CENTERS FOR DRUG ABUSE AND AIDS RESEARCH CORE GRANTS Release Date: January 21, 2000 RFA: DA-00-008 National Institute on Drug Abuse Letter of Intent Receipt Date: March 13, 2000 Application Receipt Date: April 12, 2000 PURPOSE The National Institute on Drug Abuse (NIDA) invites applications for Centers for Drug Abuse and AIDS Research (CDAAR) Core Grants (P30) in support of a large number of active research projects that are funded by the National Institutes of Health or other federal or non-federal sources. The purpose of the CDAAR Core Grants is to create centers to enhance basic, clinical, epidemiological, prevention, and applied research on drug abuse and HIV infection and other co-occurring illnesses, through the support of shared resources. The joint focus on drug abuse and HIV/AIDS focus distinguishes these applications from the more general HIV/AIDS focus of the Centers for AIDS Research (CFARs) sponsored by the National Institute of Allergy and Infectious Diseases. Any single CDAAR must integrate a predominant theme or focus, e.g., the delivery of primary care and prevention services to drug abusers not in treatment, the cognitive or behavioral problems in drug abusers with implications for HIV/AIDS. Relevant multidisciplinary efforts would be expected to address and complement the central theme, e.g., pharmacologic studies of the interactions of Highly Active Antiretroviral Therapy (HAART) with drugs of abuse in drug users not in treatment, studies of community based prevention in this population, clinical studies of nutritional and neuroendocrine factors related to disease progression. NIDA provides support for research center grants to foster a synergistic approach to drug abuse and HIV/AIDS research and to enable studies that would not occur without the climate, facilities, and research resources that a research center can uniquely provide. NIDA encourages the application of multiple scientific perspectives and approaches to the intertwined problems of drug abuse and HIV/AIDS. NIDA"s CDAAR Core Grant program is intended to support the highest quality, multidisciplinary research centers. CDAARs must have two sets of essential and defining qualities. The first of these is, of course, the highest caliber of scientific work. The second set relates to the particular characteristics of research centers, as opposed to simply outstanding work supported through other grant mechanisms. This set of center-specific characteristics emerges from the confluence of thematic integration, synergy, and multidisciplinary involvement. Research supported at a CDAAR must be thematically focused and must reflect, or come to reflect over time, clear interdependence of components of the research program that would not occur simply from the mere collection of the individual components. Taken as a whole, a CDAAR is expected to enable a level of achievement which exceeds that expected on the basis of the sum of its parts. Center support should be essential to the achievement of work that is proposed. In addition, CDAARs are expected to serve as national research resources. They are expected to attract established and promising investigators into drug abuse and HIV/AIDS research. Through the CDAARs, NIDA seeks to encourage outstanding scientists to bring a full range of expertise, approaches, technologies, and creativity to the study of problems related to drug abuse and HIV/AIDS. Investigative efforts are expected to be broadly based and to encompass a variety of areas, including biological, biomedical, social, behavioral, and/or clinical sciences and to address critical issues of neuroscience, prevention, treatment, health services, or other drug abuse and HIV/AIDS-related research areas. Further information on expected characteristics of NIDA Centers, including CDAAR Core Grants, may be found in the NIDA Research Center Grant Consolidated Program and Review Guidelines that are available at: http://www.nida.nih.gov/Funding/GrantGuidelines.html. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS- led national activity for setting priority areas. This RFA, Centers for Drug Abuse and AIDS Research Core Grants, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 at http://odphp.osophs.dhhs.gov/pubs/hp2000/. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible to apply, but CDAAR Core Grants may include research projects located at foreign sites. MECHANISM OF SUPPORT The support mechanism for this initiative is the P30 Center Core Grant (see SPECIAL REQUIREMENTS below). 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 3 years. This RFA is a one-time solicitation. The anticipated award date September 29, 2000. The CDAAR Core Grants are intended to bring together investigators currently supported by other sources to enhance and extend the effectiveness of research related to drug abuse and AIDS. The applicant may propose pooling existing core resources of currently funded grantees and request additional support for developing a research infrastructure to be shared by them. This research infrastructure support may include, for example, administrative coordination, subject recruitment, equipment, laboratories, statistical analysis and database management, and similar shared resources. It should be made clear how core center support would enhance the individually funded projects contributions and result in programmatic coherence, synergy, and integration. Applicants must demonstrate the potential for continuation of funding of projects included in the application, and there must be at least 2 years of funding left at the time of submission for each project identified in the application. FUNDS AVAILABLE NIDA intends to commit approximately $3,000,000 in FY 2000 to fund approximately five new grants in response to this RFA. An applicant may request a project period of up to 3 years and a budget for direct costs consistent with the work proposed. Because the nature and scope of the research proposed may vary, it is anticipated that the size of the 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 applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background The relationship between drug abuse and HIV/AIDS has long been recognized. Issues related to HIV natural history and epidemiology, etiology and pathogenesis, and treatment in drug abusers, their sexual partners, and their children have been studied by many researchers from many perspectives. However, often drug abuse issues are not fully integrated into the research design and conceptualization. Where drug abuse concerns are integral to the research, there is often