Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov)

Title: Claude D. Pepper Older Americans Independence Centers (OAICs)(P30)

Announcement Type
This is a reissue of RFA-AG-07-008.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AG-10-003

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: January 16, 2009
Letters of Intent Receipt Date: February 24, 2009
Application Receipt Date: March 24, 2009
Peer Review Date(s): July/August 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 2009
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: March 25, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. 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 geriatrics research and training. The goal of the OAIC program is to increase scientific knowledge that will lead to better ways to maintain or restore independence in older persons.

The OAIC awards are designed to develop or strengthen each awardee institution's 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 for young scientists. The ultimate goal is to enhance translation of basic and developmental research on aging to applications and interventions that increase or maintain independence for older persons. 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 one or more important research areas to be addressed, to specify the goals to be achieved within the five-year OAIC award period, and to provide a plan to reach these goals and 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 areas of research focus from a broad range of topics, including:

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. Institutions with strong research programs in more than one area may propose an OAIC with more than one area of focus; however, a set of activities that will fulfill this goal should be proposed for each area of focus.

Whether one or more than one focus area is selected, 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.

Cognition and Behavioral Science 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 OIAC.

Health Services Research as an Area of Focus: Research to determine effects of health practices or services, or the use of new or different types of health care providers or interventions, is generally appropriate for a Pepper Center component if the services or interventions follow a defined algorithm and are delivered to or directly involve the individual patient.  For additional information, see the NIA Division of Geriatrics and Clinical Gerontology (DGCG) program website http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/GeriatricsAndClinicalGerontology/AlternativeFormatPages.htm

OAIC Core Structure

Requirements for the OAIC Core structure are provided below. Specific instructions for preparing the OAIC application are provided in Section IV. 6. Other Submission Requirements.

To accomplish the program goals, each OAIC award will provide support for the following components and activities:

1) A Leadership/Administrative Core (LAC) (required)
2) A Research Career Development Core (RCDC) (required)
3) One or more Resource Cores (RCs) (required)
4) A Pilot/Exploratory Studies Cores (PESC) (optional)

The Leadership and Administrative Core (LAC) will support research planning and evaluation activities for the Cores, the OAIC as a whole, and other administrative activities.

The Research Career Development Core (RCDC) will support career development activities and infrastructure, including salary, fringe benefits, travel, and didactic training for junior faculty who are conducting pilot studies, developmental projects or working on independently funded projects.

An OAIC may provide support to a variety of types of research in its area(s) of focus: a) testing of prevention, intervention, diagnostic, or functional assessment techniques; b) translational research (including mechanistic studies), experimental therapeutic studies in laboratory animals, studies in animal models, and c) technology or methods development research.

Resource Cores (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, and equipment, as well as diagnostic, assessment and survey instruments to advance aging research.

A Pilot/Exploratory Studies Core (PESC) is optional.  The PESC supports pilot or exploratory research to acquire information needed to select or design future crucial studies in the OAIC area of focus.

Each OAIC must support a significant amount of clinical research with human subjects.  However, every core within an OAIC is not required to support studies on human subjects. Core support may be provided for basic and translational research in animal models and in vitro systems and for secondary data set analyses. 

While most of the research supported by RCs, the PESC and the RCDC should relate to the areas selected as the OAIC research theme(s), a limited amount of support in these Cores is acceptable for topics in other areas of aging research related to the goals of the NIA OAIC program, as noted above.

A. LEADERSHIP AND ADMINISTRATIVE CORE (LAC)

The Leadership and Administrative Core (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. At least one third of the members of each panel should be external to the awardee institution. 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 in the following activities:

Additional activities for which the LAC may provide support include:

Participation of OAIC investigators and Coordinating Unit leadership at an annual scientific meeting is mandatory. Participants will include the PD/PI, 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.

The membership of the required advisory panels/boards should not be included in the application. However, the operating procedures of these groups, including the frequency of their meetings and the methods for the identification of members should be specified.

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

B. 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. 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 salary and other support for junior faculty and research associates to acquire research skills in the area of OAIC focus. Specifically, the Research Career Development Core will provide support for salary, didactic training, travel, information resources, and secretarial or technical support. Junior faculty and research associates who receive RCDC support may also receive funding for pilot/exploratory studies (see Pilot/Exploratory Studies Core below). Funds for salaries and other expenses of the Core Leader 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. The development of strong aging-related research capabilities in individuals with clinical geriatrics competence, as evidenced by Board certification of qualifications in geriatrics, is a particular program priority. (Such individuals include both those whose sole fellowship training is in geriatrics, as well as those who have received training in both geriatrics and another clinical specialty.) Although the inclusion of such individuals among those receiving RCDC support is not a requirement for OAICs, applicants are strongly encouraged to explore possibilities for recruiting and including such persons, and to coordinate their activities with clinical training programs to encourage the development of individuals with both training in geriatrics and research interests in the OAIC area of focus. 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, fellowship, non-NIH career awards) in concerted programs for career development.

The OAIC proposal should identify the individuals 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 the individual'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 individual) will contribute to OAIC program goals for research career development in its selected area of research focus.

In addition, 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 program.

A maximum of $450,000 in first-year direct costs may be requested for the Research Career Development Core. Budget increments in future years will generally be limited to one percent.

C. RESOURCE CORES (RCs)

Each Resource Core (RC) should be based on a research field or function that contributes to the OAIC area(s) of focus. These cores 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 a required for an OAIC application.

