NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

The Midlife in the United States (MIDUS) Study was initiated in 1995 with a national sample of more than 7,000 adults aged 25 to 74. The central objective was to bring to population health research a rich array of psychosocial and behavioral factors that had previously been studied only with small select samples. In 2002, the NIA funded a longitudinal follow-up for the survey and daily diary assessments as well as new data collection on cognition, comprehensive biomarkers, and brain-based emotion regulation. MIDUS is currently recruiting a refresher cohort of 3,500 new respondents (aged 25 to 74 born 1921-1970) and a third wave of surveys and cognitive assessments on the original sample is underway. The unique multi-project design of the MIDUS study enables, broadly, (a) the investigation of the role of long-term, cumulative psychosocial factors on mid- and later-life health; (b) the identification of the biological mechanisms and pathways through which psychosocial factors influence health; and (c) the discovery of protective psychosocial factors (those that promote positive health and resilience).

The purpose of this FOA is to solicit an application for the next 5-year cycle of the Midlife in the United States (MIDUS) Study, a National Longitudinal Study of Health and Well-being. The goals of this next phase are to complete the third wave of longitudinal data collection in the area of daily stress; complete the second wave of data collection of clinical biomarkers and affective neuroscience assessments; continue innovative sub-studies such as how psychosocial influences affect gene expression and novel methods to track and reinstate non-responders; connect these content areas through innovative analyses to data on health, functioning, personality, cognitive status, affective functioning, economic well-being, social relationships, and well-being; and maintain and enhance data distribution and user support. A central goal of the MIDUS study is to support data dissemination, user support of public use files, and encourage data use broadly by the scientific community.

Harnessing the data potential in MIDUS for research that contributes in novel ways to the field of aging is critical to the continuation of the MIDUS project. The NIA is particularly interested in promoting areas of science prioritized by the NIA Division of Behavioral and Social Research described here: http://www.nia.nih.gov/research/dbsr. Such areas include, but are not limited to: (1) the elucidation and examination of integrative pathways linking behavioral and psychosocial factors with biological mechanisms to map life course trajectories of health and illness; (2) research that illuminates mechanisms and pathways linking early life adversity to later life health; and (3) research that provides insights into the potential mechanisms through which risk factors can be reversed, including risk factors linked to early adversity and risk factors that perpetuate health disparities.

The objectives for the next 5-year cycle of MIDUS are listed below. Applicants are not expected to address all the research objectives; if all research objectives are addressed, applicants are not expected to address them evenly. Applicants are encouraged to balance among these and justify their priorities and focus.

• Offer insights into the mechanistic pathways through which social, psychological, economic, and behavioral factors affect health in middle-aged and older adults, and shed new light on which pathways may be most amenable to change.

• Repeat and enhance the assessment of biomeasures currently collected, including the addition of new biomarkers (such as venous blood) and/or performance indicators, to improve nationally-representative research on longitudinal change in existing measures, to understand how such changes relate to other life circumstances and psychosocial characteristics measured in MIDUS, and to elucidate more precisely the biological pathways through which psychosocial influences impact trajectories of aging.

• Enhance the assessment of psychosocial factors, such as daily stress and well-being, to improve nationally-representative research on the complex interactions between individual psychosocial characteristics and cognition, health, and socioeconomic outcomes in mid and later life.

• Enhance approaches to assessment of biological risk and resilience, including characterization of multi-system physiological dysregulation; examine associations of these risk and resilience markers with psychosocial and economic factors; and incorporate these assessments to elucidate pathways predicting later life cognition, health, disease, and disability and mortality.

• Foster innovation in statistical approaches to modeling longitudinal and cross-project data on health, cognition, daily stress processes, economic and subjective well-being, multi-system physiological dysregulation, behavioral and psychological phenotypes, and social and economic conditions, to shed light on pathways of health and illness in mid and later life.

