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 establish a Roybal Coordinating Center (CC). The Roybal Center program provides the infrastructure and resources to conduct state-of-science translational research to improve the health and well-being of individuals as they age. Roybal Centers support the development and piloting of behavioral interventions, translated from basic behavioral and social research. The NIA Roybal Centers program will be structured according to the NIH Stage Model, conducting multi-directional research at Stages 0 through IV of the behavioral intervention development pipeline with the goal of creating potent and scalable principle-driven interventions, programs, or practices at the individual or population level. Centers will focus on the full range of translational behavioral intervention development research in a variety of domains to improve the emotional and physical well-being of adults in mid-life and beyond. The current cycle of funding will support two sorts of Roybal Centers. Traditional Roybal Centers may have a broad focus and may study a variety of behavioral interventions to improve the physical and emotional well-being on individuals in mid-life and older people and the capacity of institutions to adapt to societal aging. AD-ADRD Roybals will focus on behavioral interventions to improve AD-ADRD care and caregiving. Roybal Centers will support pilot projects intended to lead to the submission of related translational behavioral intervention development applications for R01s or SBIRs to produce implementable, principle-driven interventions. Ideally, translation projects supported through the Roybal program will not only result in benefits to mid-life and older people but will also advance our fundamental understanding of basic scientific questions in the behavioral and social sciences of aging.

The Roybal CC will facilitate and coordinate trans-Roybal activities, including meetings and conference calls. The CC will work closely with the NIA Program Officer and, in coordination with all Roybal sites, be responsive to requests generated by key Roybal site personnel, NIA, NIH, the scientific community, and the general public. The Coordinating Center should have requisite expertise in relevant areas through the behavioral intervention development pipeline, from Stage 0 (basic behavioral science) through Stage IV (effectiveness or pragmatic trials), as defined by the NIH Stage Model, to support Roybal Centers in achieving the common goal of developing principle-driven interventions that advance understanding of mechanisms of change.

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

The Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging program was authorized by Congress in 1993 and named for the Chair of the former House Select Committee on Aging, Edward R. Roybal. In 2017, the NIA evaluated the Roybal program and found that the program has been successful in translating basic behavioral and social science into interventions, programs, and practices that improve the health and well-being of adults as they go through the aging process. The NIA considers the Roybal program as a model for translational behavioral and social intervention development research promoting successful aging.

The overarching goal of the Roybal Centers is to create principle-driven interventions that are highly real-world-friendly by conducting translational behavioral intervention development research, infused with basic science. To facilitate and inform the translational process and ultimate implementation, Roybal Centers are expected to seek an understanding the basic mechanisms or principles underlying the interventions being developed incorporating an experimental medicine approach, as defined by the NIH Science of Behavior Change Common Fund Program (SOBC), as appropriate. Roybals conduct pilot and preliminary research in Stages 0 through IV of the NIH Stage Model to promote the health and well-being of individuals as they age and are therefore expected to have appropriate expertise at all relevant Stages. Stage I studies are expected to be the most prevalent type of study within Roybal Centers since multiple Stage I studies (sometimes conducted in research settings, but other times conducted in community settings, depending upon the goals) are often needed to lay the groundwork for Stage III and Stage IV studies that lead to ultimate implementation.

The NIH Stage Model of behavioral intervention development: The NIH Stage Model provides a translational framework that integrates basic behavioral science and clinical science to produce principle-driven behavioral interventions. The Model encompasses the full range of behavioral intervention development from basic psychological 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 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.

Pilot/preliminary work in the first five Stages of behavioral intervention research may be supported within Roybal Centers:

• Stage 0 (Basic psychological science relevant to the development of behavioral interventions). Basic psychological science is defined in this announcement as research involving the examination of behavioral, cognitive, affective or social 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 basic research questions regarding behavior change may also be asked within the context of later Stage intervention development studies. These basic science questions of mechanisms of behavior change are relevant to every Stage of behavioral intervention development.
• Stage I (Generation, refinement, adaptation, pilot testing) encompasses activities related to the creation of a behavioral or social intervention, or the modification, adaptation, or refinement of an existing intervention, and the feasibility and acceptability testing of the new or adapted intervention. Stage I also involves the development or adaptation and pilot testing of an intervention manual to insure adherence to the underlying principles of the intervention. The development and testing of community-friendly research and training materials, and procedures for monitoring fidelity for interventionists/providers in community settings are necessary prior to progression to Stage III and later Stages, so it is a critical component of many Stage I studies. Stage I studies may be conducted in fully in research contexts or in community contexts.
• Stage II (Efficacy) 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 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)?" (Preliminary Stage II studies only)
• 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 research is designed to answer the question, "Can this intervention work when administered under highly controlled conditions in the real world?" Stage III may also provide information about the mechanisms or principles of behavior change responsible for any observed effects. (Preliminary Stage III studies only)
• Stage IV ("Effectiveness") 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. (Preliminary Stage IV studies only).

