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

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

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

The Claude D. Pepper Older American Independence Centers (OAIC) program was established in honor of the late Representative to establish centers of excellence in research and research education to increase scientific knowledge leading to better ways to maintain or restore independence in older persons.

The OAIC awards are designed to develop or strengthen awardee institutions programs that focus on and sustain progress in a key area of aging research. Applicants should identify an area of focus in which progress could contribute to greater independence for substantial populations of older persons and offer opportunities for education in aging research. This area of focus should be a common theme around which all proposed OAIC activities are organized. NIA's expectation is that an OAIC, in a given area of focus, will:

• Provide intellectual leadership and innovation;
• Facilitate and develop novel multidisciplinary and interdisciplinary research strategies;
• Stimulate incorporation of emerging technologies, methods, and scientific advances into research designs, as appropriate;
• Provide research education for future leaders in geriatric research;
• Stimulate translation between basic and clinical research (e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research or studies to improve understanding of mechanisms contributing to clinical or functional findings);
• Promote translation of clinical research findings into practice in relevant healthcare settings (see also "Health Services Research as an Area of Focus" below);
• Collaborate substantially with other OAICs on multi-center projects such as integrating data systems, supporting multi-center observational studies, and providing infrastructure to support multi-site clinical trials, including pragmatic trials;
• Interface where possible with the NIA Research Centers Collaborative Network (RCCN) and other NIA-funded programs and centers (e.g., Resource Centers for Minority Aging Research (RCMARs), Centers on the Demography and Economics of Aging, Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging, Alzheimer's Disease Centers (ADCs), Nathan Shock Centers);
• Leverage institutional resources, including other NIH-supported programs and centers, to achieve the OAIC's aims with efficiency; and
• Serve as a source of advice and collaboration to other investigators locally and on a large scale regarding technology, methodology, analysis, or other expertise.

To achieve the objectives listed above, each OAIC should promote a sustained research program in an area of focus through which the Center will accomplish the innovation, leadership, collaboration, and research education functions described above. It is crucial to the design of an OAIC to identify an important research area to be addressed, to specify the goals to be achieved within the five-year OAIC award period, to provide a plan to reach these goals, and to outline a method to evaluate progress toward these goals during the course of the OAIC award. The selection of core activities (see below) should follow from these considerations.

An OAIC may select an area of research focus from a broad range of topics, including but not limited to:

• Aging related issues concerning a specific condition contributing to loss of independence in older persons (e.g., role of aging changes in the etiology of the condition; special issues in the diagnosis, treatment, or prevention of the condition in old age; complications, disability, or symptoms from the condition found principally in older persons).
• Causes, assessment, prevention, and treatment (including rehabilitation) of a specific type of disability in older persons.
• Causes, prevention, and treatment of geriatric syndromes (e.g., sarcopenia, falls, incontinence) that are related to multiple pathologies and/or disabilities.
• Specific aging-related physiologic changes, other risk factors, and/or interventions (e.g., physical activity) that affect risk for multiple conditions or disabilities in old age.
• Interactions of multiple diseases, disabilities, and interventions (e.g., medications) in older persons and their relationship to risk of morbidity, progression of disability, and efficacy of prevention or treatment strategies.
• Factors contributing to amelioration or delay of multiple deleterious aging changes by modulating risk factors or fundamental aging mechanisms.

In general, each research focus described above has the potential for a wide range of developmental and infrastructural activities that are likely to be interdependent and synergistic. Thus, an OAIC strategy of selecting several key activities that address its area of focus may have unique benefits.

As the level of funding for individual OAICs is unlikely to allow such a set of activities for more than one focus area, applicants are strongly encouraged to select an area in which their strengths allow their OAIC to fulfill NIA's goal for the OAIC program and to direct their proposed OAIC activities toward that research area, while also ensuring that opportunities exist for collaboration among other OAICs and other NIA programs and centers. The total impact of an OAIC's activities on progress in the selected field(s) should be a major criterion in selection of the focus area and will be a major criterion in peer review and program evaluation.

To capitalize on important new research opportunities within their institutions, OAICs may also support a limited amount of activity in their cores on topics other than those in their area of focus (see below). Applicants who anticipate providing such support should propose a system for identifying these opportunities and needs and for selecting core activities to address them.

Cognitive and Behavioral/Social Research as an Area of Focus. Cognitive or behavioral/social research should not be the major focus of an OAIC, as these areas are more appropriate for other NIA programs that also use the Center mechanism. However, where appropriate, OAICs are encouraged to support a multidisciplinary approach that includes research in these areas as they relate to the theme or focus of the OAIC.

Health Services Research as an Area of Focus. Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of healthcare providers, is generally appropriate for an OAIC or a component of an OAIC if it meets the following two criteria, in addition to the criteria above that exclude the major focus on cognitive and behavioral/social research:

1. The research is designed to obtain new knowledge about a) the effects of interventions or healthcare practices that clearly specify what will be done for, or by, the individuals treated by these interventions or practices; or b) the validity or predictive value of diagnostic or assessment techniques that clearly specify what will be measured in individuals. Examples of interventions or diagnostic strategies that may meet this criterion include:

• New drug or hormonal intervention protocols that may require a new organizational strategy to deliver them
• Disability prevention strategies based on application of treatment algorithms
• Structured physical activity programs
• New diagnostic measures for an age-related condition (e.g., tests for diastolic dysfunction)
• Determining validity or predictive value of a functional assessment algorithm

2. The research is designed to determine health or risk-factor effects relating to outcomes that are primarily clinical or functional (other than cognitive) in the individuals treated by the intervention or practice. Examples of outcomes include:

• Disease and risk-factor outcomes, including diet and physical activity
• Functional outcomes
• Physiologic outcomes

Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of healthcare providers, would generally not be appropriate as a principal focus of an OAIC or OAIC component if either of the following two criteria were met:

1. The research is neither designed to obtain new knowledge about a) the effects of interventions that clearly specify what will be done for, or by, the individuals treated by the intervention or practice, nor b) the validity or predictive value of diagnostic or assessment techniques that specify what will be measured in individuals. Examples of diagnostic or intervention research that would generally be considered inappropriate as a principal focus for an OAIC or component of an OAIC include:

• Testing effects of a geriatric assessment unit or other new health care service, without both a) specification of the assessment protocol, criteria for deciding on appropriate treatment, a protocol for implementing treatment, and an adequate design to evaluate effects of these specific elements; and b) a design adequate to determine the effects of these specific components.
• Testing the effects of adding a new type of health professional (e.g., pharmacist) to a hospital service without both a) specification of the change in specific diagnostic or intervention procedures that would be implemented, and b) a design adequate to determine the effects of these specific changes.

2. The research is not adequately designed to determine health or risk-factor effects relating to outcomes that are primarily clinical or functional (other than cognitive) in the individuals treated by the intervention or practice; for example:

• Research designed to determine effects only on healthcare providers' behavior (e g., time spent per patient or number of diagnostic tests performed).
• Research designed to determine effects only on patients' behavior (e.g., adherence to a set of dietary guidelines).

Applicants are strongly encouraged to visit the NIA OAIC webpage for additional guidance, recommended page formats, and answers to frequently asked questions.

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) 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.
• o 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST 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.

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.

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:

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Fax: 301-402-0066
Email: [email protected]

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Leadership Administrative Core (LAC))	6
Core (use for Resource Cores (RCs), Pilot/Exploratory Studies Core (PESC), and Information Dissemination Core (IDC))	6 pages per core
Research Ed (use for Research Education Component (REC) (RL5))	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; maximum 1

Leadership Administrative Core (LAC): required; maximum 1

Resources Cores (RCs): required; maximum 5

Pilot/Experimental Studies Core (PESC): optional

Information Dissemination Core (IDC): optional

Research Education Component (REC): required; maximum 1

When preparing your application, 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.

Project Summary/Abstract: Present a brief overview of the entire application and summarize the general plan and goals for the proposed OAIC.

Facilities and Other Resources: Include information here regarding the interrelationship of the OAIC to other activities in the applicant's institution (e.g., other relevant research centers and projects) and the extent of institutional, departmental, and interdepartmental cooperation (a chart or diagram may be used). In addition, describe the administrative relationships of the proposed OAIC to the institution. Include relevant issues relating to institutional commitment and settings.

Information provided in this section should be limited to describing the resources and environment available to the OAIC as a whole or its components. Applications may not proceed to review if the Facilities and Other Resources section contains information belonging elsewhere in the application.

Enter primary site only.

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

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

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

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

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

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component, which should be a summary response to the concerns expressed about the overall OAIC during the previous review.

Specific Aims: Describe the goals to be achieved by the OAIC, including the OAIC's selected area of focus and basis for selection; crucial problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the OAIC would address in the focus area selected; and advances in regard to these problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the OAIC would achieve over its five-year award period.

Research Strategy:

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

New proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities for establishing an OAIC. Renewal applications from existing OAIC sites may use this section to present overall progress report information not contained in specific core sections of the application (with citations where appropriate). Tables of OAIC activities during the previous funding period can be presented here, provided they fit within the page limits of this section.

For renewals and resubmissions, include the following additional information:

Renewals. If cores included in the prior period of support are not part of the current submission, describe their progress and explain why they are not included. Identify and justify any substantive differences in approaches from the prior period of support. Identify and justify any changes in research emphasis and level of funds requested. If the structure of cores has changed, show the correspondence to the prior structure.

Resubmissions. Follow SF424 instructions for resubmissions. If the structure of cores has changed, show the correspondence to the prior structure.

Approach. Present the OAIC's overall strategy for serving as a sustained resource to the research program in its selected area of focus. Describe how it will accomplish the innovation, intellectual leadership, translational, interdisciplinary, collaborative, and research education functions expected of an OAIC. Describe the specific activities that the OAIC will undertake to accomplish the goals and strategy described above, including how the different components of the OAIC will interact to help accomplish them, how the approaches of the cores complement each other or are inter-dependent, the mechanisms to ensure coherence of the Center and maintenance of an interdisciplinary focus, and the mechanisms to be used in assessing progress toward the OAIC's goals. Where appropriate, provide timelines and organizational charts. Note the major OAIC cores and other activities, referencing appropriate subsequent sections of this application that contain more detail.

Innovation. Considering the OAIC as a whole, show how the proposed OAIC seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Show how these concepts, approaches, methodologies, instrumentation, or interventions are novel to the research field or novel in a broad sense. Show how the proposed OAIC will refine, improve, or apply in a new way the concepts, approaches, methodologies, instrumentation, or interventions proposed.

Letters of Support: Place institutional letters of support for the OAIC as a whole in this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Only 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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide information on data and safety monitoring pertinent to the OAIC as a whole according to the guidance on NIA's OAIC webpage.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type 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 Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD(s)/PI(s) for the OAIC application should be the Core Lead(s) for the LAC. The Core Lead(s) should have sufficient expertise in the OAIC's area of research focus to exercise effective scientific judgment and leadership.

