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 using ASSIST or an institutional system-to-system solution; paper applications will not be accepted.

It is critical that applicants follow the Multi-Project (M) 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

The Centers on the Demography and Economics of Aging (D&E) (P30) Program was initiated in 1994 to seed new lines of research in the demography and economics of aging and grow the number of researchers engaged in the field through a) funding pilot research projects, b) establishing networks of scholars to advance scientific discourse in selected areas, c) holding innovative conferences, workshops and meetings to advance new areas of research, d) developing and promoting the use of unique data resources, and e) disseminating findings and resources to the research and public policy communities. In 2017, the NIA evaluated the D&E Centers program and found that the program has been successful as the primary mechanism for incubating the development of research in demography and economics of aging.

This Research and Development Center (P30) Program is designed primarily to support the infrastructure and pilot data necessary for research and program development by investigators within an institution, and/or across domestic and international institutions, in the areas of demography and economics of aging. Additional objectives are to support: the development of innovative national and international networks of researchers; the recruitment of new researchers into demography and economics of aging; the development and enhanced sharing of relevant databases; the rapid application of research results from these databases; and the development of remote data enclaves and data sharing methods for the analysis of large-scale, often-longitudinal, databases with linked administrative, electronic health record, biological and/or genetic information.

Center applications must select research theme(s) and topic areas of focus which may, as relevant, be advanced by collaborations, data sharing and interdisciplinary interactions with related scientific fields such as psychology, anthropology, biology, genetics, neuroscience, epidemiology, behavioral economics, and public health. Such interdisciplinary collaborations must be designed to advance research on how demographic, social, economic, institutional, geographic and other factors at the population level influence health at older ages. "Health is broadly defined to include physical and cognitive functioning (including Alzheimer s Disease and Alzheimer's-Related Dementias, AD/ADRD), disability, morbidity, and well-being. Comparative international research is encouraged.

Applicants are encouraged to collaborate with other Demography and Economics of Aging (D&E) Centers as well as other NIA-funded Centers programs such as the Edward R. Roybal Centers for Translational Research on Aging, the Resource Centers for Minority Aging Research, the Claude D. Pepper Older American Independence Centers, the Alzheimer's Disease Research Centers, and the National Archive of Computerized Data on Aging.

Center grant applications must include two required cores: A) Administrative and Research Support Core and B) Program Development (Pilot) Core and may choose among three optional cores: C) External Innovative Network Core, D) External Research Resources Support and Dissemination Core, and E) Remote Data Enclave Core. Successful Center grant applications are required to cooperate and work with a Coordinating Center to be funded via RFA-AG-20-003.

To achieve the objectives listed above, each D&E Center should promote a sustained research and infrastructure development program in one or more broad thematic areas, which should be stated in the application and around which the goals, Specific Aims and topic areas of the Center and of the Center Cores should be designed. Examples of research themes include but are not limited to:

• Determinants of population trends at older ages in physical and cognitive functioning (including AD/ADRD), disability, morbidity, mortality, health and well-being.
• Life course pathways by which social, behavioral, environmental and structural risk and protective factors lead to disparities in health outcomes.
• Mechanisms through which socioeconomic status, race/ethnicity, and other factors operate as risk factors for poor health and health disparities at older ages.
• Interrelationships between work, family and health, and the consequences of work trajectories for health outcomes at older ages.
• How environmental, social, economic, institutional, structural, and other factors affect health and well-being, including health-related behaviors, healthcare utilization, health disparities, and responses to public health interventions.
• Influence on the aging process and aging outcomes of different social, economic, familial, environmental, geographic, cultural and institutional contexts.
• Consequences of U.S. and global population aging/demographic change for the care and well-being of older people with disease and disability, including AD/ADRD.
• Integration of genetic approaches and data on biological risk into social science population research on aging.
• Effects of population-level interventions on health, health delivery, quality of care, and disparities.
• Impact of health care services, the health care system, and long-term supports and services, including organizational influences, on the health and well-being of older persons with chronic disease, disability and AD/ADRD, and on their care providers.

Applications that wish to focus exclusively on AD/ADRD should submit to RFA-AG-20-002.

Areas of focus that are especially encouraged are: a) socioeconomic status (SES) disparities at older ages, including geographic disparities; b) the reasons for poor U.S. performance in health and mortality in international comparisons; c) trends and dynamics in old-age disability; d) cohort trends in obesity and its sequelae; e) family demography including the demography of care and caregiving for chronic disease, disability and AD/ADRD, and; f) long-term supports and services for the disabled elderly population.

