THERAPEUTIC COMMUNITY RESEARCH Release Date: February 2, 2001 RFA: RFA-DA-01-015 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 19, 2001 Application Receipt Date: April 19, 2001 BOTH MODULAR AND NONMODULAR GRANT APPLICATIONS MAY BE SUBMITTED IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA). FOR MODULAR GRANTS, THE "JUST-IN- TIME" CONCEPT IS USED, AND THERE ARE DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST ALSO BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. FOR NONMODULAR APPLICATIONS (APPLICATIONS HAVING AT LEAST ONE YEAR"S REQUESTED DIRECT COSTS EXCEEDING $250,000), THE MODIFIED INSTRUCTIONS FOR MODULAR GRANTS AND JUST-IN-TIME PROCEDURES ARE NOT USED, AND THE TRADITIONAL PHS 398 INSTRUCTIONS SHOULD BE FOLLOWED INSTEAD. PURPOSE This RFA encourages new directions in behavioral treatment and services research in Therapeutic Communities (TCs) that provide treatment for drug abuse and addiction. As scientific knowledge on the TC has evolved, research interest has shifted from whether the TC works, to how it works and how it can be improved through a better understanding of the treatment processes involved, through a better blending of research-based interventions with TC treatment practices, and through increased understanding of organizational and management strategies to deliver more effective and efficient treatment services. This RFA encourages research aimed at improving the therapeutic efficacy and efficiency of TCs. Research on therapeutic approaches that include behavioral treatments, alone or in combination with pharmacotherapies, is encouraged. In addition, this RFA encourages studies on TC treatment processes, research to integrate new research-based interventions into TC treatment, and research on TC organizational and managerial processes. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This RFA, "Therapeutic Community Research," is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit 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 This RFA will use the National Institutes of Health (NIH) research project grant (R01) and the exploratory/developmental grant (R21). Applicants are advised to contact the National Institute on Drug Abuse (NIDA) program staff listed under INQUIRIES for additional information and specific application procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 2001. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the award will vary also. Modular budgeting procedures apply for applications up to $250,000. See http://grants.nih.gov/grants/funding/modular/modular.htm for further information about the modular budgets. When applying under the R21 mechanism, the applicant should obtain a copy of the R21 announcement, as it contains instructions for the preparation of the application and other useful information. R21 grants are limited to $100,000 in direct costs per year and to a 3 year effort. The announcement may be obtained at http://www.nida.nih.gov/ResFundslist.html. FUNDS AVAILABLE NIDA intends to commit approximately $2.0 million in FY 2001 to fund approximately four to six awards in response to this RFA. The level of support is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although the financial plans of NIDA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background The TC for drug abuse treatment has existed for about 40 years. It is generally a drug-free residential setting which provides a highly structured pro-social environment for the treatment of drug abuse and addiction. It differs from other treatment approaches principally in its use of the community as the key agent of change, in which treatment staff and recovering clientele interact in both structured and unstructured ways to influence attitudes, perceptions, and behaviors associated with drug use. The TC uses a staged, hierarchical model in which treatment stages are related to increased levels of individual and social responsibility. Peer influence, mediated through a variety of group processes, is used to help residents learn and assimilate social norms and develop more effective social skills. The therapeutic approach generally focuses on changing negative patterns of thinking and behavior through individual and group therapy, group sessions with peers, and participation in a therapeutic milieu with hierarchical roles, privileges, and responsibilities. Strict and explicit behavioral norms are emphasized and reinforced with specific contingencies (rewards and punishments) directed toward developing self-control and responsibility. The TC has evolved over time to become a comprehensive treatment model adapted to many types of patients and offering a range of services. As a result of changes in health care policy and treatment financing, TCs have adapted to serve a changing population of drug abusers that have a range of co-occurring medical and psychosocial problems. A body of research supports the effectiveness of TC treatment both for general treatment populations and for identified sub-sets such as criminal justice-involved individuals and addicts with co-occurring psychiatric and drug disorders. This RFA encourages research to understand and describe the essential components and processes of TCs, research to delineate the mechanisms through which TCs achieve their effectiveness, and research to help the TC work better to treat future patients in changing health care environments. This RFA encourages studies to better understand how the TC works, not whether the TC works. Particularly in the era of managed care, understanding the TC’s organizational and therapeutic processes has become increasingly important. This RFA is intended to stimulate research to improve understanding of the therapeutic processes in TC treatment, research aimed at improving the therapeutic efficacy of TCs through the development, refinement and testing of new and improved therapeutic strategies used within TCs, research on organizational structures and processes and their interrelationships, and research to improve TC management practices and processes. Although it is important to investigate how to adapt the TC model to treat new populations, this RFA is not intended to support such research. Over the past decade, NIDA has implemented a major program of research on behavioral therapies for drug abuse and dependence. (See PA-99-107 for a description of the Behavioral Therapies Development Program.) As a result of this research, there has been a significant increase in the number of efficacious, manualized behavioral treatments that are now available for the treatment of drug addiction. This RFA also seeks to stimulate research aimed at improving the therapeutic impact of TCs through the addition of behavioral treatments (e.g., cognitive-behavioral