Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)
National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Support of NIGMS Program Project Grants (P01)

Activity Code

P01 Research Program Projects

Announcement Type

Reissue of PAR-10-266

Related Notices

  • July 19, 2013 - This PAR has been expired and reissued as PAR-13-280.
  • March 19, 2012 - See Notice NOT-HG-12-013. The purpose of this Notice is to inform interested investigators that the National Human Genome Research Institute (NHGRI) has been added to the participating components.

Funding Opportunity Announcement (FOA) Number

PAR-11-220

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.859, 93.172

FOA Purpose

This funding opportunity announcement (FOA) issued by the National Institute of General Medical Sciences encourages innovative, interactive program project grant applications from institutions/organizations that propose to conduct research which aims to solve a significant biological problem, important for the mission of NIGMS, through a collaborative approach involving outstanding scientists who might not otherwise collaborate. The program project grant mechanism is designed to support research in which the funding of several interdependent projects as a group offers significant scientific advantages over support of these same projects as individual regular research grants.

Key Dates
Posted Date

May 31, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply  

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

(Now Expired July 19, 2013 per issuance of PAR-13-280), Originally September 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

This funding opportunity announcement (FOA) issued by the National Institute of General Medical Sciences encourages innovative, interactive program project grant applications from institutions/organizations that propose to conduct research which aims to solve a significant biological problem, important for the mission of NIGMS, through a collaborative approach involving outstanding scientists who might not otherwise collaborate.  NIGMS supports research in the broad areas of Cell Biology and Biophysics; Genetics and Developmental Biology; Pharmacology, Physiology, and Biological Chemistry; and Bioinformatics and Computational Biology.  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. Program project grants are investigator initiated, but are restricted to areas of special interest to the individual divisions within NIGMS (see http://www.nigms.nih.gov/About/overview for scientific areas of interests).

Successful program projects generally bring together scientists to apply complementary approaches to work on an important well-defined problem. In addition to individual research projects, applicants may propose one or more shared resource cores if needed for the proposed research.  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.  New cores may be proposed and/or existing cores may be augmented to support the proposed research. In this way the program project can facilitate the support of essential shared core facilities, e.g., major equipment, although the need of a group of investigators for a major piece of equipment or a core facility does not in itself justify a program project grant.  Administrative cores, except in special, well-justified circumstances, will not be allowed. It is expected that successful program projects will establish effective collaborations, particularly in emerging areas of research that extend beyond the life of the program project grant itself.  Hence, a program project generally has a finite lifetime.

Normally, a program project consists of three to five individual, interdependent projects from different investigators. All of the projects must be relevant to the common unifying central theme, focus, and overall objective of the entire program project.  Each individual project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator. The individual projects must 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.  One PI must be identified as the leader of the program project and that person will be responsible for coordinating the entire program project.  The scientist designated as the program project leader bears responsibility for the overall scientific leadership and fiscal management of the program project grant.  Each of the collaborating scientists responsible for the individual projects will be independent investigators. The option to designate one of the leaders of the individual projects or cores as project leader of the overall application is allowed. 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 have full use of, for example, core facilities and contribute to the overall collegiality of the project, but they derive no financial support from it.  Participation by associate members may not be used in the justification for a core or a piece of equipment.

Section II. Award Information
Funding Instrument

Grant.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

An upper limit of $6,500,000 direct costs for the entire five year project period may be requested in a competing program project grant application to the NIGMS. This amount is exclusive of subcontract facilities and administrative costs. Applications that exceed this cost limit without prior approval will be returned without review. 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 exceptional costs associated with equipment required for the success of the program project (e.g., for a major piece of equipment that is essential for at least two projects).

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

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.  Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Common Fund/Roadmap text, Collaborative Research, or Projects Greater than 5 years Duration:  See instructional documents in the NIH Guide Publishing System for the text to insert.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Only one program PD/PI is allowed for the overall P01, and only one leader is allowed for each individual project. Multiple PDs/PIs are not allowed in this FOA.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Current NIH policy permits a component research project  of a multi-project grant application to be concurrently submitted as a  traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project  grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi- project grant must be aware of this policy before making a commitment to the  Principal Investigator and awarding institution.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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)

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:

For Resubmission or Revision applications, also include the following:

Face Page

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Complete all items on the application's face page. For “Response to Specific Request for Applications (RFA) or Program Announcement (PA)”, enter the number of this FOA and the title, "Support of NIGMS Program Project Grants (P01)”.

Description

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

The program project grant application should be structured as a series of separate but interrelated project proposals. State the proposed program’s broad, long-term objectives, specific aims, and the significance to the mission of NIGMS. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program.

Detailed Budget for Initial Budget Period

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Use PHS-398 Form Page, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Use PHS-398 Form Page, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.