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

Up to $150,000 in first-year direct costs may be requested for LAC activities. The LAC budget should include travel expenses for OAIC personnel to attend the annual OAIC investigators meeting.

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed LAC during the previous review.

Specific Aims: The LAC is responsible for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals of the OAIC. Provide an overview of how the LAC will implement the theme or focus of the OAIC.

Research Strategy: Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Describe the overall role of the LAC in the OAIC.

Approach and Innovation. The LAC should conduct or organize the following activities:

• Regular review of utilization of core resources by the other OAIC cores and reallocation of resources within or among cores.
• Assessment of scientific opportunities for new utilization of core resources and plans to utilize them. One topic that should routinely be assessed is the potential for translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research, or studies to improve understanding of the mechanisms contributing to clinical or functional findings.
• Assessment of potential areas for collaboration among OAIC cores within the Center and with other OAICs or other projects, and planning for collaborative activities, if merited.
• Review of proposed Developmental Projects and Pilot/Exploratory Studies by an independent panel or panels. The LAC may elect to convene a single panel or separate panels to conduct reviews of the above activities. Panels may meet in person or by teleconference. Ad hoc reviewers may be invited to participate in the panels to address specific projects in their areas of expertise.
• Constitution and convening of an External Advisory Board (EAB). An EAB, whose members are entirely external to the institution(s) of the proposed OAIC, should convene yearly to review the progress of the OAIC. The EAB's non-binding recommendations are communicated directly to the LAC to inform its administration of the OAIC. The operating procedures of the EAB, including the frequency of its meetings and the methods for the identification of members, should be specified; however, for new applications, the names of potential EAB members should not be included in the application, and potential members should not be contacted until the OAIC is awarded. Inclusion of at least one Director or Core Leader from another OAIC is encouraged. EAB membership consisting entirely of Directors or Core Leaders from other OAICs is discouraged. There is no set number of EAB members; however, there should be sufficient expertise represented among the members of the EAB to provide an adequate review of all the functions of the OAIC. EAB meetings can be held in person and/or by remote conferencing, as appropriate to the needs and budget of the OAIC. A report of the EAB's annual review should be included in the yearly NIH progress report.
• Coordination of attendance of OAIC personnel at an annual OAIC Investigators meeting. Participation of OAIC leadership at the annual meeting is mandatory. Participants include the PDs/PIs, Center Administrator, Core Leads, and others as appropriate for purposes of programmatic coordination and scientific exchange. The meeting is typically held in the Washington, D.C. area.
• Timely submission of documents to the OAIC Coordinating Center for inclusion in the Annual Pepper Center Directory.
• Preparation of administrative documents relating to the award.

Additional activities for which the LAC may provide support include research planning meetings (including participants from other institutions), invited scientific presentations, and travel expenses for OAIC staff to visit other OAICs for collaborative projects.

Renewal applications from existing OAIC sites should use this section to present progress report information specific to the LAC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed LAC.

Describe the administrative structure of the LAC, the administrative relationships between the LAC and all other OAIC components, and the ways in which they will interact to achieve the OAIC’s goals and maintain quality of the OAIC. Describe the activities of the LAC leader(s), the Center Administrator, and other LAC staff in carrying out LAC functions. A crucial component of this description is the activities of the LAC leader in monitoring, stimulating, sustaining, evaluating, and reporting the OAIC s progress toward the overall goals of the OAIC. Present plans to establish and operate OAIC advisory panels, including criteria for selecting advisors, how they will be identified, the operating procedures of each panel, and the frequency of meetings. Advisory panels include:

• An External Advisory Board (EAB) as described above
• Other advisory panels to assist in selecting Pilot/Exploratory Studies, Developmental Projects, and participants in the Research Education Component (REC). At least one-third of the members of these panels should be external to the OAIC and the grantee institution(s), and panels should exhibit gender diversity. The advisory panel for the REC should be described in that component under Other Attachments. New applicants should not name potential advisors or select advisors prior to peer review of the application.

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.

Appendix:

Only 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

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

RCs will provide resources to (a) enhance or support OAIC-supported projects (i.e., Pilot/Exploratory studies, REC projects) and projects funded primarily by other mechanisms (i.e., External Projects) and (b) develop and validate model systems (e.g., animal models); methods; assays; analytic techniques; equipment; and/or diagnostic, assessment, or survey instruments to advance aging research (i.e., Developmental Projects).

The RC should be based on a research field or function that contributes to the OAIC area of focus. The RC should synergize with other OAIC components rather than merely support existing non-OAIC-funded projects. An RC may be defined in terms of a biomedical or biotechnology field (e.g., clinical trials, endocrinology, geriatric assessment, bioengineering); a service function (e.g., subject recruitment and retention, pathology, genotyping); or a supply function (e.g., animal care and use). Examples of possible RCs include, but are not limited to, the following:

• Recruitment/screening/assessment/registry units for subjects in clinical research protocols, including clinical trials
• Diagnostic and pathophysiologic units for studies of mechanisms of treatment response and interactions with disease
• Basic science laboratories providing assays or other measures of cellular, molecular, or biochemical factors for clinical or basic studies
• Biostatistical/data management units
• Cost-effectiveness analysis units
• Units for the support of laboratory animals used in aging research and the development of animal models of age-associated diseases

In designing an RC, the applicant is strongly encouraged to consider the full range of disciplines, technologies, methodologies, services, and resources that could be applied to the OAIC's selected area of focus; however, there is no requirement that an RC include this full range. The selection of areas for an RC should be made on the basis of the contribution of services and support to the overall goals of the OAIC.

