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.

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

This FOA solicits applications that will elucidate mechanisms and processes of resilience within a general framework that emphasizes its dynamics and interactions across both time and scale, multiple contexts, multiple outcomes, and multiple time frames.

The term resilience has broad associations and conveys different meanings in different contexts. It has been used to describe the absence of adverse consequences after exposure to a stressor as well as processes of recovery and adaptation that may involve learning or post-traumatic growth. Life challenges such as natural disasters, cumulative social and financial pressures, and serious illnesses are unavoidable, and have psychological and health consequences. However some individuals or social groups are able to maintain high levels of functioning and adaptation in the face of such challenges. Insights into the processes and mechanisms that maintain function, support recovery, or enhance function in response to severe challenges may help identify potential targets for behavioral or biomedical interventions to promote lifelong health.

Currently behavioral and social science research on resilience lacks a common framework, taxonomy, or approach that extends across multiple levels of analysis (e.g., genetic/epigenetic, neurobiological, physiological, psychological, behavioral, social, environmental). In addition current research does not clearly articulate the various predisposing factors, classes of adverse exposures, dynamic processes of adaptation, and potential environmental moderators of those processes. This initiative seeks to address these gaps.

This FOA encourages applications that will elucidate mechanisms and processes of resilience within a general framework that emphasizes its dynamics and interactions across both time and scale (level of analysis). This framework can be applied to multiple contexts (e.g., acute or chronic stress exposure, including disease, disaster, unemployment, divorce, etc.), multiple outcomes (health, function, psychological well-being, etc.), and multiple time frames (seconds, minutes, days, years). The framework has four features: (1) assessment of a baseline level prior to a challenge, (2) characterization of a specific challenge (acute or chronic), (3) post-challenge measures of outcomes that characterize the response over time, and (4) predictors of outcomes (including predisposing factors at the individual level and environmental moderators). Measurement of response across multiple domains (physiological, psychological etc.) is critical to this holistic framework.

Consistent application of this general framework has the potential to reveal underlying principles that describe dynamic trajectories of adaptation to a challenge and to identify potential malleable processes or mechanisms that shape those dynamic response patterns. Typically, it will require repeated measures of outcomes to differentiate resilient patterns of response from non-resilient trajectories. It may also offer insights into individual differences in reactivity and recovery that characterize resilient phenotypes.

Previous investigations have identified several genetic, biological and psychological factors that are associated with individuals more successful at adapting to an adverse experience. However, most prior research on resilience has examined processes of adaptation for a single or a limited number of outcome parameters and has addressed the phenomenon from the perspective of a single aspect of functioning, e.g. cardiovascular, mental health, disease progression, substance abuse, etc. In addition, the focus of the majority of the current research has been on the individual; only a few studies have assessed resilience at the level of the family or community. This fragmentation makes it difficult to fully test hypotheses derived from holistic dynamic models of adaptation and recovery. A full model of resilience will require measuring outcomes, processes, and moderators at multiple levels (e.g. genetic, neurobiological, physiological, psychological, behavioral, social, and environmental) as these unfold at different timescales. This poses complex research challenges and may require the development or application of novel methods from other fields, such as engineering and complex systems science. Large sample sizes will be required to address some questions, and integrated expertise is essential. Computational approaches may augment traditional methods of research.

This initiative is designed to develop the infrastructure and protocols needed to support well-designed studies of resilience in human subjects (individuals or communities) to examine patterns of response (pre-, during, and post-) to a well characterized challenge as they evolve over time. In order to develop an integrated framework for the concept of resilience, it is critical that investigators examine the concept at multiple levels of analysis and examine interactions, mediators, moderators and potential mechanisms. The goal is to develop comprehensive models of individual and/or social resilience in humans, and to shed light on the mechanisms and processes that account for adaptive or resilient response profiles, by leveraging the expertise of investigators from multiple disciplines working in a cooperative and integrated fashion.

