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. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

This Funding Opportunity Announcement (FOA) solicits NIH Research and Development Core Center Grant (P30) applications for the Roybal Centers for translational intervention development research supporting Alzheimer's disease (AD) and Alzheimer's disease related dementias (ADRD) care providers and improving quality of care for persons with dementia. The Roybal Center program was authorized by Congress in 1993 and named for the Chair of the former House Select Committee on Aging, Edward R. Roybal.

The goal of the Roybal Centers is to conduct preliminary research to develop potent and scalable principle-driven behavioral interventions, programs, or practices that promote healthy aging at the individual or population level. Roybal Center resources are intended to conduct pilot studies to create, modify, adapt and test behavioral interventions to improve the lives of mid-life and older people and the capacity of institutions to adapt to societal aging. By establishing an infrastructure organized in accordance with the NIH Stage Model, Roybal Centers will provide the necessary scientific expertise and resources to conduct pilot studies at Stages 0, I, II, III and IV of the translational behavioral intervention development multi-directional pipeline. This reissuance of the NIA Roybal Centers program focuses specifically on the full range of translational behavioral intervention development research in the priority areas described below under "Thematic Areas of Focus." Areas of research that will be considered non-responsive to this FOA are described below under "Responsiveness Criteria."

The Roybal infrastructure is also intended to facilitate related research proposals outside of the Roybal Center. NIA expects that successful Roybal Center pilot intervention projects will lead to the submission of related translational behavioral intervention development applications for R01s or SBIRs to produce implementable, principle-driven interventions. Pursuit of related NIA research applications that can successfully leverage the expertise, resources and findings of the pilot projects of the Roybal is strongly encouraged. Ideally, translation projects supported through the Roybal program will not only result in benefits to mid-life and older people, and in the case of this RFA, to those persons or systems that provide care for persons with AD-ADRD will also advance our fundamental understanding of basic scientific questions in the behavioral and social sciences of aging.

Centers are encouraged to make research resources available to the larger scientific community or to galvanize scientists at several academic institutions. Consortium arrangements are permissible, provided that the applicant institution meets the eligibility requirements. Centers are expected to participate in meetings and conference calls facilitated by a Roybal Centers Coordinating Center and are encouraged to collaborate with other Roybal Centers for Translational Research on Aging. Centers are also encouraged to collaborate with other NIA-funded Centers, including the Resource Centers for Minority Aging Research (RCMAR), the Centers on the Demography and Economics of Aging, and the Claude D. Pepper Older American Independence Centers (OAICS) and with relevant private sector partners.

Applicants are encouraged to check the NIA webpage periodically for frequently asked questions about applying to the Roybal program.

Centers are expected to leverage basic behavioral or social science principles throughout the intervention development process, with the aim of creating practical, science-based principle-driven interventions that can be successfully implemented in the real world. This will require requisite expertise at all Stages of the intervention development pipeline, from Stage 0 (basic behavioral or social science) through Stage IV (effectiveness or pragmatic trials), as defined by the NIH Stage Model).

All applications must include Stage I activities. Applications are required to include personnel or collaborators with relevant expertise in Stages 0 through IV of the NIH Stage Model. If expertise at a Stage is not included, applicants must provide a justification explaining why such expertise is not relevant and not needed.

The NIH Stage Model of behavioral intervention development: The goal of the NIH Stage Model is to create principle-driven and implementable behavioral interventions by structuring intervention development within a translational framework that integrates basic and applied behavioral and social science. The Model describes the full range of behavioral intervention development from basic behavioral science through intervention development, efficacy testing, effectiveness testing, and implementation. It helps to describe where a behavioral intervention is in the developmental pipeline and specifies research activities appropriate for different Stages of behavioral intervention development. ("Behavioral" is defined broadly here, including behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health systems level). The NIH Stage Model provides a common language to facilitate discussion of intervention development research by applicants, reviewers, and funders. An examination of the mechanisms of behavior change or the principles underlying an intervention is encouraged by the NIH Stage Model in every Stage of behavioral intervention development. Roybal Centers are expected to have expertise at all relevant Stages of the NIH Stage Model to facilitate a multi-directional approach to intervention development that is infused with both basic behavioral science with an eye toward real-world implementation.

