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

Collaborations for Macromolecular Interactions in Cells (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-GM-13-004

Companion FOA

RFA-GM-13-003, RFA-GM-13-005

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 projects to advance studies of macromolecular interactions and their relationship to function in cells.  These collaborations are designed to integrate additional research strategies into NIGMS' research base of laboratories specializing in macromolecular function in living systems.  Grantees 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(s)/principal investigator(s) (PD(s)/PI(s)) grant, the R01 activity, and the modular budget grant application format.

Key Dates
Posted Date

March 1, 2012

Open Date (Earliest Submission Date)

May 14, 2012

Letter of Intent Due Date

May 14, 2012

Application Due Date(s)

June 14, 2012, by 5:00 PM local time of applicant organization.

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 SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose/Research Objectives

The purpose of this Funding Opportunity Announcement (FOA) is to establish inter-disciplinary collaborative projects to advance studies on macromolecular interactions and their relationship to function in cells.  This FOA uses the NIH multiple program director(s)/principal investigator(s) (PD(s)/PI(s)) grant, the R01 activity, and the modular budget grant application format.

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, "Collaborations for Macromolecular Interactions in Cells" supports multiple-PD(s)/PI(s) R01s; its maximum budget is $250,000 direct costs per year.  A second FOA, "Research Networks for Macromolecular Interactions in Cells (U54)" (RFA-GM-13-005), supports multiple-PD(s)/PI(s) specialized center cooperative agreements (U54); its maximum budget is $500,000 direct costs per year.  A third FOA, "Competing Revisions for Macromolecular Interactions in Cells (R01)" (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 collaborations 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(s)/PI(s) grant and the R01 activity.  The maximum budget is $250,000/year direct costs.  Applicants may request up to four years of support.  Each grant will be directed by a team of PD(s)/PI(s) who head independent laboratories conducting research relevant to macromolecular interactions in cells that they can coordinate with the collaboration.  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. 

A priority of this FOA is to support collaborations 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 grants 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 collaborations 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.  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 collaborations. 

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(s)/PI(s) teams, potential applicants should note that one priority of this FOA is to support multi-institutional collaborations 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 NIGMS' 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

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIGMS intends to commit $1,800,000 in FY 2013.

Award Budget

The maximum award budget is $250,000/year direct costs.

Award Project Period

The maximum award project period is 4 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program 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 least 4-6 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 SF 424 (R&R) 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. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

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.
National Institute of General Medical Sciences (NIGMS)
Building 45, Room 2AS.13F, MSC6200
Bethesda MD 20892-6200
Telephone: 301-594-0828
Email: deatherj@nigms.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

SF424(R&R) Senior/Key Person Profile Expanded Component

The list of key personnel should be limited to key 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.

Modular Budget Component

The maximum budget is $250,000/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 four years of support. 

The budgets for the collaborations supported under this FOA will be modest on a per-PD/PI basis.  NIGMS will support collaborations 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.  Applicants are advised to request a modular budget step near this figure.  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 grants 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.

This FOA intends that grantees 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).

Applicants should ensure that expenses of resource and data sharing are covered either in the budget or from other sources.  The budget may include funds for meetings of the participating laboratories and associated travel.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) 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.  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.  The page limit for the Specific Aims section is one page; the Specific Aims page is not part of the Research Strategy section and does not count against its 12 page limit.

Research Strategy

The page limit for the Research Strategy section, including the Multi-PD(s)/PI(s) Leadership Plan, is 12 pages.

Significance.  Follow the SF424 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.

Innovation.  Follow the SF424 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.

Approach.  The Approach should explain how this FOA's 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.  Considerations of coordination between participants located at geographically separated sites should be addressed.  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 Research Strategy and/or the multiple PD(s)/PI(s) leadership plan should describe:  (i) how the research will be coordinated,  (ii) how scientific progress will be tracked and evaluated and how scientific directions will be set,  (iii) scientific interactions and meetings,  (iv) how the shared personnel will be managed and their roles in communication and coordination,  (v) plans for cross-training of investigators.  It should describe how the collaboration will provide an environment that can be used to prepare new scientists and provide the opportunity for established scientists to re-orient their research.  The plan may optionally describe plans to interact with the wider field and/or promote coordination and collaboration with non-members, but this is not required. 

The Research Strategy section should include a section explaining the integration of the investigators into the project.  For each PD/PI or key collaborator,  subcontractor, or other essential person 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 role in and contributions to the collaboration, (ii) the investigator's interactions with the other investigators, (iii) the investigator's qualifications for his/her role, referencing recent publications and relevant recent grant support related to their participation in the collaboration,  (iv) The contribution of the investigator's laboratory to the collaboration's resources and expertise.  This section may optionally also describe how the collaboration will enhance or extend the investigator's research.  This section, like the rest of the application, should address only scientific considerations and should not reference or discuss dollar levels of research support.  This section is part of the Research Strategy and counts against its 12 page limit.

Multiple PD(s)/PI(s) leadership plan.  The plan should provide the information requested by NIH for the Multi-PD(s)/PI(s) Leadership Plan.  This plan is part of the Research Strategy and counts against its 12 page limit.  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(s)/PI(s) webpages.  Potential applicants are encouraged to consult the Institute Scientific/Research contacts listed in Section VI about their multiple PD(s)/PI(s) leadership plans.

Resource Sharing Plan

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

Appendix

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

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review 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(s) 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 assess technical risk when determining potential impact.  For the innovation criterion, reviewers should consider whether the research strategies are new to the biological laboratories.

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

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

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

Significance

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

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 project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(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 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?

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?

Management and Coordination.  Are the PD(s)/PI(s)' participation and roles justified? Are the investigators integrated into an effective team?  Will the multiple-PD(s)/PI(s) leadership plan provide strong scientific direction?  Are the plans for coordination of the jointly conducted research activities complete and sufficient?  Is a robust framework for making scientific and budgetary decisions 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?  Does the plan make provision for responding to scientific developments and opportunities?

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

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

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 in response to this FOA.

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National General Medical Sciences 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

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

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

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
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)
Building 45, Room 2AS.13F, MSC6200
Bethesda MD 20892-6200
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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NIH Funding Opportunities and Notices


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