Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Aging (NIA)
Funding Opportunity Title	Claude D. Pepper Older Americans Independence Centers (P30)
Activity Code	P30 Center Core Grants Successful applicants will receive support through the P30 Center Core Grant activity code and a linked KL2 award supporting the Research Career Development Component (RCDC).
Announcement Type	Reissue of RFA-AG-13-002
Related Notices	July 9, 2015 - This RFA has been reissued as RFA-AG-16-011. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	RFA-AG-15-003
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.866
Funding Opportunity Purpose	This FOA supports applications for Claude D. Pepper Older Americans Independence Centers (OAICs) centers of excellence in geriatrics research and research career development. The OAIC awards are designed to develop or strengthen awardee institutions programs that focus and sustain progress on a key area in aging research.

Posted Date	April 3, 2014
Open Date (Earliest Submission Date)	May 23, 2014
Letter of Intent Due Date(s)	May 23, 2014
Application Due Date(s)	June 24, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	September - October, 2014
Advisory Council Review	January 2015
Earliest Start Date	April 2015
Expiration Date	June 25, 2014
Due Dates for E.O. 12372	Not Applicable

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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 career development that will 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 and sustain progress on a key area in aging research. Each area of focus is one in which progress could contribute to greater independence for older persons and offer opportunities for research career development in aging research. 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 career development 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 other NIA-funded programs and centers; e.g., Resource Centers for Minority Aging Research (RCMARs), Centers on the Demography and Economics of Aging, Roybal Centers, 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, collaborative, and research career development 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, treatment (including rehabilitation) of a specific type of disability in older persons.
• Causes, prevention, and treatment of a geriatric syndrome (e.g., sarcopenia, falls, incontinence) that is 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.

An OAIC may define its selected area of focus. In general, each research focus described above has the need (and/or 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 or to address unexpected needs for research career development support 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 Research as an Area of Focus. An OAIC application should not include major foci on cognition or behavioral and social sciences, as these are more appropriate for other NIA programs that also use the Center mechanism; however, 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 a major focus on cognitive and behavioral research:

1. The research is a) designed to obtain new knowledge about 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) designed to obtain new knowledge about 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 health care 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 a) designed to obtain new knowledge about the effects of interventions that clearly specify what will be done for, or by, the individuals treated by the intervention or practice, nor b) designed to obtain new knowledge about 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 health care 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).

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIA intends to commit $4.1 million in FY2015 to fund 4 awards.
Award Budget	Application budgets are limited to $800,000 in direct costs per year.
Award Project Period	The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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

Applicant Organizations

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

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

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

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

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

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

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ramesh Vemuri, PhD
Telephone: 301-402-7700
Fax: 301-402-0066
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
LAC (use for Leadership Administrative Core)	6
RC (use for Resource Cores)	6 pages per RC
PESC (use for Pilot/Experimental Studies Core)	6
IDC (use for Information Dissemination Core)	6
Inst Career Dev (Use for Research Career Development Component (RCDC) (KL2))	25

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

* The 'Inst Career Dev' component type will follow the page limits for the KL2 activity code as defined in the Table of Page Limits. Note that the limit of 25 pages refers to the combination of Background, Program Plan, and Recruitment and Retention Plan to Enhance Diversity (Attachments 2-4 of Research Training Program Plan form).

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
• Leadership Administrative Core (LAC): required
• Research Career Development Component (RCDC) (KL2): required
• Resource Cores (RCs): at least one required; maximum 4
• Pilot/Experimental Studies Core (PESC): optional
• Information Dissemination Core (IDC): optional

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary: 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.

Other Attachments: Include a table titled "Resource Core Distribution to Research Projects." This table should provide estimated percentages of funds budgeted in each Resource Core (RC) for each Career Development Research Project, Developmental Project, External Project, or Pilot/Exploratory Study. The recommended format for this table can be found at http://www.nia.nih.gov/research/dgcg/claude-d-pepper-older-american-independence-centers-oaics. The table should be uploaded in PDF format.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

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, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

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. New proposed OAIC sites may use this section to present preliminary data or evidence of preparatory activities for establishing an OAIC.

For renewals and/or 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 to mark changes in the text from the prior version. 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 career development 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. Are these concepts, approaches, methodologies, instrumentation, or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

Protection of Human Subjects: Describe fully the general principles and policies that will apply to protection of human subjects for the OAIC as a whole. List all components of the application that involve human subjects. If the OAIC will support human intervention studies, describe general procedures for developing data and safety monitoring plans and notification of NIA staff consistent with NIA policies for human intervention studies. Procedures for human subjects protection that are specific to individual cores should be described in those respective sections of the application.

