Full Text AG-95-002 CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA: AG-95-002 P.T. 34 Keywords: Aging/Gerontology Behavioral/Social Studies/Service Sociology National Institute on Aging Letter of Intent Receipt Date: April 10, 1995 Application Receipt Date: May 23, 1995 PURPOSE The National Institute on Aging (NIA) invites applications for support of Claude D. Pepper Older Americans Independence Centers (OAICs). These centers are for the purpose of increasing independence in older Americans. OAICs will provide support for research to develop and test clinical interventions, and for core laboratories in the basic sciences. OAICs also will train individuals in research approaches to develop and test methods of maintaining and increasing independence, and to enhance expertise in aging research through the provision of training in the relevant fundamental scientific disciplines. They will conduct demonstration projects and information dissemination concerning the applications of such research. Centers should promote linkages between mechanistic and outcome research and thereby foster the capacity of new investigators to develop better clinical treatments and preventive approaches. It is recognized that the balance between support devoted to intervention studies and fundamental science will differ among Centers to take advantage of areas of strength in geriatric and gerontologic research available at different institutions. In those instances where applications request significant core resources to enhance ongoing projects, the number and quality of externally funded peer-reviewed studies will be of special importance. OAICs may support a broad range of geriatric and aging research. However, applications with a predominant focus in neuroscience or the behavioral and social sciences are more appropriate for other NIA centers programs that have a primary focus in these disciplines. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Claude D. Pepper Older Americans Independence Centers, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Only U.S. organizations are eligible to apply. Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Older Americans Independence Centers will be supported through the comprehensive center grant (P60) mechanism. The awarding of funds pursuant to this RFA is contingent on availability of funds. All pertinent DHHS, PHS, and NIH grant regulations, policies and procedures are applicable. First year budgets may not exceed $1,200,000 (direct plus indirect costs). Budget increments for subsequent years generally will be limited to no more than one percent. Awards are made initially for no less than five years and may be renewed for five-year periods. FUNDS AVAILABLE Although it is anticipated that up to $1.2 million will be directed to the support of competing OAICs in Fiscal Year 1995, and that one award will be made, issuance of an Older Americans Independence Center award is contingent upon the receipt of scientifically meritorious applications and allocation of appropriated funds for this purpose. In addition to the FY 1995 award, it is anticipated that up to $3.6 million will be directed to the support of OAICs in Fiscal Year 1996 and that three awards will be issued to applicants responding to this RFA, depending on the quality of applications and the availability of funds. RESEARCH OBJECTIVES Millions of older Americans suffer from loss of abilities needed to live fully independently. Loss of independence imposes enormous personal and financial burdens on older persons and their families. The annual cost to the Nation for care of dependent older persons totals billions of dollars. Dependence is not inevitable in old age. It results from disabling conditions which are potentially, if not currently, preventable or reversible. The development and testing of interventions to reduce disability and increase independence thus offers immense benefits and potential savings in health care costs. To date efforts to develop such interventions and test their efficacy in maintaining and increasing independence have been modest, and the number of researchers with the abilities to conduct such research has been small. There is a need for more researchers and research teams with the ability to: 1. Conduct controlled clinical trials of promising interventions against disabling conditions of older persons. 2. Fill gaps in the knowledge of the pathophysiology of disabling conditions, and of the mechanisms affecting their responses to treatment, and develop and test improved treatments based on this knowledge. 3. Develop and test ways of applying independence-enhancing advances in treatment within the American health care system. The combination of these three abilities would allow the conduct of concerted research programs to increase independence for older Americans. The Claude D. Pepper OAIC program is designed to expand this research and the number of researchers capable of conducting it. Specifically, as authorized under amendments to Section 445A of the Public Health Service Act, each OAIC will conduct: "research into the aging processes and into the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause, which includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders and complications that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals and programs to develop individuals capable of conducting research in these areas." As defined by Section 445A of the Public Health Service Act, "the term independence, with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision." The overall goals of the OAIC program are: 1. To facilitate the development and testing of interventions to increase or maintain abilities needed for independence of older persons. 2. To use knowledge gained in these intervention studies in developing and testing improved interventions. 