It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This FOA invites applications to provide infrastructure support for advancing development of specific high-priority areas of behavioral and social research of relevance to Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD). The infrastructure support will facilitate research networks through meetings, conferences, small-scale pilots, short-term educational opportunities (such as intensive workshops, summer institutes, or visiting scholar programs), and dissemination to encourage growth and development of specified priority areas and build resources for advancing aging-relevant research in the field at large. Network applications are limited to the following areas: (1) AD/ADRD care and services research, and (2) the coordination of international studies conducting the Harmonized Cognitive Assessment Protocol (HCAP).

1. AD/ADRD Care and Services Research Network:

The Network would expand upon recommendations put forth during the October 2017 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers. The Network would focus on research to improve health care services and delivery and well-being for persons with dementia (PWD) and their informal and formal caregivers, within health care systems and beyond. The Network would be comprised of a standing group that would regularly assist NIA in advancing our dementia care research agenda.

Informed by the 2017 National Research Summit, research areas and activities of interest (e.g., meetings) include but are not limited to:

• Impact of health care systems and long-term supports and services (LTSS) on outcomes for persons with dementia and their care providers; this includes how outcomes differ for people living alone.
• Disparities in quality and access to dementia care. Examples include the mechanisms and risk factors that explain disparities in service access and quality for persons with dementia and their caregivers, as well as and how institutional and social contexts influence disparities in service access and quality.
• Effectiveness of models and programs of non-residential and residential care for PWD, including home modifications and Dementia Friendly Communities in the U.S. and outside the U.S.
• Causes and consequences of labor market availability and shortage of skilled individuals in the caregiving workforce; this includes factors that lead to effective workforce development and reduce precarious employment.
• Impact of dementia diagnosis on individuals, caregivers, and families, to include individual responses and/or social impacts.
• Health, financial, and social outcomes of the caregiver following the cessation of their caregiving role.
• Development of methods for measuring person-centered outcomes, to include outcomes that matter to PWD (persons with dementia) and caregivers, including self-report measures across the disease severity spectrum and across care settings.

2. AD/ADRD Data Harmonization:

NIA supports a broad range of population studies to address questions related to the prevalence, predictors, outcomes and future trends in cognitive aging and AD/ADRD in the U.S. and internationally. NIA goals include providing the research community with comparable estimates of AD/ADRD and supporting epidemiological analysis of the etiology and impact of cognitive decline and AD/ADRD. To this end, the Network would support 1) harmonization of cognitive function and AD/ADRD protocols and different diagnostic algorithms across existing studies; 2) small-scale pilots on survey content or methodology; 3) coordination and enhancement of existing studies that implement harmonized dementia assessment protocols; 4) development of new studies that implement harmonized dementia protocols; 5) dissemination of data resources to the research community; and 6) development of a research agenda for cross-national comparative research.

NIA currently funds an R24 network for harmonizing the HRS family of studies involving 30+ countries across five continents that have designed surveys to be comparable with the HRS, many of which are not supported by NIH funding. To encourage harmonization and innovation, they actively participate in the current HRS Harmonization Network. For study descriptions of most of these, see "Gateway to Global Aging" at g2aging.org /surveys at a glance.

NIA now funds dementia assessment in the U.S. HRS plus six international HRS-family studies: ELSA (England), SHARE (Europe), LASI (India), MHAS (Mexico), HAALSI (Agincourt, South Africa) and CHARLS (China). The so-called Harmonized Cognitive Assessment Protocol HCAP provides the research community with new and rich data to study the prevalence, predictors, outcomes and future trends in cognitive functioning and dementia by producing comparable national estimates of the prevalence of dementia and supporting joint epidemiological analysis of the etiology and impact of cognitive decline.

Given that NIA is now funding the HCAP studies there is a need to fund a Network to focus on harmonization across the seven (plus) studies conducting the HCAP protocol.

The National Institute on Aging, Division of Behavioral and Social Research (BSR) supports basic social and behavioral research and research training on the processes of aging at both the individual and societal level. A summary of BSR research objectives is available on the NIA website and in the summary of the 2013 National Advisory Council on Aging Review of the BSR program. Though a significant fraction of research supported by BSR in pursuit of the NIA mission falls within a specific discipline or field, BSR encourages transdisciplinary approaches to behavioral and social research. BSR also supports data resources to support analyses that span disciplines.