Roybal Centers will support Pilot intervention research intended to lay the foundation for independent, larger scale projects. Pilot/preliminary work in the first five Stages of behavioral intervention research may be supported under this RFA:

• Stage 0 is basic behavioral science relevant to the development of principle-driven behavioral interventions. Basic behavioral science is defined in this announcement as research involving the examination of behavioral, cognitive, affective or social principles (mechanisms or processes) operating at the individual or population level. It may include phenomena operating at any level of analysis (e.g., social, economic, institutional, contextual, interpersonal, behavioral, psychological, neurobiological and/or genetic). It is important to note that questions regarding principles or mechanism of behavior change are relevant at every Stage of the intervention development pipeline and may also be asked in any Stage of intervention development.
• Stage I research is where a principle-driven intervention and the intervention's associated materials are created, refined, adapted, and pilot tested for feasibility, acceptability and efficacy.
• Stage I in research contexts or in community contexts: Stage I studies may be conducted in research contexts (e.g., in an academic setting where the intervention is administered by an individual working for the researcher) or in community contexts (e.g., in a community setting, such as a home or assisted living facility, where the intervention is administered by an individual in the community), as appropriate
• Stage I for the development of associated materials: For interventions that need to be administered by individuals in the community, the development and testing of provider-friendly training materials, and community-friendly procedures for monitoring fidelity for interventionists/ providers in community settings is often necessary prior to progression to Stage III and later Stages. Thus, development of these materials is a critical component of Stage I.
• Stage II research is designed to answer the question, "Can this intervention work when administered under ideal conditions, and what is/are the mechanism(s)/ principles(s) of behavior change causing the effect(s)?" Stage II (Traditional Efficacy Testing) research consists of tightly controlled experimental testing (maximal internal validity) of promising behavioral or social interventions in research settings, with research-based interventionists/providers. It is expected that Stage II studies will include rigorous methods for ensuring key elements of intervention fidelity.
• Stage III research is designed to answer the question, "Can this intervention work when administered under highly controlled conditions in the real world?" Stage III (Efficacy in the "real-world") research consists of the experimental testing of promising behavioral or social interventions in community settings, with community-based interventionists/providers, while maintaining as high a level of internal validity as possible under these circumstances. Stage III studies are expected to include rigorous methods for ensuring intervention fidelity and validated procedures for training, developed specifically for use with individuals in a home or community-based setting. Stage III studies are also encouraged to provide information about the mechanisms or principles of behavior change responsible for any observed effects. (Preliminary
• Stage IV research is designed to answer the question, "Can this intervention work when administered under actual conditions in the real world?" Stage IV ("Effectiveness" and "Pragmatic Trials") involves effectiveness testing or pragmatic trials on behavioral interventions that have been shown to have efficacy in earlier Stages. Stage IV research attempts to have maximal external validity and is always conducted in community settings, with community-based providers or caregivers.

Behavioral intervention development is rarely a linear process and there is often a need to take advantage of new knowledge from basic or clinical science and return to earlier Stages before proceeding to later Stages to determine the principles underlying the intervention, to improve the potency of an intervention, to streamline the intervention, to develop community-friendly training procedures for the intervention, to develop methods to maximize real-world fidelity, etc. Multiple Stage I studies (sometimes conducted in research settings, but other times conducted in community settings, depending upon the goals) are often are needed to lay the groundwork for Stage III and Stage IV studies that can serve as necessary steps toward ultimate implementation. Stage I studies are expected to be the most prevalent type of study within Roybal Centers. Stage II, III, and IV studies may be conducted when justifiable (e.g., prerequisite Stage I work has been completed), and when such research is equivalent in size to Stage I trials. For the purposes of this RFA, Stage I studies and small-scale Stage 0, II, III, and IV studies will be referred to as "pilot" studies. Small-scale Stage II research may be conducted to determine efficacy and mechanisms of behavior change under optimal conditions. Small-scale Stage III research may be conducted to determine real-world efficacy, under maximally controlled conditions. In cases where interventions are highly inexpensive and simple to administer with fidelity (e.g., simple default interventions or technology-based interventions, Stage IV research may be conducted to determine real-world effectiveness, under natural conditions.

For more information about the NIH Stage Model, please see: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.

