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

Revisions for Macromolecular Interactions in Cells (R01)

Activity Code

R01 Research Project Grant

R37 Method to Extend Research in Time (MERIT) Award

Announcement Type

Reissue of RFA-GM-13-003

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-GM-14-003

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.859

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to diversify and extend the scope and capabilities of currently funded NIGMS R01 and R37 projects for studies on macromolecular interactions and their relationship to function in cells.  This FOA solicits revisions (formerly called "competing supplements") of currently funded NIGMS grants specializing in the analysis of molecular systems and mechanisms in live organelles, cells, tissues, or organisms.  Applicants may increase their budgets to extend the scientific scope of their projects or to add new approaches that enhance their capabilities for research on macromolecular interactions in cells.  Collaboration is not a requirement of this initiative, but applicants may request support for collaboration (including subcontracts) with investigators who have complementary expertise  Support for access of modestly funded laboratories to experimental approaches and research objectives that are otherwise financially out of reach is one priority of this FOA.

Key Dates
Posted Date

December 21, 2012

Open Date (Earliest Submission Date)

January 19, 2013

Letter of Intent Due Date(s)

January 19, 2013, August 19, 2013

Application Due Date(s)

February 19, 2013, September 19, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June-July 2013, February-March 2014

Advisory Council Review

October 2013, May 2014

Earliest Start Date

December 2013, July 2014

Expiration Date

September 20, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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 diversify and extend the capabilities of NIGMS R01 projects (including MERIT awardees) for investigation of macromolecular interactions and their relationship to function in cells.  This FOA is intended only for support of NIGMS-funded projects specializing in the analysis of molecular systems and mechanisms in live organelles, cells, tissues, or organisms.   Support for access of modestly funded laboratories to experimental approaches and research objectives that are otherwise financially out of reach is one priority of this FOA.

Background and Rationale

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, organelles and tissues as well as organisms.  The Council-recommended program priorities for this FOA are involvement of biologists specializing in function in living systems, support for cross-disciplinary collaboration, initiation of new lines of research, unconventional research approaches and strategies, and involvement of NIGMS's base of modestly funded laboratories.

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 remodel themselves 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 investigators who specialize in the analysis of function in living systems in multidisciplinary applications of new technologies and research strategies.

This initiative addresses barriers facing 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.

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 $500,000/year direct costs) by providing access to new research approaches and objectives.

A third barrier occurs at the interface between technology resource providers and biologists.  There are many resource laboratories and technology developers who have powerful new approaches and are eager to collaborate and transfer their technologies, but have insufficient discretionary funding to meet demands for outreach and collaboration. This initiative will provide support for biologists to collaborate with and/or access services of technology resource laboratories, including R01-funded technology developers and specialized centers and resources.  Examples of the latter  include, but are not limited to, the NIH P41 Biomedical Research Technology Centers (BTRCs, formerly called "Research Resources"),  NIH National Technology Centers for Networks and Pathways Program (U54),  NIH Roadmap Centers, NIGMS Systems Biology Centers, and the Drosophila RNAi Screening Center.  One feature of this initiative is that the biologist, rather than the technology provider, chooses the topic, applies for the funding, and is responsible for the direction of the work.

Description

The objective of this FOA is to address these barriers by expanding the scope and budgets of established NIGMS projects specializing in the analysis of molecular systems and mechanisms in live organelles, cells, tissues, or organisms as their primary approach, where the parent laboratory has limited total research support.

This FOA utilizes the revision (formerly called "competing supplement") application type to augment existing R01 and R37 projects.  The maximum budget is $75,000 direct costs per year.  Applicants may request support for additional personnel for the parent project, support for additional personnel to be shared with a collaborator, or subcontracts to support work in a collaborating resource laboratory.  Collaboration is not a requirement of this initiative, but applicants may request support for collaboration with investigators with complementary expertise. Project funds can be used to support meetings of whole laboratories for collaborative experiments, including expenses like laboratory rental and fees.

Revisions (short or long term) change the approved scope and budget of the parent project.  The new Aims and the revised budget become part of the parent project.  Grantees may choose to apply for continued support of the expanded project at the revised budget level in the next competing renewal application of the parent grant.  Continued support at or above the revised budget level in future competitive segments will depend on the recommendations of first and second level review and on the availability of funds.  It is essential that potential applicants review NIH guidance and instructions for revisions in the SF424 application guide.

The intent of this FOA is to enable the laboratory to ask questions beyond its current capabilities.  To accomplish this, it will support research ranging from established approaches to the development and/or piloting of entirely new technologies.  Applicants may use this funding opportunity to:  (a)  Complement the laboratory's capabilities with additional proven methods (for example, single laboratory-scale genetic screening, chemical and pharmacological approaches) where the innovation lies in the application rather than in the technology.  (b) Adopt proven technologies (independently, through collaboration, or by subcontracting) that are technically challenging, expensive, or not yet widely used in cell biology and allied fields (for example, affinity purification, mass spectrometry, high-throughput screening).  (c) Develop, pilot, evaluate, and/or apply emerging technologies (for example, superresolution light microscopy).  (d) Carry out feasibility studies or upstream research and development (by the PD(s)/PI(s) alone or with a collaborator) of new technological concepts that are unproven, but potentially useful for study of macromolecular interactions.

