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

Roybal Centers for Translational Research on Aging (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of RFA-AG-09-008

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-AG-14-004

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits Edward R. Roybal Centers for Translation Research in the Behavioral and Social Sciences of Aging. Center resources are intended for the development and piloting of new and innovative ideas for early stage as well as late stage translation of basic behavioral and social research findings about established or hypothesized mechanisms of action, at the individual or population level, into programs and practices that will improve the lives of older people and the capacity of institutions to adapt to societal aging.

Key Dates
Posted Date

June 25, 2013

Letter of Intent Due Date(s)

December 22, 2013

Application Due Date(s)

January 22, 2014

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2014

Advisory Council Review

August 2014

Earliest Start Date

October 2014

Expiration Date

January 23, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

This Funding Opportunity Announcement (FOA) solicits NIH Research and Development Core Center Grant (P30) applications for the Roybal Centers for Translation Research on Aging. The Roybal Center program was authorized by Congress in 1993 and named for the Chair of the former House Select Committee on Aging, Edward R. Roybal. Center resources are intended for the development and piloting of new and innovative ideas for the translation of basic behavioral and social research findings about established or hypothesized mechanisms of action at the individual or population level, into programs and practices that will improve the lives of older people and the capacity of institutions to adapt to societal aging. This reissuance of the NIA Roybal Centers program focuses specifically on early stage as well as late stage translation of basic behavioral and social science research findings in the five priority areas described below under Thematic Areas of Focus. Areas of research that will be considered unresponsive to this FOA are described below under Scope of this Initiative.

NIA expects that successful Roybal Center pilot projects will lead to submission of applications for P01s, R01s, or SBIRs for further implementation. Ideas that will lead to submission of further NIA applications are strongly encouraged. Ideally, translation projects supported through the Roybal program will not only result in benefits to older people but will also advance our fundamental understanding of basic scientific questions in the behavioral and social sciences of aging.

Basic research is defined in this announcement as involving the examination of behavioral or social mechanisms or processes operating at the individual or population level. It may include phenomena operating at any level of analysis (e.g., social, economic, institutional, contextual, interpersonal, behavioral, psychological, neurobiological and/or genetic). Translation is defined in this announcement as research that moves basic research findings about established or hypothesized mechanisms or pathways towards the development of programs or tools to be used at the individual or population level. The evidence base for translation, and the proposed path from the evidence to translation, must be justified in the application.

Although the Centers often reside at a single, specific institution, some Centers may wish to make research resources available to the larger scientific community or to galvanize scientists at several academic institutions. Consortium arrangements are permissible, provided that the applicant institution meets the eligibility requirements. Centers are encouraged to collaborate with other NIA-funded Centers, including the Resource Centers for Minority Aging Research (RCMAR) (see http://www.rcmar.ucla.edu/ ) and the Centers on the Demography and Economics of Aging (see http://agingcenters.org/ ). Centers are also encouraged to collaborate with relevant private sector partners.

The focus on investigating a practical problem will require applicants to show familiarity with the practical domain or environment being investigated as well as with relevant aspects of aging research. Such familiarity may be achieved by collaboration with specialists in the domain or community, or by prior experience in applying aging-relevant research successfully to this domain. Because practical problems will likely benefit from cross-disciplinary attention, applications that reflect broad-based expertise are welcomed.

Thematic Areas of Focus

This FOA specifically focuses on early stage as well as late stage translation of basic behavioral and social science research findings only in the following five priority areas:

1. Mechanisms of Behavior Change:

Projects focused on novel behavior change interventions to promote adaptive aging. Of particular interest are projects that incorporate approaches from emerging interdisciplinary areas of behavioral and social science, including behavioral economics; the social, behavioral, cognitive and affective neurosciences; neuroeconomics; behavior genetics and genomics; and social network analysis. Priority will be given to the following topics: decision-making, cognition, resilience/vulnerability, self-control, motivation, positive health behaviors, and well-being.

2. Novel interventions exploiting the malleability or plasticity of biobehavioral risk mechanisms associated with adverse aging outcomes:

Translational research on the malleability or plasticity of biobehavioral risk mechanisms associated with adverse aging outcomes into novel interventions aimed at reversing or compensating for these risks. Risk mechanisms of interest include those associated with the deleterious impact of early social adversity and exposure to chronic psychosocial stress. Novel interventions should have the goal of improving health and well-being among middle aged and older adults.