Each Roybal Center will have a core scientific theme, concentrating its resources and pilot investments on a focal set of principle-driven intervention approaches designed to promote the health and well-being of individuals as they age. In line with that scientific focus, Roybal Centers will support pilot behavioral intervention research studies at Stages 0 through IV. Centers should have appropriate expertise at all relevant Stages. All Roybal Centers are expected to have a research focus on the basic behavioral or social mechanisms or principles that can explain how and why an intervention works as hypothesized, unless there is a compelling justification for not doing so.

AD-ADRD Centers must have an overarching focus on people and/or systems providing AD-ADRD care. The following are meant to serve as examples of possible themes:

1. "Transdiagnostic" (TD) approaches for person who provide care to those with AD-ADRD. Centers could focus on the creation and adaptation of transdiagnostic interventions - those focused on mechanisms of change common to multiple health behaviors - into scalable multi-purpose principle-driven interventions designed to promote healthy aging and prevent chronic diseases of aging in individuals providing care to persons with AD-ADRD. Such centers could focus on the development of principle-driven interventions to optimize self-regulation, cope with and decrease negative affect, reduce stress, improve interpersonal functioning, etc.

2. Behavioral economics approaches to dementia care. Applicants may propose to create, modify and pilot test principle-based interventions that assist the care provider, assisted living residence or skilled nursing facility in the provision of services to individuals with AD-ADRD, based upon psychologically-informed behavioral economic (BE) principles to improve individual behavior or institutional processes that are linked to patient outcomes.

3. Social-connectedness for AD-ADRD care providers. A Center could conduct research aimed at developing principle-driven interventions to help AD-ADRD care providers establish and/or maintain social relationships to reduce social isolation, reduce loneliness, improve close relationships, or promote social engagement to improve health and well-being. Research may also be conducted on the development of interventions that establish AD-ADRD peer connections or volunteer networks to provide social support and to share the burden of care.

4. Music and/or other arts (e.g., sculpting, painting, dance, etc.) and dementia care. Centers may integrate basic research on music and/or other arts into development of principle-driven interventions to have a positive impact upon stress, anxiety, subjective well-being, etc. of AD-ADRD care providers and care recipients.

5. Later-stage AD-ADRD care provider. Centers might specialize in the development of principle-based interventions addressing the unique needs of those persons or systems providing care for individuals with later-stage AD-ADRD. For example, centers could develop interventions aimed at 1) improving communication and meaningful engagement with the individual with AD-ADRD; 2) helping care providers cope with their negative affect; 3) appropriately responding to agitation or other negative affect in the individual with AD-ADRD; 4) minimizing the inappropriate use of antipsychotic or other psychotropic medication; 5) educating care providers with regard to the possible capacities and limitations of the individual with AD-ADRD; 6) minimizing care provider burden; and 7) helping AD-ADRD care providers make end-of-life decisions in concert with the wishes of the care recipient.

6. Early-stage AD-ADRD care provider. Centers might specialize in the development of principle-based interventions addressing the unique needs of care providers of individuals with early-stage AD-ADRD. For example, centers could develop interventions aimed at 1) improving communications between the care provider and recipient; 2) helping care providers cope with the diagnosis; helping care providers cope with their negative affect 3) educating care providers with regard to the capacities and limitations of the individual with AD-ADRD; 4) help care providers balance the safety vs. independence and quality of life in the AD-ADRD care recipient; 5) minimizing care provider burden; and 6) helping AD-ADRD care providers make end-of-life decisions in concert with the care recipient.

7. Coordination and optimization of care. Centers might specialize in the development of principle-driven interventions to assist systems providing care to individuals with AD-ADRD. Interventions may be developed for assisted living residences and/or skilled nursing facilities to improve the coordination and quality of care. This could include interventions to maximize effective communication among AD-ADRD care providers. Interventions to maximize family care provider participation in the care planning process (e.g., within nursing homes) may be developed. Interventions to that help family care providers navigate the health care system may also be studied.

8. Non-residential care. Centers might specialize the development of principle-driven interventions to support AD-ADRD care providers and improve the quality of care for persons with dementia in non-residential care. Settings may include, for example, skilled nursing facilities, assisted living, home health care, adult day care, "enhanced" adult day care, other community programs.

Note: The examples above are not an exhaustive list but are meant to serve as examples of areas of interest for this FOA.

NIH Science of Behavior Change Common Fund Program (SOBC): Describes a method for developing behavior change interventions that yields information on mechanisms of change, the experimental medicine method. SOBC is also identifying and testing measures designed to assess whether those mechanisms are indeed engaged by an intervention.

