Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Research Networks for Macromolecular Interactions in Cells (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-GM-13-005

Companion FOA

RFA-GM-13-003, RFA-GM-13-004

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.859 

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish inter-disciplinary collaborative research networks to advance studies of macromolecular interactions and their relationship to function in cells.  These networks are designed to integrate additional research strategies into NIGMS' research base of laboratories specializing in macromolecular function in living systems.  Invetigators may use this funding opportunity to (i) complement each other's capabilities (for example, in biochemistry, genetics, chemistry, or pharmacology), where the innovation is in the biology rather than in the technology;  (ii) apply proven technologies that are technically challenging, expensive, or not yet widely used in cell biology and allied fields (for example, mass spectrometry, high-throughput screening);  (iii) develop, pilot, evaluate, and/or apply emerging technologies (for example, superresolution light microscopy);  (iv) carry out feasibility studies or upstream research and development of new technological concepts that are unproven, but potentially useful for study of macromolecular interactions.  This FOA invites unconventional research strategies, including exploratory, descriptive, and statistical approaches, and encourages discovery and hypothesis generation as research objectives.  This FOA uses the NIH multiple program director/principal investigator (PD/PI) grant and the U54  Specialized Center Cooperative Agreement mechanism.

Key Dates
Posted Date

March 1, 2012

Letter of Intent Due Date

May 14, 2012

Application Due Date(s)

June 14, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October-November 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

April 1, 2013

Expiration Date

June 15, 2012

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.

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

Purpose/Research Objectives

The purpose of this Funding Opportunity Announcement (FOA) is to establish inter-disciplinary collaborative research networks to advance studies on macromolecular interactions and their relationship to function in cells.  This FOA uses the NIH multiple PD/PI grant and the U54 Specialized Center Cooperative Agreement mechanism. 

Background

This FOA is based on an initiative approved by the National General Medical Sciences Advisory Council at its January 2011 meeting for research on macromolecular interactions in cells "in vivo", which in this FOA includes cells and tissues as well as organisms.  The Council-recommended program priorities for this FOA are involvement of NIGMS' research base of laboratories specializing in function in living systems, cross-disciplinary research coordination and collaboration, initiation of new lines of research, unconventional research approaches and strategies, participation of modestly funded laboratories, multi-institutional involvement, and scientific and budgetary flexibility.

This initiative comprises three FOAs for studies on macromolecular interactions and their relationship to function.  This FOA, "Research Networks for Macromolecular Interactions in Cells", supports multiple-PD(s)/PI(s) specialized center cooperative agreements (U54); its maximum budget is $500,000 direct costs per year.  A second FOA, "Collaborations for Macromolecular Interactions in Cells (R01 Collab)" (RFA-GM-13-004), supports multiple-PD(s)/PI(s) R01s; its maximum budget is $250,000 direct costs per year.  A third FOA, "Competing Revisions for Macromolecular Interactions in Cells (R01,R37)" (RFA-GM-13-003), supports competing revisions (formerly "competing supplements") of funded NIGMS R01 and R37 projects; its maximum budget is $80,000 direct costs per year.  All three FOAs are intended to diversify and extend the scope and capabilities of existing NIGMS cellular, molecular and developmental biology, genetics, pharmacology and physiology research projects, rather than to support independent stand-alone projects.

Rationale

Higher-order functions in cells depend upon precise organization and coordination of macromolecules and processes in space and time.  Most cellular functions are mediated by macromolecular complexes ranging in size from two to hundreds of subunits, many of which are regulated across the cell cycle and constantly remodeled in response to physiological state.  The roles played by individual components of complexes depend not only on their intrinsic biochemical properties, but also on their interactions with the surrounding environment.  While a wealth of information exists about individual cellular components from in vitro analyses, our knowledge and understanding of macromolecular interactions in whole cell contexts are limited.

