Department of Health and Human Services

Part 1. Overview Information
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 (OAICs) and Coordinating Center (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-AG-11-002

Related Notices

  • April 3, 2014 - This RFA has been reissued as RFA-AG-15-003.
  • March 19, 2012 - See Notice NOT-AG-12-006. The purpose of this Notice is to correct information regarding the number of applications an organization may submit.

Funding Opportunity Announcement (FOA) Number

RFA-AG-13-002

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

FOA Purpose

This FOA issued by the National Institute on Aging (NIA) supports new and renewal applications for Claude D. Pepper Older Americans Independence Centers (OAICs), centers of excellence in geriatrics research and training. This FOA solicits applications for OAIC sites and/or an OAIC Coordinating Center.

Key Dates
Posted Date

January 27, 2012

Letter of Intent Due Date

April 17, 2012

Application Due Date(s)

May 17, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November, 2012

Advisory Council Review

January, 2013

Earliest Start Date(s)

April, 2013

Expiration Date

May 18, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

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 training 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 training and career development in aging research. NIA's expectation is that an OAIC, in a given area of focus, will:

Area of Focus

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 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:

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.

Since 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. 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 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(s) 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:

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:

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 not generally be considered appropriate as a principal focus for an OAIC or component of an OAIC include:

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. Examples of such research include:

Coordinating Center

An OAIC coordinating unit was implemented in 2005 to promote scientific collaborations among OAIC investigators and to facilitate the sharing of unique resources across all sites. The OAIC Coordinating Center (CC) serves a facilitating role for OAIC site interactions as well as a conduit for translating OAIC objectives and findings to both general and scientific audiences. The CC must demonstrate an ability to work cooperatively with all OAIC sites and possess sufficient scientific expertise in geriatrics and related areas to serve the national clearinghouse functions required by the OAIC Program.

The CC can be a part (Core) of an OAIC or an independent program unaffiliated with an OAIC site (free-standing CC). If a CC is proposed as a free-standing Center, applicants should submit only that section of the application. Refer to the information below under "Coordinating Center" for further guidance.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIA intends to commit approximately $5.7 million for five new or renewal awards in FY 2013. NIA anticipates funding five OAICs and one OAIC Coordinating Center, which may be proposed as a Core within a P30 application for an OAIC site, or as an independent P30 application not associated with a specific OAIC site.

Award Budget

Application budgets are limited to $800,000 in first-year direct costs for OAICs and an additional $175,000 in direct costs for a Coordinating Center. Inflationary increases are limited to 2% of the previous year's budget.

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.     

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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:

The letter of intent should be sent to:

Ramesh Vemuri, PhD
Chief, Scientific Review Branch
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892 (or 20814 for express mail)
Tel: 301-402-7700
Fax: 301-402-0066
Email: vemuri@nia.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Ramesh Vemuri, PhD
Chief, Scientific Review Branch
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892 (or 20814 for express mail)
Tel: 301-402-7700
Fax: 301-402-0066
Email: vemuri@nia.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

A summary of page limits and other information can be found at http://www.nia.nih.gov/research/dgcg/claude-d-pepper-older-american-independence-centers-oaics

HOW TO PREPARE THE OAIC APPLICATION

Refer to the recommended format for the Table of Contents on the NIA website for all parts of the application. Follow PHS 398 instructions except where noted.

General Application Forms

PROJECT SUMMARY

For the Summary of the OAIC, present a brief overview of the entire application and summarize the general plan and goals for the proposed OAIC. For each Core, summarize the general plan and goals of that Core.

PROJECT/PERFORMANCE SITES

The listing of Project/Performance Sites should include the applicant institution and all other institutions collaborating via consortium or contractual arrangements.

TABLE OF CONTENTS

Due to the complexity of OAIC applications, applicants are strong encouraged to use the recommended format provided on the NIA website and to number all pages consecutively. Applicants are discouraged from using PHS 398 Form Page 3, as this is intended for single projects.

