PAR-01-014: BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION � NIDA

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BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION NIDA Release Date: November 8, 2000 PA NUMBER: PAR-01-014 National Institute on Drug Abuse (http://www.nida.nih.gov) THIS PROGRAM ANNOUNCEMENT 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 PROGRAM ANNOUCEMENT. PURPOSE This program announcement (PA) is a reissuance of PAR-97-046, which was issued March 21, 1997, and is hereby withdrawn. This reissuance will become effective as of the February 1, 2001, receipt date, and will remain in effect through the February 1, 2004, receipt date unless reissued. This reissuance differs from the prior issuance in two major ways: (1) three receipt dates are now offered, and (2) the scope of the behavioral research is expanded to include all areas of behavioral research related to drug abuse. The National Institute on Drug Abuse (NIDA), through the issuance of this PA seeks to facilitate the entry of beginning investigators into the field of behavioral science research. NIDA invites newly independent investigators to submit applications for small-scale, exploratory, or pilot research projects related to NIDA’s behavioral sciences mission. Funding of B/START awards is relatively rapid, i.e., within approximately six months of the date of receipt of the application. 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), Behavioral Science Track Award for Rapid Transition-NIDA, 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 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. Foreign institutions are not eligible for a B/START award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be eligible for a B/START award, the proposed principal investigator must be independent of a mentor at the time of award, but be at the beginning stages of her/his research career. No B/START award will be made to individuals in training status. Thus, applicants may submit applications only after their training is complete. The proposed principal investigator may not have been designated previously as principal investigator on a National Institutes of Health (NIH) or federally-supported research project or component (except a dissertation research grant) or have received similar support from another federal agency, e.g., the National Science Foundation. Previous receipt of a National Research Service Award Individual Fellowship is permissible. Recipients of mentored K-awards are not eligible. Because this program is targeted at newly independent investigators, individuals who are more than five years beyond training status should consider other mechanisms of support. MECHANISM OF SUPPORT This PA will use the NIH Small Grant (R03) award mechanism. An award is not to exceed $50,000 in direct costs and is for a period of one year only. The award is not renewable. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Because this announcement targets newly independent investigators, this mechanism is ideal for obtaining pilot data that could serve as the basis for a subsequent grant application using other mechanisms of support. Therefore, under this PA, inclusion of pilot data is not a requirement. As an alternative mechanism of support to the B/START, investigators interested in pursuing periods of supervised training and career development are encouraged to consider NIDA’s career development award mechanisms. Information on these mechanisms is provided at http://www.nida.nih.gov/ResFundslist.html. Prospective B/START applicants may also wish to consider NIDA’s standard Small Grants Program as another alternative funding mechanism (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-059.html). Resubmission of a B/START application is not permitted. The principal investigator on a B/START award may not be replaced. Transfer of a B/START award with the principal investigator to another institution may be requested. RESEARCH OBJECTIVES NIDA, through the issuance of this PA, seeks to facilitate the entry of beginning investigators into the field of behavioral science research. NIDA recognizes the contributions that behavioral methods and perspectives can make toward understanding and treating drug abuse and addiction. In order to assure the development and implementation of sustained, systematic applications of behavioral expertise to drug abuse research, it is essential to ensure that opportunities for involvement in drug abuse research are made available to behavioral investigators who are at the early stages of building their independent research programs. To be appropriate for a B/START award, research must be primarily focused on behavioral processes and research questions. Thus, research on genetic, neural, or other biological processes would be appropriate for a B/START award only if its overall emphasis were on understanding behavioral processes or outcomes. Research proposed under B/START need not be conducted in drug-abusing populations or involve administration of drugs, however, the relevance of the research to drug abuse or drug addiction must be clearly established in the application. In all proposed research, investigators are encouraged to consider designing the research so as to permit an analysis of data by gender. All areas of behavioral research related to drug abuse are sought under this announcement including (a) animal and human basic behavioral and cognitive research aimed at elucidating underlying behavioral and cognitive mechanisms, determinants and correlates of drug abuse, and characterizing the consequences of drug abuse and addiction, (b) research incorporating neural and other biological approaches if the research has a primary focus on behavior or cognition, (c) drug abuse epidemiology, risk and protective factors, prevention, treatment, and drug abuse services, and (d) behavioral as well as cognitive research directed at the relationship between drug abuse and HIV/AIDS and other infectious diseases. These areas of interest include, but are not limited to: o Measurement of the incidence, prevalence, and patterns and trends