• Enhance linkages of psychophysiological and neuroscience assessments of affective function -including emotional reactivity, recovery, and regulation - with measures of stress processes, cognitive function, biomarkers, and psychosocial assessments, to elucidate the neurobiological pathways linking behavioral and psychosocial factors to life course trajectories of health and illness.

• Enhance retention of at-risk and minority participants in MIDUS, including prior respondents lost to follow-up, to enhance the potential for study of risk and resiliency among individuals in the most vulnerable segments of our society.

• Enhance genetic and genomic research in the MIDUS sample, including integration of new methods and technologies, greater utilization of the sibling and twin data for studies of genetic and environmental influences on trajectories of aging, studies of psychosocial (both risk and protective) influences on gene expression, and genome-wide genotyping.

• Examine the behavioral, psychological and biological pathways whereby daily stress processes impact health and function in midlife and aging, and the ways in which short term fluctuations in stress processes may mediate longer term processes.

• Enhance cross-project participation, retention and data quality across the full range of MIDUS subprojects.

• Propose maintenance and innovation in data dissemination, user support of public use files, and encourage data use broadly by the scientific community, and extend harmonization efforts with internationally comparable surveys of population aging.

Applicants should provide a multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study.

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)

• 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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
oreign components, as defined in the NIH Grants Policy Statement, are not 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.

Multiple PD/PI applications are strongly encouraged for this next phase of the MIDUS study, to allow for multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

• Of an application with a changed grant activity code.

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Lis Nielsen, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892
Email: nielsenli@nia.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Core	6
Project	12

Additional page limits 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 a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

Overall: required

• Administrative Core: required

• Cores: optional

Projects: a minimum of three required; no maximum

When preparing your application in ASSIST, use Component Type Overall .

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. The U19 PD/PI(s) should have substantial background in a range of fields relevant to the content domains of the MIDUS study. These include: psychology, epidemiology, affective neuroscience, biostatistics, psychoneuroimmunology, life-span development, medicine, geriatrics, sociology, and economics. This background may be represented either in a single individual or across the leadership team in a multi-PD/PI application. Multiple PD/PI applications are strongly encouraged for this next phase of the MIDUS study, to allow for multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the aims of this phase of the MIDUS study and outline how different individual projects and cores within it contribute to these aims. Describe how the study will make major scientific contributions to the field of aging research, and promote advances in: (1) the elucidation and examination of integrative pathways linking behavioral and psychosocial factors with biological mechanisms to map life course trajectories of health and illness; (2) research that illuminates mechanisms and pathways linking early life adversity to later life health; and (3) research that provides insights into the potential mechanisms through which risk factors can be reversed, including risk factors linked to early adversity and risk factors that perpetuate health disparities..

Research Strategy: Significance: Focusing on the MIDUS study as a whole address (i) the importance of the problem or critical barrier to the field that the proposed study addresses, (ii) how the proposed study will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

Renewals: The U19 mechanism is intended to convert the MIDUS study, previously funded as a P01, to a cooperative agreement with the NIA. Hence it constitutes a renewal of the prior activity under a new mechanism. A renewal application should identify and justify how this study builds on and enhances the MIDUS study and justify the funds requested. Identify the cores and projects consecutively (numbers for projects and letters for cores) according to how they are arranged in the funded application.

Resubmissions: Follow SF424 (R&R) instructions to mark changes in the text from the prior version. If the structure of projects and cores has changed, describe their correspondence to the structure in previous submissions.

Innovation: Considering the MIDUS study as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Describe how the concepts, approaches, methodologies, instrumentation or interventions are novel to the research field or novel in a broad sense. Describe how the proposed work refines, or improves, or applies in a new way, the concepts, approaches, methodologies, instrumentation or interventions proposed. Describe how the study offers innovation in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness.

