CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS RELEASE DATE: August 21, 2003 RFA Number: RFA-AG-04-002 (This RFA has been reissued, see RFA-AG-06-001) Department of Health and Human Services (DHHS) 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) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.866 LETTER OF INTENT RECEIPT DATE: November 17, 2003 APPLICATION RECEIPT DATE: December 17, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The general goal of the Claude D. Pepper Older Americans Independence Centers (OAIC) program is to increase scientific knowledge that will lead to better ways to maintain or restore independence in older persons. Specifically, NIA's goal for the OAIC program is to develop or strengthen awardee institutions' programs that focus, and sustain progress, on a key aging research area. The means by which the OAIC program seeks to achieve this goal is provision of resources to institutions to help them address key research problems, technologic limitations, and needs for trained researchers, on issues in which progress could contribute to greater independence for older persons. RESEARCH OBJECTIVES NIA's objective for the OAIC program is development or strengthening of awardee institutions' programs that focus, and sustain progress, on key aging research areas, leading toward interventions that increase or maintain independence for older persons. NIA's goal is that an OAIC, in a given area of focus, will: o Provide intellectual leadership and innovation; o Stimulate translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research, or studies to improve understanding of mechanisms contributing to clinical or functional findings; o Facilitate and develop novel multidisciplinary and interdisciplinary research strategies; o Stimulate incorporation of emerging technologies, methods and scientific advances into research designs as appropriate; o Serve as a source of advice and collaboration to other institutions regarding technology, methodology, analysis, or other expertise and o Provide career development for future research leaders. An OAIC should be designed to promote a sustained research program in its area of focus, through which the center will accomplish the innovation, leadership, collaborative, and career development functions described above. Thus, identifying one or more important research areas to be addressed, specifying goals to be achieved within the five-year OAIC award period, and providing a plan to reach these goals, together with a method to evaluate progress toward these goals during the course of the OAIC award, are crucial to the design of an OAIC. 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: o Aging related issues concerning a specific condition contributing to loss of independence in older persons, e.g., role of aging changes in the etiology of the condition, special issues in the diagnosis, treatment or prevention of the condition in old age; complications, disability, or symptoms from the condition found principally in older persons. o Causes, assessment, prevention, treatment (including rehabilitation) of a specific type of disability in older persons. o Causes, prevention and treatment of a geriatric syndrome (e.g., involuntary weight loss, dizziness, incontinence) that is related to multiple pathologies and/or disabilities. o Specific aging-related physiologic changes, other risk factors, and/or interventions (e.g., physical activity) that affect risk for multiple conditions or disabilities in old age. o Interactions of multiple diseases, disabilities, and interventions (e.g., medications) in older persons, and their relationship to risk of morbidity, progression of disability, and efficacy of prevention or treatment strategies. o Factors contributing to amelioration or delay of multiple deleterious aging changes by modulating risk factors or fundamental aging mechanisms. OAICs may define their selected areas of focus either broadly or narrowly. For most of the types of research foci described above, each one has needs for a wide range of developmental and infrastructure activities. These activities are likely to be interdependent and synergistic. This implies that an OAIC strategy of selecting several key activities that address a selected focus may have unique benefits. Since the level of funding available to an individual OAIC is unlikely to allow such a set of activities for more than one focus area, applicants are strongly encouraged to focus their proposed OAIC on one research area, selecting an area in which their strengths allow their OAIC to fulfill NIA's goal for the OAIC program stated above. Institutions with strong research programs in more than one area may propose an OAIC with more than one area of focus but, if so, should propose, for each of these areas, a set of activities that will fulfill this goal. OAICs in such institutions may also support a limited amount of activities in their cores (see below) on topics other than their area(a) of focus, to capitalize on important new research opportunities or to address unexpected needs for career development support within their institutions. Applicants who anticipate providing such support should describe their proposed system for identifying these opportunities and needs, and selecting core activities to address them. Whether one or more than one focus area is selected, the total impact of the OAIC's activities on progress in the selected field(s), should be a major criterion in selecting them, and will be a major criterion in peer review and program evaluation. An OAIC may provide support to a variety of types of research in its area(s) of focus: o testing of prevention, intervention, diagnostic, or functional assessment techniques. o translational research (including mechanistic studies), experimental therapeutic studies in laboratory animals, studies in animal models. o technology or methods development research. To accomplish the program goals, OAIC awards will provide support for the following types of activities: Research Cores (RCs) will provide resources to (a) enhance or support projects funded primarily by other mechanisms, and (b) develop and validate model systems (e.g., animal models), methods, assays, analytic techniques, and equipment, as well as diagnostic, assessment and survey instruments to advance aging