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), (http://www.nia.nih.gov/)

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

Announcement Type
This is a reissue of RFA-AG-04-002, which was previously released August 21, 2003.

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

Request For Applications (RFA) Number: RFA-AG-06-001

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: August 3, 2005
Letters of Intent Receipt Date(s): September 30, 2005
Application Receipt Dates(s): October 25, 2005
Peer Review Date(s): February 2006
Council Review Date(s): May 2006
Earliest Anticipated Start Date : July 1, 2006
Additional Information To Be Available August 15, 2005.
Expiration Date: October 26, 2005

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
   4. Intergovernmental Review
   5. Funding Restrictions

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   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. Thus 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 either broadly or narrowly. 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 the selected area of focus may have unique benefits.

Since the level of funding available to an individual OAIC 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 in such institutions 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.

An OAIC application should not include major foci on neurosciences (with the exception of rehabilitation) or behavioral and social sciences, as these are more appropriate for other NIA programs that also use the Center mechanism.

Health Services Research as an Area of Focus: Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of health care providers, is generally appropriate for a Pepper Center component if it meets both the following criteria, as well as the criteria above that exclude major foci on behavioral and neurologic research:

1. The research is a) designed to obtain new knowledge about the effects of interventions that clearly specify what will be done for, or by, the individual recipients of the intervention (either in terms of a specific intervention or algorithms used for treatment decisions, OR b) designed to obtain new knowledge about the validity or predictive value of diagnostic or assessment techniques that clearly specify what will be measured in individuals (either in terms of a specific measure, or algorithms used for deciding which measures to apply or how to interpret them).

Examples of interventions or diagnostic strategies that may meet this criterion include:

2. The research is designed to determine health or risk factor effects relating to outcomes that are primarily clinical (other than neurologic) or functional (other than cognitive) in the recipients of the intervention.

Examples of outcomes include:

Research to determine effects of organizational or operational patterns of health practices or services, or the use of new or different types of health care providers, would generally NOT be appropriate as a principal focus of a Pepper Center component if EITHER of the following criteria were met:

1. The research is NEITHER a) designed to obtain new knowledge about the effects of interventions that clearly specify what will be done for, or by, the individual recipients of the intervention (either in terms of a specific intervention or algorithms used for treatment decisions, NOR b) designed to obtain new knowledge about the validity or predictive value of diagnostic or assessment techniques that specify what will be measured in individuals (either in terms of a specific measure, or algorithms used for deciding which measures to apply or how to interpret them).

Examples of diagnostic or intervention research that would not generally be considered appropriate as a principal focus for Pepper Center component include:

Although an area of focus may not be appropriate as a PRINCIPAL focus for a Pepper Center, such health practices or behavioral effects and outcomes may be included in research projects when primary focus of the project meets the criteria for appropriateness described above.

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 Grants award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the non-modular budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Applicants should follow the instructions for non-modular research grant applications described in the PHS 398 application instructions.

2. Funds Available

The NIA intends to commit approximately $4.2 million dollars in FY 2006 and $3.2 million in FY2007 to fund four to six new and/or competing continuation P30 grants in response to this RFA. An applicant must request a project period of five years and may request a budget for direct costs up to $1.2 million dollars per year. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004. 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.

Budget increments for subsequent years generally will be limited to no more than one percent. Awards are made initially for five years and may be renewed competitively for five-year periods. It is anticipated that additional RFAs soliciting applications for OAICs will be issued as existing centers complete their 5-year award periods. The earliest anticipated award date is July 1, 2006.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Institutions eligible for Older Americans Independence Centers grants (P30) are those at which there are (1) at least five principal investigators with any PHS agency research grant or comparable peer reviewed research project (including those funded by State governments or private foundations) related to geriatrics and/or aging research, each with at least two years of committed support remaining at the time of the application or (2) one or more program project (P01) grant(s) related to geriatrics and/or aging research which also have at least two years of committed support remaining. If P01 grant(s) exist, there should be no overlap between the P01 cores and the OAIC cores proposed.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 programs.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

NIA further requires adherence to its own clinical research policy statement to be found at http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm.

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 on line 2 of the face page of the application form and the YES box must be checked.

