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 General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering, (http://www.nibib.nih.gov/)

Title: Program Projects for Collaborative Research on the Basic Biology of Pluripotency and Reprogramming (P01)

Announcement Type

New

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

Request for Applications (RFA) Number:  RFA-GM-11-005

Catalog of Federal Domestic Assistance Number(s)
93.859, 93.286

Key Dates
Release Date: September 15, 2010
Letters of Intent Receipt Date: November 1, 2010
Application Submission Date: December 1, 2010
Peer Review Date(s): February to April 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date: August 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: December 2, 2010

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

The discovery that human non-embryonic cells can be reprogrammed to an embryonic stem cell-like state has provided an important new scientific opportunity to investigate the fundamental molecular and genetic properties of pluripotent cells. These induced pluripotent stem cells (iPSC), along with human embryonic stem cells (hESC), are valuable tools for advancing our understanding of human biology and development, and may prove to have significant therapeutic potential. However, our understanding of the biology of these cells remains limited, and additional basic research is needed to fully realize their potential.

This funding opportunity uses the program project (P01) mechanism. The program project mechanism is designed to support research in which the funding of several interdependent projects offers significant scientific advantages over support of these same projects as individual regular research grants. Successful program projects should bring together scientists with complementary approaches to work on an important well-defined problem. P01 applications submitted in response to this FOA are expected to support a minimum of three interdependent and synergistic R01-scale research projects focused on pluripotency and reprogramming.  Examples of research topics within the scope of this FOA include, but are not limited to:

The goal of this funding opportunity is to stimulate research on the basic biology of pluripotency and reprogramming of human cells using systematic and comprehensive approaches, including  high-throughput methodologies as appropriate. Accordingly, the proposed research should focus on human iPSC and on comparative studies with other human stem cells.  Any comparative studies must comply with applicable Federal regulations. Although the focus of this funding opportunity is on human cells, work that advances this goal via comparative studies of non-human mammalian pluripotent stem cells or embryos may be included. Applications focused entirely on non-human models will not be considered responsive to this FOA. Other areas of stem cell research that would not be appropriate for support under this FOA include development or refinement of methods to derive iPSC or to derive specific differentiated lineages from iPSC or Other human stem cells. Applications that are solely focused on technology development will also not be considered responsive to this FOA.

In addition to individual research projects, applicants are expected to propose one or more Shared Resource Cores to enable comprehensive and/or high-throughput approaches. The core(s) should not duplicate resources already available to the applicants at their institution(s). Each Shared Resource Core must provide support and enhance the productivity, cost-effectiveness, and/or research outcome of at least two of the proposed research projects. Examples of cores that may be requested include, but are not limited to:

The NIBIB joins this FOA because of its interest in the development of enabling technologies to advance health.  NIBIB will not fund any applications in their entirety but may co-fund applications that include high-throughput platforms critical for analyzing and evaluating reprogramming mechanisms.  Examples include (but are not limited to):

Such high-throughput platforms should be proposed only in the context of an application that investigates the basic biology of pluripotency and reprogramming.  Applications that are solely focused on technology development will not be considered responsive to this FOA. NIBIB expects to contribute up to $250,000 total costs per year (total of $1.25M for five years) in support of this effort.

Applicants will be expected to leverage existing local resources for stem cell research. A Shared Resource Core to grow and maintain iPS cell and other stem cell lines may not be requested as part of the P01 application.  Instead, applicants must provide evidence of a commitment from an existing stem cell research group or center to provide access to such basic resources and infrastructure.  This collaborating stem cell group or center may be at the same or a nearby institution, and may be supported by public or private grants, contracts or institutional funds. Applications must include a letter of support signed by the director of the facility and the Authorized Organizational Representative documenting the availability of such resources throughout the expected funding period of the grant. Applicants may include reasonable fees for use of the resources and infrastructure in the budget of the P01. To further encourage collaborative interactions, it is expected that access to the Shared Resource Core(s) supported by the P01 also will be available to members of the collaborating stem cell research group or center.