Innovative organizational approaches are encouraged for each Resource Core proposed. A Core Leader should be named, and plans for the scientific and administrative functioning should be presented. The method for prioritizing access to core 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(s) of focus. However, there is no requirement that an OAIC Resource Core include this full range. The selection of areas for Resource Cores 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 individual cores 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:

RCs may provide services for developmental studies that are part of the RC infrastructure (see below) and for pilot/exploratory studies included in the PESC (see below). RCs should also provide services to enhance and integrate the scientific contributions of 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 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.

An applicant may not propose a Resource Core unless it will support at least two projects. These projects may be external projects with funding from other NIH mechanism or developmental projects proposed as a part of the Research Core. Evaluation of the justification for proposed cores by peer reviewers will include consideration of the scientific merit of the research projects supported by the cores. External Projects will be evaluated on the basis of previous peer review and funding source. Developmental Projects within each Resource Core will be evaluated for scientific merit as a part of the OAIC application review process.

Developmental Projects

In addition to the support of services to other projects, RCs may directly conduct a limited amount of technology, resource and/or methods development projects. These projects are referred to below as Developmental Projects. The goal of these developmental projects is to establish new methods or technologies that will enrich the resources of the Core or the services it provides.   Developmental studies which challenge existing paradigms or develop new methodologies or technologies are highly valued.

Examples of activities in Developmental Projects 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.

Developmental Projects supported by a RC must relate to the overall goals of the OAIC. A proposed RC may request support of up to $70,000 (direct costs) per year for developmental projects. Specific developmental projects to be conducted by an RC using these funds may last from one to five years. The first year of developmental activities using these funds should be described in detail in the OAIC application, clearly delineating the approach taken for developing and testing the new methods or analytic approaches and discussing how the results will be analyzed. Developmental activities for 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 developmental grant award is made by an OAIC to its investigators; however, this can be done at the time of the progress report.

D. PILOT/EXPLORATORY STUDIES CORE (PESC)

OAICs may conduct pilot/exploratory studies to acquire information needed to select or design future crucial studies in the OAIC area of focus. These studies may be led by junior faculty and research associates receiving OAIC Research Career Development Core support, or by other senior or junior investigators. A scientist responsible for leadership of this core must be identified in the OAIC application.

Funding for pilot/exploratory studies may be for:

The above examples are not exhaustive of the types of pilot/exploratory studies that could be supported.

A maximum of $250,000 in direct first-year costs may be requested for the Pilot/Exploratory Studies Core.

Pilot/Exploratory Studies (PES)

Applicants may propose up to five PES in the first year. The minimum budget request for such studies is $25,000 in first year direct costs for each study. Each project is limited to no more than $150,000 direct costs over its entire period of support, which should be for no more than three years. (Thus, there is an inverse relationship between the amount of yearly support and the duration of the project.) Increments in future years will generally be limited to one percent.

PES for the first year of the proposal should be included 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.  Specific aims, background and significance, preliminary studies, and experimental design and methods sections for each proposed PES should be included in this Core. Budgets should be prepared for all 5 years of the OAIC application.

Participating researchers in OAICs are also encouraged to consider seeking additional sources of funding for pilot or exploratory studies, such as the NIH/NIA Small Research Grant (R03) Program (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html) and NIH Exploratory/Developmental Research Grant Award (R21) http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html

Pilot Study awards do not require advance approval by NIA. However, NIA does require that program staff be notified when a pilot grant award is made. This can be done at the time of the progress report (see Section VI.3).

Small Pilot/Exploratory Studies

Up to $50,000 of the $250,000 budget may be set aside for small studies ($10,000 or less in first year direct costs for each). Scientific presentations of these small studies should not be included in the proposal. However, the method for the selection of these studies should be described.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH P30 Center Core Grant award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The estimated amount of funds available for support of four new and/or renewal awards as a result of this announcement is $2.9 M for fiscal year 2009 and $1.5 M for FY2010. The maximum allowable Direct Cost that may be requested is $800,000 per year.  An applicant may request a project period of up to 5 years.  Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, See NOT-OD-05-004.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Note that foreign organizations are not eligible to apply for P30 grants.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Each applicant organization may submit one application. 

Resubmissions. Applicants may submit a resubmission application; however, such application must include an Introduction addressing issues raised in the previous critiques (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016   Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications will be permitted for this FOA.

Number of PDs/PIs. Multiple PD/PIs are not permitted.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Additional information is available in the PHS 398 grant application instructions.

Requirements for the OAIC Core structure are provided below. Specific instructions for preparing the OAIC application are provided in Section IV. 6. Other Submission Requirements.

OAIC Core Structure

To accomplish the program goals, each OAIC award will provide support for the following components and activities:

1) A Leadership/Administrative Core (LAC) (required)
2) A Research Career Development Core (RCDC) (required)
3) One or more Resource Cores (RCs) (required)
4) A Pilot/Exploratory Studies Cores (PESC) (optional)

The Leadership and Administrative Core (LAC) will support research planning and evaluation activities for the Cores, the OAIC as a whole, and other administrative activities.

The Research Career Development Core (RCDC) will support career development activities and infrastructure, including salary, fringe benefits, travel, and didactic training for junior faculty who are conducting pilot studies, developmental projects or working on independently funded projects.

An OAIC may provide support to a variety of types of research in its area(s) of focus: a) testing of prevention, intervention, diagnostic, or functional assessment techniques; b) translational research (including mechanistic studies), experimental therapeutic studies in laboratory animals, studies in animal models, and c) technology or methods development research.

Resource Cores (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, and equipment, as well as diagnostic, assessment and survey instruments to advance aging research.

A Pilot/Exploratory Studies Core (PESC) is optional.  The PESC supports pilot or exploratory research to acquire information needed to select or design future crucial studies in the OAIC area of focus.

