PA-00-135: EFFECTIVENESS, PRACTICE, AND IMPLEMENTATION IN CMHS� CHILDREN�S SERVICE SITES

Department of Health
and Human Services (HHS)

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EFFECTIVENESS, PRACTICE, AND IMPLEMENTATION IN CMHS CHILDREN’s SERVICE SITES Release Date: September 21, 2000 PA NUMBER: PA-00-135 (see replacement PA-04-019) National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Drug Abuse (http://www.nida.nih.gov/) THIS PA USES MODULAR GRANT AND JUST-IN-TIME CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE The purpose of this program announcement (PA) is to encourage research grant applications on services delivered to children, adolescents and their families through the Center for Mental Health Services (CMHS) Comprehensive Community Mental Health Services for Children and Their Families Program initiative (hereafter referred to as the Children’s Services Program). Conducting the proposed research at one of the Children’s Services Program sites (either existing sites or graduated sites) is a prerequisite for funding under this PA. This PA encourages studies of the effectiveness of treatments or services delivered at these sites, the nature and impact of routine clinical practice, and factors related to successful implementation of treatments or services. This announcement supercedes PA-94-094 and addresses recommendations set forth in the NIMH report, Bridging Science and Service: A Report by the National Advisory Mental Health Council’s Clinical Treatment and Services Research Workgroup, and in the NIMH Child and Adolescent Services Research Strategic Planning Report. Applicants may obtain a copy of these reports at http://www.nimh.nih.gov/research/bridge.htm and http://www.nimh.nih.gov/childhp/prgindex.htm. This Program Announcement expires three years from the Release Date shown directly above, unless reissued. 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 Program Announcement (PA), Effectiveness, Practice and Implementation in CMHS Children’s Service Sites, is related to the priority areas of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/ ELIGIBILITY REQUIREMENTS Conducting the proposed research at one of the Children’s Services Program sites (either existing sites or graduated sites) is a prerequisite for funding under this PA. Applications may be submitted by domestic and foreign, 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. Foreign institutions are not eligible for small grant awards. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), small grant (R03), and the Collaborative R01s for Clinical Studies of Mental Disorders mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant team. The total project period for an R01 application submitted in response to this PA may not exceed five years. An application for an R03 award is limited to $50,000 direct cost per year, is limited to two years and is not renewable. For all competing R03 applications and R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Because each of these mechanisms has special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain appropriate additional information about those grant mechanisms. Special instructions and information for the R03 are found at http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html. Special information for the collaborative R01 is found at http://grants.nih.gov/grants/guide/pa-files/ FUNDS AVAILABLE Research grant funds may not be used to operate treatment, rehabilitation or service programs. However, supplemental funding from CMHS for service development, training and other operational expenses may be available to accomplish accepted research goals based on the availability of funds. Prospective applicant teams are strongly encouraged to contact NIMH or NIDA staff (listed under INQUIRIES) and their CMHS project officer with questions about the best mechanisms to use for specific projects. RESEARCH OBJECTIVES Background The purpose of this PA is to encourage research applications that will assess the effectiveness of treatments or services, the nature and impact of routine clinical practice, and factors related to successful implementation of treatments or services. Effectiveness is defined broadly to include the impact of specific psychosocial, behavioral, pharmacologic or service models (including preventive interventions) on clinical, functional, environmental, service, or systems outcomes for children, adolescents and their families. Effectiveness may also include the processes of treatment or service delivery (e.g., mechanisms of action) that improve outcomes, and the quality of services. Clinical practice is defined to include those features of routine care that clinicians typically employ (e.g., intake, assessment, engagement strategies, case management, supervision) when providing care. Types of activities typically practiced by clinicians, types of decision-making strategies employed, and the impact of routine care are included in practice studies. Implementation is defined to include dissemination practices (e.g., training, adherence, fidelity), barriers to implementation (e.g., accessibility of program, cultural barriers) and cost-effectiveness. Of particular interest are studies that will examine aspects of care that improve child and family outcomes, whether they be specific treatments, routine clinical practices, or implementation models. Innovative approaches to treatment and service delivery, such as family-tailored treatment delivery or culturally-tailored strategies expected to improve outcomes, are especially encouraged. The overarching goal of this PA is to contribute to the development of more effective mental health service delivery systems for children and their families. The Comprehensive Community Mental Health Services Program for Children with Serious Emotional Disturbances was created as part of the Alcohol, Drug, and Mental Health Administration Reorganization Act -- Public Law 102-321, Section 119). This program is administered by the CMHS of the Substance Abuse and Mental Health Services Administration (SAMHSA). Under this authority, grants are provided to States, political subdivisions of States, Indian tribes, or tribal organizations to provide a broad array of comprehensive community-based services for children with serious emotional, behavioral, or mental disorders in order to enable communities to develop local systems of care consisting of mental health, child welfare, education, juvenile justice, and other appropriate agencies. Funds for the CMHS program are authorized to be spent on services that are underdeveloped or nonexistent in most communities: respite care, day treatment, therapeutic foster care, intensive home-based services, school or clinic-based services, emergency services, and diagnostic and evaluation services. Children can be served in small therapeutic