PAR-01-090: DEVELOPING CENTERS FOR INTERVENTIONS AND SERVICES RESEARCH (DCISR)

Department of Health
and Human Services (HHS)

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This Program Announcement expires on November 1, 2004, unless reissued. DEVELOPING CENTERS FOR INTERVENTIONS AND SERVICES RESEARCH (DCISR) Release Date: May 7, 2001 PA NUMBER: PAR-01-090 (This PAR has been reissued, see PAR-05-144) National Institute of Mental Health (http://www.nimh.nih.gov) Letter of Intent Receipt Date: August 1 annually Application Receipt Date: October 1 annually This program announcement (PA) and PAR-01-089, Advanced Centers for Interventions and Services Research, supercede the following announcements: Prevention Research Centers (PA-99-074), Social Work Research Development Centers (PAR-99-130), Specialized Mental Health Interventions Research Centers (PAR-98-020), and Centers for Research on Services for People with Mental Health Disorders (PAR-94-073). PURPOSE The National Institute of Mental Health (NIMH) encourages investigator- initiated research grant applications to establish Developing Centers for Intervention and Services Research (DCISR). The purpose of this initiative is to establish core support for building research infrastructure for intervention and services research studies in mental health. The companion program announcement (PA), Advanced Centers for Interventions and Services Research (PAR-01-089 http://grants.nih.gov/grants/guide/pa-files/PAR-01-089.html) calls for applications for advanced centers devoted to research on interventions and services in mental health. This program announcement complements that PA by providing a grant mechanism to support an earlier phase of infrastructure building to be utilized by qualified institutions with active research programs but without the existing capacity to mount the extensive and highly integrated research effort expected of an advanced center. This PA is intended to provide the initial support needed by such institutions to build a program over the next 5 years that would then qualify for the advanced centers program announcement. Applicants interested in funding a center for basic neuroscience research relevant to mental illnesses should see PAR-98-057, Silvio Conte Centers for Neuroscience Research (http://grants.nih.gov/grants/guide/pa-files/PAR-98-057.html) and those interested in a center for translational research between basic and clinical neuroscience research on severe mental illnesses should consider PAR-98-058, Silvio Conte Centers for the Neuroscience of Mental Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-98-058.html). Applicants interested in funding for a center for research at the interface between basic behavioral research and neuroscience should see PAR-00-130, Interdisciplinary Behavioral Science Centers for Mental Health (http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html). Applicants interested in a center that would foster research projects on the translation of basic behavioral research to mental disorders and public health applications should consider PAR-01-027, Translational Research Centers in Behavioral Science (http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html). Those interested in a center with a focus on HIV/AIDS should apply for funding through PAR-99-153, Core Support Program for Mental Health/AIDS Research (http://grants.nih.gov/grants/guide/pa-files/PAR-99-153.html). Researchers seeking initial infrastructure support to set up research partnerships with community settings are also referred to the program announcement PAR-00-096, Interventions and Practice Research Infrastructure Program (http://grants.nih.gov/grants/guide/pa-files/PAR-00-096.html). Applicants are strongly encouraged, if awarded a DCISR, to seek this additional support to build research collaborations with community systems described in that PA. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS- led national activity for setting priority areas. This PA, Developing Centers for Advanced Interventions and Services Research, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of Healthy People 2010 at: http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for support under this announcement. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. A single institution may have more than one DCISR but they must address distinctly different research topics. In such situations, it is expected that there will be significant savings from sharing some infrastructure resources among the centers at the institution. Institutions eligible under this PA should have both ongoing research activity in the intervention or services area and a demonstrated need for infrastructure support to take full advantage of their research potential. The existence of research activity is evidenced by the presence of ongoing mental health research funded under PHS grants or equivalent sources of peer- reviewed support, and recent record of peer-reviewed scientific publications. Due to their limited research programs, however, such institutions would not, in general, be eligible to apply under PAR-01-067, Advanced Centers for Intervention and Services Research. This PA is intended to support intervention and services research only. Those interested in basic neuroscience, basic behavioral or HIV-related research should consult other NIMH program announcements in those areas. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Exploratory Center Grant award mechanism (P20). This mechanism supports planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of NIH. Support is limited to a maximum of 5 years and is not renewable. Grants are awarded directly to the applicant’s institution and are not transferable to another institution. Under this PA, applicants can request up to $400,000 per year for direct costs, plus negotiated Facilities and Administrative Costs (formerly known as indirect costs). Allowable Costs The grant mechanism of this PA (P20) provides funding for infrastructure and developmental research projects only. Investigators seeking support for specific investigator-initiated research projects should use mechanisms other than the P20 (e.g., R01, R21, and R03). Under this PA, funds can be used to support research participant recruitment for all populations, especially activities to ensure appropriate participation by women, children and adolescents, elderly and other traditionally understudied populations, such as racial and ethnic minorities and people in rural areas. Those developing centers that will conduct clinical trials may request funds to support the establishment of a Data and Safety Monitoring Board for those trials. Funds may also be used for travel, salaries, meeting expenses, subcontracts and paying consultants. Applicants are referred to the General Clinical Research Center program at the NIH/National Center for Research Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for inpatient and outpatient facility costs. RESEARCH OBJECTIVES Background The need to increase the public health relevance of mental health interventions and services research has long been recognized and more recently highlighted in several reports by the National Advisory Mental Health Council. In particular, this PA addresses major recommendations included in Bridging Science and Service (http://www.nimh.nih.gov/research/bridge.htm) and specific recommendations in Translating Behavioral Science into Action (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm), as well as Priorities for Prevention Research at NIMH (http://www.nimh.nih.gov/research/priorrpt/index.htm), which calls for studies that would integrate behavioral and prevention research with treatment and services research. Treatment research has traditionally focused on testing the short-term efficacy of interventions on symptoms of illness. While these studies, typically conducted on homogeneous samples of research subjects at tertiary academic referral sites, have provided essential information, their impact on community practice settings has been limited by lack of generalizability to communities and restriction of outcome variables. Relatively few attempts have been made to test the effectiveness of interventions in community practice settings or to develop effective strategies for disseminating research findings among providers and consumers of care. Furthermore, current community practice has not been adequately studied to identify factors affecting utilization of mental health interventions and services or the quality of those services. Some intervention research is in the early stages of development. For these areas, there may exist a need for limited arrangements among traditional research sites that don t require extensive linkages to community treatment settings. Applicants who propose such limited arrangements should describe how the areas of research they intend to undertake are best served by such arrangements. Aims The intervention and services research that is needed to ultimately improve current community practice requires the adoption of novel methodological and organizational approaches, building of new partnerships, and, in general, enlargement of research activities beyond the traditional boundaries of academic settings and specific academic departments. This PA is intended as an infrastructure mechanism to build capacity at qualified institutions to pursue a research agenda that contributes to improving the delivery of mental health care in community settings. The goal is for these centers to: 1) build and maintain networks to conduct clinical trials and/or conduct practice and service systems research, 2) foster interdisciplinary collaboration, 3) develop new research methods and 4) cultivate training opportunities for new and established investigators. PROGRAM SPECIFICATIONS Grants awarded under this PA will provide financial support for two types of activities: (1) general development of research infrastructure and (2) funding of at least two specific developing research projects. All the activities will be under the overall direction and supervision of the Principal Investigator, who will function as director of the Developing Center for Interventions and Services Research. The Principal Investigator should be an established independent researcher in the area of mental health interventions and/or services research and will have a minimum time commitment of 30 percent to the developing center. All applications must have an Operations Core, Research Methods Core, and Principal Research Core. Development of Research Infrastructure It is expected that the applicants will have current research activities at their institution and will explain how research on mental health interventions and services can be expanded and enhanced by the support requested under this PA. The application should describe how the DCISR will expand training opportunities for junior investigators or established investigators willing to focus their efforts on interventions and services research. The direct support of training efforts (e.g., stipends), however, should be sought through other NIH training and career development grant mechanisms. Operations Core The developing center must have a clearly articulated Operations Core that should serve to integrate the scientific and infrastructure aims. This core includes administrative functions, data management and statistical analysis, dissemination activities, clinical trials operations if appropriate and any specialized interdisciplinary components. The Operations Core should foster an environment of research excellence, support methodological innovation, facilitate multidisciplinary collaborations, coordinate