Although important scientific questions and opportunities involving macromolecular interactions span a scientific spectrum ranging from whole animal physiology to molecular biophysics, some of the most important and difficult challenges lie in the analysis of molecular interactions in the context of whole cell organization and function.  In the last decade advances in chemistry, biochemistry, biophysics, bioengineering, proteomics, genetics, genomics, advanced microscopy, and structural, computational, and systems biology have opened up important new avenues for addressing these challenges.  There is a need to unite these developments with rigorous mechanistic dissection of cellular function, but the integration of these advances into NIGMS' biological research base has been limited.  A priority of this initiative is to advance this integration by involving biologists who specialize in the analysis of function in living systems in multidisciplinary applications of new technologies and research strategies.

This FOA is intended to accommodate unconventional research objectives and approaches that fall outside the traditional hypothesis-driven framework that is often favored in peer review.  The many applications responding to recent ARRA initiatives and to the Transformative R01, EUREKA and NIH Director's Pioneer Award programs reflect an unsatisfied demand by investigators not only to incorporate additional methods and approaches into their programs, but also to address discovery and hypothesis generation as research objectives.  Exploratory, descriptive, and statistical approaches will be increasingly important as cell biology addresses more complex problems.

To enable investigators to assemble the strongest combinations of multidisciplinary expertise, this FOA provides support for collaboration between investigators at different institutions.  Organizing effective collaborations between geographically separated groups requires more planning and overhead for coordination than are needed for research that is conducted locally.  These complications are compounded for larger collaborations.  To address these financial barriers, this FOA provides for shared personnel, travel, and meeting expenses.

This FOA addresses financial barriers to the diversification of research strategies and objectives in the study of macromolecular interactions.  The importance of adequate funding to support multi-disciplinary approaches is clear from the striking recent advances in this field made by well-funded laboratories.  Modestly funded investigators are a highly competitive scientific sector, but their financial options for responding to new research opportunities are limited.  This FOA is intended to leverage the scientific insights and skills of modestly funded laboratories (total support to the laboratory under $400,000/year direct costs) by providing for their involvement in collaborative opportunities.

Description

This FOA utilizes the NIH multiple-PD/PI grant and the U54 specialized center cooperative agreement mechanism.  The maximum budget is $500,000/year direct costs.  Applicants may request up to five years of support.  Each research network will be directed by a multi-institutional team of PD(s)/PI(s) who head independent laboratories conducting research relevant to macromolecular interactions in cells that they can coordinate with the network.  The PD(s)/PI(s) should hold (or have recently held) their own independent NIH, NSF, or similar support as a Principal Investigator, or have equivalent professional and scientific status in other fields, government, or industry.   In addition to current or recent grant support, PD(s)/PI(s) should also be well-enough established to have an independent track record of research publications from their own laboratories. 

NIGMS will support research networks that can accomplish their goals on a total budget comprising approximately $40,000/year direct costs per PD/PI plus $40,000/year direct costs per institution.  These figures do not imply how funds should be distributed; the PD(s)/PI(s) will determine how network funds are budgeted.  Budgets are modest because these networks are designed to link existing programs and utilize their infrastructure, rather than to stand alone as independent projects. 

All qualified individuals are invited to participate as PD(s)/PI(s) in these collaborations;  there are no restrictions on the research support or research specialization of any individual PD/PI.  However, a priority of this FOA is to support research networks in which (i) at least half of the PD(s)/PI(s) are  modestly funded NIGMS grantees (total support to the laboratory under $400,000/year direct costs) and (ii) at least half of the PD(s)/PIs are PD(s)/PI(s) of an NIGMS research grant with a primary specialization in molecular systems and mechanisms in live organelles, cells, tissues or organisms  that is active or has been active within the last four years.  Other investigators, including well-funded investigators, investigators from other research fields (for example, technology experts), and investigators not supported by NIGMS, are also encouraged to participate as PD(s)/PI(s) and share in the scientific direction and funding of these networks. 

Specific Areas of Research Interest

The goal of this FOA is to advance studies on macromolecular interactions and their relationship to function in cells.  The focus of this FOA is on understanding macromolecular interactions in vivo (cells, tissues or organisms); experimentation in vitro (for example, functional reconstitution) is included, but it must be coordinated with a research program on function in vivo.

