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 funding opportunity announcement invites applications for mechanistic research on how age- and sex-related changes in emotion processing manifest normally over the adult life course, and how these changes may interact with and inform the understanding of affective dysregulation in adult mental disorders and in Alzheimer's disease (AD). It will support studies directed at better characterizing the trajectories of change over time in emotion processing and linked neurobiological and neurobehavioral factors associated with normal aging, adult mood and anxiety disorders, mild cognitive impairment (MCI), and AD. Research is sought that will leverage already established findings about generally improved emotion regulation with aging, as well as research that will expand this evidence base. It is expected that such studies may identify sources of individual variation within normative patterns of emotion processing and clarify how maturational shifts (or lack thereof) may relate to irregularities in the integrative neural-behavioral mechanisms of emotion regulation in adults who experience affective mental disorders, MCI, or AD. The studies may also identify novel mental health intervention/prevention targets or provide clues as to which available intervention strategies might be optimally applied to normalize emotion dysregulation or to strengthen emotional resilience at different stages of the adult life cycle.

This funding opportunity is intended to support studies aligned with Strategy 2.1 of the NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml), which calls for research to characterize the developmental trajectories of brain maturation and dimensions of behavior to understand the roots of mental illnesses across diverse populations. In the context of research on emotional processes and their relation to mental illness, age-related differences occurring across the lifespan are to be understood as a major aspect of population diversity.

This funding opportunity is also aligned with NIA Strategic priorities (https://www.nia.nih.gov/about/strategic-directions-2016) to continue to conduct and support basic research in cognition, emotion, and motivation in normal aging, including their neurobiological and genetic basis; to explore these factors relationships to individual differences, social processes, and contextual factors; [and to] continue research on the interrelationships among emotion, cognition, and brain function [to] guide the development of new biobehavioral interventions.

Research suggests that, for many adults, normal aging is associated with general trends toward improved emotion regulation (e.g., as evidenced by increasing positive and decreasing negative affect, greater emotional stability, higher life satisfaction, a positivity effect in information-processing). As compared with younger adults, older adults often show superior emotion regulation capacities, employ different strategies for executive control of emotional information, and recruit different neural networks in performing affective tasks. Such patterns have been variously hypothesized to stem from increased motivation to maintain emotional well-being, learning of more skillful and efficient emotion processing strategies, or compensatory adaptations to age-related brain changes. A number of hypotheses regarding the strategies older adults employ to regulate emotion and the neurobiological systems that support them remain untested. There is also considerable evidence that men and women process emotions differently, though, to date, evidence is scarce regarding whether and how sex differences may be modulated during the aging process.

Not all adults demonstrate the positive emotion regulation profiles that characterize adaptive aging. To date, there has been little mechanistic research focused on sources of individual variability in development and maturation of emotional regulatory functions. Mood and anxiety disorders are considered examples of affect dysregulation. However, knowledge tends to be limited about the specific emotion processing deficits involved, and how these may change with maturation. Few studies employing affective neuroscience methods have examined adult maturational processes relative to mental disorder. There has been little scientific investigation of the extent to which adults with affective disorders manifest or fail to show the normative maturational shifts, or at what point(s) during the adult lifespan they may tend to traverse divergent emotion regulation trajectories.

In addition, significant gaps remain in our understanding of successful emotion regulation in adults aging without mental disorders. It is paradoxical that, despite normative cognitive declines with age, many aspects of emotional function improve with age. Though attributed to improved emotional regulatory strategies, such strategies frequently rely on the same cognitive control capacities that decline with aging. Numerous questions remain regarding the role of cognitive control in adaptive emotional aging, alternative strategies that older adults might employ to regulate emotion, the cognitive processes that undergird those strategies, and the causes of individual variation in the ability to engage these strategies with advancing age.

For NIMH, this funding opportunity is intended to support research designed to clarify these patterns, at neurobiological as well as behavioral levels of analysis, specifically in adults who experience affective disorders or manifest other forms of obvious and persistent emotional dysregulation, and to deepen our understanding of the mechanisms and contextual factors involved in their emotion dysregulation. The NIA is interested in studies of these processes in both normal aging and in adults with MCI and AD. Studies leveraging the concepts, methods, and findings emerging from research on normative adult emotional development, including environmental and life course factors, are of particular interest, so as to investigate variation and maturational shifts in emotion regulation across adults with mood and anxiety disorders together with adults without such psychopathology. Research is encouraged that assesses emotional processes dimensionally, integrating across multiple levels of analysis and employing cutting-edge methodology from such fields as cognitive and affective neuroscience, neuroimaging, neurophysiology, gene expression and epigenetics, neuroendocrinology, and lifespan developmental psychology. Research is sought that uses psychometrically sound assessment approaches and directly observes emotion processes, such as in response to emotion-evoking stimuli, situations, scenarios or the like. Ideally, the studies proposed will examine multiple domains of emotion processing so as to address, in aging adults, the key developmental concept of dynamic interactions among differentially maturing brain systems that support successful (and unsuccessful) emotion regulation.