efforts, and monitor progress according to an overall focused research agenda. As appropriate, these efforts should include the engagement of community stakeholders, such as individuals with mental illness and their families, mental health care providers, community organizations and institutions (e.g., schools, group homes, and extended care facilities), public and private purchasers of mental health care, and insurers and managed care organizations. The Operations Core should include a data management and statistical analysis component as well as a clinical trials operations component when relevant. These components may be located at a single institution or across multiple institutions. Depending on the research focus, other specialized components might be included in the Operations Core (e.g., economics component). Applicants should describe effort for recruitment of research participants and data collection activities within this core. The DCISR may consist of several collaborating sites that are not all located in a single institution or geographic region. The collaboration of multiple institutions and settings to create a virtual center must be specified and explained in the Operations Core section so the feasibility of such arrangements can be evaluated. The Operations Core of the application should outline the scientific leadership for all anticipated research. It should describe an administrative structure that maximizes efficiency through program planning and monitoring, an infrastructure development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability. The Operations Core should also address knowledge and technology transfer, and enhancing the availability of center accomplishments (e.g., data, methods, etc.) within and beyond the center. Research Methods Core Each application should describe a process for building a Research Methods Core. The purpose of this core function is to support testing of innovative approaches to research design, assessment methods, recruitment strategies, and analytic approaches needed for intervention and services research. Applicants should seek funding through traditional mechanisms (R01, R21, R03) for specific projects. There are a large number of potential areas of investigation that could be included in this core. The following are some examples of research areas that could fit in this core. These are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. For example, a center might develop and evaluate ways to adapt assessment and treatment protocols previously used in restricted settings for use in community settings. Of special interest is research on ways to integrate qualitative and quantitative methods into intervention, practice or service system studies. Developing new designs for conducting clinical trials and statistical techniques to analyze data from novel research designs would be important areas to address in centers that are conducting clinical trials. Other potential efforts in this core might include: new methods for retention and recruitment of research participants, new technology for data entry and database management, and new measures to broaden assessment of the effect of interventions at the individual and system level. In addition, centers could improve methods that increase the relevance of research findings for community stakeholders such as payers and public policy makers (e.g., economic analyses in clinical trials or expanded measures of impact such as disability and functional status). A center might develop ways to improve intervention and services research studies through utilization of theory and methods from fields outside health (e.g., decision analysis, marketing and engineering). Applicants are encouraged to focus on how this core will enhance the research activities chosen in the principal research core (see below). Principal Research Core The developing center must have a clearly articulated plan to develop a set of scientific core functions that will enhance and expand capacity for at least one of two scientific areas: intervention research and/or practice and service systems research. Although not mandatory, applicants are encouraged to consider ways in which both areas (interventions and practice/service systems research) can be integrated into a focused research agenda. Applicants should select a major mental health problem as the focus of the research core and propose studies to address it. The research area chosen should be the primary research focus of the center and all other cores should clearly relate to the efforts pursued in this core. A separate description must be provided for the Principal Research Core area, including potential research proposals in this area, summary descriptions of exploratory and developmental research projects, and how these proposals and projects will relate to and support one another as well as projects in other cores. Applicants should describe how the Operations and Research Methods Cores are integrated in the service of this Principal Research Core and related research projects. A Principal Research Core that focuses on interventions research should seek to build capacity to facilitate the testing of preventive, treatment or rehabilitative interventions with the ultimate goal of increasing the number of evidence-based interventions applicable to community practice. Support can be used to increase the capability to conduct efficacy trials, assessments of safety, and dose-finding studies, and feasibility testing, as well as effectiveness trials to test the generalizability of interventions. There are a large number of potential areas of investigation that could be included in this core. The following are some examples of interventions research areas that could fit in this core. These are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. For example, applicants