For more information about SOBC please see:

https://commonfund.nih.gov/behaviorchange/

• NIH Stage Model: Provides a translational multi-directional conceptual framework for the development of implementable principle-driven behavioral interventions. The NIH Stage Model is the required structure for the Roybal Centers.

For more information about the NIH Stage Model, please see: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.

Roybal Center applications should not focus primarily on interventions designed for use in the biomedical clinical context for disease treatment or management. This research is more appropriate for other NIA programs that also use the Center mechanism.

The following types of applications will be considered non-responsive to this FOA and will not be reviewed:

• Applications that do not have a primary focus on behavioral intervention development, as defined by the NIH Stage Model, supporting AD-ADRD care providers and/or improving quality of care for persons with dementia.
• Applications that have a primary focus on disease treatment or management in a biomedical clinical context.

Compliance

Applications that do not comply with the following instructions may be delayed or not accepted for review.

• Applications should include personnel or collaborators with relevant expertise in Stages 0, I, II, III and IV of the NIH Stage Model, unless there is a compelling justification for why such expertise is not needed and not relevant.
• Renewal applications must not report progress and/or products, such as publications from periods prior to the last five-year period of the award as part of the Progress Report or Progress Report Publication List

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)

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

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

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

An Edward R. Roybal Center Grant (P30) requires relevant pre-existing research activity at the applicant institution and at collaborating institutions. Ideally, institutions will be able to draw from a substantial base of relevant research.

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:

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

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Management and Administrative Core)	6
Project (Use for Pilot Core)	12

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Management and Administrative Core: required; maximum of 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.

All applications must include Stage I activities. Applications are required to include personnel or collaborators with relevant expertise in Stages 0 through IV of the NIH Stage Model. If expertise at a Stage is not included, applicants must provide a justification explaining why such expertise is not relevant and not needed.

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 that the Center will address with respect to the translational behavioral intervention development theme and activities proposed; and the readiness for implementation of efficacious principle-driven behavioral interventions, and the starting Stage and the subsequent anticipated Stage pathways for the interventions that the Centers will study over its entire award period.

Research Strategy: To achieve the FOA objectives, each Roybal Center application must:

• Identify a promising thematic area and justify the scientific evidence-base in the behavioral or social sciences for the theme selected.
• Create a sustained translational behavioral intervention development program, designed in accordance with the NIH Stage Model to address the chosen theme.
• Describe how the selected the theme is reflected in the design of the Roybal Cores.
• Ensure the Roybal has expertise at all relevant Stages O, I, II, III and IV of intervention development pipeline. Explain how this expertise will be used to develop principle-driven, potent, and ultimately implementable interventions.
• Describe two Pilot Studies proposed for Year 1.

o Describe how the selected the theme is reflected in the selection of these two pilots.

o Identify and justify the scientific evidence base for the translational pilot project within the context of the appropriateness of the Stage of research proposed for the intervention, for each of the two pilots proposed.

o Identify the hypothesized mechanism of action or principles underlying the intervention. Explain how mechanism of action or principles will be studied in the pilot, as appropriate.

o Include detailed research strategies for the two proposed Year 1 pilot studies.

• For Year 2 and thereafter of the Roybal (after Year I), propose and justify an anticipated pathway, through the Stages of the NIH Stage Model, of the two interventions proposed to be studied in Year 1. It is understood that depending upon the results of Year 1 pilot studies (and subsequent studies), anticipated pathways may or may not be appropriate to follow. Brief descriptions only are expected for the anticipated pilot studies in Year 2 and thereafter. Detailed research strategies are not requested and are not required for anticipated pilot studies in Years 2 through 5.
• Include an anticipated timeline for progression through the Stages for each of the two behavioral interventions proposed to be studied, (assuming there is scientific justification) over the course of the Roybal Center.
• Describe how the Roybal Center will measure its success in developing principle-driven interventions that can be successfully implemented in the real-world to have a positive effect on the health and well-being of individuals as they age.

Progress Report for Renewal Applications

Renewal applications must include descriptions of successful translation activities during the previous funding period since the last competitive review only and may not include activities during the years prior to the previous funding period, before the last competitive review as part of the progress report. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. Renewal applications must also justify continued funding of existing translation activities, in line with one or more of the focal priorities of this FOA.