Applications proposing to use economic methods, theories and concepts to address stated research themes should follow guidance about NIH priorities for health economics research in NOT-OD-16-025. Additional examples of aging-relevant economics research can be found at: https://www.nia.nih.gov/research/dbsr/population-and-social-processes-branch. Applications that are outside of NIH's mission, per NOT-OD-16-025, will be considered non-responsive.

Proposed interdisciplinary collaborations must be designed to advance demographic and economic population-based research.

Any reason Workshop summaries, publications and National Academies publications sponsored by the NIA Division of Behavioral and Social Research Program are available at https://www.nia.nih.gov/research/dbsr/publications

• NIA’s Strategic Directions for Research on Aging are available at https://www.nia.nih.gov/about/aging-well-21st-century-strategic-directions-research-aging
• Data resources for comparative international research are available at the NIA-supported Gateway to Global Aging Data at https://g2aging.org/

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

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

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

• o Hispanic-serving Institutions
• o Historically Black Colleges and Universities (HBCUs)
• o Tribally Controlled Colleges and Universities (TCCUs)
• o Alaska Native and Native Hawaiian Serving Institutions
• o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not 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).

A Center on Demography/Economics of Aging (P30) grant requires substantial pre-existing research activity on population aging at the institution. A minimum of at least two peer-reviewed, externally funded, and currently active research projects are required that are directly relevant to aging and that are rooted in population-based social science research in demography or economics. Ideally, applicant institutions will have a substantial base of such externally funded research. Sub-projects of NIA P01 grants may be counted as individual projects. Although two peer-reviewed and externally funded, currently active grants are the minimum requirement, considerable weight will be given to significant research activity in demography and economics of aging.

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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:

Georgeanne E. Patmios
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Core A (Use for "Core A. Administrative and Research Support Core")	6
Core B (Use for "Core B. Program Development (Pilot) Core")	6
Core C (Use for "Core C. External Innovative Network Core")	6
Core D (Use for "Core D. External Research Resources Support and Dissemination Core")	6
Core E (Use for "Core E. Remote Data Enclave Core")	6

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.

The application should consist of the following components:

• Overall: required; maximum 1
• Core A. Administrative and Research Support Core: required; maximum 1
• Core B. Program Development (Pilot) Core: required; maximum 1
• Core C. External Innovative Network Core: optional; maximum 1
• Core D. External Research Resources Support and Dissemination Core: optional; maximum 1
• Core E. Remote Data Enclave Core: optional; maximum 1

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.

Complete entire form.

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

Follow standard instructions.

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.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

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.

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.

Specific Aims: Describe the goals to be achieved by the Center, including the Center's selected research theme(s) and the basis for their selection; how the different Cores will contribute to these goals; crucial problems or limitations in knowledge, infrastructure, and/or availability of researchers that the Center would address; and advances in regard to these issues that the Center would achieve over its five-year award.

Research Strategy: Address how the Center integrates the proposed Cores around the proposed research theme(s); address how any proposed interdisciplinary collaborations will be designed to advance demographic and economic population-based research; clearly specify any overlap with activities funded or proposed through other NIH Center grants.

Renewal applications must include descriptions of progress during the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits

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.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

When preparing your application, use Component Type Core A.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• 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.

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

Salary support may be requested for the scientific director, core technical staff, consultants, and advisors. Travel funds may be requested for researchers to attend scientific meetings, for training of technical and scientific staff, for new program development, and for travel related to outreach and network functions.

Funds should be set aside for travel to an annual meeting held at the Population Association of America, or at another site agreed to by the PD/PIs and the NIA. This annual meeting will be joint with D&E Centers on Alzheimer's Disease and Alzheimer's Related Dementia funded through RFA-AG-20-002.

Funds should be set aside reflecting the costs for communicating with and convening the Advisory Committee, as described below.

Funds should be set aside reflecting the costs for working with the Coordinating Center to be funded under RFA-AG-20-003.

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.

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy: The Administrative and Research Support Core manages the activities of the Center, providing coordination, research planning, logistical, and centralized resources (including as data) and technical support.