Vertebrate Animals: Describe the general principles and policies that will apply to the treatment of vertebrate animals in the OAIC. List the components in the application that involve vertebrate animals. IACUC approval should be submitted as Just-In-Time information.

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

The Leadership and Administrative Core (LAC) is a required component of the OAIC. The LAC will provide support for planning, organizational, evaluation, and administrative activities relating to the other Cores and to the OAIC as a whole.

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

SF424 (R&R) Cover (LAC)

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 (LAC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (LAC)

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) (LAC)

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 (LAC)

• 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 PDs/PIs for the OAIC application should be the Core Leader(s) for the LAC. The Core Leader(s) should have sufficient expertise in the OAIC's area of research focus to exercise effective scientific judgment and leadership.

Budget (LAC)

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 Directors 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.

PHS 398 Research Plan (LAC)

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 & Innovation.

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

Approach & 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 planning 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 and review of salary support for junior faculty supported through the Research Career Development Component (KL2). 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). Active involvement of the LAC is required for yearly review of progress toward the OAIC goals by a board whose members are entirely external to the institution(s) of the proposed 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, 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. 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 Directors meeting. Participation of OAIC and Coordinating Center leadership at the annual scientific meeting is mandatory. Participants include the PDs/PIs, Center Administrator, Core Leaders, and others as appropriate for purposes of programmatic coordination and scientific exchange. The meeting is typically held in the Bethesda, Maryland, area.
• 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) and support for 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 the 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. The advisory committee for the RCDC can be summarized briefly here and more thoroughly in the RCDC section. Advisory panels include:

• An External Advisory Board (EAB) consisting of experts, all of whom are outside the OAIC and the grantee institution(s), who meet yearly to review the OAIC's progress and provide a written report to the OAIC Director, which is to be included in the Center’s annual progress report to the NIA; and
• Other advisory panels to assist in selecting candidates for RCDC support, Developmental Projects through the Resource Cores, and Pilot/Exploratory Studies. At least one-third of the members of these panels should be external to the OAIC and the grantee institution(s). 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (LAC)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (LAC)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Inst Career Dev.

A Research Career Development Component (RCDC) is a required component of an OAIC. The goal for the RCDC is 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.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application section.

SF424 (R&R) Cover (RCDC)

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 (RCDC)

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application section.

SF424 (R&R) Other Project Information (RCDC)

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application section, with the following additional modifications:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

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 Summary/Abstract. Provide an abstract of the RCDC (KL2). Include the objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral, faculty), and intended scholar outcomes

Project Narrative. Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicationg 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. .

SF424 (R&R) Project/Performance Site Location(s) (RCDC)

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.

SF424 (R&R) Senior/Key Person Profile Expanded (RCDC)

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

Budget (RCDC)

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Up to $450,000 in first-year direct costs may be requested for RCDC activities. The RCDC will provide support for salary, fringe benefits, didactic training, and travel for candidates. In addition, the RCDC may also provide research project support to its candidates.
• Funds for salaries and other expenses of the Core Leader(s), information resources, and support staff may be requested.
• Do not complete the section on Participant/Trainee Support Costs.

PHS 398 Research Training Program Plan (RCDC)

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application section must be followed, with the following additional instructions:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

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 RCDC during the previous review.

Background: Provide the rationale for the proposed Research Training Program Plan (RCDC), relevant background history, and the need for the RCDC. Indicate how the RCDC relates to current career development activities at the applicant institution.

Program Plan: The Career Development Program plan is composed of the following components: A. Program Administration; B. Program Faculty; C. Proposed Career Development Program; D. Career Program Evaluation; E. Candidates/Scholars; F. Institutional Environment and Commitment to the Program.

A. Program Administration

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. The RCDC should be led by a scientist with experience in research training and career development, and a history of successful mentoring. The RCDC PD/PI will be responsible for coordination, oversight, and reporting of all RCDC activities.

Describe the contribution of the RCDC to the OAIC s overall goals. Describe how the proposed use of RCDC funds for career development activities and research projects will contribute to OAIC's goals for research career development in its selected area of research focus. Describe how the RCDC PD/PI and other mentors will help implement the intended goals of the RCDC.

An advisory committee is a required component of a career development program. At least one-third of the members of the advisory committee should be external to the OAIC and the grantee institution(s). Provide a plan for the appointment of an advisory committee to monitor progress of the career development program. The composition, 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 program. Do not include the names of advisory committee members in the application.