research. A 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. A Pilot/Exploratory Studies Core (P/EC) will support research to acquire information needed to select or design future crucial studies in the OAIC area of focus. A Leadership and Administrative Core (LAC) will support research planning and evaluation activities for the Cores, the OAIC as a whole, and other administrative activities. As noted above, while most of the research receiving support from RCs, the P/E C, and the RCDC should be focused in 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, to capitalize on unanticipated research opportunities or to address unexpected needs for career development support within their institutions. All OAICs must support a significant amount of clinical research with human subjects in their cores. However, it is not required that every core support studies on human subjects. Support for animal, and in vitro studies is also appropriate. Proposed OAICs 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. Research Core(s). Each Research Core (RC) should be based on a research field or function that contributes to the OAIC area(s) of focus. These cores may be defined in terms of a biomedical or biotechnology field (e.g., clinical trials, endocrinology, geriatric assessment, bioengineering), a service function (e.g., subject recruitment and retention, pathology, genotyping), or a supply function (e.g., animals). A minimum of one RC is a required for an OAIC application. Though applicants are strongly encouraged to consider the full range of disciplines, technologies, methodologies, services, and resources that could be brought to bear on their selected area(s) of focus, there is no requirement that an OAIC Research Core include this full range. The selection of areas for Research Cores should be made on the basis of their contribution to the overall goals of the OAIC. A clear statement of how the 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. RCs should 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 (R01, P01, U01, non-NIH). They may also provide services for development studies that are part of the RC (see below) and for pilot/exploratory studies included in the P/E C (see below). In general, it is expected that RCs will interact with, and provide expertise in the design, conduct, and analysis of results from the studies they support, as well as provide technical services or products. Hence, support for professional staff time for such interactions is encouraged where appropriate. Applicants should not propose a Research Core unless it will support at least two projects. The evaluation of the justification for proposed cores by peer reviewers will include consideration of the scientific merit of the core. Routine patient care costs may not be requested, but research-related patient care costs are eligible for support. In designing cores, applicants are strongly encouraged to consider the full range of disciplines, technologies, methodologies, services, and resources that could be applied to their selected area(s) of focus. Examples of possible RCs include: o Recruitment/screening/assessment/registry units for subjects in clinical research protocols, including clinical trials. o Diagnostic and pathophysiologic units for studies of mechanisms of treatment response and interactions with disease. o Basic science laboratories providing assays or other measures of cellular, molecular, or biochemical factors for clinical or basic studies. o Biostatistical/data management units. o Cost-effectiveness analysis units. o Units for the support of laboratory animals used in aging research and the development of animal models of age-associated diseases. 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, (referred to below as Development Projects) for activities such as: o Development or preliminary testing of new data acquisition methods or technologies, assays, materials, or instruments to assess their feasibility and potential to provide important information, relevant to the OAIC focus, that is not available or less feasibly obtained with current methods. The range of approaches in which such projects may be conducted includes, genetic, molecular, biochemical, engineering, imaging, clinical diagnostic, functional assessment, bioinformatics, and survey methods. o Development and testing of new data analytic and computational strategies to allow more informative results from studies in the OAIC area of focus. o Preliminary evaluation of new animal models for relevant age-related outcomes. Such activities must be justified in terms of the overall goals of the OAIC. A proposed RC may request support of up to $105,000 (direct costs) per year for development projects. Specific developmental projects to be conducted by an RC using these funds may last from one to five years. Development studies which challenge existing paradigms or develop new methodologies or technologies are highly valued. The first year of development activities to be performed using these funds should be described in detail, clearly delineating the approach taken for developing and testing the new methods or analytic approaches, and discussing how the results will be analyzed. Planned developmental activities for subsequent years must be reviewed by the OAIC internal and external review mechanisms (see Leadership Core section). NIA requires that programs be notified when a pilot grant award is made. This can be done at the time of the progress report. The above list is not intended to describe the full range of activities to be supported, nor to direct applicants towards these areas. Innovative organizational approaches are encouraged for each Research Core proposed, a core leader should be named, and plans for the scientific and administrative functioning must 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. Research Career Development Core A Research Career Development Core (RCDC) is a required component of an OAIC. The RCDC should be led by a scientist with experience in research training and a history of successful mentoring. The OAIC program's goal for RCDCs 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, independence, and disability in old age with knowledge of advances in the basic sciences, including gerontology, to develop better interventions to maintain health and independence. To