3. Novel methods for survey research and data collection:

Translation of research advances in the basic behavioral and social sciences into new approaches for measuring health, cognition, well-being, social network effects, stress, disability, social environmental exposures (and their determinants). Examples include experience sampling, vignettes, internet survey methods, the use of activity meters, time-use approaches, new sensor technologies, and assays for relevant biomarkers.

4. Novel methods for analyzing programs affecting older populations:

Translation of research advances about trends in well-being, health and disability, and the effect of technological innovation, into economic and demographic models of health, health care utilization, and health spending; and translation of research advances about demographic trends in family structure into models of formal and informal caregiving.

5. Novel programs or practices at homes, workplaces, or firms benefiting older people in the following priority areas:

Translation of research advances in the basic behavioral and social sciences into a) new tools to improve financial decision making and/or prevent financial fraud; b) new technologies optimized for older adult users based on results from human factors research; c) new programs and interventions that target features of social networks and social engagement to increase well-being, reduce functional limitations, and/or decrease mortality; and d) innovative programs that address factors affecting work at older ages.

Note: The examples bulleted above are not an exhaustive list, but describe areas clearly related to the five priority areas of focus for this FOA.

Resources for Applicants

Stokes, Donald E. 1997. PASTEUR’s QUADRANT: BASIC SCIENCE AND TECHNOLOGICAL INNOVATION. Washington, DC: Brookings Institution Press.

Summary report from 2012 NIA Network on Reversibility meeting: http://www.nia.nih.gov/about/events/2012/network-reversibility-meeting

Summary report from 2009 NIH meeting on the Science of Behavior Change: https://commonfund.nih.gov/documents/SOBC_Meeting_Summary_2009.pdf

Scope of this Initiative

The following types of applications will be considered unresponsive to this FOA:

Section II. Award Information
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

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIA intends to commit approximately $3.9 Million Total Costs for 8-12 new or renewal awards in FY 2014. NIA anticipates funding one Coordinating Center which may be proposed as a Core within a P30 application.

Award Budget

NIA expects to fund Centers of different sizes. Application budgets are limited to $300,000 in first-year direct costs (for Cores A and B). An additional $50,000 in direct costs in the first year may be requested for Core C, the Coordinating Center function.

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 allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 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 Directors/Principal Investigators (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 least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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 PHS 398 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 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:

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

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 PHS 398 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:

Georgeanne E. Patmios
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Avenue, MSC 9205
Gateway Building, Suite 533
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: 301-496-3138
Fax: 301-402-0051
Email: PatmiosG@mail.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, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging
7201 Wisconsin Avenue, MSC 9205
Gateway Building, Suite 2C212
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: 301-496-9666
Email: VemuriR@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations:

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Modify PHS Form Page 3 to enable reviewers to find each component of the application easily. Number all pages consecutively. Because the first page of the application is the Title Page begin the next page with the numeral "2". Do not use lettered numbers (e.g., "2A", "2B" etc.) Use these referent numbers in the Table of Contents.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Prepare a detailed composite budget (across all Cores) for all requested support categories for the first year using Form Page 4. If applicable, provide additional budget pages for consortium/contractual arrangements.

Budget limits for the overall Center are indicated in Section II for first-year direct costs. There are no budget limits for Core components, except for the Coordinating Center function as described above. Each institution should decide on an optimal mix of research themes, research topics, and Specific Aims while staying within the maximum allowable direct costs per Section II.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Prepare a summary composite budget (across all Cores) for the entire proposed period of support using Form Page 5 of the PHS 398 application. If applicable, provide additional budget pages for consortium/contractual arrangements.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Biosketches for all Senior/Key Persons involved in the Center should be provided. Where an individual plays a role in more than one section of the application, a complete biosketch should also 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.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Describe the goals to be achieved by the Center, including the Center's selected research theme(s) and the basis for their selection; how the different Cores will contribute to these goals; crucial problems or limitations that the Center will address with respect to the translation theme and activities proposed; and advances in translation that the Center will achieve over its five-year award.