BUDGETS

Budget limits for Cores and Projects are indicated in this FOA for first-year direct costs. Inflationary increases for each Core or Project are limited to 2% of the previous year's budget.

Provide the following budget tables in the Summary of the OAIC section:

BIOGRAPHICAL SKETCHES

Where an individual plays a role in more than one section of the application, a complete biosketch should be placed in each Core where the individual has a role. As the particular qualifications for roles may differ among Cores, the selected publications and the description of qualifications of the individual may differ among the multiple biosketches provided.

TABLE II: DISTRIBUTION OF PROFESSIONAL EFFORT ON THIS APPLICATION

Complete this table for all personnel using the recommended format. After the Principal Investigator, list all other personnel in alphabetical order.

RESOURCES

There is no page limit for Resources pages; however, information listed in each Resources section should be limited to information on the resources and environment available to the OAIC as a whole or its components. Applications will be returned if Resources pages contain information belonging elsewhere in the application.

Summary of the OAIC. Reviewers will use information presented in the Summary of the OAIC section to evaluate the quality of the overall environment for the proposed OAIC. Include information here regarding the interrelationship of the OAIC to other activities in the applicant's institution (e.g., other relevant research 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.

Individual Cores. Information presented in each Core section should describe the resources and environment specific to the operations of that Core.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Renewal applications must include descriptions of progress during the previous funding period. Progress reports should be included in the Research Strategy sections of the application within the prescribed page limits.

Resubmission applications may include a one-page Introduction in the Summary of the OAIC section and in each Core. Each Introduction page should include ONLY a summary of the changes in the application from the previous review and the PD(s)/PI(s) explanations for addressing reviewers' comments. Introduction pages should not contain information that belongs elsewhere in the application.

Applications that do not adhere to the PHS 398 instructions and to the above guidelines will be returned.

Applicants are encouraged to make clear in each section how proposed Cores, projects, and studies are integrated with each other across the OAIC, and how all Cores, projects, and studies contribute to the theme or focus of the OAIC.

Summary of the OAIC

INTRODUCTION (for resubmission applications only [1 page])

Provide an overview of major changes in the application. If Cores have been deleted or added indicate that here and explain the changes under Significance (below).

SPECIFIC AIMS (1 page)

SUMMARY OF THE OAIC. 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 (12 pages)

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). Renewing applicants may wish to include summary tables of OAIC activities during the previous funding period. New 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:

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 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?

OTHER PARTS OF THE RESEARCH PLAN

Bibliography, Protection of Human Subjects, Inclusion of Women and Minorities, Inclusion of Children, Vertebrate Animals, Select Agent Research, Consortium/Contractual Arrangements, Letters of Support, and Resource Sharing Plans relevant to the OAIC as a whole should be included in the Summary of the OAIC section. Information that is specific to the Cores should be included in those respective sections.

The following provides additional guidance to that in the PHS 398 instructions:

Protection of Human Subjects. Describe fully the general principles and policies that will apply to human subjects for the OAIC as a whole.  List all components of the application that involve human subjects and page numbers for the relevant human subjects sections. Include in the appendix all consent forms for human subjects research which apply to developmental projects or pilot/exploratory studies.

Vertebrate Animals.  Approval must be by each individual protocol for projects not having approval elsewhere. List the components in the application that involve vertebrate animals and page numbers for the relevant vertebrate animal sections.

Consortium/Contractual Arrangements. Before submitting an application that contains a consortium arrangement, the applicant institution and each collaborating institution should reach agreement on the scientific, administrative, financial, and reporting requirements for the grant. Include the following statement, accompanied by signatures of the appropriate administrative officials, from each of the collaborating institutions: "The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter-institutional agreement(s) consistent with that policy." Include this information here and/or with individual Cores, as appropriate.

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

Table III: Percentage Distribution of Resource Cores to OAIC- and Externally Funded Research Projects. Use the recommended format from the NIA website for this information.

Leadership and Administrative Core (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. The Principal Investigator for the OAIC application should be the Core Leader for the LAC. He/she should have sufficient expertise in the OAIC's area of research focus to exercise effective scientific judgment and leadership.