SF424 (R&R) Cover (RC)

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 (RC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (RC)

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) (RC)

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 (RC)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Note: Leaders of Developmental Projects are considered Senior/Key personnel.
• 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 (RC)

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

There is no budget limit for an RC per se; rather, budget limits for RCs apply to their Developmental Projects (DPs; see description below). First-year direct costs for each DP should range between $35,000 and $70,000. DPs may last from 1 to 5 years.

Salary and other expenses for the Core leader and administrative staff may be requested. Research-related patient care costs are eligible for support though the RCs, but routine patient care costs may not be requested. Cost-recovery strategies may be proposed but are not required.

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 (RC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. For Resubmissions, the Introduction should be a summary response to the concerns expressed about the proposed RC during the previous review.

Specific Aims:

Show the intended role of the Resource Core in relation to the Center as a whole and to the theme of the Center. Use this section to summarize the specific aims of each External Project (EP) or Developmental Project (DP) (defined below). Any proposed RC must support 1) at least two projects (DPs and/or EPs) and 2) no more than two DPs.

If an EP is supported by more than one OAIC RC, list the EP in each RC and indicate the RC where the initial description can be found. An RC should be proposed only if it clearly serves the aims and theme of the OAIC. Applicants should consider the feasibility of supporting multiple RCs within the allowable OAIC budget.

Research Strategy:

Organize the Research Strategy into sections on Significance and Approach & Innovation.

Significance. Provide a clear statement of the way in which an individual RC will enhance the scientific productivity of the projects and assist the Center investigators to realize the OAIC's objectives in its area of focus. Clearly distinguish between material support (e.g., performing assays, facilitating recruitment) and support in the form of guidance or advice. Explain the intended strategy in developing this resource and how research quality and efficiency would be enhanced by use of the services of the RC. Specify pertinent uses of the RC by junior faculty and how such use will promote research leading to increased independence of older persons. Describe how each EP or DP planned for support through this core will achieve the goal of the RC and the overall goals of the OAIC.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the RC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed RC.

Describe the operations of the RC. Innovative organizational approaches are encouraged. Plans for the RC's scientific and administrative functioning should be presented. Present a detailed plan for how EPs and DPs eligible for RC support will be reviewed, selected, and prioritized for access to the RC resources for all years of the grant period. Include a plan for outreach to a gender diverse applicant pool. Describe how the Core Lead, together with the OAIC PD(s)/PI(s), will monitor and evaluate ongoing progress of EPs and DPs in the context of RC support. This plan should include the use of an advisory committee, the composition and functioning of which should be described in detail in the LAC research strategy.

In general, RCs are expected to interact with the studies they support, providing expertise in the design, conduct, and analysis of results, as well as technical services or products. Hence, support for professional staff time for such interactions is encouraged where appropriate.

Developmental Projects (DPs)

DPs are projects aimed at technology, resource, and/or methods development in order to establish new methods or technologies that will enrich the resources of the RC or the services it provides. DPs that challenge existing paradigms or develop new methodologies or technologies are highly valued. Examples of activities in DPs are listed below; however, this list does not describe the full range of supported activities, nor is it intended to direct applicants towards these areas:

• Development or preliminary testing of new data acquisition methods or technologies, assays, materials, or instruments to assess their feasibility and potential to provide important information, relevant to the OAIC focus, that is not available or is less feasibly obtained with current methods. The range of approaches in which such projects may be conducted includes genetic, molecular, biochemical, engineering, imaging, clinical diagnostic, functional assessment, bioinformatic, and survey methods
• Development and testing of new analytic and computational strategies for data to allow more informative results from studies in the OAIC area of focus
• Preliminary evaluation of new animal models for relevant age-related outcomes

For each DP, list the Title, Core Lead and Senior/Key Personnel, a description of the approach that the DP will use to achieve its goals, a clear analytic plan, and any innovative aspects. Also describe how DPs will interact with other cores of the OAIC. Each RC may support a maximum of 2 DPs, each lasting 1-5 years.

NIA requires that program staff be notified of DP awards made by an OAIC to its investigators. This can be done at the time of the progress report, unless the DP is a human subject study involving more than minimal risk, in which case a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

External Projects (EPs)

EPs are basic and/or clinical research projects relevant to the OAIC focus whose support is independent of the OAIC (i.e., research funded through other NIH or non-NIH mechanisms). RCs may provide services to enhance and integrate the scientific contributions of External Projects (EPs), provided that such support contributes to the overall goals of the OAIC. For each EP proposed for RC support during the first year of the OAIC grant, list the PD/PI, title of award, source of award, and duration of external support. In addition, briefly present the approach and any innovative aspects of each EP if these descriptions are not presented elsewhere. If the EP is presented elsewhere, indicate the section in the application where the initial description can be found.

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.

Appendix: Only 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 (RC)

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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide RC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

OAICs may conduct Pilot/Exploratory Studies (PESs) to acquire information needed to select or design future crucial studies in the OAIC area of focus.

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (PESC)

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 (PESC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (PESC)

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) (PESC)

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 (PESC)

ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• Pilot/Exploratory Study award recipients are considered Senior/Key personnel.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (PESC)

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

Up to $300,000 in first-year direct costs may be requested for the PESC. Each Pilot/Exploratory Study (PES) is limited to $100,000 in direct annual costs and 3 years in duration.

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 (PESC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. For Resubmissions, the Introduction should be a summary response to the concerns expressed about the proposed PESC during the previous review.