therapy, contingency management, motivational enhancement therapy, family therapy, etc) that have been shown to be efficacious in other treatment settings. As data from a variety of areas of treatment research (e.g., treatment entry characteristics, retention predictors, relapse predictors) is beginning to show gender differences, investigators are urged to incorporate gender differences into their research design and analyses. Applicants may propose studies to occur in existing TCs or may create experimental TCs based upon clearly explicated principles of the TC process. Research Areas Research on Therapeutic Community Treatment Processes A better understanding of the TC treatment process is needed in order to make TC treatment more effective and more efficient and to enable TCs to produce change in systematic and predictable ways. Treatment process research includes research on the core components of the TC, research on the community as a change agent, and research on group processes. o Elements of treatment in the TC and their relationship to outcomes. How do specific TC treatment elements address needs and attributes of clientele? What components of the TC are necessary and sufficient for attitudinal and behavioral change? What value is added by individual components? o Variations in TC models. What is the effect on outcomes of modifications to the TC model? Can core TC elements be translated into non-residential treatment settings, and what are the benefits of doing so? o Quality and persistence of change in attitudes, perceptions, and behaviors derived from the community experience compared to change resulting from more formal or discrete services (e.g., individual or group counseling). o Research on community-based learning, confrontation, games and role- playing, and catharsis in the therapeutic community. For example, how does confrontation in the TC create behavioral change, and when is confrontation therapeutically ineffective? o Research on group-level processes, including social influence (informational, normative, and interpersonal) in groups, groups and identity (individual-group connection, group membership biases), and functions of groups (e.g., belonging, intimacy, generativity, support, influence, exploration). o The relation of treatment stages to goals of TC treatment. Do specific stages achieve measurable treatment goals? How are intermediate goals related to outcomes? Are treatment progress and outcomes dependent upon successful completion of each stage? o Research on threshold treatment length of stay. What are the determinants of individual treatment length-of-stay thresholds? How can length-of-stay thresholds for persistent change be reduced through specific therapeutic interventions, treatment services, or other treatment processes? Relationship between severity of patient problems and threshold retention, need for specific components of treatment, or progress through particular treatment stages. Research to Integrate New Interventions Into TC Treatment TCs employ a variety of behavioral change strategies. Many TCs also integrate the use of medications for psychiatric disorders into treatment. Research is needed to understand how new theory-based and evidence-based treatment interventions can be effectively integrated into TC treatment processes. Areas of research interest include: o Studies aimed at developing and testing behavioral intervention strategies to enhance motivation and readiness for treatment in order to improve retention in TCs. o Research that examines the potential benefits of scientifically-based and or empirically supported behavioral treatments when combined with standard TC treatment, including but not limited to the following interventions: - Behavioral therapies for individuals with co-occurring drug and mental or other health disorders. - Behavioral therapies that can be utilized in conjunction with medications, or behavioral interventions to improve compliance with medications regimens. - HIV/AIDS risk reduction interventions. - Behavioral therapies that address the unique needs of women, racial and ethnic minorities, families, children and adolescents, criminal and juvenile justice populations, and the homeless. o "Stage I" research (see NIDA PA #99-107, "Behavioral Therapies Development Program," at http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html) on the development, refinement, or modification of efficacious manual-guided behavioral therapies for use in the TC setting. o "Stage III" research (see NIDA PA #99-107, "Behavioral Therapies Development Program," at http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html) examining how to transport efficacious behavioral treatments to TCs. o Studies that examine TC therapeutic/social processes (e.g., confrontation within a TC) to test and understand these processes in individuals with a variety of characteristics, including but not limited to: - Personality characteristics, - Developmental stage: Chronologically, cognitively, or emotionally, - Types or degrees of psychopathology, - Gender, - Cultural background, - Social/interactive styles, and - Social network characteristics. o Research on the effective use of pharmacotherapies or medications to treat drug, alcohol, or mental health disorders in the therapeutic community. Research on TC Organizational and Managerial Processes Change in the contemporary TC can be a product of internal pressures, such as a desire to improve treatment outcomes, or external pressures, such as competition or changes in treatment environment, funding, or resources. Research is needed to provide a better understanding of organizational factors and management strategies that enable TCs to improve their therapeutic and service delivery practices. Organizational factors. Structural and environmental factors can affect service efficiency and effectiveness. Areas of research interest include the following: o Structure of the TC. Research on inter- and intra-organizational forms (e.g., organizational relationships, size, and complexity, staff diversity) related to effectiveness, efficiency, and quality of care. Integrated, linked, and non-integrated service delivery models for health, mental health, and social services. o Environmental factors. Research to understand how TC climate, organizational culture, and resources affect treatment entry, engagement, retention, satisfaction, and outcomes. Role of the TC as part of a general service delivery model that includes continuing care, multiple treatment episodes, and mutual support/self-help groups. o Management and program practices. Research to improve the adaptation and adoption of emerging or underutilized service delivery technologies. Research on program policies, guidelines, and procedures to improve