The LAC is responsible for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals of the OAIC. Specifically, the LAC should conduct or organize the following activities:

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.

Additionally, active involvement of the LAC is required for yearly review of progress toward the OAIC goals by an Advisory Board external to the awardee institution. Members of the External Advisory Board (EAB) are selected by the OAIC subject to approval by NIA. For new proposed OAICs, the names of potential EAB members should not be included in the application and potential members should not be contacted until after the award; however, the operating procedures of  the EAB, including the frequency of its meetings and the methods for the identification of members should be specified.  A report of the annual review by the EAB should be included in annual Progress Reports.

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.

Participation of OAIC investigators and Coordinating Center leadership at an annual scientific meeting is mandatory. Participants will include the Principal Investigator, Center Administrator, Core Leaders, and others as appropriate for purposes of programmatic coordination and scientific exchange. Applications must include budget requests for attendance at these meetings as part of the budget for the LAC.

Up to $150,000 in first year direct costs may be requested for LAC activities.

INTRODUCTION (for resubmission applications only [1 page])

The Introduction should be a summary response to the global concerns expressed about the proposed LAC during the previous review.

SPECIFIC AIMS (1 page)

Provide an overview of how the LAC will implement the theme or focus of the OAIC.

RESEARCH STRATEGY (6 pages)

Significance (1 page recommended).  Describe the overall role of the LAC in the OAIC.

Approach & Innovation (5 pages recommended). 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 (the PI of the OAIC), the Center Administrator, and other LAC staff in carrying out its functions. A crucial component of this description is the activities of the LAC leader in monitoring, stimulating, sustaining, evaluating, and reporting the OAIC’s progress toward the overall goals of the OAIC. Present plans to establish and operate OAIC advisory panels, including criteria for selecting advisors, how they will be identified, the operating procedures of each panel, and the frequency of meetings. Advisory panels include:

Note:  New applications should not name potential advisors or select advisors prior to peer review of the application.

Research Career Development Core (RCDC)

A Research Career Development Core (RCDC) is a required component of an OAIC. The RCDC should be led by a scientist with experience in research training and a history of successful mentoring. The RCDC Core Leader will be responsible for coordination, oversight, and reporting of the activities described below.

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.

Toward this goal, the RCDC will provide support for junior faculty and research associates to acquire research skills in the area of OAIC focus. Specifically, the RCDC will provide support for salary, fringe benefits, didactic training, and travel for candidates. Junior faculty and research associates who receive RCDC support may conduct pilot/exploratory studies (see Pilot/Exploratory Studies Core below), developmental projects (see Resource Cores below), or independently funded projects. Funds for salaries and other expenses of the Core Leader, information resources, and support staff may be requested.

The 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.

At least some of the junior faculty and research associates selected for support through the RCDC should hold a clinical doctoral degree. OAIC 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., NIH "K-series" career development awards, fellowships, non-NIH career awards) in concerted programs for career development.

OAIC applicants should provide a plan for their strategy of recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive RCDC support over the proposed OAIC award period, and describe the abilities they expect recipients of this support to acquire. This plan should include provision for peer review of proposals for provision of RCDC salary support to junior faculty. At least one third of these peer reviewers should be from outside the awardee institution. Special attention should be paid to the recruitment of minority candidates for career development activities. Attention to issues of health disparities is highly valued by the OAIC program.

In addition, the OAIC proposal should identify the candidates selected for at least the first year of RCDC support, describe what their activities will be, and delineate the nature of institutional commitments to the individuals' development. A description of mentors' research activities (including a biographical sketch of each mentor) and their commitments in training and supervising these individuals should also be provided. The OAIC goals for each candidate's career progression by the end of the OAIC award period should be described. The description should explain how the proposed use of OAIC funds (including funds for pilot/exploratory study funding if this is also proposed for the candidate) will contribute to OAIC program goals for research career development in its selected area of research focus.