OppNet is a trans-NIH initiative that funds activities that build the collective body of knowledge on the nature of behaviors and social systems and deepen our understanding of basic sociobehavioral mechanisms and processes. Thirteen NIH Institutes and Centers that fund research and two Program Offices within the NIH Office of the Director (ICOs) collectively manage OppNet. The ICO members participating in this OppNet FOA appear above. All OppNet initiatives invite investigators to propose innovative research that will advance basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research. For more information about OppNet, visit http://oppnet.nih.gov.

OppNet uses NIH’s definition of basic behavioral and social sciences research (b-BSSR), http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx, to ensure that proposed projects focus primarily on basic sociobehavioral and biopsychosocial sciences. OppNet acknowledges that disease- and risk-contexts can provide opportunities to study basic behavioral or social processes, basic biobehavioral or biosocial interrelationships, or methodology and measurement relevant to BSSR. Consequently, OppNet strongly encourages prospective investigators to consult this definition and OppNet’s answers to frequently asked questions (FAQs) about b-BSSR: http://oppnet.nih.gov/about-faqs.asp and this FOA’s NIH Scientific/Research Contacts. Visit https://obssr.od.nih.gov/scientific-initiatives/basic-behavior-and-social-science-research/oppnet/ for a comprehensive list of each OppNet member IC's priorities.

The focus of studies to be funded under this FOA is on the characterization of the patterns of response to a challenge across multiple, interacting levels of analysis and the identification of the factors associated with physical, psychological or social resilience in individuals or social communities. Critical elements of all proposals include a well characterized precondition and an assessment of the dynamic changes over time on the relevant outcomes. Selection of a challenge should be based on feasibility of assessment and significance to human health. The approach must have relevance to the mission of one of the participating NIH Institutes, Centers or Offices, including assessments of health-relevant processes and outcomes. Applications may address dynamic responses over time to either acute (e.g. crime victimization, natural disaster, disease diagnosis, onset of disability, bereavement, job loss) and/or chronic (e.g. poverty, ongoing abuse, social isolation, long-term illness or disability) challenges or exposures. Optimization of quantitative outcome variables is required to evaluate the response to the stressor, so that enough variance is obtained to distinguish non-responders, normal responders, and exceptionally robust responders. Projects may include aims examining the steeling effects of a challenge, also described as stress inoculation, and how this may impact (ameliorate) risk for future problems, potential for thriving, and the ability to handle stress in the future.

Applications are encouraged that advance our ability to measure the change process, offer novel insights into pre-disposing/pre-existing factors and identify the predictive potential of these factors for distinct health-related or disease outcomes.

Importantly, assessments of dynamic processes of adaptation to challenge should focus on measuring resilience as an integrative response, rather than being specific to a given level of analysis (e.g. behavioral or physiological). Important parameters might include the identity, duration and magnitude of the stressors, as well as measures of various response parameters, including response magnitude, frequency and duration, the extent and time to recovery and refractory times. The proposed outcome measures should have the potential for predictors of future health outcomes relevant to the missions of the sponsoring NIH Institutes, Centers and Offices.

Special Note: Because of the differences in individual Institute and

Center (IC) interests for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Priorities and Scientific Contacts at https://obssr.od.nih.gov/scientific-initiatives/basic-behavior-and-social-science-research/oppnet/.

This FOA seeks teams of investigators who will develop, in the first phase (UG3), the infrastructure and research design for a project that will support testing of hypotheses derived from dynamic models of resilience, incorporating the four key aspects of the general framework articulated above. This approach is intended to address the acknowledged gaps in resilience research in the behavioral and social sciences.

Each application should be designed to bring together a diverse team of researchers who take a mechanistic approach to the study of resilience. Transdisciplinary teams are encouraged to include expertise in fields including, but not limited to, the behavioral and social sciences, biological and neurosciences, public policy and public health, and methodologists with advanced computational, systems science, and/or mathematical expertise. Projects may focus on basic processes of resilience at the individual and/or social/group or population level of analysis.