Varied research paradigms may be useful for pursuing the goals outlined above. Use of constructs from NIMH's Research Domain Criteria (RDoC) initiative (http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml), or of RDoC-compatible approaches, in assessing emotion processing, other component aspects of mental disorder, and/or related domains of brain function dimensionally is encouraged. The RDoC initiative has defined a set of constructs that may be useful in this research. These constructs are organized according to five domains of brain functioning (negative valence systems, positive valence systems, cognitive systems, arousal/regulatory systems, and systems for social processes). Research on RDoC constructs should employ assessment methods appropriate for each construct of interest and the assessment methods are expected to converge on the construct from at least two levels of analysis. RDoC units of analysis (potential levels of measurement) include genes, molecules, cells, circuits, physiology, behavior, and self-report. Details about RDoC constructs and units of analysis can be found here. Although the structure of the RDoC matrix suggests boundaries among constructs, given the densely integrated and interconnected nature of the brain's circuits, it is understood that the constructs function interactively and that promising empirical approaches to an RDoC-based analysis of emotional functioning and its relationship to psychopathology may involve examining intersections among constructs.

Applicants may propose to examine dimensional constructs that do not appear in the NIMH RDoC matrices as long as there is strong theoretical support for their relevance to a mechanistic understanding of emotional processing. Applicants should be able to cite substantial evidence for the validity of such constructs, and to indicate strong theoretical support that the construct maps onto a specific biological system, such as a brain circuit or physiological pathway, thought to be involved in emotion processing or regulation.

Specific to NIMH: With respect to assessing psychopathology or mental disorder, likewise, an RDoC approach encourages taking a dimensional perspective, and concentrating on aspects of behavior and brain function that span a range from intact to gradations of impairment, independent of diagnosis. Thus, in such an approach, recruitment and eligibility of study participants need not be determined on the basis of traditional diagnostic categories, but should instead be based on criteria that result in a sample that is optimized to study the clinical phenomena of interest over their full range of variability. Such an emphasis on understanding the full dimensionality of neurobehavioral functioning generally precludes simple, dichotomous designs comparing patients versus controls. Under this FOA, if an RDoC or other dimensional construct is proposed to serve as the primary variable representing psychopathology (as opposed to using a diagnostic characterization), the study design and sampling plan must be such as to assure that an adequate number of individuals assessed as falling within the more severely impaired ranges of that dimension will be included in the study.

For both NIMH and NIA: The particular adult age ranges over which maturational changes may be examined are not prespecified and should be determined to fit the specific research questions posed. Applicants are expected to provide compelling rationales for their particular selections in this regard, such as prior evidence that particular age ranges may represent periods in the life cycle particularly critical for observing changes in emotion processing or development of mental disorder.

Regardless of other variations in sampling and experimental approach, however, it will be considered scientifically essential that the proposed research attend to sex differences as a central issue. Inasmuch as comorbid medical conditions become increasingly common with advancing age, it will also be critical that the research plans adequately assess or control for differences in medical comorbidity as a potential confounding influence on emotional experience.

Applicants are strongly encouraged to consider the use of measures for behavioral and neurological function from the NIH Toolbox (http://www.nihtoolbox.org), particularly the cognitive and emotion batteries or subsets of these. Developed under the aegis of the NIH Blueprint for Neuroscience Research, the NIH Toolbox offers a set of brief, comprehensive, well-validated and normed assessment tools that are now available for use on the iPad (https://nihrecord.nih.gov/newsletters/2016/02_12_2016/story4.htm). These may be considered for use as the primary data collection measures or in conjunction with measures commonly used by the investigator(s). Use of the NIH Toolbox measures helps to build data collection with common measures across diverse study designs and populations, furthering the important goals of efforts such as the Precision Medicine Initiative (https://www.whitehouse.gov/precision-medicine; http://www.nih.gov/precision-medicine-initiative-cohort-program) and Big Data to Knowledge (https://datascience.nih.gov/bd2k/about) by allowing comparison of results and pooling of data across studies.

Applicants are also strongly encouraged to review the Notice on enhancing the reproducibility of NIH-supported research through rigor and transparency (NOT-OD-15-103), and to incorporate appropriate features into the proposed research plans. NIMH has published guidelines for reporting elements of rigor in experimental design in applications (NOT-MH-14-004), and examples of critical elements for a well-designed study are summarized on the NIMH website (http://www.nimh.nih.gov/research-priorities/policies/enhancing-the-reliability-of-nimh-supported-research-through-rigorous-study-design-and-reporting.shtml).

