Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Center for Complementary and Alternative Medicine (NCCAM)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Funding Opportunity Title

Modeling Social Behavior (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-13-374

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; 93.865; 93.273; 93.213; 93.121; 93.113; 93.286; 93.242; 93.399 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for developing and testing innovative theories and computational, mathematical, or engineering approaches to deepen our understanding of complex social behavior. This research will examine phenomena at multiple scales to address the emergence of collective behaviors that arise from individual elements or parts of a system working together. Emergence can also describe the functioning of a system within the context of its environment. Often properties we associate with a system itself are in actuality properties of the relationships and interactions between a system and its environment. This FOA will support research that explores the often complex and dynamic relationships among the parts of a system and between the system and its environment in order to understand the system as a whole.

To accomplish the goals of this initiative, we encourage applications that build transdisciplinary teams of scientists spanning a broad range of expertise. Minimally this team should include investigators with expertise in the behavioral or social sciences as well as in computational and systems modeling (computer science, mathematics, engineering, or other systems sciences). Applications should demonstrate bridge-building between disciplines, scales and levels.

Key Dates
Posted Date

October 17, 2013

Open Date (Earliest Submission Date)

January 5, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS dates apply by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

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.


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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

This Funding Opportunity Announcement (FOA) is a follow-on to RFA-GM-13-006, Modeling Social Behavior. The goal of this prior FOA was to build an extramural research program in computational social sciences to increase our understanding of basic behavioral and social phenomena and processes and ultimately improve human health.

Models help explain observations, understand system dynamics, illuminate uncertainties, offer options for interventions, set boundaries of parameters and outcomes, discipline our thinking, and identify new questions. These are valuable, tangible results of applying modeling, especially mathematical and computational modeling to social behavior research.

This FOA encourages applications for developing and testing innovative theories and computational, mathematical, or engineering approaches to deepen our understanding of complex social behavior. This research will examine phenomena at multiple scales to address the emergence of collective behaviors that arise from individual elements or parts of a system working together. Emergence can also describe the functioning of a system within the context of its environment. Often properties we associate with a system itself are in actuality properties of the relationships and interactions between a system and its environment. This FOA will support research that explores the often complex and dynamic relationships among the parts of a system and between the system and its environment in order to understand the system as a whole.

To accomplish the goals of this initiative, we encourage applications that build transdisciplinary teams of scientists spanning a broad range of expertise. Minimally this team should include investigators with expertise in the behavioral or social sciences as well as in computational and systems modeling (computer science, mathematics, engineering, or other systems sciences). Applications from cross-trained investigators with expertise in complex systems and computational thinking and approaches (such as computational neuroscientists, computational sociolinguists, computational anthropologists, computational epidemiologists, etc.) are encouraged. Applications should demonstrate bridge-building between disciplines, scales and levels.

This FOA encourages small research projects focusing on theory building and testing, development and testing of innovative methods or methodological approaches, as well as small infrastructure projects focusing on development and testing of shared resources (for the last, generally applicable to broadly defined domains in systems and computational biology, behavioral or social sciences, or human health and in the context of a driving biological, behavioral or social, or human health issue). This FOA also encourages larger and more integrative research projects focusing on the modeling of complex social behavior.

Applications submitted to this FOA may propose exploratory or hypothesis-generating studies, or a combination of both; it is not necessary that proposed research be solely hypothesis-driven. Studies using system science approaches to knowledge discovery are encouraged.

Applications may use real, empirical data as well as synthetic data or a combination of both to meet the aims of the proposed project. Model testing and validation are encouraged, especially when only synthetic data are used in simulations. Inclusion of preliminary data is not a requirement.  

It is not the intent of the FOA to fund projects whose sole purpose is to collect and analyze original data. However, funds can be requested for this purpose within the larger context and goal of building and evaluating theories or models or the development, implementation, and evaluation of shared resources.

Proposed research may involve model organisms or humans or both. Projects that integrate research using animal models and humans are encouraged.