a lack of infrastructure support to efficiently and effectively facilitate the needed studies, as well as provide a multidisciplinary environment that stimulates exceptional creativity and integration of approaches. This RFA attempts to foster the unique environment of a center, which stimulates work of the highest quality and where synergism results in achievements beyond those expected if the projects exist in isolation from one another. Examples of current areas of NIDA-supported drug abuse research that are considered HIV/AIDS-related and may serve as the focus of CDAARs or projects within CDAARS include those listed below, as well as cross cutting areas of relevance, i.e., racial/ethnic factors, underrepresented or minority status, socioeconomic and cultural factors, gender differences, and issues that are unique to women and to men. For example, gender-related research has shown that women"s HIV viral loads are not the same as men"s, raising the issue of whether women may need earlier interventions with anti-viral therapies. Another example may be a field such as genetics in which the rapid development of knowledge as well as technology (e.g., gene chip arrays, quantitative trait locus analysis) may be broadly applicable to a number of research areas. As relevant data emerge from laboratory, community-based, and clinical HIV/AIDS research, investigators are urged to include these and other cross cutting perspectives in their research designs and analyses, where appropriate. More details on these areas of interest and on drug abuse are available at the following website: http://www.nida.nih.gov/NIDAHome1.html Natural History and Epidemiology: International and national studies of the epidemiology and natural history of HIV and associated infectious diseases (e.g., hepatitis, sexually transmitted diseases, tuberculosis) and other co-morbid diseases (e.g., mental disorders) in drug abusing populations, and studies of health seeking behaviors, adherence to treatment regimens, access to treatment, and the organization and management of the delivery of prevention and treatment services to drug abusers at risk for HIV or who are HIV positive. Etiology and Pathogenesis: Studies to define the role of drugs of abuse and related compounds or drug abuse treatment medications on susceptibility, onset, and progression of HIV disease, including studies to identify latent HIV infection and pharmacotherapy-resistant HIV strains in drug abusing populations, and studies to identify and elucidate the interaction between abused drugs and cellular and molecular events (i.e., protein kinase function) which may modulate host defenses against opportunistic infections and other HIV co- morbid conditions. Therapeutics: Research to improve access to health services provided to and long-term therapeutic strategies designed for HIV-infected drug users, their sexual partners, and their children, including studies of adherence, recruitment and retention, service delivery models, evaluation of alternative and complementary therapies, and evaluation of interactions among drugs of abuse, medications used to treat drug abuse, and HIV pharmacotherapies, and studies on recruitment of drug abusers into clinical trials. Vaccines: Research on improving behavioral and/or biomedical methods to deliver HIV and other infectious disease vaccines to adolescent and adult drug-using populations, research to recruit injection and non-injection drug users at high risk of HIV infection into clinical trials of vaccines, including developing specific strategies to study children, adolescents, and adults, and investigation of how drugs of abuse may affect or modulate cofactors for HIV transmission. Those cofactors include, for example, vaginal/cervical epithelium changes during puberty, hormonal changes during pregnancy, and use of contraceptives, hormonal replacement therapy, or steroids. Behavioral and Social Science Research: Research to develop, evaluate, and disseminate prevention strategies to reduce the incidence of drug use-related HIV infection, including high risk drug use-associated sexual behavior (e.g., among adolescents, in perinatal transmission in drug-abusing mothers, and in commercial sex work), and research to inform and improve our understanding of behavior change, the maintenance of behavior change, and risk avoidance and relapse prevention relative to the prevention of drug use-related HIV transmission. Information Dissemination: Research on mass media and other education strategies focused on AIDS and drug abuse in children (ages 8-12), adolescents, adults, racial/ethnic groups, and gender specific groups, and studies of HIV and drug use prevention strategies for community-based organizations, health care service providers, practitioners, and other clinical and public health professionals involved in HIV prevention, risk reduction, and/or drug abuse and HIV/AIDS treatment that targets high risk and hard-to-reach community populations. Research Ethics: Studies of the ethical, legal, and social interactions and resulting issues related to research on HIV/AIDS and drug abuse in diverse settings (i.e., the community, the street setting, or the clinic). Investigators are referred for general topic areas and more background information to the program announcement Research on Ethical Issues in Human Studies (PA-99-079), available at: http://grants.nih.gov/grants/guide/pa-files/PA-99-079.html. International Research Collaboration: Research support for collaborative national and international research with a focus on drug abuse-related links to HIV/AIDS. International collaborative research may involve, for example, any of the above areas (e.g, etiology and pathogenesis, natural history/epidemiology, vaccines, social and behavioral sciences, information dissemination, research ethics). The above areas are provided as examples, but they are not meant to be comprehensive or to imply the absence of potential interest in other areas. Thus, consultation with NIDA staff is encouraged as an early step in the development of CDAAR applications. SPECIAL REQUIREMENTS NIDA has a number of special requirements for its centers, and applicants should carefully read the aforementioned NIDA Research Center Grant Consolidated Program and Review Guidelines, which are available at: http://www.nida.nih.gov/Funding/GrantGuidelines.html. Consistent with this document, CDAAR Core Grants are expected to enable centers that demonstrate the occurrence of consistent, thematically focused, and creative research productivity that emerges from interdependent components of the