DEVELOPMENT OF BEHAVIORAL METHODS FOR DRUG ABUSE STUDIES IN THE MOUSE Release Date: May 3, 2000 RFA: DA-01-002 National Institute on Drug Abuse Letter of Intent Receipt Date: July 21, 2000 Application Receipt Date: August 22, 2000 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 The National Institute on Drug Abuse (NIDA) announces the availability of funds to develop or adapt behavioral models and methods for the mouse to advance the understanding of drug abuse and addiction. The rat has been the most commonly used organism for preclinical behavioral and neurobiological research, and a wealth of data relevant to drug abuse and addiction have been collected in this species. However, the best-developed vertebrate genetic model organism is the mouse, for which there is a rich collection of well- characterized mutations and genes. Through investment of significant funds from the NIH, many genetic tools are being developed that will enhance mouse research, such as the complete mouse genome sequence, large collections of new mutations, phenotypic characterization of common laboratory strains, and techniques for regionally and temporally specific gene targeting (see http://www.nih.gov/science/models/mouse/). It is anticipated that the mouse will become increasingly valuable as a model system for behavioral, neurobiological, and pharmacological research that relates to drug-abuse vulnerability and processes of addiction. NIDA has initiated this Request for Applications in order to increase the number of laboratories capable of using behavioral approaches to study and develop models of drug abuse and addiction in the mouse. 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 Request for Applications (RFA), Development of Behavioral Methods for Drug Abuse Studies in the Mouse, 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 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. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory/developmental grant (R21). 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 three 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 April 2001. For further information on the R21 mechanism, see https://grants.nih.gov/grants/guide/pa-files/PA-98-004.html (note that the budget limitation has been increased to conform with the guidelines for modular budgets). FUNDS AVAILABLE NIDA intends to commit approximately $1,000,000 in FY 2001 to fund 10-15 new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $100,000 per year. 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 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 Drug addiction is a chronic relapsing disease that has many characteristics, including a persistent desire or compulsion to use a drug, loss of control of drug intake, reduction in other important activities because of drug use, continued use despite knowledge of harm, marked tolerance, characteristic withdrawal symptoms, and an increased negative emotional state or stress when the drug is unavailable. The process of becoming addicted to drugs often begins with non-compulsive or less frequent use, which over time can lead to compulsive, uncontrollable drug taking. Relapse to drug use occurs following short or long periods of abstinence and may result from stress and/or reexposure to environments previously associated with drug use. Individuals addicted to drugs have been known to report intense "craving" for an abused drug. NIDA supports more than $600 million in drug abuse research annually and serves as the foundation of the Nation's investment in understanding the causes, consequences, and treatment of drug addiction. As part of this research endeavor, NIDA has supported research in animal models of addiction that use behavioral, neurobiological, pharmacological, and genetic approaches. Behaviorally based animal research has proven highly useful in explaining the underlying behavioral and neurobiological processes involved in drug abuse. Research that exploits genetically defined mice is being used (1) to investigate factors that determine individual differences in drug abuse vulnerability; (2) for molecular investigations, such as the role of different receptor subtypes in drug effects; and (3) to alter the function of specific brain areas or cellular processes to determine their role in drug-related behaviors. To characterize differences among mouse strains or to determine how a specific null mutation may affect behavior, it is becoming more important to conduct converging behavioral tests. Grants funded under this RFA might be used to complement ongoing research projects currently aimed at: 1) characterizing behavior of other animal species (e.g., rat), including behavioral aspects of drug abuse and addiction, where new funds would be used to adapt this research to the mouse; or 2)investigating in the mouse the behavioral consequences of strain differences or mutations arising from large scale mutagenesis or gene targeting, where new funds would be used to extend these studies to behaviors related to drug abuse, such as the development of new screening methods or the investigation of the influence of particular genes on behavioral phenotype. Areas of Interest Appropriate studies for this RFA might include, but are not limited to, the following areas: 1. The development of methods for studying in the mouse a variety of behaviors involved in or related to drug taking, drug seeking, or motivational processes. The proposed research could include the study of: impulsive behavior; acquisition or maintenance of drug-directed behavior; behavioral models of drug relapse, including stress- or cue-induced relapse; narrowing of behavioral repertoire; compulsive behavior; reproductive or affiliative behavior; or behavioral measures of drug sensitization, tolerance, or withdrawal. Methods used in other animal species, such as the rat, could be adapted to the mouse, or the proposed research could exploit species-typical behaviors of the mouse. 2. Phenotypic characterization of behaviors that are related to drug taking and drug seeking or indicative of related central motivational states in different laboratory mouse strains or in genetically altered mice. 3. The development of methods for rapid and/or automated phenotypic screening, such as automated methods for measuring drug directed or related behaviors, or for measuring behavioral responsivity to drugs of abuse or potential therapeutic agents. 4. The development of novel methods of drug self administration, which are less technically difficult and more easily implemented than traditional methods, for rapid screening of behavioral phenotype. 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, by July 21, 2000, 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 Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier/express service) 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 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. Forms are also available at https://grants.nih.gov/grants/funding/phs398/phs398.html. 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 $100,000 per year for 3 years under the R21 mechanism. 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 initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. 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 https://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 key 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 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 key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. 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: https://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. 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 on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: https://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 Blvd., 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 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 the NIDA in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 NIDA National Advisory Council or Board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus 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? For the R21 mechanism, a strong rationale and conceptual framework may be sufficient for establishing the feasibility of the project, in lieu of extensive preliminary data. (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, the application will also be reviewed with respect to the reasonableness of the proposed budget and duration in relation to the proposed research. Schedule Letter of Intent Receipt Date: July 21, 2000 Application Receipt Date: August 22, 2000 Peer Review Date: November/December 2000 Council Review: January 2001 Earliest Anticipated Start Date: April 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan Volman, Ph.D. Division of Neurosciences & Behavioral Research Behavioral Neurobiology Research Branch National Institute on Drug Abuse 6001 Executive Blvd., Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-1315 FAX: (301) 594-6043 Email: sv36h@nih.gov Minda Lynch, Ph.D. Division of Neurosciences & Behavioral Research Behavioral Sciences Research Branch National Institute on Drug Abuse 6001 Executive Blvd., Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-1322 FAX: (301) 594-6043 Email: mlynch@nida.nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 E-mail: tl25u@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Blvd., MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 443-6847 Email: gf6s@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 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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