If any RCDC activities involve human intervention studies funded by the OAIC, NIA staff should receive, prior to study initiation, a description of the study and plans for data and safety monitoring and for notification of clinically significant events to NIA staff. Such plans should be consistent with NIA policy (see http://www.nia.nih.gov/research/dea/implementation-policies-human-intervention-studies). In addition, if an RCDC will support human intervention studies in the future, applications should describe procedures for developing data and safety monitoring plans and notification of NIA staff consistent with the above policy.

A maximum of $450,000 in first-year direct costs may be requested for the RCDC.

INTRODUCTION (for resubmission applications only [1 page])

The Introduction should be a summary response to the global concerns expressed about the proposed RCDC during the previous review.

SPECIFIC AIMS (1 page)

Describe what the intended outcomes and career advancement goals are for RCDC scholars.

RESEARCH STRATEGY (6 pages)

Significance (1 page recommended). Describe the contribution of the RCDC to the OAIC’s overall goals. Describe how the Core Leader and other mentors will help implement the intended goals of the RCDC.

Approach & Innovation (5 pages recommended). Describe the plan for recruiting, selecting, and advancing the progress of individuals who will receive RCDC support. 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). Describe the kinds of educational activities planned for the candidates. These might include regular research meetings, invited guest faculty, workshops, formal courses, etc. In addition, brief descriptions of the planned research and associated career development activities for up to five junior faculty should be presented. Descriptions in this Approach section should include the research plan proposed by each Candidate, how OAIC resources (e.g., PESC) will contribute to the research plan, and the mentor(s) for the candidate. Planned career development activities for each Candidate should be described in his/her Biographical Sketch. Mentors’ qualifications, commitment to training, and proposed support activities for RCDC candidates should be described in the mentors' Biographical Sketches. The institutional commitment to the RCDC candidates should be described in the Resources section of the RCDC application. For renewal applications, include information on the progress of the RCDC during the previous funding period.

Resource Cores (RCs)

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.

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). A minimum of one RC is required for an OAIC application.

Innovative organizational approaches are encouraged for each proposed RC. A Core Leader should be named, and plans for the scientific and administrative functioning should be presented. The method for prioritizing access to RC resources requested by multiple projects should be described. Salary and other expenses for the Core leader and administrative staff may be requested.

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. 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 in each application. The evaluation of the justification for proposed Cores by peer reviewers will include consideration of the scientific merit of the Core.

Examples of possible RCs include, but are not limited to:

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 below). RCs may also provide services to enhance and integrate the scientific contributions of External Projects (EPs), which are basic and/or clinical research projects relevant to the OAIC focus whose support is independent of the OAIC (e.g., research funded through R01, P01, U01, non-NIH mechanisms). 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. 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.

There is no limit to the number of proposed RCs; however, applicants should consider the feasibility of supporting multiple RCs within the allowable OAIC budget. Applicants may not propose an RC unless it will support at least two projects (DPs and/or EPs), and a maximum of two DPs, as described below. Evaluation of the justification for a proposed RC by peer reviewers will include consideration of the scientific merit of the research projects supported by the RC.

Developmental Projects (DPs). In addition to the support of services to other projects, RCs may propose to conduct a limited number of projects in technology, resource, and/or methods development. The goal of these DPs is 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:

DPs supported by an RC must relate to the overall goals of the OAIC. DPs should be described in detail in the OAIC application, with clear delineation of the approach taken for developing and testing the new methods or analytic approaches and discussion of how the results will be analyzed. DPs arising in subsequent years must be reviewed by the OAIC internal and external review mechanisms (see LAC section).

NIA requires that program staff be notified when a DP award is 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. Such plans should be consistent with NIA policy (see http://www.nia.nih.gov/research/dea/implementation-policies-human-intervention-studies). In addition, if the RC will support a DP involving human intervention studies in the future, the application should include a description of procedures for developing data and safety monitoring plans and notification of NIA staff consistent with the above policy.

There is no budget limit for an RC per se; however, there are budget limits for DPs. First year direct costs for each DP should range between $35,000 and $70,000. DPs may last from 1 to 5 years.