research program and that would not emerge from the mere collection of those individual components. The three necessary characteristics of NIDA centers-- thematic integration, synergy, and multidisciplinary involvement-- should be present. Although center support is not intended to support direct research activities in P30s, there should be evidence that the support of the core activities enables the implementation of associated research and that this research is innovative and of the highest caliber. Applicants must demonstrate that the CDAAR would serve as a significant national scientific research resource soon after establishment. The CDAAR Core Grant will support core components. Each core component should contribute toward cost-effectiveness and quality control in resource utilization. Data analytic capacities, database facilities, and data resources should be specified as needed. Provisions for shared laboratory resources and the quality of laboratory space should be indicated. Similar information should be provided for clinical facilities. The CDAAR Core Grant must be predicated on the existence of active and sound research projects that will share the resources supported under the grant. NIDA does not specify a minimum number of research projects or cores to include in its centers, but it is required that the proposed configuration clearly demonstrate appropriate and adequate facilities dedicated to the conduct of administrative, shared resource, and research activities. At the time of submission, all research projects participating in the CDAAR Core Grant should have at least 2 years of funding left, with clear plans for continuing or expanding the work. In order to evaluate the application, it should include sufficient detail to document the significance and aims of the studies, as well as describe the involved populations, design and methods, and anticipated uses of core resources. Each CDAAR must have a scientifically and administratively qualified director with responsibility for the scientific, administrative, budgetary, and operational aspects of the CDAAR. The CDAAR director should be a productive (as documented by publications, patents, honors, and similar indices of stature) researcher. The CDAAR director is responsible for overall coordination and for the development of the CDAAR. Because of the role and importance of the CDAAR director to the success of the center, an individual may not serve as director of more than one NIDA research center grant. In addition, it is expected that the CDAAR director will make a substantial commitment of time and effort to the CDAAR. A detailed description of each core unit proposed must be provided with a detailed budget and justification (see APPLICATION PROCEDURES for more details). The description should include a rationale to show how each core will support the research effort and contribute to the characteristics of NIDA centers. Funds for new construction will not be provided. The CDAAR must have appropriate and effective administrative and organizational capabilities to conduct research, to foster synergy, and to plan and evaluate CDAAR activities. There should be clear and convincing evidence of the applicant institution"s commitment to the CDAAR. Administrative and organizational arrangements should promote joint planning and evaluation activities, as well as collaborations and interactions within, among, and between programmatic elements of the CDAAR. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research, produces publications, generates future grant applications, and also takes maximum advantage of the CDAAR"s drug abuse and HIV/AIDS research capability (this is particularly important to explain when there are multiple participating institutions in the CDAAR), (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources, (c) a standing outside advisory structure(s) that is charged to provide appropriate and objective advice and evaluation, as needed, to the center director, (d) internal advisory, decision-making, and priority setting processes appropriately charged to conduct the activities of the center, and (e) appropriate criteria and processes for determining and sustaining individual participation in the center based on productivity, research direction, and overall contribution. Administrative support might also include plans for recruitment, training, and supervision of staff. If a CDAAR applicant wishes to identify a General Clinical Research Center (GCRC) or comparably supported clinical research facility as a source for conducting proposed research, a letter of agreement from the program director or principal investigator of the GCRC or comparably supported clinical research facility should be included in the application material. Support for one 2-day meeting of the CDAAR director with other CDAAR directors should be requested. NIDA anticipates holding one such meeting a year in the Washington, D.C., area. 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 new 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 NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the Federal Register on March 28, 1994 (FR 59 14508- 14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the Web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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 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 www.nida.nih.gov/HSGuide.html or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by March 13, 2000, that includes a descriptive title of the proposed research, the name, address, and telephone number of the Center Director, 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 IC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the Director, Office of Extramural Program Review, as listed under INQUIRIES for review matters, by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES NIDA staff will provide preapplication consultation to all applicants for NIDA CDAAR grants. Telephone conversations and meetings with NIDA staff can provide information that will be useful to ensure that applications are complete and responsive. 