Upon completion of the planning phase (UG3), progress will be administratively reviewed for consideration of awarding a second phase (UH3). The transition to the UH3 phase will depend on:

• Successful completion of awardee-specified milestones for the UG3 period of the project.
• Identification of putative assays which adequately discriminate between degrees of resiliency of individuals or social groups to specific stressors.
• Extent to which UG3 planning phase activities support the aims of the UH3 phase, including rationale for selected measures and methods, plans for the development of short- and long-term prediction models for selected outcomes, and elucidation of potential mechanistic factors underlying differences in individual or community level resilience at all relevant levels of analysis.
• Demonstrated effectiveness of strategies needed for successful conduct of the UH3 phase, such as recruitment, data management procedures, staff training, and IRB approvals.
• Potential to meet the goals of the initiative.
• Availability of funds.

In Phase 2, based on analyses from Phase 1, the awardee will conduct a study with a sufficient population and follow-up period to:

• Test hypotheses derived from dynamic behavioral and social models of resilience.
• Generate models to improve short-term and long-term prediction of the selected resiliency response patterns and trajectories, and assess the predictive value of such models.
• Assess potential mechanisms and moderating processes that influence selected resilience parameters and the extent of shared mechanistic factors across more than one outcome or level of analysis (e.g. behavioral, psychological, biological, social).
• Identify mediating mechanisms or processes that hold potential as targets of intervention, based on their role in impacting resilience trajectories in individuals or social groups.

See Section VIII. Other Information for award authorities and regulations.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must obtain 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. William Elwood
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-402-0116
Fax: 301-402-1150
Email: [email protected]

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

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.

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

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

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

Other Attachments: An attachment called "Team Science Justification and Organization" should be uploaded in Other Attachments. Although no specific page limitation applies to this section of the application, please be succinct. Applicants may not use this section to circumvent the page limits of the Research Strategy. The following points should be addressed in this attachment and are an important part of the application:

A clear plan of operation should be provided for the administrative structure and proposed interactions among the investigators. Also a clear description of the collaborative team aspect of the work proposed including the requirements and roles to be played by each member of the team. It is anticipated that members of the team may not already be interacting on this, or other, projects. Lines of communication and exchange of data should be clearly established. A rationale must be provided explaining how integration and collaboration among participants will be fostered. The role(s) for each member of the team and how this will provide the requisite synergies for the research activities in the proposed project should be clearly articulated.

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

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

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

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

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

Research Strategy: The application should include plans for an initial UG3 phase with a design that could be carried out during a possible UH3 phase.

For the UG3 phase, applications should specify:

• Strategies for characterization of participants prior to an event or challenge, or at a defined baseline for chronically stressed individuals or populations. A pre challenge baseline is essential to characterize patterns of response. However in cases where the challenge involves an unscheduled event e.g. a natural disaster or traumatic incident, the validity of estimating preexisting conditions from past history or a comparable community will need to be demonstrated.
• Approaches for measurement of relevant outcomes at multiple time points after challenge in order to obtain dynamic patterns of response that can discriminate resilient from non-resilient profiles or trajectories.
• Approaches for identification and measurement of moderating factors within the individual/group or in the social environment.
• Approaches to identify potential processes and mechanisms responsible for resilience and a design that would evaluate their role.
• Research questions focused on understanding why some individuals/social groups demonstrate successful adaptation to challenge as measured by multiple measures (behavioral, psychological, physiological, interpersonal, social) and others do not.
• Strategies to evaluate whether resilient response patterns at one level of analysis (e.g., psychological) ? are associated with response patterns at other levels of analysis (interpersonal, behavioral, neurobiological, physiological, etc.).
• Analytic strategies for comparison of resilient and non-resilient response patterns and comparison between precondition and post challenge status on all outcomes are of interest.

NOTE: Use of existing data sets to inform the design is encouraged but not required.

Applicants also need to include a description of the following organizational activities:

• Meetings of the scientific team to refine common research methods and an evaluation framework.
• Activities to develop and refine procedures for identification and characterization of participants (individuals or communities) and appropriate challenges or stressors that will support test hypotheses derived from dynamic models of resilience.
• Activities designed to develop, refine, and test new and/or already validated instruments to assess response patterns over time at multiple levels of analysis and timescales, and to test the feasibility of collecting them simultaneously in the population of interest. Selection of such instruments should take into account psychometric properties such as reliability and sensitivity to intra- and inter-individual differences, including high- and low-end extremes. Collection of such information on persons who are in ongoing longitudinal studies, or through follow-up visits with participants in completed longitudinal studies, is particularly encouraged.
• Design and conduct of pilot studies, including challenge tasks in controlled conditions, for the purposes of improving prediction and identifying contributory, mediating, or moderating factors and mechanisms influencing resilience. This includes the conduct of small controlled studies with intensive manipulations to examine resiliency in the short term to help refine assessments of the resilient response and longer-term dynamic trajectory.