Within the areas of interest the examples are illustrative, not comprehensive; unless excluded below, other research approaches within the area are eligible.  Potential applicants are strongly advised to consult with the scientific contacts listed below about research topics that are not an obvious fit to the Specific Areas of Research Interest.

Excluded Research Topics

Some research topics highly relevant to macromolecular complexes and interactions are already well-established or already targeted by other active NIGMS FOAs; these topics are not targeted for support under this FOA. 

New Research Directions.  The purpose of this FOA is to diversify and extend the scope and capabilities of the PD(s)/PI(s)' research by introducing new methods and objectives, and not to increase funding for approaches already established in the PD(s)/PI(s)' laboratories.  Evidence (for example, preliminary results and publications) that most of the proposed research objectives and strategies are already well-established in the applicants' laboratories may lower the program priority of otherwise well-reviewed applications.  This is particularly true where prior work has already demonstrated feasibility for much of the work; work that has advanced to this stage is ready to compete for support through the parent R01 solicitation or other funding opportunities and is not a priority for this FOA.

Multiple PD(s)/PI(s) Team.  In selecting their PD/PI teams, potential applicants should note that an objective of this FOA is to support multi-institutional research networks in which (i) at least half of the PD(s)/PI(s) are modestly funded NIGMS grantees (total support to the laboratory under $400,000/year direct costs) and (ii) at least half of the PD(s)/PI(s) are PD(s)/PI(s) of an NIGMS research grant with a primary specialization in molecular systems and mechanisms in live organelles, cells, tissues or organisms  that is active or has been active within the last four years.

This FOA has special application instructions, review criteria, and selection criteria for funding decisions.  Potential applicants should review the application instructions (Section IV below), the review criteria, and the selection criteria for funding decisions (Section V below).   Research topics must be within NGMS' primary mission.

Potential applicants are strongly encouraged to discuss the responsiveness of their PD(s)/PI(s) teams and their ideas to this FOA with the Institute Scientific/Research contacts listed in Section VI, and to send a letter of intent prior to submission.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIGMS intends to commit $1,500,000 total costs in FY 2013.

Award Budget

Application budgets are limited to $500,000/year direct costs.  This figure does not include subcontract F&A.

Award Project Period

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.     

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.

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.

Letter of Intent

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

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

The letter of intent should be sent to:

James F. Deatherage, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS.13F, MSC6200
Bethesda MD 20892-6200
Telephone: 301-594-0828
Email: deatherj@nigms.nih.gov

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 three signed photocopies in one package to:

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

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Helen R. Sunshine, Ph.D.
Bldg 45 Room 3AN12F MSC 6200
45 Center Drive
Bethesda MD 20892-6200
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov

Page Limitations

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

Senior/Key Personnel, Other Significant Contributors

The list of key personnel should be limited to senior co-investigators, collaborators, subcontractors, and other essential persons who will scientifically direct part of the project, provide unique skills and services and/or manage project funds.  In general, postdoctoral fellows and laboratory employees who may rotate out of their positions should not be included.

Detailed Budget for Initial Budget Period, Budget for Entire Proposed Period of Support

The maximum budget is $500,000/year direct costs.  Indirect costs associated with consortia do not count against this direct cost maximum; all indirect costs for consortia will be provided by NIGMS above and beyond the direct cost limit.  Consortia should be included in the budget request for all years in which subcontracts will be let, so that NIGMS can build in the associated indirect costs.  Applicants may request up to five years of support. 

The budgets for the research networks supported under this FOA will be modest on a per-PD/PI basis.  NIGMS will support research networks that can accomplish their goals on a total budget comprising approximately $40,000/year direct costs per PD/PI plus $40,000/year direct costs per institution.  These figures do not imply how funds should be distributed; the PD(s)/PI(s) will determine how network funds are budgeted.  The investigators will determine how project funds are budgeted.  Budgets are modest because these networks are designed to link existing programs and utilize their infrastructure, rather than to stand alone as independent projects.  To ensure that the scope of work proposed matches the funds that are available, applicants are advised to plan budgets consistent with this guidance.