Applicants should request funds for an administrative core to coordinate collaborations within the P01 and with the collaborating stem cell research group or center. The administrative core also should include a mechanism to solicit and review pilot projects to support exploratory studies and to increase the number of investigators pursuing stem cell research. These pilot projects must address basic research questions that are within the scope of this FOA and are encouraged to include investigators who are new to the stem cell field.

Awardees and their major collaborators will be required to help plan and to attend the NIGMS-sponsored workshops that are held every one to two years for NIGMS stem cell grantees. Funds for attendance must be included within the budget of the P01.

It is expected that the PI of the P01 will be responsible for coordinating the entire program project. This scientist bears responsibility for the overall scientific leadership and fiscal management of the program project grant. It is expected that each scientist responsible for the individual projects will be an independent investigator. In addition, the program project and each individual project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts. 

Associate Members

If individuals have substantial support in areas closely related to the program project, their support should be folded into the program project.  If their support cannot be folded in, they may participate as associate members.  Associate members would have full use of, for example, core facilities and contribute to the overall progress of the project, but would derive no financial support from it.  However, the research project of an associate member may not be counted as one of the three required R01-scale projects or as one of the two projects needed to justify a core, piece of equipment, or bioinformatics support.

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 P01 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 PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The total project period for an application submitted in response to this FOA may not exceed five years. For applications seeking funding, $7 million in direct costs (exclusive of sub-contract facilities and administrative costs) for the entire five-year period may be requested for core facilities, three to five R01-scale projects, and pilot projects. With approval by NIGMS staff in advance of submission, additional funds may be requested for well-justified exceptional costs associated with equipment or personnel required for Shared Resource Core(s) (e.g., for a major piece of equipment that is essential for at least two projects, or for complex bioinformatics analysis of data from two or more projects).  Additional funds may not exceed $100,000 direct costs per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.  However, such institutions may participate as members of consortia or subcontractors on the application.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Only one PD/PI of the program project is allowed for the overall P01, and only one leader is allowed for each individual project. .

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals.  Renewal applications are not permitted in response to this FOA.

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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date: October 1, 2010 (Changed to November 1, 2010 per NOT-GM-10-109)
Application Receipt Date(s):  November 1, 2010 (Changed to December 1, 2010 per NOT-GM-10-109)
Peer Review Date(s): February to April, 2011
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): August 1, 2011

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 at the beginning of this document.

The letter of intent should be sent to:

Marion M. Zatz, Ph.D.
Division of Genetics and Developmental Biology
NIGMS
45 Center Drive MSC 6200
Building 45, Room Number 2AS-25E
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
Email: Zatzm@mail.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 threesigned photocopies in one package to:

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

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

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

Helen R. Sunshine, Ph.D. 
Office of Scientific Review
NIGMS
45 Center Drive MSC6200
Building 45, Room 3AN12F
Bethesda, MD 20892
Telephone: (301) 594-2881
FAX: (301) 594-8506
Email: sunshine@mail.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 or incorrectly formatted 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. 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 award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

 $7 million direct costs for the entire five year project period may be requested in response to this FOA. This amount is exclusive of subcontract facilities and administrative costs. Applications that exceed this cost limit without prior approval will not be reviewed.  If fewer than five years are requested, the limit is prorated accordingly.  With approval by NIGMS staff in advance of submission, additional funds may be requested for well-justified exceptional costs associated with equipment or personnel required for Shared Resource Core(s) (e.g., for a major piece of equipment that is essential for at least two projects, or for complex bioinformatics analysis of data from two or more projects).  Additional funds may not exceed $100,000 direct costs per year

6. Other Submission Requirements

PHS398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the additional requirement that the Specific Aims section is limited to 1 page.

Special Instructions

The program project grant application should be structured as a series of separate but interrelated project proposals. The following format should be used:

Form Page 2 - Description, Performance Sites, and Key Personnel: Under “Description,” state the proposed program’s broad, long-term objectives, specific aims, and the significance to the goals of this FOA. Define the relevance of each proposed project 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 and their role on the project for the entire P01, beginning with the PI/PD followed by an alphabetical listing of Key Personnel and then Significant Contributors. Include all project and core leaders and consultants and consortium collaborators, if applicable.