Each OAIC must support a significant amount of clinical research with human subjects.  However, every core within an OAIC is not required to support studies on human subjects. Core support may be provided for basic and translational research in animal models and in vitro systems and for secondary data set analyses. 

While most of the research supported by RCs, the PESC and the RCDC should relate to the areas selected as the OAIC research theme(s), a limited amount of support in these Cores is acceptable for topics in other areas of aging research related to the goals of the NIA OAIC program, as noted above.

A. LEADERSHIP AND ADMINISTRATIVE CORE (LAC)

The Leadership and Administrative Core (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. At least one third of the members of each panel should be external to the awardee institution. 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 in the following activities:

Additional activities for which the LAC may provide support include:

Participation of OAIC investigators and Coordinating Unit leadership at an annual scientific meeting is mandatory. Participants will include the PD/PI, 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.

The membership of the required advisory panels/boards should not be included in the application. However, the operating procedures of these groups, including the frequency of their meetings and the methods for the identification of members should be specified.

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

B. 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. 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 salary and other support for junior faculty and research associates to acquire research skills in the area of OAIC focus. Specifically, the Research Career Development Core will provide support for salary, didactic training, travel, information resources, and secretarial or technical support. Junior faculty and research associates who receive RCDC support may also receive funding for pilot/exploratory studies (see Pilot/Exploratory Studies Core below). Funds for salaries and other expenses of the Core Leader 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. The development of strong aging-related research capabilities in individuals with clinical geriatrics competence, as evidenced by Board certification of qualifications in geriatrics, is a particular program priority. (Such individuals include both those whose sole fellowship training is in geriatrics, as well as those who have received training in both geriatrics and another clinical specialty.) Although the inclusion of such individuals among those receiving RCDC support is not a requirement for OAICs, applicants are strongly encouraged to explore possibilities for recruiting and including such persons, and to coordinate their activities with clinical training programs to encourage the development of individuals with both training in geriatrics and research interests in the OAIC area of focus. 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, fellowship, non-NIH career awards) in concerted programs for career development.

The OAIC proposal should identify the individuals 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 the individual'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 individual) will contribute to OAIC program goals for research career development in its selected area of research focus.

In addition, 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 program.

A maximum of $450,000 in first-year direct costs may be requested for the Research Career Development Core. Budget increments in future years will generally be limited to one percent.

C. RESOURCE CORES (RCs)

Each Resource Core (RC) should be based on a research field or function that contributes to the OAIC area(s) of focus. These cores 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 a required for an OAIC application.

Innovative organizational approaches are encouraged for each Resource Core proposed. A Core Leader should be named, and plans for the scientific and administrative functioning should be presented. The method for prioritizing access to core 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(s) of focus. However, there is no requirement that an OAIC Resource Core include this full range. The selection of areas for Resource Cores 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 individual cores 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:

RCs may provide services for developmental studies that are part of the RC infrastructure (see below) and for pilot/exploratory studies included in the PESC (see below). RCs should also provide services to enhance and integrate the scientific contributions of 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 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.

An applicant may not propose a Resource Core unless it will support at least two projects. These projects may be external projects with funding from other NIH mechanism or developmental projects proposed as a part of the Research Core. Evaluation of the justification for proposed cores by peer reviewers will include consideration of the scientific merit of the research projects supported by the cores. External Projects will be evaluated on the basis of previous peer review and funding source. Developmental Projects within each Resource Core will be evaluated for scientific merit as a part of the OAIC application review process.

Developmental Projects

In addition to the support of services to other projects, RCs may directly conduct a limited amount of technology, resource and/or methods development projects. These projects are referred to below as Developmental Projects. The goal of these developmental projects is to establish new methods or technologies that will enrich the resources of the Core or the services it provides.   Developmental studies which challenge existing paradigms or develop new methodologies or technologies are highly valued.

Examples of activities in Developmental Projects 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.

Developmental Projects supported by a RC must relate to the overall goals of the OAIC. A proposed RC may request support of up to $70,000 (direct costs) per year for developmental projects. Specific developmental projects to be conducted by an RC using these funds may last from one to five years. The first year of developmental activities using these funds should be described in detail in the OAIC application, clearly delineating the approach taken for developing and testing the new methods or analytic approaches and discussing how the results will be analyzed. Developmental activities for 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 developmental grant award is made by an OAIC to its investigators; however, this can be done at the time of the progress report.

D. PILOT/EXPLORATORY STUDIES CORE (PESC)

OAICs may conduct pilot/exploratory studies to acquire information needed to select or design future crucial studies in the OAIC area of focus. These studies may be led by junior faculty and research associates receiving OAIC Research Career Development Core support, or by other senior or junior investigators. A scientist responsible for leadership of this core must be identified in the OAIC application.

Funding for pilot/exploratory studies may be for:

The above examples are not exhaustive of the types of pilot/exploratory studies that could be supported.

A maximum of $250,000 in direct first-year costs may be requested for the Pilot/Exploratory Studies Core.

Pilot/Exploratory Studies (PES)

Applicants may propose up to five PES in the first year. The minimum budget request for such studies is $25,000 in first year direct costs for each study. Each project is limited to no more than $150,000 direct costs over its entire period of support, which should be for no more than three years. (Thus, there is an inverse relationship between the amount of yearly support and the duration of the project.) Increments in future years will generally be limited to one percent.

PES for the first year of the proposal should be included 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.  Specific aims, background and significance, preliminary studies, and experimental design and methods sections for each proposed PES should be included in this Core. Budgets should be prepared for all 5 years of the OAIC application.

Participating researchers in OAICs are also encouraged to consider seeking additional sources of funding for pilot or exploratory studies, such as the NIH/NIA Small Research Grant (R03) Program (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html) and NIH Exploratory/Developmental Research Grant Award (R21) http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html

Pilot Study awards do not require advance approval by NIA. However, NIA does require that program staff be notified when a pilot grant award is made. This can be done at the time of the progress report (see Section VI.3).