NIMH areas of interest include, but are not limited to:

• Research clarifying specific emotion processing irregularities characteristic of aging individuals with affective disorders;
• Investigations of whether or to what degree individuals aging with chronic or recurrent affective disorders manifest normative maturational shifts in their patterns of emotion regulation, particularly with respect to the underlying mechanistic factors involved;
• Studies identifying trajectories of change in adult affective regulation and associated neurobiological and neurobehavioral factors, and clarifying points in the adult life course at which trajectories may diverge for affectively dysregulated subgroups;
• Studies evaluating differences in the brain circuits or cortical areas recruited during emotional challenge or task performance as a function of age, sex, and mental disorder, and whether such differences predict resilience against onset or deterioration of course in mental disorders; and,
• Studies employing efficient multi-cohort designs to estimate adult neurodevelopmental changes relevant to emotion regulation processes.

NIA areas of interest include:

In addition to an interest in the topics above insofar as they relate to enhancing our understanding of normative trajectories of change in adult affective regulation and associated neurobiological and neurobehavioral factors, the NIA is interested in studies that (1) examine the extent to which cognitive or motivational changes account for age differences in emotion regulation; (2) directly test the hypothesis that biases in attention or memory serve the purpose of regulating emotion; and (3) identify the strategies that confer success in emotion regulation and the contexts that undermine success.

Additional topics of interest to the NIA include, but are not limited to:

• Studies to clarify points in the adult life course at which trajectories diverge for subgroups with successful cognitive aging, normative cognitive decline, MCI, and AD, identifying both when trajectories diverge, and in which psychological and neurobiological processes;
• Studies that further elucidate normative trajectories of age-related affective function, specifically those that integrate observational and experimental approaches to examine how basic processes manifest in real world contexts;
• Studies that clarify/resolve the paradox of age-related improvement in emotional regulation in the face of age-related cognitive decline;
• Secondary analysis of or new data collection in life-span studies with assessments of emotional and cognitive function from early life, including studies that examine the impact of early adversity on maturation of adult affect regulation; and
• Mechanistic and neuroscience studies of emotional function in samples representing population variation in social and financial circumstances, to permit examination of the link between socioeconomic inequality and later life emotional development.

Examples of studies that are not responsive to this FOA and will not be reviewed include the following:

• Applications that characterize adults emotional status solely in terms of diffuse mood states (e.g., only via depression, anxiety or other such scales), lacking assessment of specific emotion processing and/or contextual components essential for a mechanistic understanding of changes in emotion regulation;
• Applications that assess emotion processes and emotion regulatory strategies or processes at only a single level of observation and analysis (i.e., without combining multiple levels/methods such as genetic, cellular, brain circuit, physiological, behavioral, self-report);
• Applications lacking a focus on maturational shifts in emotion processing during adult phases of the life cycle as a core feature of the research design;
• Applications that fail to analyze emotion processing by sex, or if limited to a single sex, that fail to provide justification for how the proposed single-sex approach will be critical to advancing overall understanding of maturational shifts in emotion regulation and/or their relationship to mental disorder, MCI, or AD;
• Applications that propose clinical trials of potential therapies for mental disorders, including tests of interventions intended to impact mental disorders by influencing emotion processing or use of emotion regulation strategies.

Investigators interested in proposing research involving a clinical trial are referred to the NIMH Clinical Trials website and to the FOAs indicated there for submitting applications containing clinical trial components. Please note, per NOT-MH-14-007, NIMH will not accept R01, R21, or R03 applications that include clinical trials of potential therapies for mental disorders under the NIH parent R01 FOA (PA-13-302), NIH parent R21 FOA (PA-13-303), or NIH Parent R03 FOA (PA-13-304), or subsequent reissuances of these FOAs.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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:
  
  Email: NIMHReferral@mail.nih.gov

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.

Facilities & Other Resources

In addition, the Facilities & Other Resources section should include the following information:

• Describe any ways in which the proposed study utilizes existing infrastructure (e.g., CTSA, electronic health records, administrative or research data bases, patient registries, prior research cohorts) or other available resources to increase the efficiency of participant recruitment and data collection.
• Describe any features of the scientific environment, populations to be studied, or collaborative arrangements that provide unique strengths for appraising trajectories of emotion regulation across important portions of the adult life cycle, or for deriving an improved mechanistic understanding of how age-related shifts in emotion processing may be linked with mental disorder, MCI, AD, or normal cognitive changes with aging, as appropriate to the proposed research.

