EXPIRED
DRUG ABUSE DISSERTATION RESEARCH: EPIDEMIOLOGY, PREVENTION, TREATMENT, SERVICES, AND WOMEN AND GENDER DIFFERENCES RELEASE DATE: February 5, 2002 PA NUMBER: PA-02-055 (This PA has been reissued, see PAR-05-083) (See change NOT-DA-03-002) EXPIRATION DATE: February 1, 2005 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to send Inquiries o Submitting an Application o Special Requirements o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces in its entirety PA-98-109, Drug Abuse Treatment and Services Dissertation Research, published in the NIH Guide September 24, 1998 at: http://www.nih.gov/grants/guide/pa-files/PA-98-109.html. The National Institute on Drug Abuse (NIDA) announces the availability of small grants (R03) to support drug abuse doctoral dissertation research in epidemiology, prevention, treatment, services and women and gender differences where there is a significant need for new investigators. Grant support is designed to aid the research of new investigators and to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to NIDA. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research. Women and Gender Differences Historically, in drug abuse research, as in other fields of public health research, the research subjects have been almost exclusively male. Accumulating drug abuse research, however, suggests that the antecedents, consequences, and mechanisms of drug abuse and addiction are not identical in males and females and that gender may be an important variable in maximizing treatment and prevention outcomes. Thus, through this dissertation award program, NIDA seeks to foster research on females and gender differences in all areas of drug abuse research. From basic cellular and genetics research to epidemology, prevention, treatment, and services research, investigators are encouraged to explore the possible importance of gender differences in their chosen area of study or to explore drug abuse issues specific to women. Special Program Considerations for Recruiting Minority Researchers The primary objective of this PA is to prepare qualified individuals for careers that can significantly impact the Nation's drug abuse research agenda. Within the framework of this program's commitment to excellence in research and projected need for investigators in drug abuse research, special attention will be given to recruiting individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. RESEARCH OBJECTIVES NIDA supports more than 85 percent of the world's research on the health aspects of drug abuse and addiction. Research supported by NIDA encompasses basic, behavioral, and applied sciences related to the underlying mechanisms and health effects of drugs of abuse. This grant initiative is to provide students with grant-in-aid to perform drug abuse dissertation research on a topic related to the study of epidemiology, prevention, treatment, services, and women and gender differences, and thereby increase the pool of highly talented drug abuse scientists. The descriptions below are examples of the research foci of this grant program and are provided to guide potential applicants to determine whether a given scientific topic may be appropriate for this initiative. These descriptions are not intended to be comprehensive. In addition, given the complexity of drug abuse research, it is permitted to conduct the proposed dissertation research in conjunction with an ongoing research study or to use extant data. Questions on the relevance of a particular research topic to NIDA's scientific mission and other questions about this PA should be addressed to the program contact listed under INQUIRIES. Potential applicants are strongly encouraged to discuss their application with the appropriate program contact. Epidemiology: Studies of multiple factors that influence drug use outcomes. That is, studies that examine genetic, neurological, biomedical, familial, environmental, social, cultural, developmental psychopathological, psychological, their interactions, and mediating characteristics. Studies of the underlying psychosocial mechanisms associated with the transition from lower to higher levels of drug involvement and from higher levels of drug involvement to dependence and addiction. Development and improvement of techniques for studying drug abuse, including enhancements in measurement, development of improved sampling procedures, and refinement of analytic methods. Development of innovative approaches to identify both physical (ecological) and social environmental/contextual characteristics of local communities that influence drug use, emerging drug use patterns, and adverse drug-related outcomes. Delineation of the underlying dynamic causal mechanisms associated with drug use patterns and adverse drug-related outcomes by integrating individual and community level factors. Studies of emerging trends (e.g., club drugs), including studies that relate these trends to influences such as changes in social attitudes, new drugs of abuse, new patterns of social interaction, new technologies, new drug trafficking patterns, and similar macro-level changes. Research on drug use and drug-related consequences among ethnic/racial minority groups and other underserved populations. This includes studies that uncover the basis for racial/ethnic disparities in drug use and social, behavioral, and health outcomes related to drug use. Research to assess the impact of mental health interventions in childhood on subsequent drug abuse. Studies to assess the nature, scope, and consequences of drug-related crime including violent and nonviolent crime. Research to assess the impact of drug use on adverse behavioral, social, and health consequences (e.g., violence, educational attainment, HIV) as well as the role of adverse consequences on further drug involvement. Prevention: Studies to test the efficacy and effectiveness of drug prevention interventions for children with early psychiatric and behavioral disorders. Studies on the efficacy of interventions for high-risk youth designed to prevent both the initiation and progression of drug use and early sexual risk behaviors that could lead to exposure to HIV infection and AIDS. Studies that examine organizational, management, and delivery factors related to the effective and efficient provision of prevention services. Research on the efficacy of selective and indicated prevention interventions for adolescents and young adults at serious risk for increasing levels of drug abuse, dependence, and addiction. Studies to examine the use of media and other new technologies in drug prevention interventions among all populations. Studies to test the efficacy and effectiveness of new and innovative theory-based prevention approaches. Research to identify and assess the processes through which components of research-based intervention strategies and programs account for effectiveness. Studies that develop new methodologies appropriate for studying these complex aspects of prevention science. Treatment: Research on the development and/or testing of behavioral therapies for various populations of drug-addicted individuals, including but not limited to special populations and populations with comorbid mental disorders. Research integrating behavioral therapies with pharmacotherapies to maximize efficacy. Research using secondary analyses of existing behavioral treatment research data sets. Research on psychometric analysis and instrument development for the clinical assessment of drug abuse and HIV risk. Research on a behavioral treatment intervention aimed at testing a principle of behavior change. Services: Studies to assess the impact of organizational factors on access to, use of, quality or outcomes of prevention and treatment services. Research to measure the effectiveness, cost-effectiveness, and cost- benefits of drug abuse prevention and treatment. Drug abuse service delivery systems and models, such as continuity of care, or service linkage and integration models. Studies that advance the adoption and implementation of drug abuse prevention and treatment interventions into the service delivery system. Drug abuse