Specific Aims: Outline the topic areas to be solicited and the expected outcomes for pilot or exploratory study awards. PESs may be led by junior or senior investigators.

Examples of PESs that may be supported by the PESC include, but are not limited to, the following:

• Preliminary testing of an intervention or other research protocol in humans or animals for safety, feasibility, or determination of optimal time course or dosage
• Analysis of data acquired in previous or ongoing studies to explore hypotheses that may guide the selection and design of future studies

Describe up to 5 PESs to illustrate the function and scope of the PESC. The specific aims of each proposed PES must address the relationship of the PES to the overall theme or focus of the OAIC.

Research Strategy:

Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Describe how the PESs will fit within the goals of the PESC and how they will interact with the OAIC's other cores.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the PESC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed PESC.

Describe the operation of the PESC and the types of applications that will be supported. Provide a detailed plan for how PESs will be solicited (including outreach to women and minority applications), peer reviewed, selected, prioritized for access to PESC resources, and overseen. This plan should include the use of an advisory panel, the composition and functioning of which should be described in detail in the LAC research strategy. Describe how the Core Lead(s), together with the OAIC PD(s)/PI(s), will monitor ongoing progress of studies and assist in the planning for the development of PESs into independently funded grant applications, where appropriate.

Up to 5 PESs may be described. Number each PES sequentially (i.e., PES-1, PES-2, etc.). For each PES, list the Title, Project Lead, and Senior/Key Personnel, and provide a brief description of the significance, approach, and any innovative aspects. In describing each PES, applicants are encouraged to avoid details that are immaterial to the aims of the PESC or the theme of the OAIC. Descriptions of proposed PESs are intended to illustrate the scope of the PESC and its integration with the rest of the OAIC.

NIA requires that program staff be notified of PES awards made by an OAIC to its investigators. This can be done at the time of the progress report unless the PES is a human subject study involving more than minimal risk, in which case a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

Participating researchers in OAICs are encouraged to consider also seeking additional sources of funding for pilot or exploratory studies.

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.

Appendix: Only 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 (PESC)

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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide information on data and safety monitoring pertinent to the OAIC as a whole according to the guidance on NIA's OAIC webpage.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

An IDC supports activities to disseminate information relating to the OAIC's research areas and/or to enhance translation of clinical research findings into healthcare practice.

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (IDC)

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 (IDC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (IDC)

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) (IDC)

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 (IDC)

ASSIST will default to Project Lead. If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (IDC)

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

Up to $60,000 in first-year direct costs may be requested for IDC activities.

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 (IDC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. For Resubmissions, the Introduction should be a summary response to the concerns expressed about the proposed IDC during the previous review.

Specific Aims: Describe the role of the IDC in enhancing translation of clinical research findings into healthcare practice. IDC activities may include communication with professional societies and private and public organizations responsible for health care of older persons or policies affecting clinical research on older persons. Examples of possible activities include, but are not limited to, preparation of information and organization of briefings for key healthcare organizations, collaborative activities for information exchange among multiple governmental and non-governmental organizations, and participation in the development of evidence-based practice guidelines by professional societies.

Research Strategy: Organize the Research Strategy into sections on Significance and Approach and Innovation.

Significance. Explain the purpose and functions of the IDC. Present a clear statement of how the IDC relates to the theme or focus of the OAIC and how it will contribute to the goals of the OAIC.

Approach and Innovation. Renewal applications from existing OAIC sites should use this section to present progress report information specific to the IDC. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities specific to the proposed IDC.

Describe the operation of the IDC. Describe the types of activities that the IDC will conduct to disseminate information relating to the OAIC’s research areas. Describe the organizations and/or institutions that will interact with the proposed IDC. Provide a plan describing how the proposed activities of the IDC will selected and evaluated. Describe how the IDC will interact with other cores of the OAIC, including the LAC.

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.

Appendix: Only 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 (IDC)

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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide information on data and safety monitoring pertinent to the OAIC as a whole according to the guidance on NIA's OAIC webpage.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

The overarching goal of the Research Education program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral, and clinical needs in aging-related research. The REC will support creative educational activities with a primary focus on providing research experiences and mentoring to promote the development of future research leaders in the OAIC area of focus, particularly leaders who can integrate clinical insights regarding health/disease and independence/disability in old age with knowledge of advances in the basic sciences to improve clinical interventions for maintaining health and independence.

When preparing your application, use Component Type Research Ed.

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

SF424 (R&R) Cover (REC)

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 (REC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (REC)

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.

Other Attachments: REC Advisory Committee

An Advisory Committee is a required component of the REC. Provide a plan for the appointment of an Advisory Committee to select and monitor progress of REC participants. The composition of the committee, including diversity of membership; roles, responsibilities, and desired expertise of committee members; frequency of committee meetings; and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the REC program. New applications should not include the names of proposed Advisory Committee members, and proposed members should not be contacted prior to peer review.

At least one-third of the members of the REC Advisory Committee should be external to the OAIC and the grantee institution(s). REC Advisory Committee membership need not be different, in total or in part, from those of other OAIC advisory panels.

The REC Advisory Committee description must not exceed one page in length and should only include information related to the REC Advisory Committee. Applications that exceed this limit or use this page to describe information unrelated to the REC Advisory Committee may not be reviewed.

Project /Performance Site Location(s) (REC)

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 (REC)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• Note: REC program faculty and REC participants are not considered Senior/Key personnel in the REC
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (REC)

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

Follow all instructions provided in the SF424 (R&R) Application Guide, with the following additional modifications, as noted.