of drug abuse (in various stages) and its adverse effects. o Identification of risk, vulnerability, protective, and resiliency factors for drug use and dependence. o Studies of behavioral mechanisms that may underlie drug dependence, e.g., learning and conditioning processes, cognitive processes, tolerance, habituation, and sensitization. o Studies of learning, motivational, cognitive, and emotional factors contributing to the acquisition of drug taking, maintenance, withdrawal, and relapse. o Characterization of the effects of abused drugs on diverse behavioral domains, including sensory-perceptual, psychomotor, learning, motivation, cognitive, social, and cultural, as well as the reciprocal role of adverse outcomes on further drug involvement. o Development of new animal behavioral models that correlate well with the human pattern and consequences of drug use and dependence. Such models may include an examination of neural processes. o Development of new animal behavioral/cognitive models to serve as screening procedures in the search for pharmacotherapies to treat drug dependence. o Development of mathematical or computational models of learning, conditioning, or cognitive processes relevant to drug abuse. o Laboratory, field, and epidemiological studies of the behavioral, cognitive, social, and cultural factors involved in the transition from drug use to drug dependence. o Behavioral genetic approaches either in animal models (e.g., transgenic animals, development of simple high-input behavioral screens) or in human subject studies (e.g., establishment of pedigrees, twin studies). o Studies of innovative theory-based drug abuse prevention programs, including HIV prevention programs as they relate to drug abuse. o Studies of behavioral treatments of drug dependence, including animal models. o Identification of factors affecting prevention and treatment access, entry, readiness, retention, and compliance. o Studies of the effects of organization, financing, and management of services on prevention and treatment outcomes. o Studies of strategies to prevent and reduce HIV risk and other infectious diseases among drug abusers. o Studies of drug abuse treatment services for HIV seropositive patients and for those at risk for HIV infection. 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 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. 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 Council before submitting an application that will administer compounds to human subjects. The Guidelines are available on NIDA’s Home Page at www.nida.nih.gov/HSGuide.html 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the three standard application deadlines as indicated in the application kit. 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: GrantsInfo@nih.gov and may be downloaded at http://grants.nih.gov/grants/funding/phs398/forms_toc.html. Prior to submitting an application, investigators are strongly encouraged to contact the program contact listed under INQUIRIES in order to assess the responsiveness of their proposed project to the mission of NIDA and to the goals of this PA. Sections a-d of the Research Plan must not exceed ten pages in total. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-046.html) 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. B/START applicants may request a maximum of two modules for a total direct cost of $50,000. 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 FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the one-year budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. Because this award is for one year, the figures for Items 7a and 7b should be the same as Items 8a and 8b. 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. 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. 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 (see http://grants.nih.gov/grants/guide/notice-files/not98-185.html) and the NIH policy for graduate student compensation (http://grants.nih.gov/grants/guide/notice-files/not96-062.html) 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. 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. CHECKLIST - This page must 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 number and title of this PA must be typed on line 2 on the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: 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) To permit an expedited review of the applications, applicants must simultaneously send two additional copies of the application 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) The standard receipt dates apply to this PA: February 1, June 1, and October 1. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by a scientific review group organized by NIDA. As part of the initial merit review, all applications will receive a written critique. In approximately five months, applicants will be notified by NIDA staff whether or not the application will be funded. No funding will occur during the months of October and November. 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: Does this study address an important problem? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? (3) Innovation: Does the project employ novel concepts, approaches, or methods? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include 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. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans and animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, appropriateness to the goals of the B/START program, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issue or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Cora Lee Wetherington, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: 301-435-1319 FAX: 301-594-6043 E-mail: wetherington@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 E-mail: gf6s@nih.gov 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: tl25u@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 by (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 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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