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) and Coordinating Center (P30)

Announcement Type
This is a reissue of RFA-AG-06-001, which was previously released August 3, 2005 

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

Request For Applications (RFA) Number: RFA-AG-07-008

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: January 29, 2007
Letters of Intent Receipt Date(s): March 26, 2007
Application Receipt Date(s): April 23, 2007
Peer Review Date(s):  September 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date: April 2008
Additional Information To Be Available Date (Url Activation Date): January 31, 2007
Expiration Date: April 24, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This RFA supports new and competing renewal applications for Claude D. Pepper Older Americans Independence Centers (OAICs) (centers of excellence in geriatrics research and training) and an OAIC Coordinating Center.

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 and 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
  6. Other Submission Requirements

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.  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 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.

Neuroscience and Behavioral Science Research as an Area of Focus:  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. 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 Geriatrics and Clinical Gerontology (GCG) program website.

OAIC COORDINATING CENTER

The OAIC Coordinating Center (CC) serves a facilitating role for OAIC site interactions as well as a conduit for translating OAIC objectives and findings to both general and scientific audience.  The CC can be a part (Core) of an OAIC or an independent site unaffiliated with an OAIC Program. The CC must demonstrate an ability to work cooperatively with all OAIC sites and possess sufficient scientific expertise in geriatrics and related areas to serve the national clearinghouse functions required by the OAIC Program.

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

Section II. Award Information


1. Mechanism(s) 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 the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NIA intends to commit approximately $4.6 million in FY 2008 to this RFA.

OAIC Centers

Approximately $4.4 million will be committed to fund new or competing renewal applications for Claude D. Pepper OAICs.  The NIA anticipates four new and/or competing continuation P30 awards for OAIC Centers in response to this RFA.

The expected amount for individual awards in Direct Costs ranges from $750,000 to $1,000,000. Awards are made initially for five years and may be renewed competitively for five-year periods; budget increments for subsequent years generally will be limited to no more than one percent.  It is anticipated that additional RFAs soliciting applications for OAICs will be issued as existing centers complete their 5-year award periods.

OAIC Coordinating Center

One award for an OAIC Coordinating Center is anticipated in response to this RFA.  The Coordinating Center may be proposed as an independent P30 application by Institutions not submitting applications for OAIC Centers in response to this RFA, or as a Coordinating Center Core within applications for OAIC Centers submitted in response to this RFA.

The expected amount for the Coordinating Center award (or Core) in Direct Costs ranges from $125,000 to $175,000. The award is made initially for five years and may be renewed competitively for five-year periods; budget increments for subsequent years generally will be limited to no more than one percent.  It is anticipated that additional RFAs soliciting applications for OAICs will be issued as the existing Coordinating Center completes its 5-year award period.

The earliest anticipated award date is February 2008.

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.

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.

Institutions eligible for an OAIC Coordinating Center award (P30) include those with (1) ability to coordinate multi-site projects, demonstrated by previous PHS funding as a coordinating center for a multi-site research grant and (2) scientific expertise in geriatrics and related areas, demonstrated by current funding of an NIA Centers award or the funding qualifications above.

Applicants who responded to OAIC RFAs AG-06-001, AG-04-002, and AG-02-001 but did not receive awards may submit resubmission (formerly revised/amended) applications in response to this RFA (see Section IV.6.  Other Submission Requirements).  

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 support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

An organization may submit one application in response to this RFA.   An organization applying for both an OAIC site and the OAIC Coordinating Center should include the OAIC CC in the site application as a Coordinating Center Core.

NIA 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 (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 single OAIC Coordinating Center (CC) will serve all OAIC sites.  If the Coordinating Center is located at an institution with an OAIC award, the CC will be included within the OAIC infrastructure as a Coordinating Center Core.

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.

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 $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. 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 $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 LACsection). 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 should not exceed eight pages total for each study presented. This is in addition to the 15 pages for the overall presentation of the PESC. 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.

E. OAIC COORDINATING CENTER

One Coordinating Center (CC) will be established to facilitate and coordinate OAIC activities.  The CC will work closely with the NIA program administrator and, in coordination with the PIs and OAIC personnel, be responsive to requests generated by NIA or NIH.   