Mandatory objectives of this core are to:

• Develop a strategic vision for the Center. Plan, coordinate, review and manage the Center's activities.
• Manage an Advisory Committee that oversees the functioning of the Center and assists the Director in making the scientific and administrative decisions relating to the Center, including the allocation of funds for pilot studies. For new applications, members of the Advisory Committee should NOT be named in the application; instead areas of expertise should be listed. For renewal applications, members of the Advisory Committee should be named.
• Describe a plan for the Center to develop, identify, review and monitor pilot projects in a manner consistent with the overall goals of the Center. This Core is responsible for submitting new pilot projects to NIA for approval, in accordance with Section VI.
• Monitor pilot projects. The description of all pilot projects, and any results must be reported in the Center's annual RPPR progress report to the NIA, in accordance with Section VI.
• Track outcomes from all Cores for reporting requirements to the Coordinating Center that will be funded through RFA-AG-20-003.

Optional objectives of this core are to:

• Purchase and provide facilities or services. Facilities and services should have the potential for additional research use at the institution and must not be for the sole use of any single project. Construction of facilities is not permitted.
• Optional support for developing and conducting workshops in new scientific areas relevant to the Center's research theme.

Renewal applications must include descriptions of progress during the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. No extra pages are allotted for progress reports.

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:

The Data Sharing Plan should not be addressed here; the Data Sharing Plan should be addressed in the Overall component.

Appendix:

Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative and Research Support Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

SF424 (R&R) Cover (Program Development (Pilot) Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Program Development (Pilot) Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Program Development (Pilot) 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.

Project /Performance Site Location(s) (Program Development (Pilot) 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 (Program Development (Pilot) Core)

• 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.

Budget (Program Development (Pilot) Core)

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

Applicants may propose as many pilot projects per year as they wish while staying within the budget limits for the overall Center. The Pilot Core budget for the initial year only should specify the pilot projects to be conducted; these should be included in the Pilot Core Research Strategy as described below.

Funds must be requested for small-scale projects, which may include pilot or feasibility projects. These small-scale projects (for example, in the range of $15,000 to $75,000 direct costs) are ordinarily limited to two years but may be extended with appropriate justification.

Optional: Salary support may be requested for (a) new faculty development in demography and economics of aging; (b) increasing the critical mass of the scientific research staff; and (c) the development of new program areas and methodologies. The total annual salary support per faculty member cannot exceed $84,000 in direct costs for at least nine-person months (with less effort prorated) from the Center grant, and the institution is expected to supplement any such salary costs with funds from other sources.

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 (Program Development (Pilot) Core)

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy:

The objective of this core is to support small-scale and innovative research projects, especially those that will provide the preliminary data leading to larger research efforts on topics related to the Center's stated themes.

Population-based social science research (primarily demographic and economic) must be the foundation of pilot projects proposed, but the projects may be informed by psychology, anthropology, biology, genetics, neuroscience, epidemiology, behavioral economics, public health, etc. as appropriate. Pilots could be implemented by both junior and established investigators at the Center institution or at outside institutions. Centers are encouraged to devote a percentage of Pilot Core funds to support pilot projects whose Principal Investigators are from outside institutions.

Applications should:

Address the pool of researchers from whom pilot projects would be invited; describe the process by which pilot projects would be invited, reviewed, and selected.

Describe the use of program development funds in the first year of the application, including brief descriptions of pilot projects to be conducted; for interdisciplinary projects, describe how they will be designed to advance demographic and economic population-based research.

Describe the internal institutional plans and procedures to ensure that all pilot projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials, if applicable.

Renewal applications must include descriptions of progress during the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits.

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:

The Data Sharing Plan should not be addressed here; the Data Sharing Plan should be addressed in the Overall component.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Program Development (Pilot) Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

SF424 (R&R) Cover (External Innovative Network Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (External Innovative Network Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (External Innovative Network 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.

Project /Performance Site Location(s) (External Innovative Network 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 (External Innovative Network Core)

• 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.

Budget (External Innovative Network Core)

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 (External Innovative Network Core)

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy:

The objectives of this Core include but are not limited to:

The development of innovative research networks beyond the institution's boundaries on the topics listed in the ILLUSTRATIVE TOPIC AREAS section, to enhance research not only at the institution, but more generally within the field, as well as in relation to other relevant disciplines. Such networks might include workshops, collaboration on pilot projects, harmonization of international data collection efforts, and the development of common research resources.

Outreach activities that will encourage and nurture the development of researchers from underrepresented minorities, people with disabilities, and those from socially, culturally, economically, or educationally disadvantaged backgrounds.

Technical assistance activities intended to support users of large NIA-funded databases who are outside the NIA Demography and Economics of Aging Centers.