Approach: Include the major approaches and studies involved in the application showing how the approaches of cores and individual projects complement each other or are inter-dependent to allow the contribution of the whole study to be greater than the total of the individual contributions of the cores and projects. Describe the mechanisms that will ensure the coherence of the study and maintain a multidisciplinary focus.

Describe progress from the prior period of support that is of particular significance to the study as a whole. If the current submission omits individual projects or cores that were active in the prior funding period, describe their progress and explain why they are omitted. Identify and justify any substantive differences in approaches from the prior funding period.

Letters of Support: Provide letters of support that are relevant to the study as a whole. Note that any letters of support from External Advisory Board members should be submitted with the Administrative Core.

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

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

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 preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project: The Administrative Core is Core A.)

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

• The Lead and Senior/Key Personnel should have substantial background in the range of fields relevant to the aims of this component, to assure ongoing innovation and promotion of cross-project integration.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package. The application should include funds in the proposed budget for attendance of all Committee members at these meetings. The budget request may also include funds for up to two trips per year for other members of the research team to attend key meetings.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The required Administrative Core provides overall leadership to the study and the aims of the core should show the elements by which leadership and integration will be achieved.

Research Strategy: Significance: Describe how the activities of the administrative core will implement the overall vision of the study as an integrated investigation of a scientific field or problem in aging.

Approach: This Core is also expected to create and implement administrative and leadership mechanisms that will foster effective interactions among the U19 PDs/PIs and the Core and Project Leaders to ensure a productive research effort, such as through common seminars and meetings, regular convening of the study Executive Steering Committee, management of conflicts, support for an External Advisory Board, and plans for joint dissemination of study results. The management structure must include an Executive Steering Committee composed of both the U19 PDs/PIs, the Core and Project Leaders and any Senior/Key Personnel who serve who serve in joint scientific leadership roles on all Projects and Cores, and it must support the active involvement of an Expert Advisory Board as described in Section VI. 2, Cooperative Agreement Terms and Conditions of Award. If proposing new External Advisory Board members, do not list proposed members in the application. Instead list intended areas of expertise. Describe how the several elements proposed in the administrative core will be operationalized to achieve transparent communication across projects and cores, cross-project fertilization and collaboration, as well as common objectives for the MIDUS study as a whole. Elements should include, but not be limited to, means for internal quality control of research; management of day-to-day program activities, management of contractual agreements, resolution of disputes, and allocation of funds. Describe how the Executive Steering Committee will operate and how the External Advisory Board will function and interface with the Steering Committee and the NIA.

Letters of Support: If the study previously had an External Advisory Board then letters of support should be provided from members continuing in the next proposed period.

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

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

Planned Enrollment Report (Administrative Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

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

SF424 (R&R) Cover (Optional Core(s))

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project: Label the Cores alphabetically. The Administrative Core is Core A. The first optional core is Core B, and so on. Place the Core title after the letter (A, B, C, etc.)

• Proposed Core Start/Ending Dates

PHS 398 Cover Page Supplement (Optional Core(s))

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Optional Core(s))

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Project /Performance Site Location(s) (Optional Core(s))

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Optional Core(s))

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

• The Lead and Senior/Key Personnel should have substantial background in the range of fields relevant to the aims of this component, to assure ongoing innovation and promotion of cross-project integration.

Budget (Optional Core(s))

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Optional Core(s))

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Identify which projects the core will assist and the overall role of the core in the study. Describe how the core supports innovation in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness.

Research Strategy: Organize the Research Strategy into sections on a. Significance, and b. Approach. Innovation should be considered in relation to Approach and Significance.

Letters of Support: Provide any letters of support that are specific to the core.

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

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

Planned Enrollment Report (Core or Project Name)

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

PHS 398 Cumulative Inclusion Enrollment Report (Core or Project Name)

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

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Project)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project. Number each Project, beginning with Project 1. Place the Project title after the number.