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 in ASSIST, use Component Type 'Admin Core.'

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

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

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.

Detailed Budget for Initial Budget Period

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

Budget for Entire Proposed Period of Support

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

Funds should be set aside for annual travel to Center meetings. The meetings will be held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about NIH Stage Model translational research methods and findings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, and ideas.

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 Management and Administrative Core manages the activities of the Center, providing coordination, research planning, logistical, centralized resources, and technical support.

Describe plans to complete the required activities of this Core:

• Develop a strategic vision for the Center, ensuring that all relevant Stages of expertise that will be represented within the Center and the ways in which experts across the range of the NIH Stage Model will interact. 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 NIH Stage Model and 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 progress report to the NIA, in accordance with Section VI.
• Coordinate travel to Center meetings annually, held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about translational research methods and findings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, and ideas.

Optionally, the Core may describe plans to:

• Encourage and facilitate the development of networks among researchers, commercial interests, community interests, program design interests, and Governmental entities to support translation intervention development activities organized in accordance with the NIH Stage Model;
• Expand the reach of the Center's activities through strategic collaborations with, for example, private sector/commercial interests, non-profit organizations, research institutions, government agencies, etc.

It is expected that NIA will fund one Coordinating Center (CC) for the Roybal (P30) Centers program. The functions of the CC are described below. Applicants should commit to cooperate fully with the CC in its efforts to e.g., establish a multi-center website, coordinate conferences/workshops, arrange annual meetings, prepare research briefs, and respond to NIA Program Officials on behalf of the Centers program, etc. It is expected that the CC will request that all awarded Centers follow a standardized reporting template when preparing the annual Non-Competing Continuation Grant Progress Report (PHS 2590); awarded P30s should commit to submitting their PHS 2590s following the standardized format developed by the CC.

Progress Report for Renewal Applications

Renewal applications must include descriptions of successful translation activities during the previous funding period since the last competitive review only but must not include descriptions of successful translation activities or any other accomplishments prior to the previous funding period before the last competitive review as part of the progress report. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. Renewal applications must also justify continued funding of existing translation activities, in line with one or more of the focal priorities of this FOA.

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 (Management and Administrative 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 'Project.'

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

SF424 (R&R) (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 (Pilot Core)

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

Detailed Budget for Initial Budget Period

Each Roybal Center application must request funds to initiate pilot research that is consistent with the theme of the Center grant. 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.

Budget for Entire Proposed Period of Support

Each Roybal Center application must request funds to initiate pilot research that is consistent with the theme of the Center grant. Applicants may propose as many pilot projects per year as they wish while staying within the budget limits for the overall Center. Individual Core budgets should be prepared for all 5 years of the Roybal Center application.

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 (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 pilot projects. For the purposes of this FOA, Stage I studies and small-scale Stage 0, II, III, and IV studies will be referred to as "pilot" studies. Roybal pilots can include Stage 0, I, II, III, and IV pilot studies that are consistent with the theme of the Center. The expectation is that most research projects in the Roybals will be Stage I pilot studies and that pilot projects will provide the preliminary data that will lead to larger research efforts.

The Pilot Core can increase or decrease in relative size over the course of the funding period as the number of pilot projects varies.

Roybals can support pilot studies in Stages 0 IV of the NIH Stage Model. In addition to traditional pilot efficacy and effectiveness trials, Roybal pilot studies are encouraged to: 1) leverage a Stage 0 basic research finding to develop a principle-driven, implementable intervention; 2) examine the principles, or mechanism of action underlying a behavioral intervention ( Stage I, II, or III study); 3) create and/or modify, and pilot test real-world-friendly training procedures (Stage I); or 4) create and/or modify and pilot test methods to maximize real-world fidelity (Stage I).

The eligible groups for Roybal pilot studies include, but are not limited to, junior, underrepresented and established investigators at the Center institutions or at outside institutions, or in association with academic and/or corporate partners. While pilot projects may be proposed for one to three years' duration, it is expected that most will be funded for one year.