Milestones and UG3/UH3 Transition: The UG3 phase must include a description and the milestone(s) that will be reached at the end of the first phase. Milestones need to identify each critical step in the planning process and the estimated time of accomplishment. These would include time points for: full assemble of the team, selection of the overall design, selection of the measured parameters, identification of the necessary instruments, validation of outcome measures and refinement of the study design. To successfully transition to the UH3 phase, the project should reach the milestones outlined in the application. The application should provide quantifiable metrics to determine success of the UG3 phase.

For the UH3 phase, the application should describe the final comprehensive research plan including the full organizational structure, operating procedure, and role of each participant; the aims of each research group/activity along with methods, design, proposed analysis and time line for completion; and a plan for data integration across all activities and for dissemination of data, results and analysis.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans 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.

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

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

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.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

This initiative is not subject to intergovernmental review.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact 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.

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

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.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

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 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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application provide milestones that can be achieved during the UG3 phase? Are the milestones appropriate to evaluate if the UH3 should be supported?

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?

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.

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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

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.

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.

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

The PD(s)/PI(s) will have the primary responsibility for:

• Defining the objectives and approaches, and the planning, conducting, analyzing, sharing, and publishing results, interpretations, and conclusions of their studies.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Establishing collaboration among participating investigators in order to achieve the goals of the cooperative agreement.

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

• An NIH Project Scientist will be involved with development of research protocols, analyses and interpretations and re-establishment of objectives during the course of a project; assist with the selection of key project personnel other than principal investigators of projects or sub-projects; participate in technical monitoring to permit specific direction of the project, including recommending approval of changes in experimental approaches and to permit specific direction of the project; participate on committees (other than peer review) as a voting member as needed (the chairperson will be someone other than the NIH Project Scientist) or in other functions responsible for helping to guide the course of long-term projects or activities and participate in the presentation of research results, including publications from the project as justified.
• A separate NIH Project Coordinator will be involved with coordination of research networks; providing access to NIH supported research resources; identifying other researchers/resources for the project; assistance in processing FDA INDs for investigational drugs and participation on committees as a voting member as needed (the chairperson will be someone other than the NIH Project Coordinator) or in other functions responsible for helping to guide the course of long-term projects or activities, e.g., annual meetings of awardees, Chair and/or member of project oversight committees composed of NIH officials;

Areas of Joint Responsibility include:

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

Dispute Resolution:

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

William Elwood
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-402-0116
Email: [email protected]

Rebecca Ferrer
National Cancer Institute (NCI)
Telephone: 240-276-6914
Email: [email protected]

Symma Finn
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4258
Email: [email protected]

Lindsey Grandison
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0606
Email: [email protected]

Amy Lossie
Office of Disease Prevention (ODP)
Telephone: 301-594-4574
Email: [email protected]

Shelley Su
National Institute on Drug Abuse (NIDA)
Telephone: 301.402.3869
Email: [email protected]

Stephen Marcus
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: [email protected]

Lis Nielsen
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: [email protected]

Janine Simmons
National Institute of Mental Health (NIMH)
Telephone: 301-443-6652
Email: [email protected]

Lanay M. Mudd
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: [email protected]

Ricardo R. Cibotti
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone 301-451-5888
Email: [email protected]

Weijia Ni
Center for Scientific Review (CSR)
Telephone 301-594-3292
Email [email protected]

Jaclyn Crouch
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-3975
Email: [email protected]

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

Molly Puente
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: [email protected]

Judy Fox
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone 301-443-4704
Email: [email protected]

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]

Erica West
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3917
Email: [email protected]

Traci Lafferty
National institute of Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

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.

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 Part 75.