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

B. Program Faculty

The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars 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 scholar guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.]

C. Proposed Career Development Program

Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the program is intended, including the career level(s) of the scholars, the academic and research background needed to pursue the proposed program, and, as appropriate, plans to accommodate differences in preparation among scholars. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed program.

Describe the plan for recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive RCDC support over the proposed OAIC award period, and describe the abilities that RCDC 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 LAC research strategy and consistent with the requirements for advisory panels as described in the LAC section of this FOA. Special attention should be paid to the recruitment of minority candidates for research career development activities. Attention to issues of health disparities is highly valued by the OAIC program.

Describe the kinds of educational activities planned for the candidates. These might include regular research meetings, invited guest faculty, workshops, formal courses, etc.

The research career development plans for at least some of the junior faculty and research associates supported through the RCDC 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 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 research (including aging research), OAIC applicants should consider the previous training of the individual candidate in determining the nature and extent of didactic training and research activities for which RCDC support is requested.

D. Career Program Evaluation

Describe a plan to review and determine the quality and effectiveness of the RCDC program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former RCDC scholars to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program.

E. Candidates/Scholars

The RCDC program provides support for a minimum of 2 years and a maximum of 3 years of consecutive funding for each scholar, consisting of consecutive 12-month appointments. Present brief descriptions of the research and training background, planned research, and associated career development 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 RCDC support for a research project, then a description of the specific aims of the project, its scientific approach, and how other OAIC cores may contribute to the research project should be provided. Alternatively, candidates for RCDC support may conduct pilot/exploratory studies supported by the Pilot/Exploratory Studies Core (PESC), developmental projects supported by a Resource Core (RC), or independently funded projects (including External Projects associated with an RC).

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to appointment, are eligible to accept an RCDC appointment. Individuals on temporary or student visas are not eligible. Plans for recruiting scholars should include accessing under-served and under-represented minority and ethnic populations.

Candidates must be able to commit a minimum of 9 calendar months of full-time professional effort for career development and research activities associated with the RCDC program. The remaining 3 calendar months effort can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the RCDC program.

At least some of the junior faculty and research associates selected for support through the RCDC should hold a clinical doctoral degree. OAIC research career development support for RCDC-supported junior faculty and research associates should be integrated with other sources of career support that they may be receiving (e.g., GEMSSTAR, fellowships, non-NIH career awards) in concerted programs for research career development.

Applicants for RCDC appointments may not simultaneously submit or have pending an application for any other PHS mentored career development award (e.g., K01, K08, K23, K25) that duplicates any of the provisions of the RCDC program. Former or current principal investigators on any NIH research project grant (this does not include NIH Small Grants (R03) or Exploratory/ Developmental (R21) grants or their equivalents), or project leaders on sub-projects of program project (P01) or center grants (e.g., P30, P50) may not be nominated as RCDC scholars.

RCDC scholars are encouraged to apply for individual mentored K awards (e.g., K01, K08, K23, K25); if successful, the RCDC appointment would be terminated and funding would be received from the new individual K award. RCDC scholars are also encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

F. Institutional Environment and Commitment to the Program

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program. The application must include a signed letter, on institutional letterhead, that describes the applicant institution s commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful training program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed program from existing ones at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.

Recruitment and Retention Plan to Enhance Diversity: Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research: Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Human Subjects: Describe procedures for protection of human subjects that are specific to the RCDC. (General procedures for protection of human subjects across the OAIC should be described in the Overall section). If the RCDC will support studies involving human interventions, describe any RCDC-specific procedures for developing data and safety monitoring plans and notification of NIA staff consistent with NIA policies for human intervention studies.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Include in the appendix available consent forms for RCDC-supported human subject studies.

Planned Enrollment Report (RCDC)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (RCDC)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type RC.'

RCs will provide resources to (a) enhance or support projects funded primarily by other mechanisms, 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.

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

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.
• 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 Development Projects (DPs). 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. The Introduction should be a summary response to the concerns expressed about the proposed RC during the previous review.

Specific Aims: Each RC should be based on a research field or function that contributes to the OAIC area of focus. 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., animals). Examples of possible RCs include, but are not limited to:

• 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 RCs, 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 RCs should be made on the basis of the contribution of services and support to the overall goals of the OAIC.

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) (described below). Applicants may not propose an RC unless it will support at least two projects (DPs or EPs), and a maximum of 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 may not be proposed unless 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. A clear statement of how an individual RC will enhance the scientific productivity of the projects and assist the Center investigators to realize the OAIC objectives for its area of focus must be provided. 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 & 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 Core. 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. Describe how the Core leader, together with the OAIC PDs/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.