• Up to $450,000 in first-year direct costs may be requested for REC activities.
• Funds for salaries and other expenses of the Core Lead(s), information resources, and support staff may be requested.
• The REC provides support to participants, including salary, fringe benefits, training, travel, and research-project-related expenses. REC participant costs must be itemized in the proposed budget.
• Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.
• There is no minimum salary or professional effort requirement for REC participants. REC participants may receive salary support from other federal sources consistent with the institution's salary scale as long as those sources do not specifically prohibit such salary supplementation. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the REC as participants, but may not receive salary or stipend supplementation from the REC.
• Because the RL5 program is not intended as a substitute for an NRSA institutional training program (e.g., T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.
• Expenses for foreign travel must be exceptionally well justified.
• Indirect costs (Facilities & Administrative costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition, fees, and expenditures for equipment).

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 (REC)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction should be a summary response to the concerns expressed about the proposed REC during the previous review.

Specific Aims:

Describe the contribution of the REC to the OAIC s overall goals. Describe how the proposed use of REC funds for research education activities and research projects will contribute to the OAIC's goals for research education in its selected area of research focus. Describe how the REC Lead(s) and other mentors will help implement the intended goals of the REC.

Research Strategy:

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components (described below):

Proposed Research Education Program

Core Lead(s)

Program Faculty

Program Participants

Recruitment Plan to Enhance Diversity

Plan for Instruction in the Responsible Conduct of Research

Evaluation Plan

1. Proposed Research Education Program

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are ongoing in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the pre-established training program.

The research education program should include mentoring and research experiences. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe plans to accommodate differences in preparation among participants. Include information about mentored research experiences and other educational activities essential for the proposed program.

Describe the plan for recruiting, selecting, mentoring, and monitoring the progress of diverse individuals who will receive REC support over the proposed OAIC award period, and describe the abilities that REC candidates will be expected to acquire. The plan should include use of an advisory panel, the composition and functioning of which should be described in detail in the Other Attachments section and be consistent with the requirements for advisory panels as described in the LAC section of this FOA. Attention to health disparity issues is highly valued by the OAIC program.

The research education plans for at least some REC participants should provide for the development of combined competence in basic and clinical research. This should be accomplished either by enhancing the clinical research experience of basic scientists, developing the basic research skills and experience of clinical investigators, or providing a combination of the two approaches. An emphasis on development of skills for translating basic findings into clinical research and clinical findings into mechanistic studies is encouraged. Regarding the goal of developing researchers with combined expertise in clinical and basic aging research, OAIC applicants should consider the previous training of the individual candidate in determining the nature and extent of research education activities for which REC support is requested.

Renewal applications from existing OAIC sites, including those with RECs supported by other similar component mechanisms, should present progress report information specific to the REC in this section. Newly proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities relevant to the proposed REC.

2. Core Lead(s)

Describe arrangements for administration of the program. Provide evidence that the Core Lead(s) is/are actively engaged in research and/or teaching in an area related to the mission of NIA and the OAIC program and that the Core Lead(s) can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Core Leads, describe the complementary and integrated expertise of the Leads, their leadership approach, and governance appropriate for the planned program.

3. Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women, are encouraged to participate as Program Faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, participation in their intended roles.

Describe how the Program Faculty will serve as preceptors/mentors and provide guidance and expertise appropriate to the level of the participants proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful participant guidance by these individuals. Describe the criteria used to appoint and remove individuals as Program Faculty and to evaluate their participation.

Biosketches for Program Faculty should not be included in the application, unless they are senior/key personnel in other cores.

4. Program Participants

Applications must describe the intended participants and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.

REC support is intended mainly for junior faculty and postdoctoral research associates. At least some participants selected for support through the REC should hold a clinical doctoral degree. OAIC research education support should be integrated with other sources of career support that participants may be receiving (e.g., GEMSSTAR, fellowships, non-NIH career awards) in concerted programs for research education. REC support is intended primarily for U.S. citizens and permanent residents, unless there is strong justification otherwise based on exceptional relevance to NIH and NIA. Plans for recruiting participants should include plans for outreach to under-represented populations.

Present brief descriptions of the research and training background, potential research experiences, and mentoring activities for up to five candidates in the first year. Describe the goals for each candidate's career progression by the end of the OAIC award period. If a candidate will receive REC support for a research project, provide a description of the specific aims of the project, its scientific approach, and how other OAIC cores may contribute. If an REC-supported project is a human subject study involving more than minimal risk, a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

5. Recruitment Plan to Enhance Diversity

Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the U.S. scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity, and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation; enhancing global competitiveness; contributing to robust learning environments; improving researcher quality; advancing the likelihood that underserved populations or populations who experience health disparities participate in, and benefit from, health research; and enhancing public trust.

In spite of tremendous advancements in scientific research, informational, educational, and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see NCSES Publications and Data and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see NOT-OD-15-089.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size as published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields (see, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics).

New applications must include a plan to enhance recruitment of a diverse participant pool and may wish to include data in support of past accomplishments. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

For those individuals who previously participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment plan will not be reviewed.

6. Plan for Instruction in the Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the following five required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only online instruction is not acceptable); 2) Subject Matter - the breadth of subject matter (e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics); 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. The plan should be appropriate and reasonable for the nature and duration of the proposed program. See also NOT-OD-10-019.

Renewal applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

7. Evaluation Plan

Applications must include a plan for evaluating the activities supported by the research education program. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short- or long-term success of the research education program in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and provide suggestions for improvements.