INTRODUCTION (for resubmission applications only [1 page])

The Introduction should be a summary response to the global concerns expressed about the proposed RC during the previous review.

SPECIFIC AIMS (1 page)

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 EP or DP. If an EP is supported by more than one OAIC RC, list the EP in each RC and state the pages in the application where the initial description can be found.

RESEARCH STRATEGY (6 pages)

Significance (1 page recommended). 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 (5 pages recommended). Describe the operations of the Core. Clearly distinguish between material support (e.g., performing assays, facilitating recruitment) and support in the form of guidance or advice. Present a detailed plan for how EPs and DPs eligible for Core support will be reviewed, selected, and prioritized for access to Core resources for all years of the grant period. Describe how the Core leader, together with the OAIC PI, will monitor and evaluate ongoing progress of EPs and DPs in the context of RC support. This plan should include the use of an advisory committee, the composition and functioning of which should be described in detail in the LAC research strategy. In addition, present information about EPs and DPs as follows:

Pilot/Exploratory Studies Core (PESC)

Inclusion of a PESC is optional. OAICs may conduct Pilot/Exploratory Studies (PESs) to acquire information needed to select or design future crucial studies in the OAIC area of focus. 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. A scientist responsible for leadership of this Core must be identified in the OAIC application.

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

PESs for the first year of the proposal 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. 

OAIC-supported pilot studies involving human interventions require approval by NIA staff prior to their initiation. Investigators planning to conduct pilot studies involving human interventions must communicate to NIA staff a description of the study and plans for data and safety monitoring and for notification of clinically significant events to NIA staff. Such plans should be consistent with NIA policy (see http://www.nia.nih.gov/research/dea/implementation-policies-human-intervention-studies). Pilot studies that do not involve human interventions do not require advance approval by NIA; however, NIA does require that program staff be notified of such a pilot grant award having been made. This can be done at the time of the progress report. In addition, if the PESC will support human intervention studies in the future, the application should include a description of procedures for developing data and safety monitoring plans and notification of NIA staff.

Participating researchers in OAICs are also encouraged to consider seeking additional sources of funding for pilot or exploratory studies, such as the NIH Small Research Grant Program (R03)  (http://grants.nih.gov/grants/guide/pa-files/PA-11-262.html) and NIH Exploratory/Developmental Research Grant Award (R21) (http://grants.nih.gov/grants/guide/pa-files/PA-11-261.html).

A maximum of $250,000 in direct first-year 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.

INTRODUCTION (for resubmission applications only [1 page])

The Introduction should be a summary response to the global concerns expressed about the proposed PESC during the previous review.

SPECIFIC AIMS (1 page)

Outline the topic areas to be solicited and the expected outcome for pilot or exploratory study awards.

RESEARCH STRATEGY (6 pages)

Significance (1 page recommended). Describe how Pilot/Exploratory studies (PES) will fit within the goals of the PESC and how they will interact with other Core Resources of the OAIC.

Approach & Innovation (5 pages recommended). Describe the operation of the PESC and the types of applications that will be supported (e.g., will small PESs be allowed?). Provide a detailed plan for how PESs will be solicited, peer-reviewed, selected, prioritized for access to Core 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, together with the OAIC PI, will monitor ongoing progress of studies and assist in the planning for the development of PESs into independently funded grant applications, where appropriate.

In addition, applicants should 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 (e.g., PES-1, PES-2, etc.). For each PES, list the Title, Project Leader, and Senior/Key Personnel (including page references to their Biographical Sketches). 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.

Information Dissemination Core (IDC)

Inclusion of an IDC is optional. OAICs may request support for a core to disseminate information relating to their research areas and/or to enhance translation of clinical research findings into health care practice.  These 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 nongovernmental organizations, and participation in the development of evidence-based practice guidelines by professional societies.

The types of activities planned for the IDC, the criteria and process for their selection, the staffing and organization of the IDC, and its relation to the LAC should be presented.

A maximum of $60,000 in direct costs per year may be requested for an IDC.

INTRODUCTION (for resubmission applications only [1 page])

The Introduction should be a summary response to the global concerns expressed about the proposed IDC during the previous review.