Specific Areas of Research Interest

The goals of this FOA are to diversify and extend the scope and capabilities of established NIGMS projects for studies on macromolecular interactions and their relationship to function.  The research should advance the study of macromolecular interactions and their relationship to function in vivo (organelles, cells, tissues, or organisms).  Experimentation in vitro (for example, isolation, characterization, functional reconstitution) may be included, but it must be directed towards a functional understanding of complexes in vivo and must be related to, complementary to, and coordinated with the in vivo work of the parent project.

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 current active NIGMS FOAs; these topics are not targeted for support under this FOA.  

Program Priorities

This section describes the programmatic objectives of this FOA; applications must meet the programmatic as well as scientific objectives of the FOA to qualify for funding consideration.

This Funding Opportunity Announcement has special application instructions and restrictions, altered review criteria, and special award criteria.  Potential applicants should review the objectives of the FOA, the application instructions (Section IV below), and the review criteria (Section V below).

Potential applicants are strongly encouraged to consult with the Institute Scientific/Research contact listed in Section VII about the responsiveness of the research area of their parent grant and the research support of their laboratory to this FOA.  They are similarly advised to discuss their research ideas with the contact to see if they fit the goals of this initiative, and to send a letter of intent prior to submission.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

Revision, Resubmission.  All applications for this FOA must be Revisions of an existing NIGMS parent grant.  First submissions of revision applications, and resubmissions of revision applications that originally responded to RFA-GM-13-003, or to the first submission date for this FOA, are allowed.  No other resubmissions are allowed.  The "New" application type is not applicable to this FOA and should not be specified.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

NIGMS intends to commit $3,200,000 total costs in FY 2014 for this FOA.

Award Budget

The maximum award budget is $75,000/year direct costs.  This figure does not include subcontract F&A.  

Award Project Period

The maximum award project period is until the end of the currently awarded parent project period.  To qualify for a year of support, applications should be submitted at least 20 months before the end of project's last budget 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

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 SF424 (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 Directors/Principal Investigators (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 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The parent project must be an active NIGMS R01 or R37 project.  There must be at least 20 months remaining on the project when the application is submitted. The PD/PI(s) on the revision must be the same as the PD/PI(s) on the parent grant.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  1. To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  2. Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  3. Of an application with a changed grant activity code.
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, with the following additional requirement:  

Budget Component

Revisions require the same budget format (modular or non-modular) as used in the parent grant. 

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 of the PD(s)/PI(s) research support and whether or not the PD(s)/PI(s) primary research focus is on function in living systems will not figure in the scientific peer review; NIGMS staff will assess these considerations 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.

Introduction: Note that revision applications require a one page introduction. 

Specific Aims:  The Specific Aims of the competing revision application should address approaches to or questions about macromolecular interactions in cells that extend, enhance, and/or complement the Aims of the parent grant.

Research Strategy:

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.

 
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-U.S.) 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 applications before 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 before the deadline 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 SF424 (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 SF424(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 System for Award Management (SAM). 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:

The review for this FOA will emphasize the significance of the goals, biological and conceptual innovation, and the recent track record of the investigator(s).  This FOA calls for approaches and strategies that are new to applicants and their systems.  For the investigator criterion, the emphasis should be on the impact, quality and breadth of the investigator(s)' 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.  For the innovation criterion, reviewers should consider whether the research strategies are new to the PD(s)/PI(s) laboratory.

This FOA specifies several program priorities that should not be considered in the scientific review.  These include dollar levels of the PD(s)/PI(s) grant support and whether or not the PD/PI’s primary research focus is on function in living systems.  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 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 contribute significantly to the knowledge and understanding of macromolecular interactions in the biological topic area?  Will the proposed research diversify and extend the scope and capabilities of the parent project for achieving an understanding of macromolecular interactions and their relationship to function in vivo (organelles, cells, tissues and organisms)? Will the research 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is the parent grant established and making appropriate progress as judged by peer reviewed publications?  Do the investigator(s) have a record of innovation and achievement on difficult problems?  Do the impact, quality and breadth of the investigator(s)' publication records indicate that they will be able to develop the proficiencies needed for the research 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 PD(S)/PI(S)'s current research?  Does the research have the potential to open new areas of opportunity and generate new hypotheses for the parent project?  What are the prospects for novel findings and new perspectives on the biological topic of the parent grant?

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 elevated risks), 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

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 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

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

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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 the NIGMS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group 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 Institute of 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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 the parent 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
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.
Chief, Office of Scientific Review
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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