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 (required),
2) A Research Career Development Core (required), and
3) One or more Research Cores (required).
4) One or more Pilot/Exploratory Studies Cores are optional.

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

A 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.

Research 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 (P/EC) will support 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 P/EC 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.

The minimum components required to qualify for an OAIC Award are 1) a Leadership/Administrative Core; 2) a Research Career Development Core; and 3) one or more Research Cores.

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 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.

2. 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 RDC 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 $400,000 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. RESEARCH CORES (RCs)

Each Research 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 Research 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.

Although applicants are strongly encouraged to consider the full range of disciplines, technologies, methodologies, services, and resources that could be brought to bear on their selected area(s) of focus, there is no requirement that an OAIC Research Core include this full range. The selection of areas for Research 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 P/E C (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 Research 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 Research 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. Examples of activities in Developmental Projects are listed below. However, this list is not intended to describe the full range of supported activities nor to direct applicants towards these areas. Developmental studies which challenge existing paradigms or develop new methodologies or technologies are highly valued.

Developmental Projects supported by a RC must relate to the overall goals of the OAIC. A proposed RC may request support of up to $105,000 (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 Leadership Core 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 (P/EC)

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

Applicants may propose up to five P/E studies in the first year. The minimum budget request for such studies is $25,000 in first year direct costs for each study. Each 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.

Pilot/Exploratory Studies for the first year of the proposal should be included in the OAIC application. The projects and their budgets must be prepared on the 9/04 revision of the PHS 398 application package (http://grants.nih.gov/grants/forms.htm) The specific aims, background and significance, preliminary studies, and experimental design and methods sections should not exceed eight pages total for each study presented. This is in addition to the 15 pages for the overall presentation of the P/E C. 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 (less than $10,000 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).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: September 30, 2005
Application Receipt Date(s): October 25, 200 5
Peer Review Date: February 2006
Council Review Date : May 2006
Earliest Anticipated Start Date: July 1, 2006

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 at the beginning of this document.

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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:

Dr. Mary Nekola
Chief, Scientific Review Office
National Institute on Aging
Gateway Building, Suite 2C-212
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-9666
FAX: (301) 402-0066
Email: nekolam@nia.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

Appendix material should be submitted on a CD following instructions in the PHS398 (see Section IV.6). The CD should be organized with a folder for Background Information and separate folders for each Core; subfolders may be used as appropriate (e.g., for individual P/E studies, DPs, or RCDC candidates). Materials should be placed in the folder or subfolder for the Core or Project they support.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIA. Incomplete and 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, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing 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

Follow the instructions in the Form 398 application kit for all items not addressed in these supplemental instructions for OAIC (P30) applications.

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

1. Face Page, PHS 398

Item 2: Check "YES." cite the RFA number and "NIA Older Americans Independence Center" as the title in the appropriate places.

2. Page 2, PHS FORM 398

Description: The description serves as an overview of the entire application. The description should be brief and summarize the general plan and goals for the entire proposed Center or individual component. It should not be used to justify the application or component or provide an historical perspective. (Insert in the appropriate place, a separate page 2, renumbered according to its sequence in the application, for each core.)

3. Table of Contents (PHS 398, Form Page 3)

Do not use Form Page 3, "TABLE OF CONTENTS" of Form 398. It applies to grant applications for single projects. In its place, use the sample format provided in Attachment I of these instructions. Number all pages consecutively. Since the first page of the application is the "Title Page," begin the next page with the numeral "2." If necessary, disregard the preprinted page numbers. Do not use lettered numbers (e.g., 2A, 2B, etc.).

Appendix material should be submitted on one CD following instructions in the PHS398. Applicants should arrange appendix materials for individual cores and i dentify all materials by the principal investigator's name, core name and core leader's name. Send 3 copies of the CD directly to the NIA Scientific Review Office. Do not send any appendix material to the CSR. Also, do not insert appendices in the body of the application.

4. Budgets (PHS 398 Form, Pages 4 and 5):

To aid in the review of the application, insert a consolidated budget table, as shown in sample Attachment 3 (see Attachment 3. Table I. "CONSOLIDATED DIRECT COSTS FOR FIRST YEAR OF REQUESTED SUPPORT"). Attach a similar table for the entire proposed period for the overall program. Do not include detailed budgets for individual cores here: instead, place them with the corresponding component (see Section 3 of sample Attachment 1. "Table of Contents"). Justify all items carefully according to the Form 398 instructions: insufficient justification can result in the deletion of items by an initial review group. The period of support may not exceed five years.

