THE NEXT GENERATION OF DRUG ABUSE PREVENTION RESEARCH Release Date: January 15, 2001 RFA: RFA-DA-01-009 National Institute on Drug Abuse ( Letter of Intent Receipt Date: March 16, 2001 Application Receipt Date: April 16, 2001 THIS REQUEST FOR APPLICATIONS (RFA) USES THE "MODULAR GRANT" AND "JUST-IN- TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This RFA encourages a new generation of drug abuse prevention research. Applications are solicited to examine elements that may account for program effectiveness of drug abuse prevention interventions that have either been empirically validated or are currently undergoing rigorous efficacy/effectiveness trials. The purpose is to gain a better understanding of what accounts for program effectiveness through: (1) empirical tests of theoretically derived processes, (2) identification of patterns related to differential effectiveness, (3) generating and testing alternate hypotheses accounting for effectiveness based on differential outcomes from current or previous research, and (4) specification and testing of elements singularly and in combination that contribute to effectiveness. 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, "The Next Generation of Drug Abuse Prevention Research," is related to the priority area of substance abuse. Potential applicants may obtain a copy of "Healthy People 2010" at: ELIGIBILITY REQUIREMENTS 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. This RFA invites applications from both investigators with experience in drug abuse research and investigators who have not typically conducted drug abuse research. MECHANISM OF SUPPORT The mechanisms of support will include the investigator-initiated research project grant (R01) and the exploratory/development grant (R21) mechanisms. Applicants are advised to contact NIDA program staff listed under INQUIRES for additional information and specific application procedures. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Modular budgeting procedures apply for grants up to $250,000. See for further information about 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 cost per year to a 3 year effort. The announcement may be obtained from NIDA staff or at FUNDS AVAILABLE NIDA intends to commit approximately $1,250,000 in FY 2001 to fund five to six new awards in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the Institute 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Over the past 20 years, NIDA has supported research on a number of drug abuse prevention programs that have been shown to be efficacious and effective. Primary evidence for efficacy and effectiveness has taken the form of long- term positive results in reducing the onset or progression of drug abuse among intervention subjects compared to control group subjects. To date, demonstrating global results of effectiveness has been the goal of much prevention research. Given the substantial number of theory-based interventions in various stages of efficacy and effectiveness trials, the primary evolving questions address which elements of content, client, implementer, and delivery account for program success alone or in interaction. Specifically, when drug abuse prevention programs work, what accounts for their success? For whom do they work? Under what conditions are they successful? Answers to these questions should be expected to vary depending on the underlying theory, the program’s aims derived from that theory, the program’s content, the implementers, the target population, the delivery, and the interactions among these program aspects. Addressing these questions is a necessary next step for refining both prevention science and the theories that contribute to prevention science. Drug abuse may include illicit drug use and/or tobacco, as well as illicit drug use or tobacco in combination with alcohol. Although few studies have focused exclusively on examining success-related drug abuse prevention program elements in any depth, several have studied such factors. These studies suggest that crucial elements include the match between program aims and content delivered, the number of sessions provided, the number of sessions attended, the match between the program design and the program delivered, the use of interactive techniques, and the grouping of clients. Research in other domains suggests that other components may also influence successful outcome. These include implementer training, "goodness of fit" between implementer and target population, characteristics of the target population, interpersonal communication styles, and sequence in which content is delivered. Since these findings have emerged from program evaluation studies, few careful descriptions of how program elements contribute to outcomes have emerged, findings rarely rely on theory-driven analyses, studies have not yet tied results back to the theoretical aims that inform the development of programs, and studies are only beginning to advance new hypotheses aimed at the refinement of underlying theories and program components. In general, the active elements of prevention interventions that account for successful outcomes have not been adequately examined. At least four general areas should be considered in determining what accounts for program success, i.e., content, delivery, implementer, and client. Each area may include "active ingredients" in the change process intended by the intervention, and both process and outcome research can provide important information. Examples of unanswered research questions related to each of these four areas follow. Content Theories on which prevention programs are based inform the development of program content. Because most prevention programs draw from multiple theories, drug abuse prevention programs have multiple content areas such as drug information, drug refusal skills, communication skills, and academic achievement skills. In general, programs with multiple content areas have been found to be more effective than single-focused programs. However, little research has examined, either prospectively or retrospectively, the effectiveness of content areas singularly or in combination. It is possible, for example, that one content area of a program may be ineffective in bringing about