NIGMS is interested in mathematical and computational systems modeling of behavioral and social phenomena and processes. Specific content areas of research interest include but are not limited to:

Specific infrastructure development focus areas of interest to NIGMS include but are not limited to:

NIAAA encourages basic and applied research on systems-based modeling approaches to advance understanding of behavior, decision-making, and interventions pertaining to alcohol consumption and alcohol-related outcomes. Examples of research topics appropriate to this FOA and of interest to the NIAAA include but are not limited to:

NICHD is interested in basic and applied research on models of behavior and social processes associated with health, disability, and developmental outcomes from the pre-conception period into adulthood. See: http://www.nichd.nih.gov/about

Applications that make use of computational, mathematical, or engineering methods to deepen our understanding of the following topics would be of interest to the NICHD:

NIDCR particularly encourages projects that help develop and test causal explanations of oral health behavior across complex social systems and/or multi-level causal explanations of oral health. For social behavior research related to oral health, note that the NIDCR does not accept applications that include clinical trials in response to trans-NIH FOAs.  Applicants proposing a clinical trial to the NIDCR should refer to the following websites; http://www.nidcr.nih.gov/clinicaltrials/, http://grants.nih.gov/grants/guide/notice-files/NOT-DE-11-002.html, and http://grants.nih.gov/grants/guide/pa-files/PAR-11-338.html.

NIEHS is interested in supporting research in the following specific content areas:

NIMH is interested in supporting applications that propose: 1) integrative approaches to understanding the neurobiological systems governing social behavior and cognition in humans and animals, and 2) the development of realistic models for understanding brain function and the combination of mathematical and computational tools with neurobiological techniques. NIMH is particularly interested in applications to this FOA that seek to build transdisciplinary teams that can apply appropriate modeling techniques to multidimensional social neuroscience data.

Examples of topics and approaches of interest to NIMH include, but are not limited to, the following:

Applicants with interests in these areas are encouraged to refer to the NIMH programs in Affect, Social Behavior and Social Cognition and/or Theoretical and Computational Neuroscience http://www.nimh.nih.gov/about/organization/dnbbs/behavioral-science-and-integrative-neuroscience-research-branch/index.shtml.

NCCAM is interested in applications proposing studies which utilize information shared through social media or geocoded data to:

Applications submitted to this FOA should adhere to the following definitions:

"Modeling" is defined as the use of a simplified abstraction or representation of a system in time or space to enable and promote understanding of the real system. "Systems modeling" refers not only to systems dynamics, agent-based modeling, and network analysis, but also includes all other appropriate and applicable computational, mathematical, or engineering approaches.

"Social behavior" is defined as emergent collective behavior arising from the behaviors of individuals in a population. Exploring interactions and emergent behaviors should include study of the context in which the behaviors and the system exist. A broad range of theoretical frameworks is encouraged.

For other relevant definitions of "behavior" and "social" and research in these areas, see: http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx#def

"Transdisciplinary research" is defined as research efforts conducted by investigators from different disciplines working jointly to create new conceptual, theoretical, methodological, and translational innovations that integrate and move beyond discipline-specific approaches to address a common problem. One resource of tools to foster transdisciplinary team science can be found at:  https://www.teamsciencetoolkit.cancer.gov/public/home.aspx?js=1

"Systems biology" is a conceptual framework for the analysis of complex biological and behavioral systems. Such systems derive from interactions among many distinct components, in varying contexts. These systems exhibit properties, such as nonlinear dynamics and emergent behavior that cannot easily be inferred from studies of components in isolation. Systems biology often uses mathematical methods and computational models along with data to test hypotheses and design experiments. The demands of the approach often require high-throughput data acquisition technologies and cross-disciplinary collaborations. Iteration between theory and experimentation is critical. When applied to human health, systems biology can be a powerful tool to test hypotheses relevant to health and disease, particularly the results of therapeutic interventions.

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

New
Renewal
Resubmission
Revision

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.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years for New and Early Stage Investigators  and 4 years for established investigators.

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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:

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.

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Funds for travel of the PD(s)/PI(s) and relevant staff to awardee meetings should be included in the proposed budget.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: Applications should address plans to build transdisciplinary teams of scientists spanning a broad range of expertise. Minimally this team should include investigators with expertise in the behavioral or social sciences as well as in computational and systems modeling (computer science, mathematics, engineering, or other systems sciences). Applications from cross-trained investigators with expertise in complex systems and computational thinking and approaches (such as computational neuroscientists, computational sociolinguists, computational anthropologists, computational epidemiologists, etc.) are encouraged. Applications should demonstrate bridge-building between disciplines, scales and levels.

