The following table summarizes the page limits for the various sections of the Subprojects:

Subproject Section

Page Limit

Introduction to the Subproject (for resubmission applications only).

1

Specific Aims for the Subproject

1

Research Strategy

12


Shared Resource Cores:

Applicants may propose one or more (as needed) appropriate shared technical or administrative shared resource cores. These shared resources must not duplicate analogous resources already established in the applicant institutions (although supplemental funding to such existing resources may be requested). Each shared resource core should be prepared according to the standard PHS 398 instructions as modified below.   Instead of the standard PHS 398 face page for each shared resource core, create a title page that lists the shared resource core number, the name of the shared resource core and the name and academic title of the shared resource core director and each participating investigator. Do not repeat biographical sketches included at the beginning of the application. Specific Aims should not exceed one page.  The page limit for the description of the Core is 6 pages.  The description must present clearly the facilities, techniques, and professional skills that the Core unit would provide.  As justification for the Core unit, briefly indicate the specific research subprojects that would use the resources of the Core unit.  Keep in mind that a Core unit is not designed for conducting research but rather for providing services for the research subprojects.  Each shared resource Core must have a single designated Core Director.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date(s):  30 days before receipt dates.   
Application Receipt Date(s):  Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

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

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

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

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Phone: (301) 496-8633
Fax: (301) 480-0675
Email: GeorgeD@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Phone: (301) 496-8633
Fax: (301) 480-0675
Email: GeorgeD@nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs)  must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

Software Sharing Plan

A software dissemination plan, with appropriate timelines, is expected to be included in the application only if software development is a part of the application.  There is no prescribed single license for software produced through grants responding to this announcement.  However, NIH does have goals for software dissemination, and reviewers will be instructed to comment on the dissemination plan relative to these goals:

1.  The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. 

2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4.  The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues.  An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.

5.  To further enhance the potential impact of their software, applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.  This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The plan for software sharing will be evaluated during peer review (but not factored into the final score), and any accepted software sharing plans will become a condition of the award of the grant. Any software sharing plan should be included in the Resource Sharing Plan.

The adequacy of the software sharing plans will be considered by program staff when making recommendations about funding applications. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the Principal Investigator(s). Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.

The final version of any accepted software sharing plans will be referenced as a condition of the award of the grant. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590).  See Section VI.3., “Reporting.”

Intellectual Property 

An institution's stance must be consistent with the goals of advancing and not hindering future research. Refer to the NIH Intellectual Property Policy for more details. The application should include a written statement from the officials of the institution(s) responsible for intellectual property issues, to the effect that the institution supports and agrees to abide by the NIH Intellectual Property Policy.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIBIB and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

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

Review Criteria for the Overall Program as a Whole:

Reviewers will provide a single overall impact/priority score for the Program Project as a whole to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. The overall application will be evaluated as an integrated research effort focused on a central theme. Individual research subprojects, supporting cores (if proposed), and the Program as an integrated effort are collectively considered. The relationship and contributions of each research subproject and core to the overall theme of the program project are evaluated.

Significance:

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

Investigator(s)/Overall Program Leadership:

Are the qualifications of the PD(s)/PI(s) and other senior key personnel appropriate to lead the P01 and coordinate all P01 activities? Is the Program Project PI an established researcher with the ability to ensure quality control and the experience to effectively administer and integrate all components of the program? Is the Program Project PI fully established at the applicant institution? Do the subproject leaders provide expertise from several disciplines? Will they contribute to the overall theme of the program project? Do most of the subprojects leaders have significant research experience? Are the subproject leaders fully established at their applicant institution(s)? Is there evidence of previous collaborations that may have led to the goals and hypotheses of the program presented?  

Innovation:

To what degree does the overall program challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation or interventions?

Approach:

Is the overall design of the P01, including strategies, methodologies and analyses, well-reasoned and appropriate to accomplish the specific aims of the program?  Is the administrative structure carefully organized to foster interactions among investigators and accelerate the pace of research? Does the application describe strong inter-project utilization of resources and research findings? Is the relationship of each subproject to the central theme clearly described? Are the scientific and fiscal relationships of each component project to each core clearly described? Can the objectives of the program be completed in the requested program project period (5 years maximum)? If contractual arrangements are used for participation of scientists from other than the applicant organization, are they appropriately integrated into the team? Is there an adequate plan to establish both internal and external advisory committees to evaluate progress and the level of interaction among participants? Is the role of external and internal advisory committees, their interactions with each other and with the Project Leaders outlined? Does the application propose venues for interaction such as seminar series, monthly group meetings, and semi-annual retreats? Are there any other activities proposed to promote close communication and collaboration?

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 projects proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of sufficient institutional support for the Program Project?

 Integration/Synergy:

Is there evidence of scientific and administrative integration of the proposed Program? Is there evidence of coordination, interrelationships, and synergy among the individual research projects and core components? Does the application present a clearly defined, unifying, central theme to which each component subproject relates and research investigator contributes? Are there clear advantages or value added by conducting the proposed research as a Program Project rather than through separate research efforts? Are the target goals outlined carefully in the introduction with special reference to contributions expected from the multidisciplinary team? For competing renewal applications, is there evidence of productive collaborations during the current funding period?

Review Criteria for Individual Research Subprojects:

Overall Impact/Priority:  Reviewers will provide an overall impact score for each individual subproject to reflect their assessment of the likelihood for the subproject to exert a sustained, powerful influence on the research field(s) involved, in considering the following five scored review criteria and the additional review criteria listed below (as applicable for the subproject proposed). 

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

Significance:  Does the subproject address an important problem or a critical barrier to progress in the field?  If the aims of the subproject 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 subproject?  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 subproject 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 subproject?

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 subproject?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the subproject is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the subproject 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 subproject proposed?  Will the subproject benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Review Criteria for Shared Resource Core(s):

Each Shared Resource Core must provide essential functions or services for at least two subprojects. The merit of each shared resource core will be assessed based on the following criteria:

Additional Review Criteria 

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

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

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

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

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

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.

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

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

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the 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 

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

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

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

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

Software Sharing Plan   If software development is proposed, the initial review group will comment on the appropriateness of the proposed software sharing according to the guidelines in Section IV.6.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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.

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.

The final version of any accepted software sharing plan will be referenced as a condition of award.

3. Reporting

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Christine A. Kelley, PhD
Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telephone: (301) 451-1614
Fax: (301) 480-4973
Email: kelleyc@mail.nih.gov

Alan McLaughlin, Ph.D.
Director, Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telephone: (301) 496-9321
Fax: (301) 480-4973
Email: mclaugal@mail.nih.gov

2. Peer Review Contacts:

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telehone: (301) 496-8633
Fax: (301) 480-0675
Email: georged@nih.gov

3. Financial or Grants Management Contacts:

Katie Ellis
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 900, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Phone: (301) 496-8521
Fax: (301) 451-5735
Email: kellis@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

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

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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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

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

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

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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