Applicants may optionally provide a summary that itemizes direct cost expenditures independently of performance site (perhaps as a table) in the Budget Justification section.  This summary would be in addition to, not in lieu of, the required PHS398 budget pages for each component.

Budget Categories.  Applicants should develop a detailed budget for the first year of the project and tentative budgets for the future years.  This FOA intends that the investigators have flexibility to reallocate resources in response to scientific developments in accordance with the NIH Standard Terms of Award, which allows grantees to rebudget within and between budget categories to meet unanticipated needs within the approved scientific scope of the project (NIH Grants Policy Statement IIA.8.1).

Budget for the Research Project Component

This initiative will provide full or part-time support for shared scientific personnel.  The shared personnel should be listed as TBN (to be named), unless they are key personnel as described above.  In general, positions that will be occupied by students, postdoctoral fellows and laboratory employees who may rotate out of their positions should be listed as TBN, even if candidates for the positions have already been identified.  Other than for administrative effort, NIGMS has not built salary for PD(s)/PI(s) into its budget projections for these networks.

Budget for the Coordination and Collaboration Core

Applicants may request salary support for project administration, for example arranging travel and meetings, and preparing scientific components of non-competing applications, reports, and subcontract agreements.  This includes salary for PD/PI effort spent on project management and administration.  Applicants should ensure that expenses of resource and data sharing are covered either in the budget or from other sources.  The budget may request funds for investigator meetings and travel. 

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

This FOA specifies several program priorities that applicants should NOT address in their research plans.  The dollar levels and sources of the investigators' grant support, the count of biologists on the team, and the institutional affiliations of the investigators will not figure in the scientific peer review; NIGMS staff will assess them using information sources other than the application.  It is especially important that applicants not address or discuss dollar levels of research support of the participating laboratories anywhere in the application.

Specific Aims (page limit one page).  The Specific Aims should clearly define the goals and scientific scope of the project.  At the same time, they should be framed in a way that allows the collaboration flexibility to respond to scientific developments during the project period without changing the project's scientific scope.

Research Strategy

Research Component

The research strategy for the research component must include three sections within its 12 page limit:

(1)  Significance (Research Component).  Follow the PHS398 instructions from the perspectives of both the immediate biological field and of the broader topic of macromolecular interactions in cells.  Identify the specific gaps in knowledge that will be addressed.  Identify challenges or barriers that the project will overcome.

(2)  Innovation (Research Component).  Follow the PHS398 instructions from the perspectives of both the immediate biological field, and the broader topic of macromolecular interactions in cells.  Explain what is unconventional and different about the project and the ideas behind it.  Identify research strategies that are new to the biological topic and/or the study of macromolecular interactions.

(3)  Approach (Research Component).  The Approach should explain how this FOA's network organization and flexibility in adjusting scientific directions will be utilized.  As is usual for collaborative research, this Approach section should include the scientific interactions that will occur among investigators for the jointly conducted research activities, including how information will flow, be integrated, and be responded to.  Applicants may organize the Approach section of the Research Project component into sections or subprojects, but no extra pages are allotted for this purpose.

The page limit for the research strategy for the Research Component, comprising the sections (1)-(3) (Significance, Innovation, and Approach) is 12 pages.

Coordination and Collaboration Core

The research strategy for this Core must include four sections within its 12 page limit:  (1) the Coordination and Communications Plan,  (2) the Investigators' Scientific Roles section,  (3) the Multiple PD(s)/PI(s) and Project Management Plan, and (4)  the Intellectual Property (IP) plan.  The pages allocated for this Core may not be used to circumvent the page limits for the Research Component; it should cross-reference but not describe research strategies, methodology and analyses.

(1)  Coordination and Communications Plan.  This plan should describe the activities through which scientific communication will occur and the research will be coordinated.

The Coordination and Communications Plan should describe:  (i) how the research will be coordinated,  (ii) scientific interactions and meetings.  (iii) how the shared personnel will be managed and their roles in communication and coordination.  (iv) plans for cross-training of investigators.  It should describe how the network will provide an environment that can be used to prepare new scientists and provide the opportunity for established scientists to re-orient their research.