group homes that have a bed capacity of less than 10 beds. Additionally, each child must have an individualized service plan, developed with the participation of family and, where appropriate, the child. The plan must designate a case manager to assist the child and family by coordinating services among several systems. To date, 65 sites have been awarded five-year grants by the CMHS since the first Request for Applications was announced in the Spring 1993. Over 40,000 children and adolescents with serious emotional, behavioral or mental disorders have received or are receiving services in the systems of care that have been established for them. This PA is open to both existing sites and to graduated sites that are no longer receiving support from CMHS, but are continuing to provide services to the population of children and adolescents served under the current CMHS programs. In the child and adolescent services research field, concerns have been raised about the disseminability of already-established services, as well as the development of strategies for deploying empirically-based pharmacological, psychosocial, or combined treatments whose efficacy but not effectiveness has been established. Such issues as child and family outcomes associated with treatment or service programs, the potent elements within either treatments or services that contribute to outcomes, and the processes that link care delivery to outcomes are not well understood. The range of services provided through the Children’s Services Program provides a unique research opportunity to study many of these issues. The CMHS Children’s Services Program, because of the diversity of services offered to communities, provides an opportunity to examine both the disseminability of already-established services (e.g., multi-systemic family therapies, therapeutic foster care, intensive case management) and the effectiveness of specific treatments whose efficacy has been established, but whose effectiveness has not. While pharmacological, psychosocial, or combined therapies are available within many community service programs, most such therapies have not been studied within mental health clinics, schools, juvenile facilities, foster homes, primary care offices, or other naturalistic settings, where features of the settings themselves may affect child or family outcomes. Often treatments tested in one population or within one setting cannot be easily deployed into other settings without attention to the processes of adaptation, and the organizational or structural factors that enhance, modify, or interfere with implementation. Studies of the factors affecting deployability of pharmacological, psychosocial and combined therapies for specific mental disorders of children and adolescents, such a anxiety, depressive, conduct, attention-deficit hyperactivity, or substance abuse disorders, and the outcomes associated with treatment delivery, are strongly encouraged. Another unique aspect of the Children’s Services Program is the significant numbers of children and families from American Indian, Hispanic, and African American backgrounds. Some of these communities have developed and use services and treatments that are specific to the culture. While these cultural service and treatment practices may be relatively common in these communities and are perceived as effective, investigators have the opportunity to gather empirical evidence to determine the effectiveness of these practices. Resources in the CMHS Children’s Services Program The primary resource in the sites of the Children’s Services Program is the availability of a relatively comprehensive array of community-based services and treatments. Funding for residential care and hospitalizations, however, is not permitted. Directors of the site service systems may be willing to use some of their grant funds to help train clinicians and other personnel in the application of new interventions, as long as these interventions are consistent with the mission of the site service systems. Many sites are experimenting with responses to managed care, privatization, welfare reform, and other organizational and political reforms that can make the research on effectiveness, practice, and implementation current, meaningful, and policy relevant. Research Issues Listed below are examples of research topic areas that are of interest under this PA: o Research on the effectiveness of family-driven or culturally-based treatment or services, contrasted with provider-driven or usual care delivery o Research on the factors that predict treatment fidelity and clinical outcomes within different service approaches o Studies of the impact of different levels of service intensity or integration for children and adolescents, relative to their diagnosis or level of functioning, on long-term outcomes o Studies examining the quality of care and appropriate matching of services to level of impairment o Studies of the meaning of quality to children and families from diverse ethnic backgrounds o Research on the effectiveness of interventions designed to prevent adverse mental health outcomes in family members and caregivers o Development of improved methods for measuring and analyzing service integration and, within comprehensive systems, for measuring service intensity and service outcomes o Studies of the effectiveness of pharmacological, psychosocial or combined treatments in these sites o Research on strategies for deploying treatments into service communities o Research on the potent elements of effective services o Studies examining the processes within treatments or services (e.g., therapeutic engagement, family choice or involvement in care delivery, provider attitudes) that improve outcomes o Research on the effects of cost containment strategies o Research on organizational variables, such as culture or climate, that enhance disseminability of already validated services or influence outcomes or quality of care o Research on the effectiveness of interventions designed to prevent substance abuse and other adverse mental health outcomes in family members and caregivers o Research on the impact of prevention services on delivery of other services, outcomes, or quality of care o Studies of behavioral strategies that enhance treatment adherence o Studies of routine practices (e.g., supervision, assessment, referral, triaging, etc) by clinical practitioners (e.g., case managers, pediatricians, social workers, clinicians) which impact clinical outcomes or the quality of care o Research on the effect of family-centered services on treatment adherence o Studies of the effectiveness of services for co-occurring conditions, such as emotional, behavioral, or mental disorders, drug or alcohol abuse, AIDS, or homelessness Research Plan Proposed studies should be based on a strong conceptual framework, drawing on