Small Pilot/Exploratory Studies

Up to $50,000 of the $250,000 budget may be set aside for small studies ($10,000 or less in first year direct costs for each). Scientific presentations of these small studies should not be included in the proposal. However, the method for the selection of these studies should be described.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: February 24, 2009
Application Receipt Date: March 24, 2009
Peer Review Date(s): July/August 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Susan G. Nayfield, M.D., M.Sc
Division of Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 3C-307
Bethesda, MD 20892
Telephone: (301) 496-6761
FAX: (301) 402-1784
Email: nayfiels@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Ramesh Vemuri, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging 
7201 Wisconsin Avenue
Gateway Building, Suite 2C-212
Bethesda, MD 20892
Telephone: (301) 496-9666
FAX:  (301) 402-0066
Email: vemuri@nia.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, applications submitted in response to the prior OAIC solicitations, AG 06-001 and AG 07-008, but unfunded may be resubmitted to the current solicitation. Follow instructions in the PHS 398 form for preparing resubmissions. Other previously unfunded applications, originally submitted as an investigator-initiated application, that are to be submitted in response to this funding opportunity, should be prepared as NEW applications. That is, the application for this funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of an award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Follow the instructions in the PHS 398 application kit at http://grants.nih.gov/grants/funding/phs398/phs398.html. Additional instructions and recommended formats for providing the information requested for this RFA are available at the Division of Geriatrics and Clinical Gerontology (DGCG) website.

SECTION 1.  Information for the Entire OAIC (P30) Application

Note:  Follow font and format specifications for the PHS 398.

1. Face Page (PHS 398):  Use Form Page 1. For Item 2, check YES and cite the OAIC RFA number and title. 

2. Description, Project/Performance Sites, Senior/Key Personnel, and Other Significant Contributors (PHS 398). Use Form Page 2 and 2-continued.  The description serves as a brief overview of the entire application and summarizes the general plan and goals for the proposed OAIC.

3. Table of Contents.  Due to the complexity of OAIC applications, applicants are strongly encouraged to use the example format provided on the DGCG website and to number all pages consecutively.

4. Budget.  Use PHS 398 Form Page 4 and Form Page 5 to provide information listed in the recommended Table of Contents.  To aid in the review of the application, insert consolidated budget tables (Table IA for the first year and Table IB for the entire project period).  The recommended format for these tables is on the DGCG website. Place detailed budgets for individual cores with the corresponding Cores, as in the recommended format for the "Table of Contents."  Justify all items carefully according to PHS 398 instructions.

5. Biographical Sketches.  Use the PHS Biographical Sketch Format Page.  Insert Biographical Sketches for all investigators and scientific personnel referenced in this section of the application.  The PD/PI Biographical Sketch should be first, followed by others in alphabetical order.  Biographical Sketches are limited to 4 pages per individual.  NOTE that this is the only place in the application in which Biographical Sketches are provided, except for Consultants and RCDC candidates. The Biographical Sketches part of each subsequent core should be a listing of the Core Leader and senior/key personnel or consultants with page references to individual Biographical Sketches in the appropriate sections of the application.

6. Table II: Distribution of Professional Effort.  Provide information on the distribution of professional effort of senior/key personnel for the application.  The recommended format for this information is the example table "DISTRIBUTION OF PROFESSIONAL EFFORT (Person Months) ON THIS APPLICATION" on the DGCG website. Note that Other Grant Support for senior/key personnel is included as part of the Biographical Sketches.

7.  Resources and Environment.  Describe resources and environment that are relevant to the OAIC as a whole. Note that resources relevant to the individual cores are described in the section for that core. 

SECTION 2. Summary Research Plan.  Present a succinct plan for the entire application. Refer to the recommended format for the Table of Contents (DGCG website) to include the information requested below:

1. Introduction to the Application (Resubmission or revision applications only).  All resubmission and revision applications must include an Introduction.  This section may not exceed 3 pages for resubmission applications and 1 page for revision applications.

 2. Specific Aims. Describe the goals to be achieved by the OAIC, including:

3.  Background and Significance

Present the OAIC's overall strategy for serving as a sustained resource to the research program in its selected area(s). 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, how the different components of the OAIC will interact to help accomplish them, mechanisms to ensure the coherence of the Center and maintain 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.

Discuss the relation of the Center to other activities in the applicant institution (such as related research projects) and the extent of institutional, departmental, and interdepartmental cooperation. Summarize the major resources available to the Center and the environment in which it will be conducted. In addition, describe the administrative relationships of the proposed Center to the institution. Include relevant issues relating to institutional commitment and settings.

Present the scientific expertise of the Principal Investigator in the proposed OAIC's area(s) of focus and his/her capacity for the leadership of a core center of excellence in aging research.

4.  Preliminary Studies/Progress Report.  For all applications: Include a brief summary of aging and other active and recent aging related research, and career development programs, at the applicant institution that are relevant to the proposed Center, including sources of support and selected recent references. 

A Progress Report must be provided for Renewal and Revision Applications.  Describe activities conducted by the OAIC or applicant through the previous award period or the period since the previous application that are relevant to the goals of the current application. As part of the Progress Report, renewal applications from existing OAIC sites are encouraged to include summary tables of OAIC activities (such as those prepared for the mid-cycle review) in the Appendix.

Do not exceed 10 pages total for the Introduction, Specific Aims, Background/Significance, and Preliminary Studies/Progress Report.  Additional information may be provided in the Appendix or the descriptions of the proposed cores, as appropriate.