change when implemented alone, but in combination with another content area, it may be very effective. It is important to identify combinations of content areas that work synergistically to produce effects. Effectiveness or ineffectiveness could also be related to the sequencing of content areas. Some prevention interventions use self-contained sessions or units, whereas others use a curriculum approach with each session building on previous sessions. With each of these two approaches, it will be important to discover if there are within or across session sequencing effects. Client Many prevention models are effective for some populations in some contexts. But what kinds of clients make what kinds of gains in specific programs and why? Characteristics of individuals and groups can include fixed characteristics, such as gender, receptivity characteristics, such as cognitive and communication styles, and grouping characteristics, such as high-risk behaviors. Theory-based drug abuse prevention programs typically specify target populations based on level of client risk. In general, the universal, selective, and indicated audiences classification is used, with some studies taking a tiered approach in which individuals are moved from universal to selective to indicated based on level of risk or need. Beyond these rather global classifications, little work has focused on targeting prevention content to specific subgroups, and it remains unclear how well client characteristics fit with content, delivery, and implementer elements of programs. For example, interactions between the target group and the group leader, or among members of the target group, may lead to changes in norms that then influence outcomes independent of content. Alternately, normative change could result from interaction between content and environment. Thus, what is effective in one setting may not be effective in another due to differences in either the environment or the target population. In some cases, it may be easier to uncover answers to these question through data on universal intervention in which there is a full range of client types who can be carefully monitored to determine which program elements appear to lead to the greatest gains for which subgroups. Recent findings regarding gender and ethnicity differences in program effectiveness underscore both the usefulness of universal level data for examining these issues and the need to develop a better understanding of what subgroup characteristics influence effectiveness. On the other hand, when specific subgroups are selected for inclusion in selective and indicated interventions, they are high-risk populations, which can offer special opportunities for uncovering client- related program elements because of the homogeneous nature of the group. This maximizes the potential for identifying interpersonal processes that might account for outcomes and underlying processes that contribute to or detract from program effectiveness. Subgroup analyses can be used to provide feedback for program design and for the development of alternative hypotheses concerning the processes through which program content may be more or less effective for subgroups. Further, some subgroups may self-select out of particular portions of the intervention. Program content should be examined in terms of whether the client actually learned or mastered the content in the way intended. Implementer For drug abuse prevention programming to be maximally useful it must be capable of being delivered by a wide variety of implementers. However, there is wide variation in implementer characteristics that may influence effectiveness. Some intervention studies have examined training, personal and interpersonal characteristics, and fit between target populations and implementers. This research is only beginning to extend to drug abuse prevention. Thus, characteristics related to implementers need to be examined to explore the possibility that the success of some program results are in large part contingent on the qualities of the group leader. Untapped areas of research include identifying skills of excellent implementers and identifying which skills can be taught in implementation training with lasting effects. Further, characteristics of the implementer may influence the selection of content delivery, which introduces an interaction that may affect outcome. The extent to which the implementer feels supported in the work environment and is given adequate time and resources to complete the intervention may have an effect on program effectiveness. In addition, research in other areas suggests that characteristics such as open interpersonal communication style, receptive body language, ability to empathetically listen, and social reinforcement of pro-social qualities are important characteristics of successful implementers. However, qualities such as these may not affect all members of a target group in the same way. Moreover, there may be bi-directional effects in the implementer-individual client process such that those individuals who are experiencing positive changes may be more receptive and motivated. In turn, when particular group members are more receptive and motivated, this may make implementers more responsive in general. Gender and ethnicity may be important, particularly when considering characteristics of the client. Delivery Delivery refers to the methods through which program content is imparted to program clients. Delivery is perhaps the most well-studied area of drug abuse prevention effectiveness. There is well-documented evidence of effectiveness of delivery features, such as, factors that boost recruitment and retention rates, number of sessions provided, number of sessions attended, booster sessions, and match between program design and program delivered. However, these delivery features have not been well tied to other program aspects, including content, client, and implementer. For example, most drug abuse prevention interventions incorporate multi-feature delivery systems. Research exploring the differential effectiveness of these features has found that interactive delivery is more effective than didactic delivery. However, there is little research to suggest why this is the case, which