5. Biographical Sketches (PHS 398, Part I. Preparing Your Application, p. 29)

Insert biographical sketches next.

6. Table II: Distribution of Professional Effort.

Table II (See sample Attachment 4). "DISTRIBUTION OF PROFESSIONAL EFFORT (%) ON THIS APPLICATION."

Other grant support Support" for the key personnel is included under Biographical Sketches.  

Section 2.  Summary Research Plan for the Entire Application

In this section, present a succinct plan for the entire application. These guidelines and instructions supplement those found in PHS 398, Part I: Preparing Your Application, beginning on page 30 - Research Plan. Note that Section b (Background and Significance) and Section d (Research Design and Methods) in the Form 398 instructions are omitted from this overall summary.

1. Introduction to the Application (Specific Aims).  This section is limited to 10 pages.

Describe the goals to be achieved by the OAIC, including:

Describe 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 (see page 4 of these Instructions).

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, timelines and organizational charts should be provided.) 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. Issues relating to institutional commitment and settings are relevant.

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.

2.  Preliminary Studies/Progress Report (Form 398, Part I. Preparing Your Application, p. 31).

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.

For applications from institutions previously awarded a P60 Older Americans Independence Center: Describe activities conducted by the Center that are relevant to the goals of the proposed new P30 Center.

Information in the above sections should be provided in very brief form. Additional information may be provided as appropriate in the description of the proposed cores.

3.  Human Subjects .  Institutional Review Board approval or exemption must be provided for each individual research protocol involving human subjects, as required by 45 CFR 46. This includes all developmental and pilot projects involving human subjects (see PHS Form 398, Part I. Preparing Your Application, p. 32). 

Describe fully the general principles and policies that will apply to human subjects.  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.

4. Vertebrate Animals , if applicable .  Approval must be by each individual protocol for projects not having approval elsewhere (Form 398, Part I. Preparing Your Application, p. 35).

List the components in the application that involve vertebrate animals and page numbers for the relevant vertebrate animal sections.

5. Literature Cited (Form 398, Part I. Preparing Your Application, section g, p. 35).

List only those references cited in this section. Include appropriate full citations with each core and project.

6. Consortium/Contractual Arrangements (Form 398, Part I. Preparing Your Application,

Section, p. 35.

Before submitting an application that contains a consortium arrangement, the applicant institution and each collaborating institution should reach at least tentative 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 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.

7. Consultants

Summarize this information on all Consultants for all Cores of the Center. Identify the consultants by name and include biographical sketches and signed letters of agreement to serve.

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. However, criteria for the selection of advisors should be included. Advisors/ consultants already employed, or with whom prospective employment has already been discussed, must be named and their institution identified.

8. Table III (See Attachment 5) "PERCENTAGE DISTRIBUTION OF RESEARCH RESOURCES CORES TO OAIC AND EXTERNALLY FUNDED RESEARCH PROJECTS."

Section 3A. General Plan of 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 Attachment2) and a detailed first year and summary budget for all years.  Continue to number the pages consecutively.

1. Title Page for Individual Cores

Use the format of sample Attachment 2.  Do not use the face page of Form 398.

2. PHS Form 398, Page 2

Follow instructions in the Form 398 application kit and the instructions in Section 1 of these guidelines for the “Description,”  “Performance Sites,” and “Key Personnel.”  For Key Personnel, include after each name, in parentheses, the page number where the individual Biographical Sketch can be found.  Do not insert additional copies in this section.

3. PHS Form 398, Pages 4 and 5

Provide budgets for the first 12-month budget period and for the entire grant period for individual cores (including a detailed budget justification).

The individual responsible for a component is the “Core Leader.”  Categorize other scientific staff as “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) (see PHS 398, Part I, page 24). Since only one individual is recognized as the responsible person, do not use “Co-investigator .”

Budgets and Justification pertaining to Consortium/Contractual Arrangements (see PHS 398, Part I. Preparing Your Application, Consortium/Arrangements, p. 35).  Provide documentation, if applicable.