the effectiveness and efficiency of business and therapeutic work practices. Studies of the ability of various management models to improve organizational capacity to use resources and adapt to changes in programs, systems, or environments. o Organizational development. Research on human resources management practices for personnel selection, staff credentialing, training, continuing education, clinical supervision, and job performance incentives. Research on methods to enhance staff performance quality and capabilities. Research into counselor attributes and roles, including formal vs. informal aspects, relation to TC self-identity, culture, and climate, use of recovering staff. Self-monitoring and quality improvement. Self-monitoring is intended to insure that treatment processes conform to established treatment models or protocols. Quality improvement processes are intended to systematically review new knowledge, new methods for treatment, and new business practices and to utilize or adopt those offering advantages, such as improvement in business efficiencies or in the quality of services. Research is encouraged on topics such as the following: o Use of quality improvement methods in the TC. Research on the role of quality monitoring and improvement, management information systems, internal/external evaluation, and performance indicators to improve treatment. o Research to identify practices for routine monitoring and improvement of quality of care, instituting a quality of care conceptual framework, developing and validating treatment process or performance measurement, or establishing practical, routine benchmarking procedures. o Measurement of TC in-treatment performance. Development of in-treatment measures for quality monitoring and improvement, for comparisons across programs, for communication with treatment case or cost managers, for benchmarking, or for developing standards of care. Research on the relationship of in-treatment performance indicators (both patient and program) with post-treatment measures of outcomes. MONITORING PLAN Applicants should be aware of NIH"s recently revised policy regarding safety monitoring for Phase I and II clinical trials (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). NIDA intends this guidance to apply to behavioral, as well as pharmaceutical, interventions. The policy requires investigators to submit a general description of a data and safety monitoring plan as part of the research application. In addition, a detailed monitoring plan must be approved by the Institutional Review Board and the funding Institute before the trial begins. Additional information may be obtained at http://www.nida.nih.gov/. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of 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 is 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 these policies. 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. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA"s Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit 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 is being submitted. 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 NIDA staff to estimate the potential review workload and plan the review. Send the letter of intent (by receipt date listed in the heading of this RFA) to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms 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, E-mail: GrantsInfo@nih.gov. 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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. 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. 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 all personnel, and their 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. 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 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, and - 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. 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. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed in line 2 on the face page of the application form, and the YES box must be marked. The sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Research (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR 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. REVIEW CONSIDERATIONS This RFA invites applications from investigators who have not typically conducted therapeutic community drug addiction treatment research. For exploratory research, reviewers will assess innovation, creativity, and related factors as described below. Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NIDA in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. Review Criteria The goals of NIH-supported research are to advance the 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 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. (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 method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: 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) Relevance: To what extent are the aims of the proposal relevant to the purpose and objectives of the RFA? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: 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 subjects will also be evaluated. The adequacy of plans to make data available to other investigators in a timely fashion. The reasonableness of the proposed budget and duration in relation to the proposed research. The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. The above criteria apply to R01 applications, and there are additional criteria for the R21 mechanism. When applying under the R21 mechanism, the applicants should obtain a copy of program announcement PA-98-004 from either their office of sponsored research or from the NIH Guide Web site (http://grants.nih.gov/grants/guide/pa-files/PA-98-004.html). This program announcement contains instructions for the preparation of R21 grant applications. Schedule: Letter of Intent Receipt Date: March 19, 2001 Application Receipt Date: April 19, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Start Date: September 30, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include scientific merit as determined by peer review, availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issued to: Lisa Onken, Ph.D. Division of Treatment Research and Development or Bennett W. Fletcher, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 443-0107 or 443-4060, respectively FAX: (301) 443-8674 or (301) 443-6815, respectively Email: lo10n@nih.gov or bfletche@nida.nih.gov, respectively Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov Direct inquiries regarding review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@nida.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.