3. To strengthen core laboratories in the basic sciences as they relate to aging research and to train researchers in the techniques of fundamental research relevant to studies in aging and geriatric medicine. 4. To train researchers capable of leading and conducting research programs as described in 1, 2, and 3 above. OAIC research projects should provide opportunities to train such researchers. 5. To translate OAIC research findings into improvements in health care practice through demonstration and dissemination projects. The components of OAICs derive from these goals. OAICs will support: Intervention Studies (IS) and Intervention Development Studies (IDS) At least one Intervention Study or Intervention Development Study that utilizes older persons as subjects must be eligible for funding following peer review to qualify as an OAIC. Intervention Studies. Proposed intervention studies must test the efficacy of interventions to prevent or ameliorate functional impairments contributing to loss of independence. Studies may be of effects on long-term disability and/or temporary disability following illness or injury. In studies of prevention interventions, a focus on subgroups at high risk for disability is encouraged where appropriate. All Intervention Studies should measure direct effects on functional status and have adequate statistical power to determine important intervention effects on functional abilities. Central in the evaluation of these studies will be the adequacy and appropriateness of the plans for measurements of changes in functional status. Measures of related medical and physiologic endpoints are encouraged wherever pertinent. Because older persons with multiple health problems are at especially high risk for disability, determinations of the efficacy of interventions in such persons, and analyses of the effects of different health problems on treatment efficacy, are encouraged where feasible. Tests of interventions specifically designed against disabilities resulting from the interaction of two or more comorbid conditions are also encouraged. Besides measurements of intervention effects on the above outcomes, each proposed intervention study must also include planned investigations of: o Mechanisms underlying the interventions' effects on functional status, to provide a basis for further improvements in interventions. Intervention interactions with intermediary response variables such as underlying disease mechanisms, symptoms, and behavioral factors should be measured and analyzed as needed for this purpose. o Factors affecting recruitment into the study and participants' compliance, to provide data for potential wider applications of the interventions are considered pertinent and must be included. o Cost-effectiveness and effects on health care utilization (e.g., hospitalizations, nursing home admissions and stays, use of home care services) of the intervention(s) tested. Proposals for intervention studies that do not contain the above elements will be returned to applicants. Examples of types of interventions for study include, but are not limited to: o Interventions to prevent or reduce frailty and increase physical performance abilities. Exercise, nutritional, pharmacologic, rehabilitative, surgical, and other interventions against disorders such as osteoarthritis, congestive heart failure, chronic pulmonary disease, pathologic loss of muscle mass and/or strength, protein- calorie malnutrition, dizziness, and gait and balance problems are encouraged. o Interventions to reduce risk of disabling events such as hip fractures and strokes, and to reduce impairments following these events. Studies of interventions against osteoporosis and to prevent hip fracture, and studies of techniques to improve functional status after hip fracture and strokes are encouraged. o Interventions to prevent or reduce disabling side effects from medication use. Examples include drug withdrawal studies and testing of non-pharmacologic therapeutic alternatives, as well as testing improved pharmacologic agents or regimens. o Interventions to prevent, lessen, or shorten temporary disability from exacerbation or complications of chronic diseases of older persons. Examples include transient disability associated with exacerbations of chronic pulmonary disease, deconditioning during hospitalization, and acute confusional states. o Interventions to prevent or reduce disabling sequelae of menopause and associated estrogen deficiency. Examples include osteoporotic fractures and urge incontinence. o Combined intervention strategies to prevent or ameliorate disabilities in older persons with multiple impairments. The above list is not exhaustive and its order is not intended to reflect NIA priorities. All studies of promising interventions to enhance independence in older persons are encouraged. No priority is placed on having a diversity of intervention topics associated with a single OAIC. Applicants may find it advantageous to concentrate on one or a few topics in which their strengths are greatest. Subjects for these studies may include older persons living at home, recipients of home care, nursing home residents, hospitalized patients, and those in other pertinent clinical settings, as appropriate to each intervention study. Organizational liaisons involving one or more medical centers, nursing homes, home care services, and other care organizations are encouraged wherever appropriate for the conduct of OAIC activities. All activities to be performed by proposed cores as part of Intervention Studies should be clearly described in the plans for the Intervention Study itself. Examples include functional assessment and biostatistical support. Intervention Development Studies. The OAIC center grant may support other studies to identify, develop, or refine potential interventions to preserve or increase independence. Each proposed Intervention Development Study should present a complete plan for conduct of the