(2)  Investigators' Scientific Roles.  The research strategy for the Coordination and Collaboration Core must include this section, which should should explain the integration of the investigators into the project.  For each PD/PI or senior co-investigator, collaborator, and/or subcontractor who will play a major role in directing parts of the research include a clearly marked section titled "Investigator's Scientific Role" with the investigator's name.  This section should describe (i) the investigator's scientific (not administrative) role in and contributions to the network, (ii) the investigator's interactions with the other investigators and the network, (iii) the investigator's qualifications for his/her role, referencing recent publications related to his/her participation in the network.  (iv) The contribution of the investigator's laboratory to network resources and expertise.

(3)  Multiple-PD(s)/PI(s) Leadership and Project Management Plan.  The research strategy for the Coordination and Collaboration Core must include the this plan, which should describe how the project will be governed.  It should include a mechanism for making decisions and for resolving disagreements within the team of PD(s)/PI(s).  The plan should describe how scientific progress will be tracked and evaluated and how scientific directions will be set.  The plan should provide the information requested by NIH for the Multi-PD/PI Leadership Plan, and also provide the additional management information specific to this FOA which follows.

Steering Committee.  The project must be directed by a steering committee chosen by the PD(s)/PI(s).  The steering committee will have the responsibility and the authority to make and implement decisions about research activities, personnel, and the project budget.  The steering committee may comprise all or a subset of the PD(s)/PI(s).  The plan should list the initial roster of steering committee members.  The steering committee should hold at least two business meetings per year.  These may be phone conferences.  The plan should describe how the steering committee will govern the project. 

In contrast to most NIH projects, which are directed by one to three PD(s)/PI(s), the number of PD(s)/PI(s) on these grants will be large.  This poses a number of challenges for project direction and management.  It is important that the applicants devise a robust and workable management scheme and describe it clearly and completely.  Useful guidance is posted at the NIH Multi-PD/PI webpages.  Potential applicants are encouraged to consult the Institute Scientific/Research contacts listed in Section VI about their project management plans.

(4)  Intellectual Property (IP) plan.  The research strategy for the Coordination and Collaboration Core are expected to include an IP plan.  Awardees will retain custody of and have primary rights to the intellectual property developed under these awards by their respective organizations, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.  The IP plan should describe how IP rights will be coordinated and managed among the participating organizations to achieve the goals of the program.  It should describe how the awardees will manage intellectual property in a way that is consistent with the Resource Sharing Plans and ensures the free and timely availability of data and research resources to the scientific community in accordance with applicable NIH guidelines for resource and data sharing, consistent with achieving the goals of this program.

The page limit for the research strategy for the Coordination and Collaboration Core, comprising sections (1)-(4) immediately above, is 12 pages.

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 Resource Sharing Plan section of the application should explain how the the project will follow all applicable NIH policies and guidance for sharing of resources and data.

Resources.  Describe the major categories of resources likely to be produced and the plans for sharing them.  Where applicable, the plan should specifically address model organisms, cell lines, antibodies, methods, reagents, instructions for the preparation of reagents, computer algorithms, and software (including source code).  If any of these categories of resource are unlikely to be produced, state this.

Data.  Describe the nature of data likely to be generated by the project that will not be included in publications.  Identify categories that can be deposited in public databases and describe the plans for sharing them.  Identify categories of data for which public databases are not available, and describe the plans for sharing them.  If bulk data will be analyzed, and the conclusions but not the data published, describe the plans for sharing the unreduced data.  In all cases, estimate the volume of data that will be produced and discuss the disposition of high-throughput data.

Model Organisms.  Identify model organisms likely to be created and describe how they will be shared freely and in a timely fashion.  If it is expected that no model organisms will be generated, state this explicitly.

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.

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

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.