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

• The Lead and Senior/Key Personnel should have substantial background in the range of fields relevant to the aims of this component, to assure ongoing innovation and promotion of cross-project integration.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: At least one aim in the project should reflect the theme of the overall MIDUS study directly. Describe how the project will promote advances in either: (a) investigating the role of long-term, cumulative psychosocial factors on mid and later life health; (b) identifying the neurobiological mechanisms and pathways through which psychosocial factors contribute to health; and/or (c) advancing knowledge of protective psychosocial factors (those that promote positive health and resilience). Describe how the project will make major scientific contributions to the field of aging research, in areas such as, but not limited to: (1) the elucidation and examination of integrative pathways linking behavioral and psychosocial factors with biological mechanisms to map life course trajectories of health and illness; (2) research that illuminates mechanisms and pathways linking early life adversity to later life health; and/or (3) research that provides insights into the potential mechanisms through which risk factors can be reversed, including risk factors linked to early adversity and risk factors that perpetuate health disparities.

Research Strategy: The Research Strategy should be organized into sections on Significance, Innovation and Approach. The Significance section should include discussion of how this project relates to the overall MIDUS study goals.

Letters of Support: Provide any letters of support that are specific to this project.

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

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

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

Planned Enrollment Report (Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Project)

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

Applicants are responsible for viewing their application before the 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

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

Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

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

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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 MIDUS study 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 study 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 study that by its nature is not innovative may be essential to advance a field.

Significance

Does the study address an important problem or a critical barrier to progress in the field? If the aims of the study 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?

Specific to this FOA:

Will the study make major scientific contributions to the field of aging research, and promote advances in areas including, but not limited to: (1) the elucidation and examination of integrative pathways linking behavioral and psychosocial factors with biological mechanisms to map life course trajectories of health and illness; (2) research that illuminates mechanisms and pathways linking early life adversity to later life health; and (3) research that provides insights into the potential mechanisms through which risk factors can be reversed, including risk factors linked to early adversity and risk factors that perpetuate health disparities.

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Specific to this FOA:

Is there sufficient diversity of interdisciplinary representation among U19 PD/PI(s) and among the Project and Core Leads and Senior/Key Personnel, including representation from the behavioral, social, and biomedical sciences? Do the U19 PD/PI(s) have substantial background in a range of fields relevant to the content domains of the MIDUS study, including: psychology, epidemiology, affective neuroscience, biostatistics, psychoneuroimmunology, life-span development, medicine, geriatrics, sociology, and economics, to allow for multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study. Do the Project and Core Leaders and associated Senior/Key Personnel have substantial background in the range of fields relevant to the aims of those components, to assure ongoing innovation and promotion of cross-project integration?

Innovation

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

Specific to this FOA:

Does the study continue to offer innovation in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness?

Approach

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

If the study 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?

Environment

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

As applicable for the study proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed study 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

Significance

Does the core address an important problem or a critical barrier to progress in the field? If the aims of the core 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?

Investigator(s)

Are the Core Leaders, collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 core is collaborative involving joint leadership of additional Senior/Key Personnel, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the Core Leader and Senior/Key Personnel who serve in joint scientific leadership roles on the Core have substantial background in the range of fields relevant to the Core aims, to assure ongoing innovation and promotion of cross-project integration?

For the Administrative Core: How well do the core leader(s)'s administrative, management, and leadership capabilities provide oversight and direction to the management activities of the core?

Innovation

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

Specific to this FOA: Does the core continue to offer innovation in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness?

Approach

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

If the project involves 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?

Administrative Core: Are the operational plan and organizational structure well justified? Is the core adequate to support and encourage optimal interactions among the overall study team? How appropriate are the plans for internal quality control of research; management of day-to-day program activities; management of contractual agreements; resolution of disputes, and allocation of funds? Is there an adequate plan for governance of the project by an Executive Steering Committee comprised of Senior/Key Personnel? Is the role of the External Advisory Board clearly spelled out, and are procedures in place for adequate interaction between the Board and the Executive Steering Committee?