Each applicant OAIC is invited to submit a section proposing a Coordinating Center Core (CC) as part of its response to the Pepper Center RFA.  Institutions not submitting a Pepper Center application may  apply for a freestanding CC if they meet the eligibility requirements for an OAIC site (Section 1.A), and equal consideration will be given to non-OAIC applying institutions as to OAIC sites for award of the CC.  The first year budget for the CC is expected to be between $125,000 and $175,000 Direct Costs.  The application should be for a 5-year period of support.

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

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

a.      The CC will make all arrangements for a yearly OAIC meeting and, in coordination with other OAIC PIs and NIA program staff, create the agenda and manage the meeting.  The CC will set aside a portion of its funds for logistical and facilities support of the Annual Investigators meeting; however, funds to support attendees are the responsibility of the LAC of each OAIC.

b.      The CC will organize and conduct regular conference calls among NIA staff, OAIC Directors, and other OAIC key personnel.  The agendas for these calls will be established by the CC in coordination with NIA staff and OAIC directors, and the CC will take and circulate minutes of each call for discussion and approval at the subsequent call.

c.       The CC will collect and organize information from OAIC sites to prepare and publish the annual Pepper Centers Directory.  This report will be cumulative and highlight significant developments by the OAICs, individually and collectively, in research achievements and program progress.

d.      The CC will collect, organize, and disseminate information relevant to the OAIC program as needed for program evaluation, planning, and reporting.

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

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

(4)  Provide logistic and educational support for OAIC trainees:

a.      Facilitate communications among OAIC trainees through conference calls, on-line chat rooms, electronic newsletters, etc., as determined by trainees.

b.      Organize and conduct an annual trainees’ conference in conjunction with the annual OAIC Investigators’ meeting, involving a topic or activity selected by trainees in conjunction with RCDC Directors and NIA staff.

c.       Serve as a clearinghouse for educational opportunities and exchange experiences among OAIC trainees at all OAIC and related sites.

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

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

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
Letter of Intent Receipt Date: March 26, 2007
Application Receipt Date(s): April 23, 2007
Peer Review Date: September 2007
Council Review Date: January 2008
Earliest Anticipated Start Date: April 2008

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 research grant applications 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:

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.

3.C. Application Processing

4. Intergovernmental Review

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. Applicants who responded to OAIC RFAs AG-06-001, AG-04-002, and AG-02-001 but did not receive awards may submit resubmission (formerly revised/amended) applications in response to this RFA (see Section IV.6.  Other Submission Requirements).   That is, the application for this funding opportunity, if it is a resubmission from one of these three RFAs just named, must include an Introduction describing the changes and improvements made, and the text must be marked to indicate the changes from the previous unfunded version of the application. All other previously unfunded applications must be prepared as NEW applications.

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/.

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 PHS 398 application kit. Additional instructions and recommended formats for providing the information requested for this RFA are available at the Geriatrics and Clinical Gerontology (GCG) website. (The website for these pages will be available after January 31, 2007.)

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

1. Face Page (PHS 398)

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

2. Description, Performance Sites, Key Personnel, and Other Significant Contributors (PHS 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.  Guidance for completing the Table of Contents is presented on the GCG website.  As the goal of the Table of Contents is to organize the application as a whole, including the presentation of the individual cores, applicants are strongly encouraged to use the example format provided on the GCG website.  Number all pages consecutively.

Applicants are encouraged to submit appendix material on one CD following instructions in the PHS 398. Applicants should arrange appendix materials for individual cores in the order they appear in the Table of Contents for the application and should identify 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 insert appendices in the body of the application. Do not send any appendix material to the CSR.

4. Budget.  To aid in the review of the application, insert a consolidated budget table, Table IA.  The recommended format for this table is shown in the  example "CONSOLIDATED DIRECT COSTS FOR THE FIRST 12-MONTH GRANT PERIOD " on the GCG website.  Insert a similar table (Table 1B) 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, as shown in the recommended format for the "Table of Contents."  Justify all items carefully according to PHS 398 instructions; insufficient justification can result in the deletion of items by an initial review group.

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

6. Table II: Distribution of Professional Effort.  Provide information on the distribution of professional effort of 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 GCG website. Note that Other Grant Support for 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.  Refer to the recommended format for the Table of Contents (GCG website) to include the information requested below:

1. Introduction to the Application (Specific Aims/Background and Significance).  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.

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.