For this particular announcement, note the following:  This FOA emphasizes the significance of the goals, biological and conceptual innovation, and the recent track record of the investigators.  This FOA calls for approaches and strategies that are new to the biological investigators and their systems.  For the investigator criterion, the emphasis should be on the impact, quality and breadth of the investigators' recent publication records as indicators of the likelihood that they will be able to master the new skills needed, rather than on documentation of technical proficiency in specific techniques.  For the approach criterion, the emphasis should be on the rationale, objectives and general strategy, rather than on demonstration of feasibility and experimental details.  Reviewers should balance potential impact against technical risk.

This FOA specifies several program priorities that should not be considered in the scientific review.  These include the dollar levels and sources of the investigators' grant support, the count of biologists on the team, and the count of institutions.  NIGMS staff will assess these considerations during the selection process using information sources other than the application.

Overall Impact - Overall

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, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

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

Significance

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

Will the proposed research significantly advance our knowledge and/or understanding of the biological topic and of macromolecular interactions and their relationship to function in vivo (cells, tissues, and organisms)?  Will the network catalyze the introduction of new concepts and research strategies to the biological field?

Investigator(s)

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

Do the applicants have a record of innovation and achievement on difficult problems?  Do the impact, quality and breadth of the investigators' publication records indicate that they will be able to develop the proficiencies needed for their assigned roles and be resourceful enough to solve the kinds of problems expected to arise in the course of the research?     

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 different are the proposed activities from the investigators' current research?  Does the research have the potential to open new areas of opportunity and generate new hypotheses?  What are the prospects for novel findings and new perspectives on the biological topic?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the network? 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 network 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?

Coordination and Collaboration Core.  (1) Coordination and Collaboration Plan.  Are the plans for coordination of the jointly conducted research activites complete and sufficient?  Does the plan make provision for responding to scientific developments and opportunities?  (2) Investigators' Scientific Roles.  Are the PD(s)/PI(s)' participation and roles justified?  Are the investigators integrated into an effective team?  (3) Project Management Plan.  Will the management plan provide effective scientific direction?  Is a robust framework for making decisions proposed?  Are the roles of the multiple PD(s)/PI(s) and the Steering Committee clear?  Are sound principles for scientific and budgetary decision making set forth?  Have the applicants anticipated and addressed management issues and problems that may arise during the course of the project?  Are the plans for monitoring progress adequate?

Research Component.  Does the application go beyond the testing of previously formulated mechanistic models of function?  In this FOA's context of exploration and discovery for the generation of hypotheses, where outcomes and findings cannot be predicted, is the rationale sound?  Are the objectives clearly defined?  Is the strategy reasonable?  In the context of this FOA's solicitation of unconventional approaches, which entail risk, do the potential benefits justify the risks?

Environment

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

Additional Review Criteria - Overall

As applicable for the 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 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

Not Applicable

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the 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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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) convened by, NIGMS 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:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The Terms and Conditions of Award will include the currently approved versions of the Coordination and Collaboration plan, the Multi-PD(s)/PI(s) Leadership and Project Management Plan, the Sharing Plans for Resources and Data, and the Intellectual Property Plan.  Before the initial award is made, NIGMS and the awardees may negotiate changes or additions to the versions of these plans in the application.  Future changes or additions to these plans may be developed by the NIGMS and the PD(s)/PI(s).  Changes will be documented by an exchange of correspondence and the updated  plans will become part of the Terms and Conditions of Award. 

Awardees will retain custody of and have primary rights to the resources, data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies and the Terms and Conditions of this award.

All investigators and institutions receiving funding through the project must abide by the provisions of the Multi-PD(s)/PI(s) Leadership and Project Management Plan, Sharing Plans for Resources and Data, and Intellectual Property Plan as part of The Terms and Conditions of Award.