4. Biographical Sketches of Project Leader and Key Personnel

State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies here.

5. Resources and Environment (self-explanatory)

Section 3B. Specific Individual Plan for Each Core

1. Leadership/Administrative Core (LAC)

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

a. Title page (see Attachment 2 of these guidelines). Do not use page 1 of PHS Form 398 for individual components.)

b. Description, Performance Sites, Key Personnel, and Other Significant Contributors - Use page 2 of PHS 398.

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

d. Overview:

1)    Describe the Administrative structure and activities of this core.

2)   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.

3)   Describe the activities and role of the LAC Leader (who is also the 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.

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.

Do not name the members of the required advisory panels 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.

The presentation of the LAC is limited to 15 pages.

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

2. Research Career Development Core (RCDC)

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

a. Title page (see Attachment 2)   Do not use page 1 of PHS Form 398.

b. Description, Performance Sites, Key Personnel, and Other Significant Contributors - Use page 2 of PHS 398.

c. Budgets for First 12-month Budget Period and for Entire Period - Use pp 4-5 of PHS 398.

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

1)  Its contribution to the OAIC's overall goals

2)  A discussion of the role and qualifications of the proposed Core Leader

3)  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.)

4) The abilities that junior faculty who are recipients of this support are expected to acquire during their period of support by the core.

e. Career Development Plans:  Present the RCDC's career development plans for at least some of the junior faculty and research associates to be supported. The Career Development Plans should identify the individuals selected for at least the first year of RCDC support, and should describe for each:

1) The candidate's preparation (include a biosketch) proposed research and other career development activities, and the nature of institutional commitments to the individual's development:

2) The mentor's research activities and past history of research training (include a biosketch) and the commitments to training and supervising the candidate and,

3) The OAIC's goals for the individual's career progression by the end of the OAIC award period. The description should explain how the proposed use of OAIC funds (including funds for Pilot/Exploratory Studies Core funding, if this is also proposed for the individual) will contribute to OAIC program goals for research career development in its selected research area.

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

A maximum of $400,000 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.

3. Research Cores (RC)

Research Cores (RCs) should be identified by titles (Recruitment Core, Biostatistics Core, etc.) and by consecutive numbers (RC 1, RC 2, etc.).

Each RC should be presented in the following format.

a. Title page (see Attachment 2.)  Do not use page 1 of PHS Form 398.

b. Description, Performance Sites, Key Personnel, and Other Significant Contributors – Use page 2 of PHS 398.

c. Budgets for First 12-month Budget Period and for Entire Period for Individual Core - Use pp 4, 5 of PHS 398. If other than inflationary increases are requested in future years, detailed budgets should be provided for all years.

d. Presentation of Proposed Core Activities:

1) Specific Aims of Core. Explain the purpose and functions of the core. Present a clear statement of how the core will contribute to the goals of the OAIC.

2) 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.

3) Background and Significance . Include brief descriptions of the research projects for which the core is to provide support, and how research quality and efficiency would be enhanced by use of core services, specifying any pertinent uses of cores by junior faculty and how such use will promote research leading to increased independence of older persons.  The core resources requested for each project from the RC and the other cores will be summarized in Table IV (Attachment 6).

4) Summary of Services, Experimental Design and Methods. Include descriptions of core services and methods/techniques employed and a completed Gender and Minority Inclusion Table, Attachment 8. This table may also be found in PHS398 (Rev 9/04).

These items (1-4) may not exceed 25 pages.

e. External Projects

1) 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. (These must be prepared on the 9/04 revision of the PHS 398 application package and included in the OAIC proposal as part of an RC.) Summarize specific aims, background and significance, experimental design and methods, and evaluation by peer review. The summary should not exceed 2 pages total for each external project. This is in addition to the 25 pages that may be used for items a-d above.

2) Present a general plan for the selection of external projects for Research Core support for subsequent years of the grant period.

f.  Developmental Projects

1) Present developmental projects proposed for the 01 year of the OAIC Grant and justify their selection in terms of the overall goals of the OAIC. (These must be prepared on the 9/04 revision of the PHS 398 application package and included in the OAIC proposal as part of an RC.) If human subjects are involved, include plans for the protection of human subjects in accordance with NIH and NIA policies. The specific aims, background and significance, preliminary studies, and experimental design and methods sections should not exceed 8 pages total for each developmental project. This is in addition to the 25 pages that may be used for items a & d above.