help reach this goal, the RCDC will provide salary and other support for junior faculty and research associates to acquire research abilities in the area of the 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). Support for salaries and other expenses of the RCDC Core Leader, who will be responsible for coordination, oversight, and reporting of the above activities, and support staff may be requested. The RCDC's career development plans for at least some of the junior faculty and research associates to be supported should provide for the development of combined competence in basic and clinical research, either by enhancing clinical research experience of basic scientists, basic research experience of clinical investigators, or providing a combination of the two. An emphasis on development of skills for translating basic findings into clinical research, and clinical findings into mechanistic studies, is encouraged. OAICs should consider the extent of previous training of individual candidates for OAIC RCDC support with regard to the goal of developing researchers with combined expertise in clinical and basic research, including aging research, in deciding on the nature and extent of didactic training and research activities for which they request support for particular individuals. At least some of the junior faculty and research associates selected for support through the RDC should hold a clinical doctoral degree. A particular program priority is the development of strong aging-related research capabilities in individuals with clinical geriatrics competence, as evidenced by Board certification of qualifications in geriatrics. (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.) Though 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 at their institutions and others to encourage the development of individuals who have both training in geriatrics and research interests in the OAIC area of focus. OAIC career development support for individuals supported through the RCDC 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 their development. The OAIC proposal should identify the individuals selected for at least the first year of RCDC support, and should describe what their activities will be, and the nature of institutional commitments to the individuals' development. A description of mentors' research activities (including a biographical sketch) and their commitments in training and supervising these individuals should also be provided. The OAIC goals for the individual, 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 research area. In addition OAICs should provide a plan for their strategy, over the proposed OAIC award period, of recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive RCDC support, 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. Pilot/Exploratory Studies Core 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 named. Funding for pilot/exploratory studies may be for o preliminary testing of an intervention or other research protocol in humans or animals for safety, feasibility, or determination of optimal time course or dosage o analysis of data acquired in ongoing or previous studies to explore hypotheses that may guide the selection and design of future studies The above examples are not exhaustive of the types of pilot/exploratory studies that could be supported. A maximum of $250,000 in direct first-year costs may be requested for the Pilot/Exploratory Studies Core. Pilot/Exploratory Studies Applicants may propose up to five P/E studies in the first year. The minimum budget request for such studies is $25,000 for each study in first year direct costs. Each of these projects is limited to no more than $150,000 (direct costs) over its entire period of support, which should be for no more than three years. (Thus, there is an inverse relationship between the amount of yearly support and the duration of the project.) Increments in future years will generally be limited to one percent. Present these projects and budgets for the 01 year of the proposal. These studies must be prepared on the 5/01 revision of the PHS 398 application (http://grants.nih.gov/grants/forms.htm) package and included in the OAIC proposal. However, the specific aims, background and significance, preliminary studies, and experimental design and methods sections should not exceed eight pages total for each study presented. This is in addition to the 15 pages for the overall presentation of the P/E C. Budgets for all 5 years should be prepared. 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. However, the method for the selection of these studies should be described. Participating researchers in OAICs are also encouraged to consider seeking additional sources of funding for pilot or exploratory studies, such as the NIA Small Research Grant Program and NIH Exploratory/Developmental Research Grant Award (http://www.nia.nih.gov/GrantsAndTraining/FundingOpportunities/ResearchProjects.htm#r03). NIA requires that programs be notified when a pilot grant award is made. This can be done at the time of the progress report. Leadership and Administrative Core The Leadership and Administrative Core (LAC) will provide support for planning, organizational, evaluation, and administrative activities relating to the other Cores and the OAIC as a whole. 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: o Regular review of utilization of core resources by the other OAIC cores, and reallocation of resources within or among cores. o Assessment of scientific opportunities for new utilization of core resources, and planning to utilize them. One topic that should routinely be assessed is the potential for translation between basic and clinical research, e.g., research to develop or test interventions or diagnostic tests based on new findings from basic aging research or other basic research, or studies to improve understanding of the mechanisms contributing to clinical or functional findings. o Assessment of potential areas for collaboration among OAIC cores within the center, and with other OAICs or other projects, and planning for collaborative activities, if merited. o Review by an independent panel or panels of proposed Developmental Projects (see Research Core(s); Pilot/Exploratory Studies; and salary support for specific junior faculty by the Research