Environment

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Specific to this FOA: In the prior project period, did the MIDUS Study contribute significantly to advances in (a) investigating the role of long-term, cumulative psychosocial factors on mid and later life health; (b) identifying the biological mechanisms and pathways through which psychosocial factors contribute to health; and (c) advancing knowledge of protective psychosocial factors (those that promote positive health and resilience).

Revisions

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

Significance

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

Specific to this FOA: Will the project make major scientific contributions to the field of aging research and promote advances in areas including, but not limited to: (1) the elucidation and examination of integrative pathways linking behavioral and psychosocial factors with biological mechanisms to map life course trajectories of health and illness; (2) research that illuminates mechanisms and pathways linking early life adversity to later life health; and (3) research that provides insights into the potential mechanisms through which risk factors can be reversed, including risk factors linked to early adversity and risk factors that perpetuate health disparities.

How well connected is the project to the overall aims of the study?

Investigator(s)

Are the Project Leader(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 involving joint leadership of additional Senior/Keyersonnel, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the Project Leader(s) and Senior/Key Personnel who serve in joint scientific leadership roles on the Project have substantial background in the range of fields relevant to the aims of the Project, to assure ongoing innovation and promotion of cross-project integration?

Innovation

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

Specific to this FOA: Does the project continue to offer innovation in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness?

Approach

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

If the project involves 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?

Environment

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Specific to this FOA: For projects continuing from the prior project period, the project contributed significantly to advances in (a) investigating the role of long-term, cumulative psychosocial factors on mid and later life health; (b) identifying the neurobiological mechanisms and pathways through which psychosocial factors contribute to health; and (c) advancing knowledge of protective psychosocial factors (those that promote positive health and resilience).

Revisions

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute on Aging 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 will receive a written critique.

Applications will be assigned 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 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.

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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:

• The Principal Investigator(s) will have the primary responsibility for the design and details of the study, and will retain primary responsibility for performance of the activity including analyzing and publishing results, negotiating agreements for access to administrative data as required, and maintaining ownership over data collected. The awardee agrees to accept assistance from the designated NIH/NIA Program Official and Project Scientist in aspects of the scientific and technical management of the study.

• After award, the PD/PI(s) should work with other members of the Executive Steering Committee, made up of the study’s Senior/Key Personnel, including Core and Project Lead and those Senior/Key Personnel who serve as de facto scientific co-leaders on Cores and Projects, and the NIA Project Scientist, to establish procedures for governance of the project.

• After Award, the PD/PI(s) should work with the Executive Steering Committee and the NIA Project Scientist to nominate members of an External Advisory Board, consisting of up to 8 experts in the scientific community who are not connected with the study except in this capacity, to advise the PD/PI(s) on the overall scientific and financial management of the study and on the recruitment of new investigators, which is critical to the future of this already long-running study. The Executive Steering Committee should continue to liaise with the External Advisory Board as described below.

• Meetings: The Executive Steering Committee and NIA staff will meet two times per year, at least once in the Washington, D.C. area. Each meeting will be approximately two days in length.

• 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.

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

NIH/NIA Project Scientist

An NIH/NIA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH/NIA Project Scientist will participate as an active voting member of the Executive Steering Committee, and as such will assist in activities including refining study objectives, methodologies, and aims; setting priorities in the content of data collection; exploring the use of alternative strategies for incorporating new measurement approaches and instruments; facilitating cross-project coordination and cross-project analyses; analyzing and publishing results of the study. Given the function of the MIDUS Study as a resource for the larger aging research community, the NIH/NIA Project Scientist will facilitate coordinating the study with other surveys (nationally and internationally) of the midlife and older adult population in order to enhance the capacity for comparative and integrative analyses. This will include facilitating efforts to harmonize data with other NIH and NIA-supported projects, engaging study investigators in formal harmonization activities supported by the NIA, promoting efforts to enhance the accessibility of study data to a wider range of scientists, and offering advice on how to enhance the value of the study for addressing scientific questions of priority to the NIH/NIA.