SPECIFIC AIMS (1 page)

Describe the role of the IDC in enhancing translation of clinical research findings into health care practice.

RESEARCH STRATEGY (6 pages)

Significance (1 page recommended). 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 (5 pages recommended). 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 be evaluated.  Describe how the IDC will interact with other core resources of the OAIC.

Coordinating Center (CC)

The CC facilitates and coordinates OAIC activities.  The CC will work closely with the NIA program administrator and, in coordination with the PIs and OAIC personnel, respond to requests generated by NIA or NIH.   

Each applicant OAIC is invited to submit a section proposing a Coordinating Center Core as part of its response to the OAIC FOA.  Institutions not submitting an OAIC application may apply for a free-standing CC. In either case, the CC should be proposed only by institutions with (1) the ability to coordinate multi-site projects as demonstrated by previous HHS funding for a coordinating center of a multi-site research grant, and (2) demonstrated scientific expertise in clinical aging research. A CC proposed as a free-standing Center will receive equal consideration as one proposed as a Core of an OAIC site.

The CC will create a mechanism for maintaining an active involvement in all aspects of the OAIC program. It will, as a minimum, fulfill the following functions: 

1. Provide logistic support to the OAIC sites and the NIA program administrator:

2. Develop and maintain an OAIC website to serve as an interface with the lay public, a resource for researchers in aging and related areas, and a forum for scientific exchange among OAIC investigators across sites.  

3. Work with NIA staff and OAIC Directors to develop and implement shared resources, such as databases of measurement tools and recruitment techniques, and to facilitate the sharing of scientific resources with other NIA and NIH centers programs and with the broader scientific community.

4. Provide logistical and educational support for OAIC trainees:

5. Foster communications, cooperative arrangements, and collaborative projects among OAIC sites and between OAICs and other institutional research centers, NIA- or NIH-funded research infrastructures, and other Federal or private organizations promoting geriatrics training and/or research.

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

The first year budget for a CC is limited to $175,000 in direct costs. For applications proposing a CC Core within an OAIC site, this amount is in addition to the $800,000 direct cost cap for an OAIC. The CC should be budgeted for a 5-year period of support.

INTRODUCTION (for resubmission applications only [1 page])

The Introduction should be a summary response to the global concerns expressed about the proposed CC during the previous review.

SPECIFIC AIMS (1 page)

Present a clear statement of how the CC will contribute to the goals of the OAIC.

RESEARCH STRATEGY (6 pages)

Significance (1 page recommended). Explain the purpose and functions of the CC. Present a clear statement of how the CC relates to the theme or focus of the OAIC and how it will contribute to the goals of the OAIC.

Approach & Innovation (5 pages recommended). Describe the administration and operation of the CC. Describe the types of activities that the CC will conduct to achieve its goals. Describe how the proposed activities of the CC will be evaluated.

For applications proposing a free-standing Coordinating Center, applicants should submit only this section of the application as described in the recommended format for the Table of Contents.

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 PHS398 Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

Overall Impact of the Proposed OAIC

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

Scored Review Criteria - Overall

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:

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the OAIC?  Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), 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:

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:

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 OAIC 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?

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

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:

Qualitative Review Criteria - Cores

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

Significance

Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project 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 significance of each Core:

Investigators

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?  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(s)/PI(s), 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 each Core:

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?

The following questions are also considered in evaluating the approach of each Core:

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 environment of the Core:

Additional Review Criteria - Overall

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed OAIC involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 proposal.

Renewals

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

Revisions

Not Applicable.

Additional Review Considerations - Overall

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/priority 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.   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Aging in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

1. Award Notices

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

2. Administrative and National Policy Requirements

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Basil Eldadah, MD, PhD
National Institute on Aging (NIA)
Tel: 301-496-6761
Email: eldadahb@nia.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, PhD
National Institute on Aging (NIA)
Tel: 301-496-9666
Email: vemuri@nia.nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Tel: 301-451-9802
Email: blakeney@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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