Career Development Core. The LAC may elect to convene a single panel or separate panels to conduct reviews of the above activities. Ad hoc reviewers to address specific projects may be used. On each panel, at least one third of the members should be external to the awardee institution. Panels may meet in person or by teleconference. Additionally, active involvement in the following activities is required of the LAC. o Yearly review of progress toward the OAIC goals by an Advisory Panel external to the awardee institution, selected by the OAIC, subject to approval by NIA. A report by this Panel of its review should be included in annual non-competing renewal applications. o Preparation of information for a progress review by an external advisory board, selected and convened by NIA, at the conclusion of the second year of the OAIC award. (This board will review multiple OAICs.) o Preparation of administrative documents relating to the award Additional activities for which the LAC may provide support include: o Research planning meetings (including participants from other institutions) and support for invited scientific presentations. o Travel expenses for OAIC staff to visit other OAICs for joint projects. The membership of the required advisory panels 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. The Principal Investigator of the OAIC should be the Principal Investigator of the LAC, and should have sufficient expertise in the area of the OAIC's research focus to exercise effective scientific leadership and judgment. Up to $150,000 in direct costs per year may be requested for LAC activities. MECHANISM OF SUPPORT This RFA will use the NIH P30 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. Although this RFA is a one-time solicitation NIA expects to re- issue the RFA to allow either new applications to be paid or continuing competitive support to applications funded through this RFA. The anticipated award date is June 1, 2004. Follow the instructions for non-modular budget research grant applications in the PHS 398 form (rev. 5/2001) http://grants.nih.gov/grants/funding/phs398/phs398.html . This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIA intends to commit approximately $3.5 million in FY 04 and $1.6 million in FY 05 to fund 3 to 4 new and/or competitive continuation grants from the applications received in response to this RFA. An applicant must request a project period of 5 years and may request a budget for total costs of up to $1.8 million per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NIA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Budget increments for subsequent years generally will be limited to no more than one percent. Awards are made initially for five years and may be renewed competitively for five-year periods. It is anticipated that additional RFAs soliciting applications for OAICs will be issued as existing centers complete their 5-year award periods. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Foreign institutions are not eligible to apply 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. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS 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. SPECIAL NOTE: Required Components of an OAIC. In order to qualify for an OAIC Award, the minimum required components which must be recommended by the peer reviewers to be eligible for consideration for funding are 1) one or more Research Cores; 2) a Research Career Development Core; and 3) a Leadership/Administrative Core. All OAICs must support a significant amount of clinical research with human subjects, but support for animal and in vitro studies, and for secondary data set analyses, is also appropriate. All required components, as well as the support of research utilizing human subjects, must be recommended for the full five years in order for the applications to be considered for funding. NIA further requires adherence to its own clinical research policy statement to be found at http://www.nia.nih.gov/ResearchInformation/FundingAndTraining/Policies/ HumanIntervention. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Direct your questions about scientific/research issues to: Evan C. Hadley, M.D. Associate Director Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Suite 3C307 7201 Wisconsin Avenue Bethesda MD 20892-9205 Phone: (301) 435-3044 Fax: (301) 402-1784 E-mail: HadleyE@nia.nih.gov Direct your questions about peer review issues to: Mary Nekola Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 Phone: (301) 496-9666 Fax: (301) 402-0066 Email: Nekolam@nia.nih.gov Direct your questions about financial or grants management matters to: Cynthia Riddick Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Room 2N212 Bethesda, MD 20892-9205 Phone: (301) 402-1472 Fax: (301) 402-3672 Email: RiddickC@nia.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NIA 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: Evan C. Hadley, M.D Associate Director Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Suite 3C307 7201 Wisconsin Avenue Bethesda MD 20892-9205 Phone: (301) 435-3044 Fax: (301) 402-1784 E-mail: HadleyE@nia.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applications must be complete at the time of submission. The rules for submitting appendix material must follow the instructions in PHS 398. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form 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. SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20817 (for express/courier service) 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 Scientific Review Office National Institute on Aging Gateway Building, Suite 2C212 Bethesda, MD 20892-2292 Bethesda, MD 20814 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. SUPPLEMENTARY INSTRUCTIONS Important supplemental instructions needed for preparation of an OAIC application can be found at http://www.nia.nih.gov/GrantsAndTraining/Policies/OAICguidelines.htm. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NIA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Council on Aging. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The 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. The criteria to be used in the evaluation of OAIC applications are listed below. 