RCs may provide services for Developmental Projects (DPs) that are part of the RC infrastructure (see below) and for Pilot/Exploratory Studies (see PESC section). 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 Core 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 data analytic and computational strategies 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, Project Leader 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 involves a human intervention study funded by the OAIC, in which case a description of the study and plans for data and safety monitoring must be communicated to, and approved by, NIA staff prior to initiation of the study consistent with NIA human intervention study policies (see Protection of Human Subjects section).

External Projects (EPs). External Projects 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). 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 that are not presented elsewhere. If the EP is presented elsewhere, indicate the section in the application where the initial description can be found.

Protection of Human Subjects

Describe procedures for protection of human subjects that are specific to the RC. (General procedures for protection of human subjects across the OAIC should be described in the Overall section). If the RC will support DPs involving human intervention studies, describe any RC-specific procedures for developing data and safety monitoring plans and notification of NIA staff consistent with NIA policies for human intervention studies.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Include in the appendix available consent forms for RC-supported human subject studies.

Planned Enrollment Report (RC)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (RC)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 in ASSIST, use Component Type PESC.

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)

• 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 (PESC)

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

Up to $250,000 in first-year direct costs may be requested for the PESC. Applicants may propose up to 5 PESs in the first year. Direct costs should range between $25,000 and $50,000 per year for standard PESs, and $10,000 or less for small PESs. All PESs may not exceed 3 years in duration. Up to $50,000 of the $250,000 budget for the PESC may be devoted to small PESs. Budgets should be prepared for all 5 years of the OAIC application.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (PESC)

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 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 categorized as standard PESs or small PESs based on their budgets (described below). These studies may be led by junior faculty and/or research associates receiving OAIC RCDC support, or by other senior or junior investigators.

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

• 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 ongoing or previous studies to explore hypotheses that may guide the selection and design of future studies

PESs for the first year of the application should be described briefly in the OAIC application. 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 (1 page recommended), and Approach & Innovation (5 pages recommended).

Significance. Describe how the Pilot/Exploratory studies (PES) will fit within the goals of the PESC and how they will interact with other Cores of the OAIC.

Approach & 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, 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 Leader(s), together with the OAIC PD/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.

Provide an overview of each of the proposed first-year PESs. Up to 5 PESs may be supported in the first year. Number each PES sequentially (i.e., PES-1, PES-2, etc.). For each PES, list the Title, Project Leader, and Senior/Key Personnel. Provide a brief description of the significance, approach, and any innovative aspects of each PES. 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.

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 involves a human intervention study funded by the OAIC, in which case a description of the study and plans for data and safety monitoring must be communicated to, and approved by, NIA staff prior to initiation of the study consistent with NIA human intervention study policies (see Protection of Human Subjects section).

Participating researchers in OAICs are encouraged to consider also seeking additional sources of funding for pilot or exploratory studies, such as the NIH Small Research Grant Program (R03) and NIH Exploratory/Developmental Research Grant Award (R21).

Protection of Human Subjects: Describe procedures for protection of human subjects that are specific to the PESC. (General procedures for protection of human subjects across the OAIC should be described in the Overall section). If the PESC will support PESs involving human intervention studies, describe any PESC-specific procedures for developing data and safety monitoring plans and notification of NIA staff consistent with NIA policies for human intervention studies.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Include in the appendix available consent forms for PESC-supported human subject studies.

Planned Enrollment Report (PESC)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (PESC)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

Inclusion of an IDC is optional. An IDC supports activities to disseminate information relating to the OAIC's research areas and/or to enhance translation of clinical research findings into health care practice.

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)

• 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. 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 health care 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 health care 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, Approach & 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 & 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (IDC)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (IDC)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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 by the Center for Scientific Review and responsiveness by National Institute on Aging (NIA), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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 OAIC 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.

Significance

Does the OAIC address an important problem or a critical barrier to progress in the field? If the aims of the OAIC 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 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?

Investigator(s)

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

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/PI and lead investigators appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? Is the PD/PI an established investigator in a major area selected as a focus of OAIC research?

To what extent does the PD/PI have the 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/PI and lead investigators demonstrate the ability for the translation of new scientific findings in basic aging research into testing of interventions in animals and humans?

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

If there are plans to recruit investigator(s), are those plans reasonable and necessary and can those efforts be completed in a timely manner, such that the recruited investigator(s) can make meaningful contributions to the OAIC?