BSR supports a range of initiatives to seed integrative and transdisciplinary research that exploits new methodologies and knowledge as well as infrastructure development in emerging and high priority areas of behavioral and social science related to aging. These areas are typically developing rapidly and require ongoing flexible dynamic infrastructure support to advance the production of high quality research and facilitate collaborations between scientists whose diverse areas of expertise are essential for actualizing innovative research in the field. They also require training new investigators and recruiting the best scientists to aging research to ensure continued growth in these fields.

Background information on currently supported BSR networks can be found here.

Reports and publications from many of the scientific workshops that have informed the selection of priority emerging areas can be found here.

Frequently asked questions about this FOA are addressed here.

This FOA is designed to address the network development needs of researchers interested in advancing transdisciplinary AD/ADRD-relevant research agendas in the social and behavioral sciences. The goal is to produce resources that will serve the field at large. Applications must propose efforts to advance one of the above-listed high priority aging-relevant research areas in the behavioral and social sciences. Applications should prepare plans for new high impact activities that are not feasible with existing resources. For the purposes of this FOA, AD/ADRD-relevant research is that which addresses issues of importance to the well-being and health of either mid-life or older adults and can include data spanning the entire life course. Applicants need not have a prior history of conducting research in aging.

Network support includes all activities designed to bring together leading scientists across disciplines and institutions to develop an emerging priority area. This program is intended to be flexible and support the creation of innovative networks that will propose activities and bring unique resources necessary to advance a set of well-articulated research goals. The application should be designed to have a substantial impact on the progress and quality of behavioral and social research of relevance to aging by virtue of the proposed activities. Networks are intended to serve the broader community of behavioral and social researchers engaged in aging-relevant research in the designated scientific area and are consequently unlikely to be limited to a single institution. Applications should propose activities designed to advance a field to the point of no longer requiring network support to sustain growth. Applicants should articulate criteria for assessing this progress.

Examples of network support activities include, but are not limited to:

• Meetings, both large and small, to develop novel research areas and interact on the development of infrastructure.
• Small-scale pilots to obtain data, theoretical frameworks, empirical methods, or support the development of novel or high-risk approaches requiring interdisciplinary collaboration.
• Dissemination and outreach activities to draw researchers from relevant disciplines into the field.
• Educational activities such as intensive summer institutes, series of workshops and related network activities, advanced seminars on methodology, or short-term residential opportunities.

The networking, education, and infrastructure-building activities required for these efforts are rarely covered under an individual grant, and often do not fit the timelines for typical support mechanisms. In many instances the researchers that can support a successful network in an emerging area span multiple disciplines and are rarely located at a single institution. Therefore, this FOA is designed to provide research resources that create opportunities to shape the direction of an emerging field by addressing the network and infrastructure development needs required.

A goal of Network projects is to disseminate network resources to the field at large. These resources can include (but are not limited to) meeting papers/summaries; scientific publications; web resources; tools or guides to support research or data enhancement; data sets ranging from public-access "user-friendly" research data to meta-data, macro data or other aggregations of data to support research; and harmonized versions of existing data or instruments.

Networks may propose to support small-scale pilot projects. Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects proposing small-scale pilot programs must propose how pilot projects will be solicited and reviewed in the Approach section of the Research Plan.

NOTE: Applicants are strongly encouraged to limit the number of key personnel on Network applications, to avoid establishing conflicts of interest throughout the emerging field. Participation in network activities, including presentation at workshops, or serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. Network activities are intended to advance the field at large. An important consideration in developing a network is the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

For network activities that span multiple institutions, applicants are encouraged to propose how those activities will be coordinated across institutions, and how the proposed activities will effectively engage with other relevant activities at participating institutions. Projects must propose a plan for dissemination of network products to the field at large.

The NIA encourages potential applicants to contact Scientific/Research staff listed in Section VII to discuss potential network development programs prior to submission of an application. The NIA encourages network applicants to support activities that will foster diversity of the scientific workforce.

Responsive applications to this FOA must propose network activities (described above) in one of the two priority AD/ADRD-relevant areas identified in the Purpose section (i.e., AD/ADRD care and services research network and AD/ADRD data harmonization). Specific foci within a priority area must be defined in the application and must reflect the intent of the FOA for developing research infrastructure in each area, as outlined in the Purpose section. Applications in other areas will not be deemed responsive to this announcement and will not be reviewed.