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 projects and cores as well. In the upper left-hand corner of the initial year and summary budget forms, identify the project or core. Since NIGMS expects to bring Program Project awardees to the NIH every one to two years during the term of these awards to discuss progress and exchange information, travel funds should be budgeted for this purpose.  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 overall program project PD/PI followed by all other investigators, including the individual project/core leaders, in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resources cores.

Program Overview:  Summarize the overall goals and significance, the overall theme and integration, the overall research strategies, preliminary studies, the overall institutional resources and environment, including access to basic resources and infrastructure for stem cell research, and the overall organization and administrative structure for the P01 as a whole. The overview section must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants.  This section should include: a description of the objectives of the program as a whole that delineates the relationship of the individual research projects to the entire program project and the special scientific benefits to be achieved by funding as a program project grant rather than as a series of individual research grants; a description of facilities available including major instruments and special program resources; administrative arrangements for overall scientific leadership, quality control, and management of the program project grant. The length of this section may be no more than 12 pages.  The Program Overview does not include a Specific Aims page.

Individual Research Projects: Each P01 program project application must include a minimum of three individual (albeit connected) research projects each of which is pertinent to the central goal of the program. Associate Member Projects, if any, do not count toward this minimum number of three projects.  Each research project should be prepared according to the standard PHS 398 instructions. The overall format and page limits for an R01 application apply to each of the component projects.  Each individual project of a program project grant should represent both a separate and an interdependent research effort. The individual project cover page includes title and project leader (note that it should not use the PHS398 face page form), a description of the research to be conducted and any justification for human and animal experimentation, if applicable, should be included. The special benefits associated with being part of the program project must also be addressed. Do not repeat the individual budget pages and biosketches. If support of core resources is requested, a separate component describing and justifying these should be included.  For each individual project, page limits are 1 page for Specific Aims and 12 pages for the Research Strategy portion. For cores, the page limit is 6 pages.  The component R01-scale projects should include:

  1. Specific Aims

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. Specific aims should be built around serving the goals of the FOA.

  1. Research Strategy

a)    Significance

Describe how the project will address the goals of this FOA. Applicants are expected to elaborate on the importance of the problem to be addressed by the proposed project. A compelling reason for conducting the proposed research should be the focus of this section.

b)    Innovation

Describe the innovative nature of the proposed research.

c)     Approach

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Applicants should also discuss the rationale for assembling the research team, including qualifications and selection criteria for the participating investigators and collaborators. Expertise with iPSC and/or other stem cells should be described. The special benefits associated with being part of the program project and the relationship of this project to the other projects and cores should also be addressed. An account of preliminary studies pertinent to this application should be included in this section. This information will also help to establish the experience and competence of the investigator to pursue the proposed project.

Shared Resource Cores: Applicants may propose one or more (as needed) appropriate shared resources, or cores. Shared resource cores must not duplicate resources already established in the applicant institutions. Each shared resource core must have a single designated Core Director.  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 of the shared resource core director. Do not repeat biographical sketches included at the beginning of the application.  Do not exceed 6 pages for the description of each core. If a core includes major equipment or bioinformatics personnel for which additional funds are requested, the core description must include information about which P01 projects will make use of the equipment or require extensive bioinformatics analysis of project data, and how the equipment or the bioinformatics effort will facilitate interactions among the projects and progress on the central theme of the P01.

The administrative core is responsible for soliciting and supporting pilot projects and coordinating collaborations within the P01 and with the collaborating stem cell research group or center. Applicants are expected to include within the budget approximately $100,000 per year in direct costs to support pilot projects. These pilot projects must address basic research questions that are within the scope of this FOA. Inclusion of investigators who are new to the stem cell field is encouraged. As part of the administrative core description, include details on the process and criteria for soliciting, reviewing and selecting pilot projects to be supported. Describe the general characteristics of the pilot projects (e.g., duration, maximum costs).

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). 

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: Investigators seeking $500,000 or more in direct costs in any year 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 in the application only if software development is a part of the application. Software sharing plans should be included with the Resource Sharing Plan. 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 evaluate the dissemination plan relative to these goals:

The plan for software sharing will be evaluated during peer review together with any other resource sharing plans.

The adequacy of the software sharing plans will be considered by program staff when making recommendations about funding applications as appropriate. 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.