Innovation

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?

Approach

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

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

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

Has an important topic been selected as an area of research focus? Is the proposed strategy adequate for promoting 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, the allocation of funds, day-to-day management, contractual agreements, the 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?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 institutional-, NIA-, and NIH-supported resources, including Centers and large collaborative projects, particularly in sharing resources (e.g., Resource Cores) and research career development opportunities?

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

Leadership and Administrative Core (LAC)

Significance

Do the proposed activities address an important problem or a critical barrier to progress in the field? If the aims of the activities are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How will the LAC contribute to achieving the overall goals of the proposed OAIC?

Investigators

Are the PD/PIs, collaborators, and other researchers well suited to the Core? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the LAC?

Are the leadership and administrative staff of the LAC qualified in leading the operations of the proposed OAIC?

Innovation

Does the LAC challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, 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, technologies, or interventions proposed?

How effectively will the LAC facilitate novel multidisciplinary and interdisciplinary research strategies?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

How well will the proposed LAC staff 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 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?

Will the resources and environment of the LAC adequately contribute to the leadership of the proposed OAIC and to achieving its goals?

Career Development Program and Environment

Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities? When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the 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?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program? Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates? Are there well-defined and well justified recruitment and selection strategies? Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program? Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholar candidates? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

To what extent do the proposed Career Development Candidates demonstrate commitment to, and potential for success in, a career in aging research? If research projects are proposed, are the proposed research questions, design, and methodology of significant scientific and technical merit? Are the research plans relevant to the candidates' research career objectives? Are the research plans appropriate to the candidates' stages of research development and as a vehicle for developing the research skills described in their career development plans?

Training Record

Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

Significance

Do the proposed studies address an important problem or a critical barrier to progress in the field? If the aims of the studies are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How do the aims of the RC fit with the goals and theme(s) of the proposed OAIC? How will the quality and efficiency of the proposed OAIC be enhanced through the RC? How will the RC contribute to the success of other Cores? How will the External and Developmental Projects contribute to the aims of the RC and to the overall goals of the proposed OAIC?

Investigators

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

Are the personnel qualified to achieve the proposed aims of the RC? Are the investigators qualified in achieving the proposed aims of their External or Developmental Projects?

Innovation

Does the RC challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, 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, technologies, or interventions proposed?

How effectively will the RC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? Do the RC and its associated Developmental 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, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the RC? Are potential problems, alternative strategies, and benchmarks for success presented? If the RC is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the RC involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the RC benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Are the resources and environment of the RC adequate to achieve its aims and the goals of the proposed OAIC?

Significance

Do the proposed studies address an important problem or a critical barrier to progress in the field? If the aims of the studies are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Are the personnel qualified to achieve the goals of the PESC? Are the investigators qualified to carry out the proposed PESs?

Innovation

Does the PESC challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, 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, technologies, or interventions proposed?

How effectively will the PESs facilitate and develop novel multidisciplinary and interdisciplinary research strategies? Do the PESs challenge existing paradigms or develop new methodologies or technologies? 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, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the Core is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the PESC involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, 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 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 proposed PESC? Will the PESC benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

To what extent will the resources and environment of the PESC contribute to the quality and success of PESs?

Significance

Do the proposed activities address an important problem or a critical barrier to progress in the field? If the aims of the activities are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How will the IDC contribute to the overall goals and theme(s) of the proposed OAIC? How will the IDC enhance the function of other Cores?

Investigators

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

Are the personnel qualified to achieve the proposed aims of the IDC?

Innovation

Does the IDC challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, 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, technologies, or interventions 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

What is the quality of the proposed activities of the IDC? How successful are the proposed activities likely to be in achieving the goals of the IDC?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed IDC? Will the IDC benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Are the resources of the IDC adequate to achieve its proposed aims? 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 OAIC 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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

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 project.

Renewals

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

Revisions

Not Applicable

As applicable for the OAIC 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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

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

As part of the scientific peer review, all applications:

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

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

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

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

NIH considers the following in evaluating Center grant applications:

• The scientific and technical merit of the proposed program;
• The qualifications and experience of the Center director and other key personnel;
• The statutory and program purposes to be accomplished;
• The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the Center;
• The extent to which the Center's activities would be coordinated with similar efforts by other organizations; and
• The administrative and managerial capability of the applicant

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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Awardee-selected projects that involve human intervention studies require prior approval by NIA prior to initiation.

• The awardee institution will provide NIA with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies and NIA policies for human intervention studies.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

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

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

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
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 285) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.