existing empirical literature and relevant theory, for both the selection of the research components and the specific research hypotheses. In addition, it is suggested that the following considerations be addressed in the preparation of an application: Evidence of strong collaborative research teams involving CMHS evaluation staff is required. The selection of each component of the study should reflect existing research findings and have a strong conceptual foundation, but may also include new theory-driven or research-based components. Feasibility issues should be clearly addressed in detail. Plans for implementation of the research should include procedures for obtaining and maintaining the necessary community relations, training and supervising project staff, insuring implementation fidelity, securing ongoing access to the participants, recruiting a representative sample of the target population, recruiting appropriate staff for the research intervention, and monitoring subject participation over time. Applicants should document the commitment, support, cooperation, and nature of the proposed collaboration of community agencies or other entities or settings outside the applicant organization whose support is essential for the conduct of the research. Special attention should be directed toward understanding unique variations in treatments and services across cultural, ethnic, or racial groups and the appropriateness of services for families from various backgrounds so that services and opportunities are appropriate and acceptable to these individuals (where feasible and appropriate to the study question). 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, 1`998, 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. 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. 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) and will be accepted at the standard application deadlines as indicated in the application kit. 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 at the following address: http://grants.nih.gov/grants/forms.htm. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs (Modular Total Direct plus Facilities and Administrative (F&A) costs) for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. o For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. o Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH The Biographical Sketch provides information used by reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to the PA and will be returned without further review. Applicants planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html Any application subject to this policy that does not contain the required information in a cover letter sent with the application will be returned to the applicant without review. The title and number of the program announcement must be typed on line 2 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 five 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 courier-overnight mail service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group 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 appropriate national advisory council or board. Review Criteria The goals of the NIH-supported research are to enhance health, improve the control of disease, and advance understanding of biological systems. 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 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. Criteria to be considered in evaluating applications for scientific-technical merit are: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigators: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) Quality and strength of the proposed partnership: Is there evidence that the partnership among the investigator team, the Children’s Service Program site administrators, project staff, and families is strong and likely to be sustained throughout the project? (7) Adequacy of the proposed means for protecting against or minimizing adverse effects to human subjects (8) Adequacy of plans for recruitment and retention of research participants (9) Adequacy of plans to ensure that informed consent procedures are to be strictly followed. The research participants must by fully informed regarding the purpose and potential uses of the research, and the possible positive or negative effects. Participants must be informed of their freedom to refrain from answering any or all questions, and every effort must be made to be sure that the participants understand all aspects of the assessment activities, and that efforts to ensure confidentiality are fully addressed. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to the Institute. 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 NIMH staff are available for consultation concerning application development in advance of or during the process of preparing an application. Potential applicants are advised to contact NIMH as early as possible for information and assistance in initiating the application process and developing an application. CMHS staff of SAMHSA are available for consultation on the Children’s Service Program sites. Direct inquiries regarding NIMH research issues to: Heather Ringeisen, Ph.D. National Institute of Mental Health 6001 Executive Blvd., Rm 6200 Bethesda, MD 20892 Telephone: (301) 443-9263 E-Mail: HRINGEIS@NIH.GOV Kimberly Hoagwood, Ph.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Blvd., Rm 7131 Bethesda, MD 20892 Telephone: (301) 443-3364 E-Mail: KHOAGWOO@NIH.GOV Direct inquiries regarding the CMHS Children’s Services Program to: Rolando L. Santiago, Ph.D. Child, Adolescent, and Family Branch Center for Mental Health Services 5600 Fishers Lane, Rm. 11C-16 Rockville, MD 20857 Telephone: (301) 443-1333 E-mail: RSANTIAG@SAMHSA.GOV Diane Sondheimer, M.S., M.P.H. Child, Adolescent, and Family Branch Center for Mental Health Services 5600 Fishers Lane, Rm 11C-16 Rockville, MD 20857 Telephone: (301) 443-1333 E-mail: DSONDHEI@SAMHSA.GOV Direct inquiries regarding NIDA research issues to: Elizabeth Rahdert, Ph.D. Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Blvd., Rm 4230 Bethesda, MD 20892 Telephone: (301) 443-0107 E-Mail: erahdert@nida.gov Direct inquiries regarding fiscal matters for NIMH to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Blvd., Room 6115 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 Fax: 301-443-6885 Email: Diana_Trunnell@nih.gov Direct inquiries regarding fiscal matters for NIDA to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Blvd., Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443- 6710 Fax: (301) 594-6847 E-Mail: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 93.277 (NIDA). 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 PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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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