2.  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.  Applications from institutions previously awarded an OAIC should describe activities conducted by the OAIC through the previous award that are relevant to the goals of the proposed competing continuation or new P30 Center.

The Introduction to the Application and Preliminary Studies are limited to 10 pages for both sections together.  Additional information may be provided as appropriate in the description of the proposed cores. As part of their Progress Report, existing OAIC sites are encouraged to include summary tables of OAIC activities (such as those prepared for the mid-cycle review) in an Appendix as described above.

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

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

6. Consortium/Contractual Arrangements.  Before submitting an application that contains a consortium arrangement, the applicant institution and each collaborating institution should reach agreement on the scientific, administrative, financial, and reporting requirements for the grant. 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.  Identify consultants for all Cores of the Center by name 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.  Include a Letter of Agreement from each Consultant.  Each Letter of Agreement is limited to one page.  Identify consultants for all Cores of the Center by name and include biographical sketches and signed letters of agreement to serve.  Biographical Sketches are limited to four pages per individual; one additional page is allowed for the Letter of Agreement.

8.  "PERCENTAGE DISTRIBUTION OF RESEARCH RESOURCES CORES TO OAIC AND EXTERNALLY FUNDED RESEARCH PROJECTS." The recommended format for this information is provided in the example table "PERCENTAGE DISTRIBUTION OF RESEARCH RESOURCES CORES TO OAIC AND EXTERNALLY FUNDED RESEARCH PROJECTS" on the GCG website.

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 example Title Page format on the GCG website) and a detailed first year and summary budget for all years.  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 GCG website. 

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

Budgets and Justification pertaining to Consortium/Contractual Arrangements:  Provide documentation, if applicable.

3. Biographical Sketches of Core Leader and Key Personnel. 

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). Since only one individual is recognized as the responsible person, do not use “Co-investigator.”

Provide a list including Core Leader, 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 GCG website)

2. Budgets for First 12-month Budget Period and for Entire Period for Individual Core (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.

3.  Biographical Sketches:  Provide a list including Core Leader, 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 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 competing continuation 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.

The presentation of the LAC Overview and Advisory Panels 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.

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 GCG website)

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

3.  Biographical Sketches:  Provide a list including Core Leader, Key Personnel, and Other significant Contributors. State the pages in the application where the appropriate biographical sketches for the Core leader and professional staff can be found.  Provide only biographical sketches of the RCDC candidates in this section.   Each biographical sketch is limited to four pages.

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

5. 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)

The Overview is limited to 15 pages.

6.  Career Development Candidates.  Present the RCDC Career Development Plans for up to five junior faculty or research associates considered for the first year of RCDC support. The Career Development Plan for each RCDC trainee is limited to three pages (including the Research Plan).

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 1.5)

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.

7.  Human Subjects (relevant to RCDC projects)

8.  Vertebrate Animals (relevant to RCDC projects)

9.  Literature Cited

10.  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.

11.  Consortium/Contractural Arrangements

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.

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 GCG website)

2.   Budgets for First 12-month Budget Period and for Entire Period for Individual Core (PHS 398).  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, 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 GCG 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 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 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).

The Overview , External Projects, and Developmental Projects Administration should not exceed 25 pages together. The summary of each EP should not exceed 1 page. 

8.  Individual Developmental Projects (DPs). 

Each RC may support Developmental Projects to explore new technologies, resources and/or methodologies for application by the Resource Core. 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.

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 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.       Experimental design and methods

h.       Plans for the protection of human subjects and animals, if relevant

i.         Literature Cited

j.         Consultants

This description (d-g above) should not exceed 8 pages total for each developmental project. This is in addition to the 25 pages that may be used for the Overview, External Projects, and Developmental Projects Administration.

9.  Human Subjects (procedures relevant to RC projects)

10.  Vertebrate Animals (procedures relevant to RC projects)

11.  Literature Cited

12.  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.

13.  Consortium/Contractural Arrangements

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.

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 GCG website)

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

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, 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 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 is limited to 15 pages.

7.  Human Subjects (procedures relevant to PESC projects)

8.  Vertebrate Animals (procedures relevant to PESC projects)

9.  Literature Cited

10.  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.