Research Strategy:

To achieve the FOA objectives, each Roybal Center must choose one or more of the five thematic areas described above and develop a sustained translation research program relevant to the social and behavioral sciences of aging through which the Center will accomplish its goals and

Specific Aims.

State the theme of the proposed Roybal Center program, justify the scientific evidence-base in the behavioral or social sciences for the theme selected and the translation activities proposed, describe the proposed path from the scientific evidence to the translation proposed, describe how the selected the theme is reflected in the design of the Cores and in the selection of pilot projects, and describe how the Center will measure success of the proposed translation efforts.

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

Resource Sharing Plan:Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Core A, Management and Administrative Core (Required)

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

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

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

Budget for Entire Proposed Period of Support (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

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

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

Biographical Sketch (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Biosketches for all Senior/Key Persons involved in this Core should be provided. Where an individual plays a role in more than one section of the application, the biosketch provided in this section may reflect qualifications and publications of relevance specifically to this Core.

Resources (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Management and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:.

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy: The required activities of this Core are to:

Optional objectives of this Core are to:

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

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Core B, Pilot Core (Required)

The objective of this Core is to support small-scale and innovative pilot projects that are consistent with the theme of the Center. The expectation is that pilot projects will provide the preliminary data that will lead to larger research efforts.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Pilot Core)

All instructions in the PHS 398 Application Guide must be followedm with the following additional instructions:

Each Roybal Center application must request funds to initiate small-scale (up to $100,000 Direct Costs) pilot research that is consistent with the theme of the Center grant. Applicants may propose as many pilot projects per year as they wish while staying within the budget limits for the overall Center. The Pilot Core budget for the initial year only should specify the pilot projects to be conducted; these should be included in the Pilot Core Research Strategy as described below.

Budget for Entire Proposed Period of Support (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Each Roybal Center application must request funds to initiate small-scale (up to $100,000 Direct Costs) pilot research that is consistent with the theme of the Center grant. Applicants may propose as many pilot projects per year as they wish while staying within the budget limits for the overall Center. Individual Core budgets should be prepared for all 5 years of the Roybal Center application.

Biographical Sketch (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Biosketches for all Senior/Key Persons involved in this Core should be provided. Where an individual plays a role in more than one section of the application, the biosketch provided in this section may reflect qualifications and publications of relevance specifically to this Core.

Resources (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Pilot Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:.

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy: Pilots can support research to: 1) move a basic research finding towards its ultimate translation, 2) conduct additional basic research needed to allow a specific step(s) in the translation process (i.e. back-translation), or 3) support the development of preliminary data leading to larger research efforts to further implement translation activities into a program or product. The eligible groups for such pilots include, but are not limited to, junior, underrepresented and established investigators at the Center institutions or at outside institutions, or in association with academic and/or corporate partners. While pilot projects may be proposed for one to three years' duration, it is expected that most will be funded for one year. The Pilot Core can increase or decrease in relative size over the course of the funding period as the number of pilot projects varies.

Application should:

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Coordinating Center Core (Optional)

Applicants are encouraged to apply for the coordinating center function in order to promote collaboration and networking among the NIA Roybal Centers. Coordinating Center (CC) Cores will be scored separately from the parent Roybal (P30) Center application, and the score for the Coordinating Center (CC) will NOT be considered in determining the overall scientific merit of these P30 applications.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Biosketches for all Senior/Key Persons involved in this Core should be provided. Where an individual plays a role in more than one section of the application, the biosketch provided in this section may reflect qualifications and publications of relevance specifically to this Core.

Resources (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Coordinating Center Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:.

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy: Mandatory Coordinating Center functions are: establishing a multi-center website that would include significant research advances from Roybal Centers; arranging occasional workshops; and developing a standardized reporting template for use by P30s funded through this FOA that will facilitate the reporting of aggregated information to NIA Program Officials on Centers results, productivity, and plans (individually and collaboratively).

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 PHS 398 Application Guide, with the following modification:

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modification:

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 PHS 398 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 - Overall

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

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

How significant is the chosen topic for advancement of one or more of the five priority areas of focus (listed in Section 2.I) for this FOA? What is the strength of evidence base for the translation theme and pilot projects proposed? Is there potential for significant scientific and translation progress in the specific themes and pilot projects addressed by the application? Is there scientific merit in the proposed pilot projects?