proposed research, analogous in the level of detail to an individual research project grant application. It should be presented in sufficient detail to allow for full scientific review. Types of such studies include: o Tests of therapies on physiologic factors known to affect functional status. Both beneficial and adverse effects may be studied. o Studies to identify or confirm reversible or preventible risk factors for disability and/or disabling events. Examples include diseases, and previously unidentified pathophysiologic changes leading to functional impairment and/or disabling events. Large- scale epidemiologic studies are outside the scope of this RFA. o Studies of experimental therapeutics directed at the prevention or treatment of morbid conditions associated with aging. Research utilizing animal and/or human subjects is appropriate. (If a study utilizing animal subjects is proposed, another study utilizing older persons as subjects must be included in the IS/IDS section to satisfy the requirements of this RFA.) All activities to be performed by proposed cores as part of Intervention Development Studies should be clearly described in the plans for the Intervention Development Study itself. Examples include functional assessment, biostatistical support, etc. Research Resources Cores (RRC) Applicants may request core resource support to enhance the quality of OAIC research projects, i.e., Intervention Studies, Intervention Development Studies and Pilot Research Projects. RRCs for the support of laboratories in the fundamental sciences as they relate to aging research or geriatric medical subspecialties may be requested as well. RRCs may also provide support for research projects relevant to the mission of OAICs whose major support is independent of the OAIC. Opportunities to participate in the scientific activities of RRCs should serve to enhance the development of research skills of new investigators and where appropriate should encourage linkages between fundamental science and clinical intervention research. Applicants should not propose a core unless its services/resources are required by at least two projects (otherwise the core could simply be included in the one project it supports). The justification for proposed cores (including the merit and number of projects they would support) will be evaluated by peer reviewers. Routine patient care costs may not be requested, but research-related patient care costs are eligible for support. Examples of possible RRCs include: o Recruitment/screening/assessment/registry units for subjects for different OAIC intervention study research protocols. o Functional assessment units to monitor functional status of subjects in OAIC studies. o Diagnostic and pathophysiologic units for studies of mechanisms of treatment response and interactions with disease. o Basic science laboratories providing state of the art technologies and training to center investigators. o Biostatistical/data management units. o Cost-effectiveness analysis units. o Veterinary Units for the support of laboratory animals used in aging research and the development of animal models of age-associated diseases. The above list is not intended to describe the full range of activities to be supported, nor to direct applicants towards these areas. Inclusion of research resources cores of any or all these types in a single proposed OAIC is neither required nor necessarily advisable. Innovative organizational approaches are encouraged. Institutions that are recipients of NIH General Clinical Research Center awards who wish to apply for an (OAIC) award are encouraged to use core resources from these Centers for support of OAIC projects where appropriate. For each Research Resources 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. Research Development Core (RDC) The Research Development Core is a required component of all OAICS. The RDC will provide salary and other support for junior faculty and research associates to acquire abilities in research to enhance the independence of older persons. This includes all phases of research to develop interventions to enhance independence, including clinical trials, studies of mechanisms of treatment response, and cost- effectiveness/health care utilization studies. The development of persons who will have the necessary breadth and depth of experience needed to lead teams spanning this range of research is of high priority. The career development of individuals acquiring skills in fundamental aging research related to the mission of OAICs may also be supported here. The research development core should promote linkages between mechanistic and outcome research. This will enhance the capacity of young scientists to develop better clinical treatments and preventive approaches. This goal may be achieved in a variety of ways including periodic meetings of center staff and other scientists and most importantly through the provision of suitable training opportunities. While the creation of these linkages is an important overall function of the RDC, it is recognized that this will not in all cases be feasible. However, the plan for the educational program of the RDC as a whole should describe the approach to be followed and the training plan for at least one (preferably more) of the individuals receiving support under the RDC should document how training opportunities will be utilized to achieve the goal of creating these linkages. The components of the Research Development Core are: Junior Faculty Development Support. Support may be requested for salary and fringe benefits for junior faculty participating in OAIC Intervention Studies and other OAIC research. The Research Development Core should present a plan for achieving development of junior faculty supported under this component, including a mechanism for monitoring their scientific progress and development toward independent research. Applicants