NIA Program Official

Additionally, an agency Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Official will approve all major stages of the study and all new major additions/changes to content and methods. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIA Program Official for any replacements of key personnel or other changes in subcontracts.

Areas of Joint Responsibility include:

Executive Steering Committee

To enable this complex project to continue to serve as a catalyst for innovative, multidisciplinary aging research and to permit incorporation of new ideas and input from the scientific community, an Executive Steering Committee will function as the governing board of this collaborative research study. This Executive Steering Committee will serve as the project's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. Its actions and decisions will be determined by majority vote. The Executive Steering Committee is composed of the PD/PI(s), Leaders and those Senior/Key Personnel who serve in joint scientific leadership roles on each Core or Project (NIA encourage no more than 3-4 individuals per Core/Project), and the NIA Project Scientist, each of whom has one vote, regardless of the number of roles they play in the study. In the case of a tie, the vote of the NIA Project Scientist will not count. In the event of co-funding, representatives of other NIH and co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.

The Executive Steering Committee will meet twice yearly in person and will participate in telephone or video conferences on a monthly basis. During the meetings, the Executive Steering Committee will discuss research progress and problems for each project and core, refine common theoretical and analytic approaches, and discuss emerging findings and pending publications. Subcommittees may be established as needed, and subcommittee chairs will be chosen by the Executive Steering Committee. Subcommittee members and other project personnel may participate in face-to-face meetings and conference calls as needed.

The Executive Steering Committee will be responsible for all major decisions regarding implementation and completion of study aims. This includes refining study objectives, methodologies, and aims; setting priorities in the content of data collection; exploring the use of alternative strategies for incorporating new measurement approaches and instruments; facilitating cross-project coordination and cross-project analyses; setting conventions for how data files should be structured and organized; establishing timelines for delivering datasets to the Administrative Core; analyzing and publishing results of the study.

The Executive Steering Committee members will, in carrying out the above roles:

• Establish procedures for chairing meetings, setting the agenda, maintaining minutes and recording decisions at all meetings;

• Establish procedures for conflict resolution;

• Agree to accept the participatory and cooperative nature of the group process and agree to collaborate with NIA;

• Approve the direction of joint research efforts and facilitate the conduct and monitoring of the overall study;

• Adhere to all established policies and procedures;

• Approve amendments to research plans based on feasibility and scientific relevance, and provide advice on implementation and evaluation strategies;

• Identify a need and propose subcommittees to undertake specific activities or to review issues, policies, or procedures for completion of MIDUS aims;

• Consider recommendations from the External Advisory Board.

External Advisory Board

In order to ensure that MIDUS achieves NIA assistance objectives under the cooperative agreement, it will consult with an External Advisory Board, comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of MIDUS. The External Advisory Board will be supported by the project to attend in-person meetings of the Executive Steering Committee; its purpose is to provide expert independent advice to the MIDUS Principal Investigator(s) and Executive Steering Committee on the successful implementation of the study, including on how to best utilize the comprehensive data already collected, promote cooperative efforts with other large studies involving relevant comparative samples, evaluate security procedures for public data release, and identify new scientific directions. Experts, including but not limited to the Principal Investigator(s), co- Investigators, NIA Project Scientist, and invited independent experts, will make presentations to the External Advisory Board on scientific and administrative issues regarding the development and implementation of study aims. The study’s Principal Investigator and Executive Steering Committee will consider the recommendations of the External Advisory Board regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement. This advice is not binding on the Principal Investigator(s) who retain(s) primary responsibility for the scientific direction and implementation of the study.

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 Executive 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 Non-Competing Continuation Grant Progress Report (PHS 2590 or 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: GrantsInfo@nih.gov

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

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: Vemuri@nia.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 Parts 74 and 92.