Letters of Support: A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources to contribute to the planned research education program.

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.

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 (REC)

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.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

Provide REC-specific information on data and safety monitoring according to the guidance on NIA's OAIC webpage.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). 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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

In addition, for applications involving clinical trials:

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 OAIC 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 the prior research that serves as the key support for the proposed project rigorous? 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?

The following questions are also considered in evaluating the overall significance of the proposed OAIC:

How important is the OAIC's selected area of focus in regard to potential advances in understanding or treating age-related conditions affecting the independence of older Americans? Will the goals set for the OAIC over the project period significantly contribute to advances in its area of focus? Will the OAIC have a significant effect on the concepts or methods that drive efforts to enhance independence for older persons? To what extent will the OAIC cores facilitate other ongoing research to advance aging and geriatric research? Does the proposed OAIC demonstrate evidence of leadership and collaboration on a large scale, rather than just locally? Have collaborations with other OAICs and other NIA- or NIH-supported programs and centers yielded significant outcomes?

In addition, for applications involving clinical trials

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

Are the PD(s)/PI(s), 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?

The following questions are also considered in evaluating the investigators of the overall proposed OAIC:

Is the proposed leadership adequate for achieving the goals of the OAIC? Are the OAIC PD(s)/PI(s) and lead investigators appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? Is/Are the PD(s)/PI(s) (an) established investigator(s) in a major area selected as a focus of OAIC research?

To what extent do(es) the PD(s)/PI(s) have leadership qualities, including the ability to work collaboratively with other investigators, to establish mechanisms for quality control of the science receiving core funds, and to move the OAIC into new innovative research areas as appropriate?

Do the PD(s)/PI(s) and lead investigators demonstrate the ability to translate new scientific findings in basic aging research into testing of interventions in animals and humans?

Do the PD(s)/PI(s) and lead investigators have the capacity to translate proven interventions into larger-scale clinical or community studies?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD(s)/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?

The following questions are also considered in evaluating the overall innovation of the proposed OAIC:

How effectively will the OAIC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? Does the OAIC group challenge existing paradigms or develop new methodologies or technologies? To what extent will the OAIC stimulate translation between basic and clinical research and/or between clinical research and practice? To what degree will the OAIC add new research directions that are based on insights from basic aging research or geriatrics?

In addition, for applications involving clinical trials

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

The following questions are also considered in evaluating the overall approach of the proposed OAIC:

Is the proposed strategy adequate to promote a sustained research program in the selected area of focus, through which the OAIC will accomplish the innovation, leadership, collaborative, and research career development functions sought? Are the goals to be achieved within the five-year OAIC award period specified? Is the plan to reach these goals, and the proposed methods to evaluate progress toward these goals, adequate during the course of the OAIC award?

Are the plans for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals of the OAIC adequate? Are they clearly stated and are approaches specified to deal with inadequate progress toward achieving goals, should this occur?

Are the plans for the external review of the overall OAIC adequate?

Are the arrangements adequate for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among investigators in the program?

How effectively does the program incorporate both fundamental discovery and the development of applied research?

How clear is the plan for defining sharing of responsibilities among investigators and between institutions (if more than one institution is involved)? If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the OAIC?

How thoughtfully does the applicant acknowledge potential problem areas and consider alternative approaches?

How effective are proposed collaborations with other OAICs and other NIA- and NIH-supported programs and centers?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

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

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

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

Data Management and Statistical Analysis

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

Will the 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?

The following questions are also considered in evaluating the overall environment of the proposed OAIC:

To what extent is there evidence of significant commitment of the institution to fulfilling the objectives of the OAIC?

What is the quality of the academic and physical environment as it bears on patients, space, and equipment, and on the potential for interaction among scientists within the Center and with scientists from other departments, institutions, and OAICs? Will the OAIC serve as a source of advice in the area of its theme regarding technology, methodology, analysis, or other expertise?

To what extent will the OAIC leverage other institution-, NIA-, and NIH-supported resources, including centers and large collaborative projects, particularly in sharing resources (e.g., Resource Cores) and research education opportunities?

In addition, for applications involving clinical trials

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

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

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

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

For each core, reviewers will provide adjectival descriptors based on the following criteria:

Leadership and Administrative Core (LAC)

Significance

Does the proposed core address the needs of the OAIC that it will serve? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the OAIC?

Investigators

Are the Core Lead(s) and other personnel well suited to their roles in the core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do core personnel demonstrate significant experience with coordinating collaborative clinical research? Are the leadership approach, governance strategies, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core? Do core personnel have experience overseeing selection and management of subawards, if needed?

Innovation

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

Approach

Are the overall strategy, operational plan, and organizational structure well reasoned and appropriate to accomplish the goals of the core? Will core personnel promote strategies to ensure a robust and unbiased scientific approach across the core, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the core? Is 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?

Will the proposed LAC staff effectively lead the proposed OAIC and interact with other OAIC components and other organizational components within and outside the institution? Are the plans adequate for the establishment and functioning of the proposed advisory panels?

Environment

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

Research Education Component (REC) (RL5)

Significance

Does the proposed research education program address a key audience and an important aspect or important need in research education? Does the application provide convincing evidence that the proposed program will significantly advance the stated goal of the OAIC program?

How effectively will the OAIC promote the development of future research leaders in its area(s) of focus, particularly leaders who can integrate clinical insights regarding health, disease, independence, and disability in old age with knowledge of advances in the basic sciences, including gerontology, to develop better interventions to maintain health and independence?