should clearly specify the role of senior mentors in training and supervising junior faculty and research associates. A biographical sketch (two pages maximum), a list of active research support, and a brief description of the mentor's role in proposed OAIC activities should be provided for all proposed mentors. Though applicants are not required to identify individual junior faculty, research associates, and their specific roles in advance, they are encouraged to do so if possible, since this information is useful to peer reviewers. If support is requested for "to-be-named" junior faculty or research associates, applicants should present their plans for recruiting, training, and supervising these persons. The Research Development Core may also serve to encourage the research career development of other junior faculty and research associates (in addition to those receiving salary support from this core) by coordinating the participation in OAIC research projects of other junior faculty and research associates whose salary support may come from other sources, such as NIA's Geriatric Academic Program Award (GAP), Geriatric Research Institutional Training Award (GRIT), Physician Scientist Award (PSA), NIA Academic Award, and Clinical Investigator Award (CIA). The overall contribution of the OAIC to the development of researchers throughout the grantee institution who can contribute to the development of independence-enhancing interventions will be considered in the evaluation of OAIC proposals. Didactic Training. Support may be requested for didactic training in such topics as clinical trials methodology, biostatistics, pertinent topics in disease mechanisms and related basic sciences, behavioral sciences, health services research, etc. Such support is not restricted to individuals receiving salary support from the core, but may be provided to other personnel on OAIC research projects or OAIC Intervention Development Studies. Pilot Research Projects. Support may be requested for pilot projects on topics related to the activities of the OAIC. Examples of project topics include pilot studies of new interventions, and probes of disease mechanisms and their interactions with interventions. The procedures by which awardees will solicit, select, monitor and evaluate the results of pilot projects should be specified in the application, but applicants are not required to present specific pilot projects as part of the application. Pilot projects are limited to a maximum of one year in duration, a maximum of $25,000 (direct costs) per pilot project, and a maximum of $100,000 (direct costs) per year for the total allocated to all pilot projects contained in an OAIC. Pilot project funds may be used for salaries, equipment, and supplies. Research Development Core Leader. Support may be requested for a core leader who will be responsible for coordination of the above activities and must report annually on the progress of all individuals supported thorough this core, and other core activities. A maximum of $250,000 in total (direct plus indirect) first-year costs may be requested for the Research Development Core. Budget increments in future years will generally be limited to one percent. Demonstration and Information Dissemination Core (DIDC) OAICS must include a DIDC that supports activities to translate findings from their research into health care practice. A maximum of $80,000 annual total (direct plus indirect) costs may be requested for these activities. Specific projects for demonstration/ information dissemination activities should be described. The staffing plan and a rationale for the organization of this core should be presented. The methods and techniques to be employed for information dissemination and the audience targeted and size should be defined. Attention should be directed to issues of cultural sensitivity with regard to the target audience. Where appropriate, the information should be structured so that it can effectively reach minority populations, including non-English-speaking older people. Examples of projects that may be supported include dissemination of research results to the public, professionals, and paraprofessionals, through symposia and in-service training. Planning and pilot activities for larger scale demonstration projects to evaluate the practicability of interventions tested in OAICs within various health care settings are also appropriate. Leadership/Administrative Core Applicants may include a Leadership/Administrative Core that requests funds for the OAIC director, OAIC administrator, and support staff. The OAIC director should be a scientist who can provide effective administrative and scientific leadership and coordination with OAIC Intervention Studies. An OAIC administrator, who will assist the director in managing the Center, addressing issues of fiscal management and compliance with institutional, PHS, NIH, and NIA policies, should be identified. A maximum of $120,000 (direct plus indirect costs) per year for this core, for salary, travel, and other expenses of the director, administrator and appropriate administrative staff may be requested. Future year annual increases will generally be limited to no more than one percent. OAIC Advisory Panel. OAIC applications, regardless of whether a Leadership/Administrative Core is requested, must describe a plan and budget for the selection of experts from outside the OAIC who will meet yearly to review the progress of the OAIC and provide a written report to the OAIC Director. Potential outside experts should not be selected or named. The outside experts' review will be included in the annual OAIC Progress Report to the NIA. (A member of the NIA extramural staff assigned to each Center will routinely attend the Advisory Panel meetings. It will be the OAIC Director's responsibility to notify NIA Staff well in advance of the date scheduled). Coordination Among OAICs. OAICs