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

Biographical Sketch:

In addition, the Biographical Sketches of investigators for whom it is appropriate should include the following information:

• As appropriate, in the Personal Statement and/or under Contributions to Science, describe or present information documenting the investigator's expertise in studying emotional processes at the proposed levels of analysis.
• As appropriate to the proposed study, in the Personal Statement and/or under Contributions to Science, describe or present information documenting the investigator's prior experience in conducting research on psychopathology, MCI or AD in aging adults, or on patterns of change in cognitive function in normal aging.

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

In addition, the Research Strategy should include the following information:

Significance

• Explain how examination of adults in the particular age range(s) proposed will contribute to an improved understanding of trajectories of change in emotion regulation or in related neurobiological and/or contextual factors.
• Describe how successful completion of the proposed specific aims will substantially advance a mechanistic understanding of how change trajectories in emotion regulation or in related neurobiological and/or contextual factors may relate to mental disorder, MCI, AD, or normal aging, as appropriate to the planned study.

Innovation

• Explain whether the proposed research is innovative because it will evaluate novel constructs, and whether these constructs pertain to emotion processing, psychopathology, or other key variables in the research design.
• Indicate whether the methods proposed for measuring emotion processes and/or related neurobiological or contextual factors, or for tracking change or stability in them over time, are novel.
• Describe whether the study will use innovative design features or analytic methods, and how these features or methods will contribute to efficient appraisal of change trajectories over the portions of the adult life cycle to be studied.

Approach

• Outline a clear conceptual framework or schema that defines the key constructs to be investigated in the research, and that delineates how they relate to particular components of emotional experience.
• As part of the conceptual framework or schema, indicate the hypothesized pattern of interrelationships among the key constructs, linking this discussion to the proposed set of hypotheses or study questions.
• Describe the preliminary evidence that is available to support the proposed hypotheses and the research plans for evaluating them, and indicate the degree of capacity that the study will have to test and potentially refute the hypotheses.
• Explain how the proposed methods will accomplish an objective assessment of emotion processes and emotion regulatory strategies or processes at multiple levels of observation and analysis.
• Describe plans for assessing comorbid medical conditions and controlling or accounting for their potential confounding influence on emotion processing.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The NIMH has published updated policies and guidance for investigators regarding data sharing expectations for clinical research funded by NIMH (NOT-MH-15-012). In general, applicants are strongly encouraged to indicate plans to share data by depositing them in the NIMH Data Archive, in which the Research Domain Criteria Database is available to receive clinical research data pertinent to all mental disorders.

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.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

NIMH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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?

Will examination of adults in the particular age range(s) proposed contribute to an improved understanding of trajectories of change in emotion regulation or in related neurobiological and/or contextual factors? Will successful completion of the specific aims substantially advance a mechanistic understanding of how these change trajectories may relate to mental disorder, MCI, AD, or normal aging?

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

Is there evidence that the investigators have adequate expertise in studying emotional processes at the proposed levels of analysis? Depending on the specifics of the proposed study, are the investigators appropriately experienced in conducting research on psychopathology, MCI or AD in aging adults, or on patterns of change in cognitive function in normal aging?

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?

Does the application propose to evaluate novel constructs pertinent to emotion processing, psychopathology, or other key variables in the research design? Are novel methods proposed for measuring emotion processes and/or related neurobiological or contextual factors, or for tracking change or stability in them over time? Will innovative design features or analytic methods be used to enable efficient appraisal of change trajectories over designated portions of the adult life cycle?

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?

Does the application include a conceptual framework that clearly identifies the key constructs to be investigated and their hypothesized pattern of interrelationships? Are the proposed methods adequate to achieve objective assessment of emotion processes and emotion regulatory strategies or processes at multiple levels of observation and analysis? Are adequate plans described for assessing comorbid medical conditions and controlling or accounting for their potential confounding influence on emotion processing? Is there preliminary evidence to support the proposed work and any hypotheses that are described? Does the project propose clear hypotheses and have adequate capacity to test and potentially refute them?

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?

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?

Does the proposed study utilize existing infrastructure (e.g., CTSA, electronic health records, administrative or research data bases, patient registries, prior research cohorts) or other available resources to increase the efficiency of participant recruitment and data collection? Are there features of the scientific environment, populations to be studied, or collaborative arrangements that provide unique strengths for appraising trajectories of emotion regulation across important portions of the adult life cycle, or for deriving an improved mechanistic understanding of how age-related shifts in emotion processing may be linked with mental disorder, MCI, AD, or normal cognitive changes with aging?

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 NIMH, 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.

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

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council and National Advisory Council on Aging. 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

Not Applicable

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: http://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
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)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

George Niederehe, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-9123
Email: gniedere@mail.nih.gov

Lis Nielsen, Ph.D
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: nielsenli@nia.nih.gov

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstrda@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: ballj@nia.nih.gov

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.