Investigators

Are the Core Lead(s) capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or involves multiple Core Leads, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

To what extent do potential program participants demonstrate commitment to, and potential for success in, a career in aging research? Is there evidence of adequate numbers of outstanding junior investigators with interest and commitment to aging research?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

How effectively will the REC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? To what extent will the REC stimulate translation between basic and clinical research and/or between clinical research and practice? To what degree will the REC add new research directions that are based on insights from basic aging research or geriatrics?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Does the REC provide adequate educational and other career enhancement opportunities for junior investigators associated with the OAIC? How well does the REC provide training of young investigators in clinical translational research? The quality of the plans to promote linkages between mechanistic and applied research are an important aspect in the evaluation of the REC.

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

To what extent will the resources and environment of the REC lead to selection of high-quality Career Enhancement Candidates? To what extent will REC resources contribute to the successful development of junior faculty?

Resource Cores (RCs)

Significance

Does the proposed core address the needs of the OAIC that it will serve? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the OAIC?

Will the RC contribute to the success of other cores? Will the External Projects and Developmental Projects contribute to the aims of the RC and to the overall goals of the proposed OAIC?

Investigators

Are the Core Lead(s) and other personnel well suited to their roles in the core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do core personnel demonstrate significant experience with coordination of collaborative clinical research? Are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core? Do core personnel have experience overseeing selection and management of subawards, if needed?

Are the investigators qualified in achieving the proposed aims of their External Projects or Developmental Projects?

Innovation

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

Will the RC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? Do the RC and its associated Developmental Projects and/or External Projects challenge existing paradigms or develop new methodologies or technologies? To what extent will the RC stimulate translation between basic and clinical research and/or between clinical research and practice? To what degree will the RC add new research directions that are based on insights from basic aging research or geriatrics?

Approach

Are the overall strategy, operational plan, and organizational structure well reasoned and appropriate to accomplish the goals of the core? Will core personnel promote strategies to ensure a robust and unbiased scientific approach across the core, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the core? Is 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 RC involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the RC enhance the quality of research, research education, and pilot projects? Is the plan adequate for prioritizing access to RC resources? Are plans adequate for the external review of proposed Developmental Projects?

Environment

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

Pilot/Exploratory Studies Core (PESC)

Significance

Does the proposed core address the needs of the OAIC that it will serve? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the OAIC?

How will the proposed PESs and types of future PESs contribute to the goals of the OAIC? How will the PESs contribute to the success of other cores?

Investigators

Are the Core Lead(s) and other personnel well suited to their roles in the core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do core personnel demonstrate significant experience with coordinating collaborative clinical research? Are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core? Do core personnel have experience overseeing selection and management of subawards, if needed?

Innovation

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

How effectively will the PESs facilitate and develop novel multidisciplinary and interdisciplinary research strategies? To what extent will the PESs stimulate translation between basic and clinical research and/or between clinical research and practice? To what degree will the PESs add new research directions that are based on insights from basic aging research or geriatrics?

Approach

Are the overall strategy, operational plan, and organizational structure well reasoned and appropriate to accomplish the goals of the core? Will core personnel promote strategies to ensure a robust and unbiased scientific approach across the core, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the core? Is 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 PESC involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

What is the scientific quality of the PESs proposed, and are they likely to acquire information needed to select or design future crucial studies in the OAIC area(s) of focus? Are the plans adequate for the external review of the proposed PESs? To what extent will the PESC support translational PESs?

Environment

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

Information Dissemination Core (IDC)

Significance

Does the proposed core address the needs of the OAIC that it will serve? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the OAIC?

Will the IDC contribute to the overall goals and theme(s) of the proposed OAIC? Will the IDC enhance the function of other cores?

Investigators

Are the Core Lead(s) and other personnel well suited to their roles in the core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do core personnel demonstrate significant experience with coordinating collaborative clinical research? Are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the core? Do core personnel have experience overseeing selection and management of subawards, if needed?

Innovation

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

Does the IDC challenge existing paradigms or develop new methodologies or technologies?

Approach

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

If the IDC involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

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

To what extent will the IDC be able to access and interact with other institutional resources for its proposed activities? To what extent will existing relationships between the institution and other organizations or societies, as well as those to be developed, contribute to the success of the IDC’s goals?

As applicable for the Center 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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program and the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Study Timeline

Specific to applications involving clinical trials

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

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

As applicable for the Center 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.

Authentication of Key Biological and/or Chemical Resources

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

For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

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

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

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

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

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.

Not Applicable

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

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

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

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

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.

Authentication of Key Biological and/or Chemical Resources

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute on Aging in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

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

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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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).

Awardee-selected projects involving greater than minimal risk to human subjects require prior approval of their data and safety monitoring plans by NIA prior to initiation.

The awardee institution will provide NIA with specific plans for data and safety monitoring, and will notify the IRB and NIA of serious adverse events and unanticipated problems, consistent with NIA DSMP policies.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see 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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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.

In carrying out its stewardship of human resource-related programs, NIA will periodically evaluate REC programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIA may request information from databases, Core Leaders, and from participants themselves. Where necessary, Core Leaders and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

In evaluating REC, NIA expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Postdoctorates and Early Career Investigators:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:
• Subsequent participation in research
• Subsequent employment in a research or research-related field
• Subsequent authorship of scientific publications
• Subsequent independent research grant support from NIH or another source

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Basil Eldadah, MD, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Fax: 301-402-0066
Email: [email protected]

Lesa McQueen, M.Sc.
National Institute on Aging (NIA)
Telephone: 301-402-7738
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, 284, and 285e-3)and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.