For renewal applications, to what extent have the translation activities in the previous funding period been successful? To what extent has the Center justified continuation of the translation activities for another five year period?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

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

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?

To what degree will the Center stimulate new and important translation of basic behavioral and social science research that will improve the health, well-being, and productivity of older people?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center 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?

Will the Center’s approach to translation likely lead to significant practical outcomes?

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?

Is there significant ongoing research activity at the applicant and collaborating institutions that is relevant to the theme of the proposed Center? Does the environment facilitate the ability to translate a body of basic behavioral and social research into significant practical outcomes for the benefit of older people?

Additional Review Criteria - Overall

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 Center 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

Not Applicable

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

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.

Qualitative Review Criteria - Cores A and B

For Cores A and B, 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?

Core B, Pilot Core (Required): How will the proposed pilot projects and types of future pilot projects contribute to the goals of the Center and relate to the selected research theme(s)? Is the evidence base for the proposed translation project justified? Is the pilot project likely to lead to a significant practical outcome? To what extent will the pilots lead to additional significant translational research opportunities?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

Core B, Pilot Core (Required): Are there sufficient qualified personnel from whom to solicit project projects in order to achieve the goals of the Pilot Core?

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?

Core A, Management and Administrative Core (Required): Are the proposed approaches to planning and coordinating the Overall Center and the Pilot Core effective?

Core B, Pilot Core (Required): To what degree will Core B stimulate new ideas that will lead to successful translation related to the proposed Center theme?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Is the pilot project review process adequate to assess the scientific merit of proposed pilot or program development projects? 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 Center 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?

Core A, Management and Administrative Core (Required): How well will the proposed Management and Administrative Core staff lead the proposed Center and interact with other organizational components within and outside the institution? Is the proposed Advisory Committee process for developing, soliciting, reviewing, selecting, monitoring and evaluating pilot projects adequate?

Core B, Pilot Core (Required): Are the personnel qualified to achieve the goals of the Pilot Core? What are the scientific quality and significance of the pilot projects proposed and are they likely to lead to translation into significant practical outcomes? Is the proposed path from the evidence base to translation justified? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research 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 project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Core A, Management and Administrative Core (Required): Will the resources and environment of the Administrative and Research Support Core of the Center adequately contribute to the leadership of the proposed Center and to achieving its goals? Does the institutional environment of the applicant and collaborating institutions have significant ongoing research activity that is relevant to the theme of the proposed Center? Does the environment facilitate the ability to translate a body of basic research into significant practical outcomes? Does the administrative structure maximize the Center’s capability to take advantage of research opportunities?

Scored Review Criteria - Core C, Coordinating Center Function (Optional)

Coordinating Center (CC) Cores will be scored separately from the parent Roybal Center (P30) application, and the score for the Coordinating Center (CC) will NOT be considered in determining the overall scientific merit of these P30 applications.

Significance

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

How well does the proposed Coordinating Center address the coordination and communication needs of the Roybal Center program? If the aims of the application are achieved, how will the proposed Coordinating Center bring added value to the scientific activities and accomplishments of this program?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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?

Is the leadership structure appropriate for the proposed Coordinating Center? Is the proposed team experienced in the coordination of multi-site activities or research collaborations?

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?

To what extent will the Coordinating Center facilitate the effectiveness and impact of the Roybal Center program?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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?

Is the proposed organization adequately developed, well integrated, well-reasoned, and appropriate to the aims of the Coordinating Center? Is the approach to the coordinating functions effective?

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 Center proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the technologic and scientific environment in which the work will be done contribute to the probability of success? Do the proposed activities benefit from unique features of the scientific environment? Is there evidence of institutional support?

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

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.

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

Prior Approval of Pilot Projects

All awardee-selected projects require prior approval by NIH prior to initiation (with exceptions allowed as described below).

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 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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: 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Georgeanne E. Patmios, M.A.
National Insitute on Aging (NIA)
Telephone: 301-496-3138
Email: PatmiosG@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Insitute on Aging (NIA)
Telephone: 301-496-9666
Email: VemuriR@mail.nih.gov

Financial/Grants Management Contact(s)

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: BallJ@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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