5.  Bibliography and References Cited. 

6.  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 and pilot/exploratory studies.

7.  Inclusion of Women and Minorities (as applicable to the OAIC). 

8.  Inclusion of Children (as applicable to the OAIC). 

9.  Vertebrate Animals (as applicable to the OAIC).  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.

10.  Consortium/Contractual Arrangements (including Consultants).    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. For consortium arrangements, the application must include the following additional information:

a.       A list of all project/performance sites, including the applicant institution and the collaborating institutions.

b.       A separate detailed budget for the initial and future years for each institution and, where appropriate, for each unit of activity at each institution. Request F&A costs for the consortium institution as a direct cost and include them in the "Other" category. Insert the amounts requested in the appropriate budgets for the applicant institution. The detailed consortium/contract budgets follow those for the appropriate applicant institution budgets.

c.        A composite budget for all units of activity at each institution for each year, as shown under section b above, as well as a composite budget for the total proposed funding for each year. Insert these budget pages after the composite budgets for the applicant institution.

d.       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 or with individual projects, as appropriate.

Consultants.  Use the PHS Biographical Sketch Format Page.  Insert Biographical Sketches for all Consultants listed in the OAIC application in alphabetical order with a letter of agreement to serve as a Consultant.  Biographical sketches are limited to 4 pages, and one page is allowed for the letter of agreement. 

11.  Letters of Support. Place Institutional letters of support for the OAIC in this section.

12.  "PERCENTAGE DISTRIBUTION OF RESEARCH RESOURCES CORES TO OAIC AND EXTERNALLY FUNDED RESEARCH PROJECTS."

The recommended format for this information is provided in Table III "PERCENTAGE DISTRIBUTION OF RESEARCH RESOURCES CORES TO OAIC AND EXTERNALLY FUNDED RESEARCH PROJECTS" on the DGCG website.

13.  Personnel Report (Renewal applications only).

GENERAL PLAN for INDIVIDUAL CORES

Prepare each core as a separate section that begins on a new page of the application.  Begin each with a title page (see the Title Page format on the DGCG website) and detailed first year and summary budgets.  Continue to number the pages consecutively.

The items below represent the first five subsections of each core.  Additional instructions for these items are included as needed in the sections for specific cores.

1. Title Page for Individual Cores.  Use the recommended Title Page format on the DGCG website. 

2. Budget (PHS 398 Form Page 4 and Form Page 5).  Provide budgets for the first 12-month budget period and for the entire grant period for individual cores (including a detailed budget justification).

3. Biographical Sketches of Core Leader and Senior/Key Personnel.  The individual responsible for a component is the “Core Leader.”  Categorize other scientific staff as “Senior/Key Personnel” (who contribute to the scientific development or execution of the project in a measurable, substantive way, whether or not salaries are requested) and “Other Significant Contributors” (who have committed to contribute to the scientific development or execution of the project but are not committing any specified measurable effort). Since only one individual is recognized as the responsible person, do not use “Co-investigator.”

Provide a list including Core Leader, Senior/Key Personnel, and Other Significant Contributors.  State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

4. Resources and Environment.  Describe resources and environment that are relevant and/or unique to the specific Core and are not described elsewhere in the application.

SPECIFIC INDIVIDUAL PLANS for EACH CORE

SECTION 3. LEADERSHIP/ADMINISTRATIVE CORE (LAC). 

 The Leadership/Administrative Core (LAC) should be presented in the following format:

1. Title page (recommended format on DGCG website)(N.B. Not the 398 face page)

2. Budgets for First 12-month Budget Period and for Entire Period for Individual Core (PHS 398 Form Page 4 and Form Page 5).  Be sure to include a request for travel to the NIH for the yearly meeting of Center Directors, Center Administrators, and NIA Program Staff.

3.  Biographical Sketches of Core Leader and Senior/Key Personnel:  Provide a list including Core Leader, Senior/Key Personnel, and Other significant Contributors.  State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

4.  Resources and Environment not previously described that are relevant to the LAC. 

5. Overview:

a.       Describe the administrative structure and activities of this core.

b.       Describe the administrative relationships between the LAC and all other OAIC components, and how they will operate to achieve the OAIC's goals and maintain quality of the OAIC as a whole and its individual components.

c.        Describe the activities and role of the LAC Leader (who is also the PD/PI of the OAIC), the Center Administrator, and other LAC staff, in carrying out the functions of the LAC. A description of the activities of the LAC Leader in monitoring, stimulating, sustaining, evaluating, and reporting the OAIC's progress toward the overall goals of the OAIC is a crucial component of this description.

6.  OAIC Advisory Panels:  Present plans and budget requests for the establishment and operation of OAIC advisory panels including:

a.       An External Advisory Committee composed of experts from outside the OAIC and the grantee institution who will meet yearly to review the progress of the OAIC and provide a written report to the OAIC Director for inclusion in the OAIC's annual progress report to NIA.

b.       Other advisory panels to assist in the selection of developmental projects, pilot/exploratory studies and selection of junior faculty for salary support.

For new applications, advisory committee members should not be recruited before peer review of the OAIC application is completed and comments in the Summary Statement have been considered.  For renewal applications, advisors/ consultants already employed, or with whom prospective employment has already been discussed, must be named and their institution identified.

Criteria for the selection of advisors and the operating procedures of these groups, including the frequency of their meetings and the methods for the identification of members, should be specified.

Do not exceed 10 pages for the LAC Overview and Advisory Panels.

Special Requirement: Participation of OAIC investigators at an annual scientific meeting is mandatory.  Participants will include the PD/PI, 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.