interactive methods are the most effective, and whether there are subgroup differences in delivery acceptance and effectiveness. In addition, drug abuse prevention researchers have not yet examined which delivery features account for the largest effects, whether widely used features are indeed the most effective for imparting program content, whether the level of exposure interacts with subgroup differences, or whether there is situational specificity in effectiveness. Barriers and Approaches Moving into the next generation of drug abuse prevention research will be challenging. Tying program content, delivery, client, and implementer elements to theory in a way that allows for decomposing theory into testable hypotheses is a difficult task. In this applied area of research, this strategy will result in the ability to test the generated hypotheses and reformulate theory on the basis of the findings from experiments in laboratory and real-world settings. Challenges exist for accomplishing the drug abuse prevention research that will be necessary to answer questions about these and other program elements. A number of approaches could be taken in conducting the next generation of prevention research. For example, in addition to data from drug abuse prevention interventions, data from a variety of other relevant sources, such as those from early mental health and violence prevention interventions that incorporate data on substance abuse, could be used to detect mechanisms of change. Data might also come from existing longitudinal studies on a single implementation of a given program, from the collapsing of data across multiple replications of the same intervention, or through the conduct of small-scale microanalyses that address a limited number of specific hypotheses developed out of prior prevention research. Specific approaches could include dismantling designs, test of mediational models, experimental studies, or tests of process models. Dismantling designs can be used to systematically add in or take away program elements or to determine combinations of elements that produce maximum effectiveness for specific subpopulations. Mediational models can use new or existing data to test specific hypotheses generated from the underlying theoretical base. Confirmation and disconfirmation of specific aspects of these models can lead to theory and program refinement. Experimental studies can be used to test hypotheses derived from prior prevention interventions. Finally, process evaluations can be used to document and describe important sequences and patterns related to effectiveness. Despite the challenges inherent in conducting this research, there are important heuristic and practical reasons for moving in this direction at this time. The next stage of prevention science is to validate findings and build new hypotheses for theory refinement and more effective programs. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale or justification is provided 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 (, a complete copy of the updated Guidelines is available at 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. POLICY AND GUIDELINES ON THE 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: 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. 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 these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA’s home page at or may be obtained by calling (301) 443-2755. 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 a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent 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. Application kits are available at most institutional offices of sponsored research and may be obtained 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: 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 for PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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 Direct Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD Do not complete the categorical budget table on 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 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 role in 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 F&A) 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 the role in 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 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: - 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. 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 title and number of this RFA must be typed in Item 2 on the face page of the application for, and the YES box must be marked. The RFA number must be typed on the label as well. The sample RFA label is available at: 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 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. 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. (1) Significance: Are the goals and objectives of this application relevant to this RFA? Does the 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? For the R21 mechanism, a strong rationale and conceptual framework are normally sufficient for establishing the feasibility of the project in lieu of extensive preliminary data. This may be true of some R01 applications as well. (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? 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, 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 human, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. - The adequacy of plans for including children as appropriate for the scientific goals of the research. Schedule Letter of Intent: March 16, 2001 Application Receipt Date: April 16, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Anticipated 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 issues to: Elizabeth Robertson, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-1514 FAX: (301) 443-2636 E-mail: 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) 443-594-6847 E-mail: Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. 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 E-mail: 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 are 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.

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