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

The Roybal Coordinating Center is intended to support the traditional and AD-ADRD Roybal Centers by facilitating and coordinating trans-Roybal activities. The CC will work closely with the NIA Program Officer and, in coordination with all Roybal and AD-Roybal sites, be responsive to requests generated by key Roybal site personnel, NIA, NIH, the scientific community, and the general public.

The Roybal CC will serve as a hub for the Roybal program. Activities may include but are not limited to: supporting research networks across a distributed set of Roybal and AD-ADRD Roybal Centers; sharing of best practices for conducting translational behavioral intervention research in line with the NIH Stage Model; and dissemination of Roybal and AD-ADRD Roybal scientific advances to the broader lay and scientific community.

The Coordinating Center will provide logistical support to the individual Roybal Centers by performing the following necessary functions:

• Make arrangements for a yearly Roybal meeting where scientific advances are shared. In coordination with Roybal and AD-ADRD-Roybal PD/PIs and NIA program staff, the CC will create the agenda for and chair that meeting. The CC will set aside a portion of its funds to support the Annual Investigators' meeting.
• Maintain a centralized database through which the Roybal and AD-ADRD Roybals can track pilot/preliminary study progress, including recruitment and retention data.
• Foster communication and cooperative arrangements between Roybals and other NIA research Centers (e.g., Centers on the Demography and Economics of Aging, RCMARs, Alzheimer's Disease Centers (ADCs), Nathan Shock Centers, Claude D. Pepper Centers).
• Arrange for and host PD/PI conference calls such as monthly PD/PI conference calls, as needed.
• Support centralized infrastructure, resources, and sharing of best practices in the development of principle-driven interventions.

The CC will create mechanisms for maintaining active involvement for all sites in all aspects of the program. Such involvement should include:

• Link and foster joint activities between various Roybal sites, based upon available funds. This may include supporting pilot funding, workshops or other collaborative efforts serving the broader Roybal program.
• Answer queries from the scientific and lay communities about the program.
• Link other NIA-supported research activities and Centers to the unique expertise of the Roybals.
• Actively demonstrate to a broad and diverse audience the Roybals' impact upon the health of mid-life and older Americans.
• Coordinate and facilitate communication and activity among the Centers.

The CC will be proactive in establishing a mechanism for informing and making visible scientific advances of Roybal scientists to the research community, policymakers, and other relevant stakeholders. The CC will:

• Highlight Roybal and AD-ADRD Roybal research advances related to relevant research areas identified by the Program Officer, including advances related to the National Advisory Council on Aging recommendations from their 2013 review of the Division of Behavioral and Social Research, the AD-ADRD Research Implementation Milestones, etc.
• Keep all Roybal Centers apprised of each participating Roybal Center's scientific activities. Efforts in this regard should involve other NIA-funded Centers and major research projects as well as the broader research community, at relevant national and international scientific meetings.
• Highlight Roybal advances in principle-driven behavioral intervention development research in aging.
• Maintain an active Roybal website with links to each Roybal site and the NIA. The website will serve as the source of information dissemination to scientific and lay audiences and will be accessible and readily identifiable.

Additional activities or functions may be proposed to promote collaboration among Roybal sites, encourage interactions between the Roybal program and other NIA- and NIH-supported resources, and enhance the value and visibility of the Roybal program as a whole.

The goal of this FOA is to establish a Coordinating Center (CC) to provide coordination and support of a set of Roybal Centers (Including traditional Roybal Centers and AD-ADRD Roybal Centers) aimed at enhancing translational research in the behavioral and social sciences. The Roybal Centers will conduct research at relevant Stages of the behavioral intervention development pipeline, to produce potent and highly implementable principle-driven interventions that promote the health and well-being of adults as they age. The goal of the CC is to potentiate the success of the Roybal Center program. The CC is charged with maintaining data to facilitate future NIA Roybal program evaluation. The CC will also support information exchange among Roybals, including facilitating sharing of best practices and good clinical practice. The CC will facilitate scientific dissemination across participating Roybal and AD-ADRD Roybal Centers and Research Education programs, other NIA Centers, and the broader scientific community. The success of the program will be determined by the extent to which traditional Roybals and AD-ADRD Roybals, supported by this Coordinating Center, lead to impactful publications and to successful grant awards for principle-driven intervention research in priority areas of behavioral and social research on aging.

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:

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@nih.gov

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

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

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

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

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

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

The PD/PI of the Roybal CC must be the lead Director of the center and is the person responsible for the overall management of the CC; if there are multiple PDs/PIs of the CC, the MPIs will serve as co-Directors. The relationship between the CC and the traditional Roybals and AD-ADRD-Roybals should be one of equal and substantial partners in all joint activities.