Applications that propose activities that only serve investigators at a single institution or small number of institutions, rather than the field at large, will not be considered responsive.

Investigators seeking support for traditional scientific meetings should use PA-18-648" NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed)". Investigators who wish to seek support for a pre- and post-doctoral research training program should use PA-18-403 "Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)".

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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Dana Jeffrey Plude, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

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

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

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

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

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

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

Key personnel should describe their experience and an ongoing record of accomplishments in managing transdisciplinary behavioral and social research projects and coordinating collaborative research. Teams should include both established and emerging leaders in the scientific area of focus. Teams should include expertise in resource sharing through web-based platforms or other means.

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

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

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

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

Research Strategy: The application should address how the proposed project will have a substantial impact on the progress and quality of behavioral and social research of relevance to AD/ADRD care and services and data harmonization by virtue of the proposed activities. The application should address how the proposed networking activities will advance an emerging field of research relevant to AD/ADRD care and services or AD/ADRD data harmonization. The application should propose new high impact activities that are not feasible with existing resources.

Networks are intended to serve the broader community of behavioral and social researchers engaged in AD/ADRD-relevant research in the designated scientific area and are consequently unlikely to be limited to a single institution. For network activities that span multiple institutions, applicants must explain how those activities will be coordinated across institutions, and how the proposed activities will effectively engage with other relevant activities at participating institutions.

The application must include plans for dissemination and access to ensure that the network and its products will be appropriately targeted for the highest impact to potential participants and beneficiaries.

The application must describe how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

Networks may propose to support small scale pilot projects. Network funding for pilot projects should either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. Projects proposing small scale pilot programs must include a description for how pilot projects will be solicited and reviewed in the Approach section.

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.

Resource Sharing products can include (but are not limited to) meeting papers/summaries, scientific publications, web resources, tools or guides to support research or data enhancement, and data sets ranging from public-access "user-friendly" research data; meta-data, macro data or other aggregations of data to support research; and harmonized versions of existing data or instruments.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 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.

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Applicants 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Does the proposed Network address the needs of the research area that it intends to develop? Is the scope of activities proposed for the Network appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the emerging field?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Network? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary behavioral and social research projects and coordinating collaborative research? Does the team include both established and emerging leaders in the scientific area of focus? Does the team include expertise in resource sharing through web-based platforms or other means? If the Network 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 Network? Does the applicant have experience overseeing selection and management of subawards, if needed?

Does the application propose novel approaches to advancing interdisciplinary research in the emerging, high priority scientific area the Network will serve? Does the application address how the proposed networking activities will advance an emerging field of research relevant to AD/ADRD care and services and data harmonization and why these goals cannot be met through existing institutional programs or structures? Does the application propose new high impact activities that are not feasible with existing resources?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Network? Does the application appropriately address how the proposed Network will have a substantial impact on the progress and quality of behavioral and social research of relevance to AD/ADRD care and services and data harmonization by virtue of the proposed activities?

Are the proposed network activities likely to serve the broader community of behavioral and social researchers engaged in AD/ADRD-relevant research in the designated scientific area beyond a single institution or set of institutions? For applications that span multiple institutions, are appropriate procedures in place for coordination across institutions and for effectively engaging with other relevant activities at participating institutions?

Is there an appropriate plan for dissemination of network products to the field at large that will ensure that the network and its products will be appropriately targeted for the highest impact to potential participants and beneficiaries? Does the application address how the proposed activities will have the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team?

Networks may propose to support small scale pilot projects to either advance broad network goals or support preliminary studies with potential to form the basis for independent research applications consistent with network goals. If proposed, is the approach for soliciting and reviewing pilot projects appropriately aligned with networks goals and likely to advance progress in the field at large?

Will the institutional environment in which the Network will operate contribute to the probability of success in facilitating progress in the field? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Network proposed? Will the Network benefit from unique features of the institutional environments, infrastructure, or personnel? Are resources available within the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products?

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

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

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 (GDS).

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

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.
• Programmatic balance.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Dana Jeffrey Plude, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

Karen Molina
National Institute on Aging (NIA)
Telephone: 301-827-8226
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.