treatment services for HIV seropositive patients and for those at risk of infection. Studies focusing on management strategies (e.g., work team models, quality management) aimed at improving the adaptation and adoption of emerging or underutilized proven service delivery technologies. Women and Gender Differences: Gender differences in the basic behavioral, biological, and genetic mechanisms underlying drug abuse and addiction; and laboratory (both human and animal), clinical, and epidemiological studies of gender differences in the determinants of initiation, progression, and maintenance of drug use and addiction. Laboratory (both human and animal), field, and clinical research aimed at: (1) identifying gender differences in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining drug-related consequences that are unique to females. The application of gender-specific theories and empirical research on the origins, pathways, and risk and protective factors related to drug use, progression/transition, and maintenance, to the design, development, and testing of gender-sensitive prevention strategies and interventions to determine effectiveness and efficacy. The development and testing of theoretically-based drug treatment approaches (including behavioral treatment and pharmacotherapies) that address gender-specific issues and the examination of gender-specific issues related to the effective and efficient delivery of drug abuse treatment services. Develop and evaluate gender-specific interventions directed at preventing HIV infection and treating HIV/AIDS among drug using populations. For additional details about other areas of research supported by NIDA, please refer to the program announcements found at http://www.nida.nih.gov/ResFundslist.html. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) R03 award mechanism. 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 PA may not exceed two years. Grants to support dissertation research will provide no more than $50,000 in direct costs per year; they are awarded for up to two years and may be extended without additional funds for up to 12 months. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. ELIGIBILE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign The applicant institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The applicant for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must propose to conduct research in one of the areas specified in this Program Announcement. The applicant must be a registered doctoral student in good standing. Information on the student's academic standing as well as a commitment from the school to implement the study as proposed must be included in the application. The letter regarding the latter should be from the student's advisor and cosigned by the department chair, dean or program director. These awards support research training applied toward preparation of a dissertation and do not support study leading to the M.D., D.O., or D.D.S., or similar professional degrees unless they are part of a combined degree program (for the latter see: Individual Pre-doctoral National Research Award for M.D./Ph.D. Fellowships - PAR-96-003, which may be obtained from: http://grants.nih.gov/grants/guide/pa-files/PA-99-089.html). The doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of an Alien Registration Receipt Card) at the time of application. An applicant who receives support for dissertation research under a grant from NIDA may not hold concurrently another federally sponsored fellowship or similar Federal award, such as a National Research Service Award (NRSA) that provides a stipend or otherwise duplicates provisions of this grant program. A NIDA dissertation grant recipient may, however, accept concurrent educational remuneration from the Department of Veterans Affairs (VA) and loans from Federal funds. Receipt of non-Federal funds during the grant period is also allowable if it is in accordance with the sponsoring institution's policy and does not detract from or prolong the approved doctoral training program. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: William J. Bukoski, Ph.D. Office of the Director Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 402-1526 FAX: (301) 443-2636 E-mail: [email protected] o Direct inquiries regarding drug treatment to: Melissa Racioppo, Ph.D. Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4230, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-2261 E-mail: [email protected] o Direct inquiries regarding research on women and gender differences to: Cora Lee Wetherington, Ph.D. Women & Gender Research Coordinator 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: [email protected] o Direct your questions about financial or grants management 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 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIAL REQUIREMENTS Allowable Costs Expenses usually allowed under PHS research grants will be covered by the NIDA dissertation research grant, but may not exceed $50,000 per year in direct costs. An application that requests more than $50,000 per year in direct costs will be returned to the applicant. Allowable costs include the investigator's salary (not to exceed $18,156 for 12 months full-time effort). In developing the modular budget, applicants may also include costs for research assistants' salaries, and direct research project expenses, such as data processing, payments to subjects, supplies, and dissertation costs (e.g., printing and binding of the dissertation). No tuition, alteration/renovations, contracting costs, or space rental are allowed on dissertation research grants. Indirect costs are limited to eight percent of requested direct costs, less equipment. Level of Effort Any level of effort by the investigator that is less than full time (40 hours per week) must be fully justified, and the investigator's salary must be prorated accordingly. Letter of Certification A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must: (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIDA support; and (d) briefly describe the facilities and resources for the project and certify that they are adequate to conduct the proposed research. Official Transcript A copy of an official transcript of the applicant's graduate school record should be included with the application. Statement of Career Goals Applicants must provide a statement of career goals, including reference to their interest in the specific areas of research designated in this program announcement and a description of their intended career trajectory. This information will be used by NIDA program staff to determine how the proposed study addresses program priorities. Biographical Sketch of the Mentor A four page biographical sketch of the mentor, normally the dissertation director, should be sent. This should be on the biographical sketch form found in the form PHS 398. The applicant should also include material on the mentor's previous, and active related research support. Narrative of the Proposed Research Plan The applicant must provide a narrative project description (not to exceed 10 pages in sections a-d of the Research Plan) that contains a detailed scientific and technical discussion of the following specific points: a. A description of the research project and what it is intended to be accomplished. b. A summary of related published research that addresses the identified problem(s). c. The questions to be answered or the hypotheses to be tested by the project. d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be used, and steps that will be taken to protect human subjects. e. The management of the project including a schedule of the main steps of the proposed investigation. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches, or methods? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. 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 http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. 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 PA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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