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, or they may be downloaded from the Web at http://grants.nih.gov/grants/funding/funding.htm. Applications must be complete in order to be accepted. Applicants are encouraged to organize their application by initially presenting the face page, the abstract page with key personnel, a table of contents, summary budget pages for the entire CDAAR Core Grant, and other documentation pertaining to the entire application. This should be followed by an introductory section of no more than five pages that addresses the ways in which the application meets the essential elements that define a NIDA Center and how the application is consistent with the aims of the CDAAR Core Grant initiative. After that introduction, each core should be presented with its accompanying individual budget, budget justification, biographical sketches, other support information, and planned research activities. For each core component, there is a 25 page limit. Appendix material limits apply to each core component separately, each component"s appendix may include up to 10 publications, manuscripts, abstracts, patents, or other printed material directly related to the project. Surveys, questionnaires, data collection instruments, and clinical protocols may also be submitted in the appendix. Original glossy photographs or color images may be included, provided that a photocopy (that may be reduced in size) is included within the 25 pages of the research plan. Applications exceeding page limits, font limits, or appendix limits will be returned to the applicant without review. Appendices should not be placed within the body of the application but should be bundled separately, component by component. 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 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: 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 Program Review 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 Review (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 Center for Scientific Review 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 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 National Advisory Council on Drug Abuse. 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. Review Criteria for Overall Center Application o Significance and relevance of the proposed program to the mission of NIDA research. Potential of this program to become a national resource. o Potential of the program to foster communication, interaction, innovation, and high-quality research so that it will be a thematic integrated, synergistic, stimulating, and multidisciplinary program. Ability of the program to attract both established and promising new investigators. o Scope, breadth, and overall quality of the center"s program, the core units, and the research projects and the ability to coordinate the research projects and core units. o Participation of a suitable number of responsible and experienced investigators. o Leadership ability and scientific stature of the Center Director, his/her ability to meet the program"s demands of time and effort, and his/her ability to promote the center mission among participants. o Presence of structure(s) presenting a clear line of authority for effective decision-making process. Adequacy of oversight structures. o Academic and physical environment as it bears on research subjects, space, and equipment, as well as on the potential for interaction with scientists from other departments and institutions. o Arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among the investigators in the program. o Presence of an administrative and organizational structure conducive to attaining the objective of the proposed program. o Institutional commitment to the requirements of the program. o 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 also will 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, animals, and/or the environment to the extent they may be adversely affected by the activities proposed in the application. Review Criteria for Cores o Technical merit and justification of each core unit. Likelihood of the cores to successfully attain the proposed objectives. o Evidence of cost-effectiveness and documentation of quality control of core units. o Evidence of sound data collection, analysis, management, and transfer. o The extent to which core units contribute to greater cooperation among center investigators. o The scientific appropriateness of the research project’s use of core services. o Qualifications, experience, and commitment to the center mission of the investigators responsible for the core unit and their ability to devote the required time and effort to the program. o Appropriateness of the budget request for the core unit, including consideration of overall administrative costs. o As appropriate, the adequacy of the means proposed for protecting against risks to human subjects, animals, and/or the environment. o As appropriate, the adequacy of representation of both genders, minorities and their subgroups, and children in study populations. Review Criteria for Research Projects In general, NIH- and National Science Foundation (NSF) funded research projects will not be reviewed for scientific and technical merit since they have been peer-reviewed before they are funded. All other funded projects will be reviewed for scientific and technical merit using the following criteria: 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? Approach: Are the conceptual framework, design (including composition of study population), 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? Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigators: Is the principal 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)? DO NOT INCLUDE descriptive biographical information unless important to the evaluation of merit. 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? DO NOT INCLUDE description of available facilities or equipment unless important to the evaluation of merit. In addition to the above criteria, in accordance with NIH policy, projects will be reviewed with respect to 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. Schedule Letter of Intent Receipt Date: March 13, 2000 Application Receipt Date: April 12, 2000 Peer Review Date: Summer 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 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 encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sander G. Genser, M.D., M.P.H. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone : (301) 443-1801 FAX : (301) 594-6566 E-mail: SG73F@NIH.GOV 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) 594-6847 E-mail: gf6s@nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Director Office of Extramural Program Review 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 the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and are administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (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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