1. Significance. o How important are the OAIC's selected area(s) of focus in regard to potential advances in understanding or treating age-related conditions affecting independence of older Americans? o Will the goals set for the OAIC over the project period significantly contribute to advances in its area(s) of focus? o How effectively will the OAIC promote the development of future research leaders in its area(s) of focus, particularly leaders who can integrate clinical insights regarding health, disease, independence, and disability in old age with knowledge of advances in the basic sciences, including gerontology, to develop better interventions to maintain health and independence? o Will the OAIC have a significant effect on the concepts or methods that drive efforts to enhance independence for older persons? o To what extent will the center cores facilitate other ongoing research to advance aging and geriatric research? 2. Approach. o Has one or more important topics been selected as an area of research focus? How adequate is the proposed strategy for promoting a sustained research program in the selected area(s) of focus through which the OAIC will accomplish the innovation, leadership, collaborative, and career development functions sought? Are the goals to be achieved within the five-year OAIC award period specified? How adequate is the plan to reach these goals, and the proposed methods to evaluate progress toward these goals during the course of the OAIC award? o How adequate are the LAC's plans for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals of the OAIC? Are they clearly stated and are approaches specified to deal with inadequate progress toward achieving goals, should this occur? o How adequately do the Research Cores, enhance the quality of research, career development and pilot projects? How adequate is the plan for prioritizing access to RC resources? o What is the scientific quality of the pilot/exploratory studies proposed and are they likely to acquire information needed to select or design future crucial studies in the OAIC area(s) of focus? o How adequately does the Research Career Development Core provide educational and other career development opportunities for fellows, junior faculty and other professional and paraprofessional personnel associated with the Center? The quality of the plans to promote linkages between mechanistic and applied research are an important aspect in the evaluation of the RCDC. o How adequate are the arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, the internal communication and cooperation among investigators in the program? o How effectively does the program incorporate both fundamental discovery and the development of applied research? o How clear is the plan for defining sharing of responsibilities among investigators and between institutions (if more than one institution is involved)? If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the OAIC? o How thoughtfully does the applicant acknowledge potential problem areas and consider alternative approaches? o How adequate are the plans for the external review process? 3. Innovation. o How effectively will the OAIC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? o How original and innovative are the developmental projects and pilot/exploratory studies? o Does the OAIC group challenge existing paradigms or develop new methodologies or technologies? o To what extent will the OAIC stimulate translation between basic and clinical research? o To what degree will the OAIC add new research directions that are based on insights from basic aging research or geriatrics? 4. Investigators. o How adequate is the proposed leadership for achieving the goals of the OAIC? Are the OAIC PI, and lead investigators appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? Is the PI an established investigator in a major area selected as a focus of OAIC research? o To what extent does the PI have the leadership qualities, including the ability to work collaboratively with other investigators, to establish mechanisms for quality control of the science receiving core funds, and to move the OAIC into new innovative research areas as appropriate. Does the PI demonstrate the ability for the translation of new scientific findings in basic aging research into testing of interventions in animals and humans? Has the OAIC PI created adequate plans for the external review of the overall OAIC and for the review of the proposed developmental projects and pilot/exploratory studies? o Is there evidence of adequate numbers of outstanding junior investigators with interest and commitment to aging research? o If there are plans to recruit investigator(s), are those plans reasonable and necessary and can those efforts be completed in a timely manner, such that the recruited investigator(s) can make meaningful contributions to the OAIC? 5. Environment. o To what extent is there evidence of significant commitment of the institution to fulfilling the objectives of the OAIC? o What is the quality of the academic and physical environment as it bears on patients, space and equipment and on the potential for interaction among scientists within the center and with scientists from other departments, institutions and Claude D. Pepper OAICs? Will the center serve as a source of advice in the area(s) of its theme(s) regarding technology, methodology, analysis or other expertise? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN AND MINORITIES: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). 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 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 17, 2003 Application Receipt Date: December 17, 2003 Peer Review Date: March 2004 Council Review: May 2004 Earliest Anticipated Start Date: June 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 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. 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, 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 (see 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. PUBLIC 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 public 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 PA 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. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. 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.

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