are expected to meet together yearly to compare research results and to explore possibilities for collaborative efforts. Funds should be requested to permit travel of the OAIC director, administrator and on all OAIC Intervention Studies, and Intervention Development Studies for meetings with NIA staff and staff from other OAICs. Responsibility for organizing these meetings will rotate among OAIC sites. Required Components of an OAIC. The minimum required components that must be determined to be eligible for funding by the peer reviewers in order to qualify for an OAIC Award are (1) at least one Intervention Study or Intervention Development study that utilizes older persons as subjects (2) a Research Development Core, and (3) a Demonstration and Information Dissemination Core. All required components must be recommended for the full five years in order for the application to be eligible for funding. The total first year budget may not exceed $1,200,000 (direct plus indirect costs) and the total first year budget for the sum of the Research Resources Cores, Research Development Core, Demonstration and Information Dissemination Core and the Leadership/Administrative Core may not exceed $825,000. Thus, a center application requesting the full $1,200,000 will have an Intervention Study/Intervention Development Study first year total budget request of at least $375,000. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 10, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIA staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent Dr. Stanley L. Slater at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The application should be prepared using the OAIC (P60) Guidelines available from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Michael Oxman, Ph.D., Chief, SRO National Institute on Aging Gateway Building, Room 2C212 Bethesda, MD 20892 Complete applications must be received by May 23, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications may not exceed a total of 25 pages for parts 1-4 of the Research Plan for each project and 10 pages for parts 1-4 of the Research Plan for each core section. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIA. Incomplete applications will be returned to the applicant without further consideration. The 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. Applications judged by the NIA Program Staff to be non-responsive (those that fail to include all required components, request amounts that exceed allowable limits, or are not directed at the goals of this RFA) will be returned to the applicant without review. Because no site visits will be conducted, each application must be thorough and complete enough to stand on its own. Additional materials or revisions will not be accepted after the receipt date. It is strongly recommended that Institutional Review Board and, if appropriate, Institutional Animal Care and Use Committee approval be secured before the application is submitted. Otherwise, it is the applicant's responsibility to ensure these certifications are sent to the Scientific Review Office, NIA, within 60 days of the receipt date, unless an earlier date is set by the Scientific Review Administrator. Applications failing to comply with this requirement well be returned without review. There will be no further notifications on this issue. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria The primary criterion for review by the NIA review committee in evaluating each OAIC grant application will be the effectiveness of the proposed program in contributing to increasing independence for older Americans through the conduct of research, demonstration, and dissemination projects; and development of academic leaders in geriatrics with effective research, teaching and clinical capabilities. Specific criteria related to this standard include: 1. Scientific merit of the proposed research and its expected impact on the maintenance of independent functioning of older persons. 2. Contribution of Research Resources Cores, where included, to enhancement of research, training and pilot projects. Where major resources are requested for the RRCs, the number and quality of externally-funded peer-reviewed studies will of considerable importance. 3. Role of the Research Development Core in providing 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 RDC. Other review criteria are: 1. Leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort. 2. Qualifications, experience, and commitment of the investigators responsible for core units and their ability to devote the required time and effort to the program. 3. Presence of an administrative and organizational structure conducive to attaining the objectives of the proposed program. 4. 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. 5. Quality of proposed external review process. 6. Appropriateness of the total budget and budgetary requests for the individual components. 7. 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 Centers. 8. Institutional commitment to the requirements of the program. 9. The adequacy of the means for protecting against risks to human subjects, animals and the environment. 10. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA The award criteria are: o priority score o availability of funds o programmatic priorities INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Stanley L. Slater, M.D. Geriatrics Program National Institute on Aging Gateway Building, Room 3E-327 Bethesda, MD 20892-9205 Telephone: (301) 496-6761 FAX: (301) 402-1784 Email: slater%nihniagw.bitnet@cu.nih.gov Direct inquiries regarding fiscal matters to: Margaret Kuhn Grants Management Office National Institute on Aging Gateway Building, Room 2N-212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Email: kuhn%nihniagw.bitnet@cu.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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