Application should:

• Address the pool of researchers from whom pilot projects would be solicited; describe the process by which pilot projects would be solicited and selected; and describe how the pilot process relates to the NIH Stage Model and the overall Roybal Center theme.
• Describe two Pilot Studies proposed for Year 1.

o Describe how the selected the theme is reflected in the selection of these two pilots.

o Identify and justify the scientific evidence base for the translational pilot project within the context of the appropriateness of the Stage of research proposed for the intervention, for each of the two pilots proposed.

o Identify the hypothesized mechanism of action or principles underlying the intervention. Explain how mechanism of action or principles will be studied in the pilot, as appropriate.

o Include detailed research strategies for the two Year 1 pilot studies.

• For Year 2 and thereafter of the Roybal (after Year I), propose and justify an anticipated pathway, through the Stages of the NIH Stage Model, of the two interventions proposed to be studied in Year 1. It is understood that depending upon the results of Year 1 pilot studies (and subsequent studies), anticipated pathways may or may not be appropriate to follow. Brief descriptions only are expected for the anticipated pilot studies in Year 2 and thereafter. Detailed research strategies are not requested and are not required for anticipated pilot studies in Years 2 through 5.
• Include an anticipated timeline for progression through the Stages for each of the two behavioral interventions proposed to be studied, (assuming there is scientific justification) over the course of the Roybal Center.
• Applicants must indicate in the Pilot Core Budget the budgets of the pilot projects are proposed to be conducted in Year 1. (See Section VI for information about prior approval of Pilot Projects for awarded Centers).
• Describe the internal institutional plans and procedures to ensure that all 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. All plans must be consistent with all relevant NIH policies and the NIA policies for human intervention studies. A master Data and Safety Monitoring Plan (DSMP) must be proposed for each Roybal that is applicable to all studies proposed and done in the Roybal.

Progress Report for Renewal Applications

Renewal applications must include descriptions of successful translation activities since the last competitive review. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. Renewal applications must also justify continued funding of existing translation activities, in line with one or more of the focal priorities of this FOA.

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 (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.

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.

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.

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.

A proposed Clinical Trial application 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 Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How significant is the chosen theme for advancement of behavioral intervention research to promote health and well-being? What is the strength of evidence base for the translation theme and the goal and Stage of the pilot projects proposed? Is there potential for significant scientific and translation progress (including infusing basic science into the intervention development pipeline, increasing knowledge regarding the underlying principles or mechanisms of the interventions being studied, readying an intervention for use in the community by simplifying, developing training materials, developing methods to maximize fidelity, etc.) in the specific themes and pilot projects addressed by the application? Is there scientific merit in the proposed pilot projects?

For renewal applications, to what extent have the translational behavioral intervention development activities in the previous funding period made efficacious behavioral interventions more principle-driven and readied them towards real-world implementation? To what extent has the Center justified continuation of the translation activities for another five-year period?

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

Do the investigators demonstrate familiarity with the practical domain or environment being investigated as well as with relevant aspects of aging research? Do the key personnel listed contribute relevant expertise - at all relevant Stages (0 through IV)- and effort to the project? Are there sufficient qualified personnel from whom to solicit project projects in order to achieve the goals of the Center?

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

To what degree will the Center stimulate new and important behavioral intervention development research, informed by basic behavioral and social science research that will improve the health, well-being, and productivity of mid-life and older people?

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, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the 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 children, justified in terms of the scientific goals and research strategy proposed?

Are the pathways described to move from one Stage of behavioral intervention development to the next Stage (or a previous Stage) likely to help produce interventions with maximal efficacy as well as maximal potential for implementation? Will the Center's approach to translation likely lead to significant practical outcomes?

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 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?

Is there significant ongoing research activity at the applicant and collaborating institutions that is relevant to the theme of the proposed Center? Does the environment facilitate the ability to conduct behavioral intervention research, informed by all relevant Stages of the NIH Stage Model, into significant practical outcomes for the benefit of mid-life and older people?

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

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 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

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

Not Applicable

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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

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 . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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).

• 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.
• 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.
• In the competing year, pilot projects (including those 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 should 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.
• NIA will not accept pilot project proposals at other times during the year there are unexpected opportunities or timeliness issues arise, if the institution wishes to redirect existing funds within the Center. If a pilot is proposed at another time, there must be a compelling justification citing the unexpected opportunity or timeliness issue. These pilot projects should be sent by email directly to the NIA Program Official and the NIA Grants Specialist, along with an explanation of how funds would be redirected.

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

Lisa Onken, 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]

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
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.