The PD(s)/PI(s) will have the primary responsibility for: leading and directing the project, intellectually and logistically.  The PD(s)/PI(s) will choose the Steering Committee, which will manage the project and have authority over the project's budget.  The Steering Committee may comprise all or a subset of the PD(s)/PI(s).  The PD(s)/PI(s) are responsible for abiding by and implementing decisions made by the Steering Committee. The PD(s)/PI(s) will set scientific goals and milestones and monitor their scientific progress in accordance with the principles in Project Management Plan.  The Steering Committee will hold at least two official business meetings yearly, and the whole multi-PD(s)/PI(s) leadership team at least one official business meeting yearly.  These may be telephone conferences.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The involvement of NIGMS staff in oversight of the scientific aspects of the project is not expected to be above and beyond the normal stewardship typical for NIGMS R01 and program project awards.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards in oversight of project governance and management.  The NIGMS (GM) Science Officer (GMSO) is the Institute point-of-contact except for special circumstances designated by NIGMS.  The GMSO (or designee) will attend all business meetings of the multi-PD(s)/PI(s) leadership team and steering committee as a non-voting member and must be kept informed of all substantive deliberations and developments affecting the project.  The GMSO will provide advice and guidance to ensure that the project adheres to NIH and NIGMS rules and regulations, and the Terms and Conditions of this award.  The GMSO will support and assist the Steering Committee in ensuring that its decisions are implemented.  The GMSO will keep the PD(s)/PI(s) informed of any issues and concerns involving the project and provide advice on how to address them.

Additionally, an agency program official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NIGMS Program Director (GMPD) will monitor the project on an ongoing basis and will formally evaluate the project on a yearly basis.  The yearly evaluation will be based on the non-competing application and progress report and recommendations of the GMSO.  NIGMS will monitor the conduct of the research and its compliance with agency policy and the Terms and Conditions of the Award.  NIGMS will monitor that the research activities are within the approved scientific scope of the grant, and that funds are being used in accordance with Steering Committee directives.  NIGMS must approve in advance (i) changes to the roster of PD(s)/PI(s), key personnel, and the Steering Committee, (ii) changes and exceptions to the Project Management Plan and Sharing Plans, (iii) changes in the scientific scope of the project, (iv) changes to the frequency of business meetings.

Annual Review.  NIGMS will make a yearly determination whether the investigators are working together effectively and successfully as a team to conduct the project.  The PD(s)/PI(s) are expected to reach agreement within the project team about project management, including budgeting, personnel, research directions, and sharing of resources and data.  All participants are expected to abide by and support management decisions reached in accordance with the Multi-PD(s)/PI(s) Leadership and Project Management Plan.  Certification by the GMPD that project management is satisfactory will be required for funding of the next year of support.  The GMPD will also review the effectiveness of resource and data sharing in the annual reviews.  If there are substantial changes in the roster or status of the PD(s)/PI(s), NIGMS may modify the budget and/or term of support.

Special Reviews.  NIGMS does not anticipate conducting special or mid-course reviews of scientific progress beyond the normal yearly non-competing progress review.  However, if concerns are identified about the management and conduct of the project, NIGMS may conduct special reviews of the project as it deems necessary.  NIGMS may engage outside experts to assist in these reviews.  If concerns about the project arise and are not resolved, NIGMS may reduce or restrict the budget or reduce the term of support to phase out the project.

Other Requirements.  All research publications supported by this grant must acknowledge its support by citing the grant number in the form "supported by NIGMS grant U54 GM000000".  The PD(s)/PI(s) should maintain a current listing of all publications supported by the grant, which includes the exact acknowledgement of support that appears in the paper.  This list should also explain the contributions of this grant to the publication.

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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)

Division of Cell Biology and Biophysics
James F. Deatherage, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: deatherj@nigms.nih.gov 

Division of Cell Biology and Biophysics
Alexandra M. Ainsztein, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email:ainsztea@mail.nih.gov

Division of Genetics and Developmental Biology
Daniel E. Janes, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0943
Email: janesde@mail.nih.gov

Division of Pharmacology, Physiology, and Biological Chemistry
Vernon E. Anderson, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email:andersonve@mail.nih.gov

Center for Bioinformatics and Computational Biology
Paul Brazhnik, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: brazhnikp@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: sunshinh@nigms.nih.gov

Financial/Grants Management Contact(s)

Earl C. Melvin
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3912
Email:melvine@nigms.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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