Budgets for Individual Research Project Components and Core Components

Prepare “Detailed Budget for Initial Budget Period” for each component

Prepare “Budget for Entire Proposed Period of Support” for each component

Budget Justifications and Explanations

Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations.

Biographical Sketch

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Biographical sketches are required for all key personnel participating in the Research Project components and Core units. Compile all biographical sketches starting with the overall program project leader 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.

Resources

Follow instructions in the PHS 398 Application Guide, and note the following additional instructions.

Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

Project overview

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. If support of core resources is requested, a separate component describing and justifying these should be included. Associate Member Projects, if any, do not count toward the minimum number of three projects. 

Research Projects

The Research Projects should include:

Each individual project of a program project grant should represent both a separate and an interdependent research effort. Each research project should be prepared according to the application guide instructions.  The overall format and page limits for an R01 application apply to each of the component projects. The special benefits associated with being part of the program project must also be addressed.  Do not repeat the individual budget pages and biosketches.

Instead of the standard PHS 398 face page for each project, create a title page for the project that lists the project name and the name of the project director.

Specific Aims

Specific aims should be built around serving the goals of the program project.

Research Strategy

Approach. The special benefits associated with being part of the program project and the relationship of this project to the other projects and cores should be addressed.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

The plan for software sharing may be commented on during peer review 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.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Shared Resource Cores

Applicants may propose one or more (as needed) appropriate shared resources, or cores. Administrative cores, except in special, well-justified circumstances, will not be allowed. Shared resource cores 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 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. 

If a core includes major equipment for which additional funds are requested, the core description must include information about which P01 projects will make use of the equipment and how the equipment will facilitate interactions progress on the central theme of the P01 and strengthen interactions among the projects.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be postmarked on or before the due dates in Part I. Overview Information.

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

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

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.   

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Review Criteria for the Overall Program Project

Overall Impact- Overall

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, in consideration of the following review criteria and additional review criteria (as applicable for the program project proposed). The overall impact/priority score will also take into consideration 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. Separate criterion scores for the overall program will not be assigned.

Review Criteria - Overall

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

Significance

Does the program project address an important problem or a critical barrier to progress in the field? If the aims of the program project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the added value to scientific knowledge, technical capability, and/or clinical practice of the program project considered as a whole compared to the separate impact of the individual subprojects? How important is the program project structure to the prospects for success of the individual subprojects?  

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the program project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the commitment (percent effort) of the project leader and other senior investigators adequate? How compelling are the program project’s principal investigator’s skills, research record and prior leadership experience? Has the program project principal investigator devoted sufficient effort to accomplish the goals of the program project? Do the investigators on the separate subprojects and cores show evidence of collaborating to advance the goals of the overall program project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How much does combining the different cores and subprojects into a single overall program project enhance innovation or increase the originality of the proposed work?    

Approach

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

If the program project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? What is the overall quality of the projects and the adequacy of the services provided by the shared resource cores (if proposed)? Are the approaches of the different subprojects consistent?

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? Is there evidence of sufficient institutional support for the program project? Does the environment encourage collaborative work among the project investigators? 

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? Is there thematic cohesion to the program? Is the interrelationship of individual projects and cores clear and scientifically well-justified? How will the administrative structure of the program contribute to its probability of success? Does the application clearly describe and justify the proposed administrative and organizational structure? Is the proposed structure adequate to support and encourage optimal interactions among participants of the overall program?  Does the administrative plan provide for internal quality control of ongoing research, management of day-to-day program activities and for fair and effective communication and cooperation among program project members including resolution of disputes and allocation of funds?  For competing renewal applications, is there evidence of productive collaborations during the current funding period?   

Additional Review Criteria - Overall

As applicable for the program project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, 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 for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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

Software Sharing Plan

If sortware is to be developed, the reviewers will comment on the plan for software sharing  

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Scored Review Criteria - Individual Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. 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.

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

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

Environment

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

Review Criteria for 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:

Additional Review Criteria

As applicable for the program project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Additional Review Considerations

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

Software Sharing Plan

If sortware is to be developed, the reviewers will comment on the plan for software sharing.  

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned NIGMS and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Cell Biology and Biophysics:

Dr. Catherine Lewis
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: lewisc@nigms.nih.gov

Genetics and Developmental Biology:

Dr. Judith H. Greenberg
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0943
Email: greenbej@nigms.nih.gov

Pharmacology, Physiology and Biological Chemistry

Dr. Michael Rogers
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: rogersm@nigms.nih.gov

Center for Bioinformatics & Computational Biology

Dr. Karin Remington
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: remingka@nigms.nih.gov

For general information, applicants should contact:

Dr. Ann A. Hagan
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-4499
Email: hagana@nigms.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ms. Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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