Intellectual Property 

An institution's stance must be consistent with the goals of advancing and not hindering future research. Please refer to the NIH Intellectual Property Policy and the Grants Policy Statement 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 policies. The institution’s intellectual property statement will be considered by program staff when making recommendations about funding applications as appropriate.

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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS 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. 

A. Review Criteria for the Overall Program Project:

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program project as a whole to exert a sustained, powerful influence on the research field(s) involved,  The overall impact/priority score will take into consideration: the core review criteria and any specified additional review criteria; the extent to which the individual projects enhance the strength of the overall program project; and the importance of the individual projects to the success of the program project.

Review Criteria

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/Overall Program Leadership: Are the qualifications of the PD/PI and other senior scientists appropriate to lead the P01 and coordinate all P01 activities? Do they provide effective scientific and administrative leadership, as demonstrated by selection of individual projects for scientific excellence and thematic relatedness? Is the commitment (person months of effort) of the PD/PI and other senior investigators adequate? Does the PI have adequate knowledge and experience with iPSC and/or other stem cells?

Innovation: To what degree does the overall program challenge and seek to shift current research 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?  What is the overall quality of the projects and the adequacy of the services provided by the shared resource cores (if proposed)?  If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) the 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 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?  Is the infrastructure adequate to support the use and maintenance of cultured iPSC and/or other stem cells? Are these resources complementary to those supported by the P01?

Integration: 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? Are there clear advantages or value added by conducting the proposed research as a Program Project rather than through separate research efforts?

B. Review Criteria for Individual Research Projects:

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.  The overall impact/priority score will take into consideration:  the scored review criteria and any specified additional review criteria; the extent to which the individual project enhances the strength of the overall program project; and the importance of the individual project to the success of the program project.

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.  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/PI, collaborators, and other researchers well suited to the project?  Is there evidence of knowledge and experience with iPSC and/or other stem cells? 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, 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 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? 

C. Review Criteria for Shared Resource Core(s) (IF APPLICABLE):

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

D. Review Criteria for Administrative Core

The administrative core is responsible for supporting pilot projects, coordinating collaborative efforts, and contributing to the synergy of the program project.

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. Resubmissions are not permitted in response to this FOA.

Renewal Applications. Renewals are not permitted in response to this FOA.

Revision Applications. Revisions are not applicable to this FOA.

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.

Applications from Foreign Organizations. Foreign applications are not allowed for this FOA.

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).

Software Sharing Plan. The reviewers will comment on the plan for software sharing, if applicable.

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.

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:

3. Anticipated Announcement and Award Dates

Not Applicable

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 Notice of Award will be generated via email notification from the awarding component to the grantee business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

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.

The effectiveness of the resource sharing plan, software sharing plan if applicable, intellectual property statement may be evaluated as a part of the administrative review of each progress report.

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:

NIGMS

Marion M. Zatz, Ph.D.
Program Official, Genetics and Developmental Biology Division
NIGMS
45 Center Drive Room 2AS-25E, MSC 6200
Bethesda , MD 20892-6200
Telephone: (301) 594-0943
Email: zatzm@mail.nih.gov

Susan R. Haynes, Ph.D.
Program Official, Genetics and Developmental Biology Division
NIGMS
45 Center Drive Room 2AS-25J, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
Email: hayness@nigms.nih.gov

NIBIB

Rosemarie Hunziker, PhD
Program Director, Tissue Engineering and Regenerative Medicine
NIBIB
6707 Democracy Boulevard
Room 235
Bethesda, MD  20892
Telephone: (301) 451-1609
Email: hunzikerr@mail.nih.gov

2. Peer Review Contacts:

Helen R. Sunshine, Ph.D.
Chief, Office of Scientific Review
NIGMS
45 Center Drive, Room 3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
Email: sunshinh@mail.nih.gov

3. Financial or Grants Management Contacts:

Nicole Fleisher
Grants Management Officer
NIGMS
45 Center Drive, Room 2AN.50E, MSC 6200
Bethesda, MD  20892-6200
Telephone: (301) 594-3923
Email: fleishen@nigms.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/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 public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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/.


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NIH Funding Opportunities and Notices


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