Renewal applications must include descriptions of progress during the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits.

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:

The Data Sharing Plan should not be addressed here; the Data Sharing Plan should be addressed in the Overall component.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (External Innovative Network Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

SF424 (R&R) Cover (External Research Resources Support and Dissemination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (External Research Resources Support and Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (External Research Resources Support and Dissemination 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.

Project /Performance Site Location(s) (External Research Resources Support and Dissemination 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 (External Research Resources Support and Dissemination Core)

• 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.

Budget (External Research Resources Support and Dissemination Core)

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 (External Research Resources Support and Dissemination Core)

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy:

The objectives of this Core include but are not limited to:

• The communication and dissemination of research resources (e.g., important databases for secondary analysis), research findings, new theoretical concepts, and new methodological techniques to the larger scientific community beyond the institution. Encouragement is given for the development, support, and sharing of user-friendly databases and specific analytic methodologies. e.g., research and training workshops, development of user-friendly extract files with imputed variables, newsletters, and electronic bulletin boards providing technical support.
• The timely dissemination of synthesized research results to the Federal government, scientific community, and the public. Such dissemination might include briefings, training seminars, working paper series, research briefs, and newsletters.

Renewal applications must include descriptions of progress during the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits.

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:

The Data Sharing Plan should not be addressed here; the Data Sharing Plan should be addressed in the Overall component.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (External Research Resources Support and Dissemination Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

SF424 (R&R) Cover (Remote Data Enclave Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Remote Data Enclave Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Remote Data Enclave 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.

Project /Performance Site Location(s) (Remote Data Enclave 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 (Remote Data Enclave Core)

• 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.

Budget (Remote Data Enclave Core)

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 (Remote Data Enclave Core)

Demographic and economic aging research depends heavily on large-scale, often-longitudinal, datasets with complex, deeply-described phenotypes that are linked to a variety of data, including administrative data (e.g., National Death Index, claims data from the Centers for Medicare & Medicaid Services (CMS), electronic health records), geographic data, biological and genetic data. As there is the potential for deductive disclosure and risks to confidentiality and privacy resulting from data merging, these datasets are typically "restricted" and accessible only by eligible researchers with appropriate permissions. Changes in remote access technology enable secure access to restricted datasets to researchers who are not located near physical enclaves.

Specific Aims: State concisely the goals of the proposed Core, which datasets are proposed for the Remote Data Enclave, and for data linkages as relevant, how they advance research on the stated thematic areas of focus, and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy:

The objectives of this Core include but are not limited to:

• Establishing remote data enclaves for sharing of important restricted datasets useful for demographic and economic population aging research. Remote data enclaves are strongly encouraged to serve both Center researchers and investigators at outside institutions, and to house important datasets based at any institution, not only those that are based at the Center institution. Thus, the Remote Data Enclave Core will advance NIA objectives to expand access to and use of important data by the wider research community for population aging research.
• Developing methodology for linking administrative, biologic and genetic data with longitudinal data sources and distributing the linked files, and for statistically protecting confidential information.

Applications should describe procedures to protect confidentiality, and the access provided to statistical analysis software, specialized application software, compilers, and utilities necessary to manipulate and analyze restricted data. Applications should describe an active outreach program to foster use by the national research community of the available data resources.

Renewal applications must include descriptions of progress during the previous funding period. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits.

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:

The Data Sharing Plan should not be addressed here; the Data Sharing Plan should be addressed in the Overall component.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Remote Data Enclave Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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) 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. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://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. 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) 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 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 {IC} Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

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.

In addition, for applications involving clinical trials:

Proposed Clinical Trial pilot projects in Core B may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

Does the proposed Center address the needs of the research that it will administer? Is there potential for significant scientific progress in the specific areas or themes addressed by the application? Does the overall strategy for developing research in population-based social science research, in the demography and economics of health and aging generally and specifically within the areas or themes proposed, have potential for significant scientific progress? Is population-based social science research the foundation for the themes, topics and pilot projects proposed? How well does the Center integrate the Cores around the proposed research theme(s)? Is there scientific merit in the proposed pilot or new program development projects? Will the support and maintenance functions proposed, for e.g., databases and methodologies, provide value to the institution's researchers? Will scientific value and public good result from any proposed external outreach and network building activities?