A maximum of $150,000 in direct costs per year for salary, travel, and other expenses of the LAC director, administrator and appropriate administrative staff may be requested. Future year annual increases will generally be limited to no more than one percent.

SECTION 4.  RESEARCH CAREER DEVELOPMENT CORE (RCDC). 

 The Research Career Development Core should be presented in the following format:

1. Title page (recommended format on DGCG website)

2. Budgets for First 12-month Budget Period and for Entire Period (PHS 398 Form Page 4 and Form Page 5))

3.  Resources and Environment: 

4. Overview:   Describe the purpose, function, leadership and administrative mechanisms planned to achieve the objectives of this core including:

a.       Administrative Structure and Activities should include the contribution of the RCDC to the OAIC's overall goals and a discussion of the role and qualifications of the proposed Core Leader.

b.       Procedures for Recruitment, Selection, Mentoring, and Monitoring Progress should comprise a general plan for recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive RCDC support. This plan should include the use of an advisory panel with at least one third of the members external to the OAIC and the grantee institution. (Plans for the constitution, and function of this committee, along with a budget request for its support, will be more completely presented as part of the Leadership/Administrative Core.)

c.        Other Educational Activities sponsored or supported by the RCDC: Describe other educational activities of the RCDC such as regular research meetings, conferences, workshops, formal courses, etc., which will be used to achieve the objectives of this core and for which support is requested.

d.       Gender/Minority Enrollment Table (Target Population) for recruitment of trainees to RCDC. (PHS 398)

e.       Progress Report (continuing renewal applications only)

Do not exceed 15 pages the Overview for the RCDC.

5.  Career Development Candidates.  Present the biosketches and RCDC Career Development Plans for up to five junior faculty or research associates considered for the first year of RCDC support. Do not exceed 3 pages for the Career Development Plan for each RCDC trainee (including the Research Plan) or 4 pages for his/her biosketch.

The individual Career Development Plans should describe:

a.       The proposed Research Plan

b.       The abilities that the candidate is expected to acquire during his/her period of support by the core, and how these will be achieved

c.        The mentor's research activities and past history of research training and the commitments to training and supervising the candidate (including a Biographical Sketch of the mentor in Section 1)

d.       The institutional commitments to the individual's development

e.       The OAIC's goals for the individual's career progression by the end of the OAIC award period and how the proposed use of OAIC funds (including Pilot/Exploratory Studies Core funding, if proposed for the individual) will contribute to program goals for research career development in the OAIC focus area.

6. Bibliography and References Cited

7.  Protection of Human Subjects (relevant to RCDC projects)

8.  Inclusion of Women and Minorities (relevant to RCDC projects)

9.  Inclusion of Children (relevant to RCDC projects)

10.  Vertebrate Animals (relevant to RCDC projects)

11.  Consortium/Contractual Arrangements (including Consultants).  Provide a list of Consultants participating in the Core.  State the pages in the application (Section 2) where their biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

A maximum of $450,000 in first-year direct costs may be requested for the Research Career Development Core. Budget increments in future years will generally be limited to one percent.

SECTION 5. RESOURCE CORES (RCs).  Each Resource Core (RC) should be presented in a Section numbered sequentially (beginning with SECTION 5) and identified by titles (Recruitment Core, Biostatistics Core, etc.) consecutive numbers (RC 1, RC 2, etc.). For example:

SECTION 5:  Recruitment Core (RC1)

SECTION 6:  Biostatistics Core (RC2)

Each RC should be presented in the following format:

1. Title page (recommended format on DGCG website)

2.   Budgets for First 12-month Budget Period and for Entire Period for Individual Core (PHS 398 Form Page 4 and Form Page 5).  Total direct costs for each Developmental Project (DP) within a RC should be included as a “line item” in the budget for the RC. A detailed budget for each DP should be included later in the application with the detailed description of the DP.  If other than inflationary increases are requested in future years, detailed budgets should be provided for all years.

3.  Biographical Sketches:  Provide a list including Core Leader, Senior/Key Personnel, and Other Significant Contributors.  State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

4.  Resources and Environment not previously described that are relevant to the RC. 

5.  Overview of Proposed Core Activities:

a.       Specific Aims of the Core. Explain the purpose and functions of the core. Present a clear statement of how the core relates to the theme or focus of the OAIC and how it will contribute to the goals of the OAIC.

b.       Administration. Describe the administration of the core, and how projects eligible for core support will be selected and prioritized for access to core resources. A discussion of the role and qualifications of the proposed Core Leader should be included here.

c.        Proposed Core Services and/or Activities. Include descriptions of core services and methods/techniques employed and describe how research quality and efficiency would be enhanced by use of core services.  Specify pertinent uses of cores by junior faculty and how such use will promote research leading to increased independence of older persons.  Note that the core resources requested for each project from the RC and the other cores should be summarized in Table IV (see example table at the DGCG website).

d.       Progress Report (continuing renewal applications only).

6.  External Projects. 

For the application as a whole, number External Projects sequentially as EP-1, EP-2, etc., regardless of the core to which they are attached.

a.       Briefly present the external projects proposed for core support during the 01 year of the OAIC Grant and justify their selection in terms of the overall goals of the OAIC. Provide the PD/PI, Title of award, source of award, and duration of external support.  Briefly summarize specific aims, background and significance, experimental design and methods.

If an External Project is supported by more than one OAIC RC, list the External Project in each RC and state the pages in the application where the initial description can be found.  Do not insert additional copies of the presentation here.

b.       Provide a general plan for the selection of external projects for Resource Core support for subsequent years of the grant period.