Transdisciplinarity applies both to the proposed project (it should address issues of relevance to and that cut across and integrate multiple domains) as well as to the team proposed to carry out the project.

One resource of tools to foster transdisciplinary team science can be found at:  https://www.teamsciencetoolkit.cancer.gov/public/home.aspx?js=1

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.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

All applicants are expected to include a plan with appropriate milestones for disseminating and sharing software that is developed using funds provided through this FOA.  There is no prescribed single license for software produced in this project, however reviewers will be asked to comment on the dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:

1.  The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

2.  The terms of software availability should include the ability of outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators.  The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3.  To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4.  Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources that are contributed by others. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The adequacy of the software sharing plans will be considered by Program staff when making recommendations about funding applications. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the PD/PI before recommending funding of an application. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.  The final version of any accepted software sharing plans will become a condition of the award of the grant. The effectiveness of software sharing may be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590).  See Section VI.3, “Reporting".

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report 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 due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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. See Section III of this FOA for information on registration requirements.

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. 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, NIH. Applications that are incomplete will not be reviewed.

Conference Calls and Meetings

The PD(s)/PI(s) of each research group will participate in quarterly videoconferences or conference calls. In addition, each research group will present its scientific progress at annual investigator meetings. These activities are designed to encourage collaboration and provide formal opportunities for synergy among the research groups.

Through the Multiscale Modeling (MSM) Consortium, the Interagency Modeling and Analysis Group (IMAG) promotes collaborative team science and the sharing of good quality scientific modeling and analysis tools as a result of employing appropriate software engineering practices (http://www.nibib.nih.gov/research/featured-programs/interagency-modeling-and-analysis-group-imag). Applicants to this FOA are welcome and encouraged to join the MSM. Moreover, efforts will be made to coordinate the planning and scheduling of the annual investigator meetings with the annual MSM Consortium Meetings.­ When this timing is possible, the proposed budget will cover travel to the joint meeting. As a part of the IMAG/MSM Consortium (http://www.imagwiki.org/mediawiki/) funded investigators of this FOA can interact with the broader IMAG/MSM community of modelers to further promote model sharing and scientific collaboration.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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?

Does the proposed project address issues of relevance to and that cut across and integrate multiple domains of science (i.e., is the proposed project transdisciplinary)?  

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?

Does the team include investigators with expertise in the behavioral or social sciences as well as in computational and systems modeling (computer science, mathematics, engineering, or other systems sciences) and/or investigators cross-trained in the behavioral or social sciences as well as complex systems and computational thinking and approaches?

Innovation

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

Approach

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

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

Does the application demonstrate bridge-building between disciplines and scales or levels?

Environment

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

Is the environment conducive and supportive of transdisciplinary collaboration and team science?  

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 Guidelines for the Review of Human Subjects.

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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not 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 CSR, 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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Stephen E. Marcus, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2987
Email: marcusst@mail.nih.gov

William Riley, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6973
Email: wiriley@mail.nih.gov

Gregory Bloss, M.A.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: gregory.bloss@nih.gov  

Grace C.Y. Peng, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: penggr@mail.nih.gov

Regina Bures, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: buresrm@mail.nih.gov

David B. Clark, Dr.P.H.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: clarkd2@nidcr.nih.gov

Symma Finn, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: finns@niehs.nih.gov

Janine M. Simmons, M.D., Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1576   
Email: simmonsj@mail.nih.gov

Wendy Weber, N.D., Ph.D., M.P.H
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov    

Barry Portnoy, Ph.D.
Office of Disease Prevention (ODP)
Telephone: 301-402-4337
Email: PortnoyB@OD.NIH.GOV

Peer Review Contact(s)

Gabriel B. Fosu, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: fosug@csr.nih.gov

Financial/Grants Management Contact(s)

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: burgel@nigms.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: James.Huff1@nih.gov

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Molly Puente, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  919-541-1373
Email: puentem@niehs.nih.gov

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov        

George Tucker
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-9102
Email: tuckerg@mail.nih.gov   

Section VIII. Other Information

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

Authority and Regulations

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


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