2) Present a general plan for the selection 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).

A proposed RC may request support of up to $105,000 (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 $105,000 (first year directs costs). Thus, a maximum of three Developmental Projects can be requested as part of a Research Core.  Specific developmental projects to be conducted by an RC using these funds 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 progress report.

4. Pilot/Exploratory Studies Core (P/EC)

The Pilot/Exploratory Studies Core should be presented in the following format:

a. Title page (see Attachment 2) Do not use page 1 of PHS Form 398.

b. Description, Performance Sites, Key Personnel, and Other Significant Contributors - Use page 2 of PHS 398.

c. Budgets for First 12-month Budget Period and for Entire Period - Use pp 4, 5 of PHS 398.

d. Overview:  The purpose and function of this core should be fully described.

1)   Describe how the activities of this core will promote progress in the OAIC's area(s) of research focus.

2)   Present the qualifications and experience of the proposed core leader.

3)   Present a general plan for the selection of studies proposed for the Pilot/Exploratory Studies Core 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 of this committee, along with a budget request for its support, will be more completely presented as part of the Leadership/Administrative Core.)

4)   Describe how, together with the OAIC PI, the Core Leader 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.

5) If human subjects are involved, include plans for the protection of human subjects in accordance with NIH and NIA policies.

The presentation of the above aspects of the P/E C should be limited to 15 pages total.

Pilot/Exploratory Core Studies:

A maximum of $250,000 in direct first-year costs may be requested for the Pilot/Exploratory Studies Core. The method for the selection of all Pilot/Exploratory studies (including small studies) should be described (See 3, above).

Applicants may propose up to five P/E studies 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.

Present these projects and budgets for the 01 year of the proposal. These studies must be prepared on the 9/04 revision of the PHS 398 application package and included in the OAIC proposal. However, the specific aims, background and significance, preliminary studies, and experimental design and methods sections should not exceed eight pages total for each study presented. This is in addition to the 15 pages for the overall presentation of the P/E C. Budgets for all 5 years should be prepared. NIA requires that programs be notified when a pilot grant award is made. This can be done at the time of the progress report.

Small Pilot/Exploratory Studies

Up to $50,000 of the $250,000 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.

Participating researchers in OAICs are also 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 4. Alternative Form Pages

See the hyperlink for the Alternative Form Pages for this RFA at the Geriatrics and Clinical Gerontology (GCG) website. (The website for these pages will be available after August 15, 2005.)

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIA in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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 high 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 preventive interventions that drive this field?

The following questions are also considered:

For applications competing for continued funding of an existing OAIC, 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:

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:

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:

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:

Required Components of an OAIC : In order to qualify for an OAIC Award, the minimum required components which must be recommended by the peer reviewers to be eligible for consideration for funding are 1) a Leadership/Administrative Core; 2) a Research Career Development Core; and 3) one or more Research Cores. All required components, as well as the support of research utilizing human subjects, must be recommended for the full five years in order for the applications to be considered for funding.

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 priority score:

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 14 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

In addition to standard NIA/NIH reporting requirements above, recipients of OAIC P30 awards are required to report information on program performance to the OAIC Coordinating Unit for inclusion on the OAIC Website and to report changes in OAIC staff and staff contact information to update the OAIC Directory on an annual basis.

Specific reports of program activities will be required once during the duration of the award for the mid-cycle review.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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 Contact:

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

2. Peer Review Contact:

Dr. Mary Nekola
Chief, Scientific Review Office
National Institute on Aging
Gateway Building, Suite 2C-212
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-9666
FAX: (301) 402-0066
Email: nekolam@nia.nih.gov

3. Financial or Grants Management Contact:

Ms. Janis Peterson
Grants Management Specialist
National Institute on Aging
Gateway Building, Suite 2N-212
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 402-7739
FAX: (301) 402-3672
Email: petersonja@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.

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 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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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 or Health Systems Agency review. 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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NIH Funding Opportunities and Notices


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