7.  Developmental Projects - Administration

Present a general plan for the selection and oversight of developmental activities for subsequent years of the grant period that includes the use of an advisory committee with at least one third of the members external to the OAIC and the grantee institution.  (Plans for the constitution, and function for this committee, along with a budget request for its support, will be more completely presented as part of the Leadership/Administrative Core (see below).

8.  Bibliography and References Cited

9.  Protection of Human Subjects (with Inclusion of Women and Minorities and Inclusion of Children): general procedures relevant to projects supported by the RC

10. Vertebrate Animals. (General procedures relevant projects supported by the RC)

11.  Consortium/Contractual Arrangements (including Consultants):  Provide a list of Consultants participating in the Core and state the pages in the application (Section 2) where their biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

12.  Individual Developmental Projects (DPs). 

Each RC may support a maximum of 2 Developmental Projects to explore new technologies, resources and/or methodologies for application by the Resource Core. Direct Costs of individual DPs should not exceed $35,000. The goal of the developmental projects is to establish new methods or technologies that will enrich the resources of the Core or the services it provides.

For the application as a whole, number Developmental Projects sequentially as DP-1, DP-2, etc., regardless of the core to which they are attached. For Each DP, provide the following:

a. Title

b. Project Leader and Senior/Key Personnel (include page references to their Biographical Sketches)

c. Budgets for First 12-month Budget Period and for Entire Period (PHS 398).  NOTE:  The total direct costs for each DP should be included in the budget for its corresponding RC as a “line item.” 

d. Specific Aims

e. Background and Significance, including justification for selection in terms of the overall goals of the OAIC and the potential contribution of its results to its RC services.

f. Preliminary Studies

g. Research Design and Methods

h. Bibliography and References Cited

i. Protection of Human Subjects (relevant to the individual DP)

j. Inclusion of Women and Minorities (relevant to the individual DP)

k. Inclusion of Children (relevant to the individual DP)

l.. Vertebrate Animals (relevant to the individual DP)

m. Consortium/Contractual arrangements and Consultants (include page references to Consultant Biographical Sketches)

The Overview, External Projects, and Developmental Projects Administration should not exceed 10 pages together. Additional Resources should not exceed 5 pages.  The summary of each EP should not exceed 1/2 page.  DP descriptions (d-h above) should not exceed 5 pages for each developmental project.

A proposed RC may request support of up to $75,000 (first year direct costs) per year for Developmental Projects. The minimum budget request for each proposed Developmental Project is $35,000 with the maximum being $75,000 (first year directs costs). Thus, a maximum of two Developmental Projects can be requested as part of a Research Core. 

Developmental projects may last from one to five years. NIA requires that programs be notified when a developmental grant award is made. This can be done at the time of the annual grant progress report.

SECTION (5 + number of RCs).  PILOT/EXPLORATORY STUDIES CORE (PESC)

NOTE:  The number for this SECTION depends on the number of Research Cores in the OAIC application.  For example, an application with three RCs, RC-1 will be described in SECTION 5, RC-2 in SECTION 6, and RC-3 in SECTION 7; thus SECTION 8 should be used to describe the PEC.   Continue this numbering sequence for subsequent Sections in this application.

The Pilot/Exploratory Studies Core (PESC) should be presented in the following format. 

1. Title page (recommended format on DGCG website)

2. Budgets for First 12-month Budget Period and for Entire Period (PHS 398 Form Page 4 and Form Page 5) 

For Pilot/Exploratory Studies (PES), number the PES sequentially as PES-1, PES-2, etc. and include total direct costs for each PES within the PESC as a “line item” in the PESC budget. A detailed budget for each PES should be included later in the application with the detailed description of the PES.

3.  Biographical Sketches.  Provide a list including Core Leader, Senior/Key Personnel, and Other significant Contributors.  State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

4.  Resources and Environment.  Features not previously described that are relevant to the PESC. 

5. Overview of Proposed Core Activities.

a. Specific Aims of Core. Explain the purpose and functions of the core.

b. Background and Significance. Present a clear statement of how the PESC will contribute to the goals of the OAIC and promote progress in the OAIC's area(s) of research focus.

c. Administration. Present the qualifications and experience of the proposed core leader. A general plan for the selection of all Pilot/Exploratory studies (including small studies) should be described. This plan should include the use of an advisory committee with at least one third of the members external to the OAIC and the grantee institution. (Plans for the constitution and function of this committee, along with a budget request for its support, should be included as part of the LAC.) Describe how the Core Leader, together with the OAIC PD/PI, will monitor ongoing progress of studies and assist in the planning for the development of pilot/exploratory studies, where appropriate, into independently funded grant applications.

d. Proposed Core Services and/or Activities. Include descriptions of core services and the types of applications that will be supported (e.g., will small pilot/exploratory studies be allowed, as described below?).

e. Pilot/Exploratory Studies (PES).  List the PES proposed for the first year. Maintain the numbering system used for the PESC budget and provide the title of the study and the lead investigator. A detailed description of each PES should be included in the following Section of the application

f. Progress Report (continuing renewal applications only)

The presentation of the Overview of the PESC should not exceed 10 pages.

6.  Bibliography and References Cited

7.  Protection of Human Subjects. Provide general procedures relevant to projects supported by the PESC.

8. Inclusion of Women and Minorities. Provide general procedures relevant to projects supported by the PESC.

9.  Inclusion of Children. Provide general procedures relevant to projects supported by the PESC.

10.  Vertebrate Animals. Provide general procedures relevant projects supported by the PESC.

11.  Consortium/Contractual Arrangements (including Consultants.) 

Provide a list of Consultants participating in the Core. State the pages in the application where their biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

A maximum of $300,000 in direct first-year costs may be requested for the PESC.   Applicants may propose up to five PES in the first year. The minimum budget request for such studies is $25,000 for each study in first year direct costs. Each of these projects is limited to no more than $150,000 (direct costs) over its entire period of support, which should be for no more than three years. Thus, there is an inverse relationship between the amount of yearly support and the duration of the project. Increments in future years will generally be limited to one percent.