In addition, for applications involving clinical trials:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s)/Directors and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing population-based social science research? Do the investigators demonstrate significant experience with coordinating collaborative population-based social science research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials:

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Does the application propose novel organizational concepts, management strategies, or methodologies in coordinating the research activities the Center will serve? Are the concepts, strategies, or methodologies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or methodologies proposed? To what degree will the Center stimulate new research directions in the demography and economics of aging?

In addition, for applications involving clinical trials:

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research activities the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the activities, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the proposed activities are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Center? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of biological variables, such as sex, for studies of human subjects?

If the Center 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials:

Does the application adequately address the following, if applicable?

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research activities it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Is the funded research ongoing at the institution, and at the administrative components of the institution(s) proposed for interdisciplinary collaboration, adequate and directly rooted in population-based social science research, especially in the demography and economics of health and aging? Has there been successful training activity in the area of population aging (including the recruitment and training of junior investigators)? Is there evidence of concrete commitment of the institution's administration to develop and support research and training on population aging (e.g., provision of new resources, co-funding or new positions)?

In addition, for applications involving clinical trials:

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials:

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Center 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 individuals of all ages (including children and older adults) 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

For Renewals, the committee will consider the progress made in the last funding period. To what extent did the Center: generate and select innovative pilot projects on significant topics; attract new researchers (junior and/or senior) into aging research; develop new research directions in the demography and/or economics of aging; and generate scientific value and/or public good from any external outreach and network building activities that were conducted?

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.

Not Applicable

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 .

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.

For Cores A-D, reviewers will provide adjectival descriptors based on the following criteria:

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 or technical capability be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Core B, Program Development (Pilot) Core (Required): Is there scientific merit in the proposed pilot projects? How will the proposed pilot projects and types of future pilot projects contribute to the goals of the Center? How will the pilot projects contribute to the success of other Cores? Are the pilot projects likely to lead to the development of larger research initiatives? For interdisciplinary pilot projects, are they relevant to the demography or economics of aging? To what extent is the Center having an impact on research beyond the institution's borders by supporting pilot projects led by outside investigators?

Core C, External Innovative Network Core (Optional): Will scientific value and public good result from proposed external outreach and network building activities?

Core D, External Research Resources Support and Dissemination Core (Optional): Will scientific value and public good result from proposed dissemination activities?

Core E, Remote Data Enclave Core (Optional): Are there benefits to the research community within the institution and more broadly to the wider research community? Will scientific value and public good result from proposed activities?

Investigator(s)

Are the Core Leader(s), collaborators, and other researchers well suited to the Center? 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?

Core B, Program Development (Pilot) Core (Required): Are there sufficient qualified personnel from whom to invite pilot projects in order to achieve the goals of Core B?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Is the pilot project review process adequate to assess the scientific merit of proposed pilot or program development projects? 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 Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Core A, Administrative and Research Support Core (Required): How well will the proposed staff lead the Center and interact with other Center components and other organizational components within and outside the institution? Are the plans adequate for the establishment and functioning of the proposed advisory panels?

Core B, Program Development (Pilot) Core (Required): Is the pilot project review process adequate to assess the scientific merit of proposed pilot or program development projects? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

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?

Does the technologic and scientific environment in which the work will be done contribute to the probability of success? Do the proposed activities benefit from unique features of the scientific environment? Is there evidence of institutional support?

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:

• 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 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 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.
• Program balance across this Centers program in terms of scientific disciplines, research themes and research topics supported.
• The extent to which the various components of the proposed program would be coordinated into one integrated effort within the Center.
• The extent to which the Center's activities would be enhanced by coordination with other Demography and Economics of Aging Centers or with other NIA-funded Centers programs.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All awardee-selected projects require prior approval by NIH prior to initiation (with exceptions allowed as described below).

• In the competing year, pilot projects (including those briefly described in the competing application) must be submitted for approval by no more than six months after the start of the award.
• All pilot projects for subsequent award years must be described in the non-competing continuation progress report; descriptions should be a maximum of 2 pages in length. The progress report should include detailed budgets for proposed pilots and the Curriculum Vitae of the proposed pilot project investigator. The progress report should also contain appropriate human subjects clearances for proposed pilot projects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan. Pilot projects with foreign components will require NIH and State Department foreign clearance prior to award.
• For clinical trial pilot projects, the awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• For clinical trial pilot projects, the awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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, application errors and warnings, documenting system problems that threaten on-time submission, and 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)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Georgeanne E. Patmios
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]

Nia Pree
National Institute on Aging (NIA)
Telephone: 301-827-6374
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.