could propose to test interventions that target multiple levels of risk and severity, test various ways of delivering interventions such as sequenced approaches or algorithms and test interventions in large community populations that have shown some promise in small restricted populations. A DCISR could propose to develop new ways of identifying groups most likely to benefit from various intervention approaches as well as determining factors that would predict variability in response to interventions. Other possible research topics might include research to determine optimal dosing and duration of interventions to prevent relapse and recurrence. In addition, a center might propose to test ways of improving adherence to interventions and how to minimize side effects from interventions. A center might also propose to test new intervention models that take into account the service context in which the intervention will be embedded and the impact of an intervention on much broader measures of outcome (e.g., disability and functional status). A DCISR may choose to have a Principal Research Core that focuses on practice and service systems research. The purpose of such a research focus should be to examine sources and consequences of variability of the treatments or services provided in the community and to identify better ways to disseminate and implement research-based interventions and services in community settings. Practice research is based on three areas of research investigation: clinical epidemiology, quality of care research, and dissemination research. Service systems research addresses broad organizational, financing, and policy questions. There are a large number of potential areas of investigation that could be included in a core focused on practice and services systems research. The following are some examples of research that could fit in this core. These are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. For example, applicants could propose to conduct research on the various factors that may enhance or detract from the effective delivery of interventions and test ways of modifying these factors to improve the delivery of care. Other potential topics include: how consumer and clinician choices impact effective delivery of interventions and the outcomes from the intervention, how perspectives on quality of care vary by stakeholder and how those differences can be used to improve care. In addition, centers could propose to test various dissemination or implementation strategies for incorporating and sustaining the delivery of effective interventions in community settings. A DCISR might choose to examine usual care in the community and how an improvement in such care is influenced by individual, clinician and system factors. Research on the feasibility and utility of alternative methods to deliver interventions (e.g., telehealth) or studies to improve delivery of interventions in traditionally underserved areas (e.g., rural and frontier areas) would be other possible research topics for study. Specific Research Projects At least two developmental research projects must be described in the application with enough detail to allow appropriate peer-review of their scientific merit and methodological soundness. Due to the purposes of this PA and its funding limitations, such projects are not expected to be major research proposals, able to test major experimental hypotheses in a definitive manner. Rather, such projects are intended to provide preliminary data to be utilized in guiding the design of future more definitive investigations. These projects are similar to the ones typically supported under the developing grant mechanism (R21), e.g., Exploratory Development Grants for MH Intervention Research (http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html) and Pilot Effectiveness Trials for Mental Health Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-99-118.html). The focus of these specific research projects will be relevant to the focus of the Principal Research Core that the applicant has chosen to include in the developing center. ORGANIZATION OF CENTERS A developing center may be organized in a variety of ways and may include one institution or several. There is no single model for a: the structure will depend upon the research questions and approaches selected to study them. One type of center could adopt a Clinical Research Organization type approach, providing administrative, management, and operational support to a large set of ongoing and planned intervention or services studies in various community sites. Another type of center could adopt a decentralized, multi- site focus in which specialized activities are supported in different sites. A conceptual and theoretical rationale for the organizational structure should be discussed in the application. However, they must include the required cores outlined above. AWARD MANAGEMENT Because of the complexities of this funding mechanism and associated scientific aims, applicants should note that higher levels of program scrutiny, both pre- and post-award, may be necessary. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH GRANTS POLICY STATEMENT The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The provisions of the revised NIHGPS are effective for all funded NIH grants and cooperative agreements with budget periods beginning on or after March 1, 2001. The revised NIHGPS is available at: http://grants.nih.gov/grants/policy/nihgps_2001. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by the date indicated in the heading of this PA, a letter of intent that includes a descriptive title of the proposed center, 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 this PA. 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 NIMH staff to estimate the potential review workload and to plan the review. The letter of intent should be sent to the appropriate program contact, at the address listed under INQUIRIES, below. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applications are also available on the Internet at: http://grants.nih.gov/grants/forms.htm. Submit a signed, typewritten original of the application, including the Checklist of the documents included, 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 must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9663 Bethesda, MD 20817 (for courier/express service) Applications must be received by the application receipt date indicated in the heading of this PA. If an application is received after that date it will be returned to the applicant without review. APPLICATION PAGE LIMITS The description of the Operations Core, Methods Core, Principal Research Core, and Specific Research Projects should be limited to a total of no more than 30 pages. REVIEW CONSIDERATIONS Applications will be reviewed by CSR for completeness and by NIMH program staff for responsiveness. Applications that are incomplete and/or non- responsive will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIMH in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Mental Health Council. 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 discuss the following aspects of the application 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 the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserves 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. (1) Public Health Significance: Does this center and its associated research projects address an important public health problem? If the aims of the application are achieved, how will scientific knowledge of intervention and/or services research be advanced? What will be the effect of the center and its affiliated studies on care in community settings? (2) Innovation: Does the center propose to develop novel concepts, approaches, measures or methods in the development and assessment of interventions and/or services research? Are the aims original and innovative? Does the center extend existing approaches or develop new methodologies or technologies appropriate to the assessment of interventions and services? (3) Approach: Is there adequate rationale to support the importance of a center approach as opposed to other mechanisms (e.g., individual R01 applications)? Does a conceptual and theoretical framework focused on a major topic in intervention and/or services research inform the center organization and infrastructure development? Is the concept of a center fulfilled, including: (1) an integrated theme bringing together a multidisciplinary team of investigators in a common mission, (2) development of a pooled, core database or access to research participants that can yield results beyond that accomplished with individual projects alone, (3) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise, (4) a research mentorship component for new investigators through research training and career development mechanisms, and (5) a process for stimulation and evaluation of new pilot study proposals? Is the approach for the center adequately developed, well integrated, and appropriate to the general aims of the center? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are collaborations across sites well justified and reasonable to carry out the research activities? (4) Leadership: Are the center director and other senior investigators at the forefront of their respective fields? Do they have the experience and authority necessary to organize, administer and direct the center? (5) Environment: Does the scientific environment of the center contribute to the probability of success? Does the center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is the center able to gain and sustain access to a representative range of people in a broad set of academic and community settings? Is there evidence of institutional support? Are the collaborating sites chosen for the center the appropriate ones to address the research questions proposed? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The reasonableness of the proposed budget and duration in relation to the proposed research. The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of research participants will also be evaluated. The adequacy of the proposed protection for humans to the extent they may be adversely affected by the activities proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer-review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants may also consult NIH staff for advice concerning collaborations and access to patients and patient material. Direct inquiries regarding programmatic issues about practice and service systems research to: Junius Gonzales, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7141 , MSC 9631 Bethesda, MD 20892-9631 Telephone: (301) 443-3364 FAX: (301) 443-4045 Email: jgonzale@nih.gov Direct inquiries regarding programmatic issues about interventions for adults and the elderly to: Barry Lebowitz, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7162, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-1185 FAX: (301) 443-4045 Email: blebowit@nih.gov Direct inquiries regarding programmatic issues about interventions for children and adolescents to: Benedetto Vitiello, M.D. Child and Adolescent Treatment and Preventive Intervention Research Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7147, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: bvitiell@nih.gov Direct inquiries regarding fiscal matters to: Joy R. Knipple Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jknipple@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 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 NIH 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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