Small Pilot/Exploratory Studies

Up to $50,000 of the $300,000 budget may be set aside for small studies (less than $10,000 each in first year direct costs). Scientific presentations of these small studies should not be included in the proposal.  OAIC researchers are encouraged to consider seeking additional sources of funding for pilot or exploratory studies, such as the NIA Pilot Research Grant Program or the NIA Small Research Grant Program and NIH Exploratory/Developmental Research Grant Award (http://www.nia.nih.gov/GrantsAndTraining/FundingOpportunities/ResearchProjects.htm).

SECTION (6 + number of RCs).  PILOT/EXPLORATORY STUDIES

Maintain the sequential numbering system described above for the Pilot/Exploratory Studies Section.  Number the PES sequentially.  For each PES, provide the following:

1.  Title Page (recommended format on DGCG website)

2.  Budget for First 12-Month Period and for Entire Project Period (PHS 398)

3.  Biographical Sketches. Provide a list including the Project Leader, Senior/Key Personnel, and Other Significant Contributors.  State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies of Biographical Sketches here.

4.  Research Plan.

a. Specific Aims

b. Background and Significance

c. Preliminary Studies

d. Experimental Design and Methods

5.  Protection of Human Subjects (relevant to the individual PES)

6.  Inclusion of Women and Minorities (relevant to the individual PES)

7.  Inclusion of Children (relevant to the individual PES)

8.  Vertebrate Animals (relevant to the individual PES)

9.  Bibliography and References Cited

10.  Consortium/Contractual Arrangements and Consultants.  Provide a list with page references to Consultant biographical sketches.

The Research Plan (a-d above) should not exceed 5 pages for each pilot/exploratory project.

RESUBMISSION. 

Applicants who responded to OAIC RFAs AG-06-001 and AG-07-008 but did not receive awards may submit resubmission applications in response to this RFA.  Revisions should follow the PHS 398 guidelines.  Three additional pages are allowed at the beginning of Section 2. Introduction to the Application to outline the response to reviewers’ concerns, and one additional page is allowed at the beginning of each Core (following Resources and Environment) to address concerns relevant to the Core.

Recommended Formats and Example Tables

See the hyperlink for the Recommended Formats for this RFA at the Division of Geriatrics and Clinical Gerontology (DGCG) website.

Research Plan Page Limitations

Page limitations for the following sections of the application are as follows:

Section 1.  General Information :  Biographical Sketches for PD/PI, Senior/Key Personnel, and Other Significant Contributors are not to exceed 4 pages per individual Biographical Sketch (including Other Active Support

Section 2.  The Summary Research Plan:  Introduction/Preliminary Studies section should not exceed 10 pages.  Consultant Biosketches are limited to 4 pages each, and Letters of Agreement to serve as Consultant should not exceed one page from each Consultant.

Section 3.  The LAC Overview and Advisory Panels section should not exceed 10 pages.

Section 4.  The  RCDC Overview should not exceed 15 pages.  The RCDC may include descriptions of up to five Career Development Candidates.  The Biographical Sketch for each Candidate is limited to 4 pages, and the Career Development Plan for each Candidate should not exceed 3 pages.

Section 5.  For each RC, the Overview, External Projects, and Developmental Projects Administration should not exceed 10 pages total.  Each RC may include up to two Developmental Projects (DPs).  The Research Plans for each DP may not exceed 5 pages. 

Each application may have no more than five RCs (excluding the LAC, RCDC, and PESC).

Section for PESC.  The PESC Overview should not exceed 10 pages.

Section for Pilot/Exploratory Studies.  Each OAIC application may include up to five Pilot/Exploratory Studies (PES). The Research Plan for each PES should not exceed 5 pages.

Appendices.  Appendices are limited to one 20MB file.

Resubmission Applications.  Resubmission applications are allowed 3 additional pages at the beginning of Section 2 (Summary Research Plan for the Entire Application) to address concerns of the previous review regarding the application in general, and one additional page at the beginning of each Core description to address concerns for each Core in greater detail.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Aging and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

The following questions are also considered for OAIC applications:

For renewal applications from existing OAICs, the following questions are also considered:

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

The following questions are also considered for OAIC applications:

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

The following questions are also considered for OAIC applications:

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

The following questions are also considered for OAIC applications:

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

The following questions are also considered for OAIC applications:

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate? Remove if not applicable

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

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.

Awardees will be required to submit the annual Non-Competing Continuation Grant Progress Report (PHS 2590) following a standardized reporting template that will be developed by the NIA Program Official and distributed upon award. The purpose of this standardized template is to facilitate the annual reporting of aggregated information to the NIA Program Official for program evaluation and reporting purposes.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Susan G. Nayfield, M.D., M.Sc
Division of Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 3C-307
Bethesda, MD 20892
Telephone: (301) 496-6761
FAX: (301) 402-1784
Email: nayfiels@mail.nih.gov

2. Peer Review Contacts:

Ramesh Vemuri, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging 
7201 Wisconsin Avenue
Gateway Building, Suite 2C-212
Bethesda, MD 20892
Telephone: (301) 496-9666
FAX:  (301) 402-0066
Email: vemuri@nia.nih.gov

3. Financial or Grants Management Contacts:

Linda Whipp
Grants and Contracts Management Branch
National Institute on Aging
Gateway Building, Room 2N212
7201 Wisconsin Avenue
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email: whippl@nia.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as senior/key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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