The CC team is expected to have significant experience and knowledge in priority areas of behavioral and social science research on aging, including research on health disparities; in program management and coordination; and in support of activities to promote diversity in the scientific research workforce.

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

The CC will be responsible for organizing and attending annual face-to-face meetings. These meetings are meant to facilitate coordination among Roybals, AD-Roybals, and any subcommittees in which they participate. The CC application budget should include funds for organizing the annual meeting and for travel of the CC PD(s)/PI(s) and key CC personnel to the meeting. The CC is not responsible for the travel of participants from individual Roybal and AD-Roybal sites.

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: Describe plans for accomplishing the following four objectives of the Roybal CC:

1) Working in collaboration with approximately 12-16 traditional Roybals and AD-ADRD-Roybals in order to facilitate and coordinate trans-Roybal activities including: providing logistical support to the Roybals and the NIA Program Officer to arrange a yearly Roybal meeting; developing and maintaining a database for collecting information from the Roybal Research Education Components on research advances from pilot projects and Roybal scholar progress; fostering communication and collaborative arrangements between Roybals and other NIA research Centers; and arranging for and hosting monthly PD/PI conference calls, as well as arranging for similar calls and support for the various Cores, as needed.

2) Creating mechanisms for maintaining active involvement for all sites in all aspects of the program.

3) Establishing a mechanism for making visible scientific advances of Roybal scientists to the research community, policymakers, and other relevant stakeholders.

4) Maintaining an active Roybal website with links to each Roybal site and the NIA

Applicants should describe how the CC will function to serve as the Roybals' point-of-contact for linking the Roybal and AD-ADRD-Roybal Centers with one another, with other NIA Centers, and with the broader scientific community around priority areas of behavioral and social science on aging, including topics related to AD-ADRD.

Applicants should describe how they will support Roybal research and advances in behavioral and social intervention development research, as conceptualized by the NIH Stage Model, as well as Roybal activities related to the recruitment and retention of diverse older adults for aging research. Applicants should describe how they will support Roybal activities aimed at diversifying the scientific workforce in behavioral and social research on aging. The application should highlight how the relevant expertise of the team will support these activities.

Applicants should describe their organizational plan and management structure for providing administrative support for the activities of the Roybal program.

Evaluation Plan Applications must include a clear description of their objectives and a plan for evaluating the Coordinating Center, including all activities supported by the CC, in line with the broader Roybal goals. The application must specify baseline metrics of CC activities (e.g., numbers and characteristics of workshop participants, scientific dissemination, databases, users of resources), as well as clearly defined milestones with metrics to gauge the short or long-term success of the CC in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. The CC evaluation plan should focus on the activities of the CC, not the entire Roybal program. NIH will evaluate the entire Roybal program (traditional Roybals, AD-ADRD Roybals, and CC) in five years, including the role of the CC in fostering the success of the Roybal program. Based on the review, NIA will evaluate the effectiveness of the program, and determine whether to (a) continue the program as currently configured; (b) continue the program with modifications; or (c) discontinue the program after sunset and review period.

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:

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.

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 Center address the needs of the research programs that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?

Is there strong evidence of the availability of sufficient scientific expertise and of the ability to work with scientists to serve as the Roybal's point-of-contact for a broad scientific community around priority areas of behavioral and social science intervention development in aging, including topics related to the NIH Stage Model, the SOBC experimental medicine approach, AD-ADRD; advances in principle-driven mechanism-focused behavioral intervention development research; recruitment and retention of diverse older adults for aging research; and activities aimed at diversifying the scientific workforce in behavioral and social research on aging?

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

Does the investigative team have relevant experience and expertise in project management and coordination required for this CC? Will the investigative team proposed by the Roybal CC be able to facilitate cooperation between behavioral and social basic and intervention development scientists across a wide range of fields?

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the proposed procedures for communication and cooperation among Roybals adequate? Are there appropriate plans to coordinate interaction between the Roybals and other NIA Center programs?

How extensive is the experience of the team, and how reasonable is it to expect further success, in providing diverse sites with logistic support in arranging annual meetings, preparing pre- and post-meeting materials, and the coordination of Roybal Center activities (e.g., preparation of presentations at professional meetings)? To what extent is there evidence that the Center will be able to foster or has fostered interaction between sites for sharing developments and findings such as new research tools, recruitment and retention strategies that work/do not work, etc.? How strong is the evidence that the CC can coordinate and maintain on-time progress reporting through a database for the cumulative progress reports or other documents?

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

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 NIA, 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.

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: support@grants.gov

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

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-493-3136
Email: lisa.onken@nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: Ramesh.vemuri@nih.gov

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

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

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