11.  Consortium/Contractural Arrangements

A maximum of $250,000 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 $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 (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 GCG website)

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

3.  Biographical Sketches of Project Leader and Key Personnel

4.  Research Plan.

a.  Specific Aims

b.  Background and Significance

c.  Preliminary Studies

d.  Experimental Design and Methods

6.  Human Subjects

7.  Vertebrate Animals

8.  Literature Cited

9.  Consultants.  Provide a list with page references to biographical sketches.

10.  Consortium/Contractural Arrangements

The Research Plan should not exceed 8 pages for each pilot/exploratory project.

SECTION (7 + number of RCs).  OAIC COORDINATING CENTER CORE (CCC)

Include this section as an OAIC Core only if the applicant Institution is applying for the Coordinating Center (CC) award in addition to an OAIC site award.

1. Title page (recommended format on GCG website)  

2.   Budgets for First 12-month Budget Period and for Entire Period for Individual Core (PHS 398).  If other than inflationary increases are requested in future years, detailed budgets should be provided for all years.

3.  Biographical Sketches:  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 CC.

5.  Core Structure

a.       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

b.       Administration. Describe the administration of the core, and how activities will be selected and prioritized. A discussion of the role and qualifications of the proposed Core Leader should be included here.

6.  Core Functions

a.        Background and Significance. Include brief descriptions of the services and activities supported through the core, and how OAIC functions would be enhanced by these activities

b.       Proposed Core Services and/or Activities. Include detailed descriptions of proposed core services and activities

c.        Progress Report (continuing renewal applications only)

Items (5-6b) may not exceed 15 pages.  The Progress Report (6c) may not exceed 5 pages.

7.  Literature Cited

8.  Consultants.  Provide a list with page references to biographical sketches.

9.  Consortium/Contractural Arrangements

Applications for an OAIC Coordinating Center ONLY (i.e., independent of a new or continuing OAIC Center) should use the PHS 398 format.  Applicants are strongly encouraged to use the format for Subsections 5 and 6 above (Core Structure and Core Function) for the Research Plans Section described in the PHS 398. Page limitations for Biosketches and for Subsections 5 and 6 above apply to independent applications.

Revisions of previously submitted applications.  Applicants who responded to OAIC RFAs AG-06-001, AG-04-002, and AG-02-001 but did not receive awards may submit revised 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 two additional pages are 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 Geriatrics and Clinical Gerontology (GCG) website. (The website for these pages will be available after January 31, 2007.)

Appendix Materials 

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.  See NOTICE OD-07-018.  (While this Notice pertains mostly to electronic submissions, which this RFA does not use, there are important guidelines in it to follow for submission of Appendix material under this announcement.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

Section V. Application Review Information


1. Criteria

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

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 the 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 preventative interventions that drive this field?

The following questions are also considered for OAIC applications:

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 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:

For applications for the OAIC Coordinating Center, and for Coordinating Center Cores within OAIC applications, the following criteria will be used.  Coordinating Center Cores will be scored separately from the parent OAIC Application, and the score for the Coordinating Center will NOT be considered in determining the overall scientific merit of OAIC applications.

Significance: How well does the proposed CC address the coordination and communication needs of the OAIC program? If the aims of the application are achieved, how will the proposed CC bring added value to the scientific activities and accomplishments of the OAIC program?  How will the proposed CC enhance the career development opportunities within the OAIC program?  What will be the effect of the proposed coordinating activities on the concepts, methods, technologies, treatments, services, or preventative interventions that drive the field of geriatrics?

Approach: Are the proposed organization and methodologies adequately developed, well integrated, well reasoned, and appropriate to the aims of the CC?

Innovation: Is the approach to the coordinating functions original and innovative? For example: Are additional activities proposed that challenge existing paradigms in geriatrics career development, data/resource utilization and sharing, or collaborative research?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for coordination and communication?

Investigators: Is the leadership structure appropriate for the proposed CC?  Are the investigators appropriately trained to carry out this work? Is the proposed team experienced in the coordination of multi-site activities or research collaborations? Does the investigative team bring complementary and integrated expertise to the project?

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

2.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:

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?

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

N/A

2.D. Sharing Research Resources

N/A

3. Anticipated Announcement and Award Dates

N/A

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 (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 Notice of Award 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 NoA. 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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

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.

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.

Detailed reports of program activities will be required for the mid-cycle review, at the beginning of the third year of the 5-year award.

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.
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 Contacts:

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 Contacts:

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://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/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. 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 RFA 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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