PAS-00-058: SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS

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SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS Release Date: February 10, 2000 PA Number: PAS-00-058 National Institute on Drug Abuse THIS PROGRAM ANNOUNCEMENT (PA) 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 PA. PURPOSE The National Institute on Drug Abuse (NIDA) announces the availability of funds to supplement existing federal research project grants for the study of issues related to drug abuse and HIV/AIDS. Funding will be available through competing supplements. HEALTH PEOPLE 2010 The Public Health Services (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS led national activity for setting priority areas. This Program Announcement (PA), Supplements for the Study of Drug Abuse And HIV/AIDS, is related to one or more of the priority areas. Potential applicants may obtain a copy of Healthy People 2010, at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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 PA will supplement the National Institutes of Health (NIH) research project grant (R01) award mechanism only. 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 five years or the life of the parent grant (i.e., the grant being supplemented), whichever is less. FUNDS AVAILABLE NIDA will set aside $500,000 total cost for this program for FY 2000. RESEARCH OBJECTIVES Background The HIV/AIDS epidemic has demonstrated an increasing association with drug abuse, through transmission of HIV by contaminated drug injection equipment, high-risk sexual behavior with an infected drug user, and perinatal exposure of newborns from infected drug-abusing mothers. With this Supplement Announcement, NIDA plans to continue to develop a strong multidisciplinary research program in response to the complex challenges of drug abuse and HIV/AIDS. The Supplement Program is designed to encourage and enhance interactive, multidisciplinary collaborative projects involving researchers with primary foci both within and outside the area of drug abuse. Areas of Interest In an effort to improve and expand its research on drug abuse-related aspects of HIV/AIDS, NIDA will consider requests from current NIDA grantees and those with grants from other NIH components to expand and/or enhance ongoing research that includes drug use-related HIV/AIDS issues. The primary intent of this Program is to encourage grantees who have not focused on drug use- related HIV/AIDS issues to do so, thus recognizing that drug abuse/dependence and HIV/AIDS are two diseases that often co-occur and interact and that they must be prevented and treated together and in parallel. Projects that currently focus solely on either AIDS-related or drug abuse issues are encouraged to strengthen efforts in the complementary area. Thus, grantees are encouraged to examine for HIV/AIDS relevance ongoing drug abuse research projects that may not have been designed to examine AIDS-related issues. Similarly, those doing AIDS research, but who have not investigated how drugs of abuse may act within their area of investigation, are encouraged to think about these issues and consider submitting an application. Current areas of NIDA supported drug use research that are considered HIV/AIDS related include those listed below, as well as crosscutting 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 crosscutting perspectives in their research designs and analyses, where appropriate. Natural History and Epidemiology o International and/or national studies of the epidemiology and natural history of infectious diseases commonly transmitted by drug injection and/or sexual behavior and/or other behaviors associated with drug use (e.g., hepatitis A, B and C, Sexual Transmitted Diseases (STDs), Tuberculosis, and HIV). o Studies of interactions among chronic drug use and the treatment of HIV and comorbid mental disorders and other infectious diseases, including studies of health seeking behaviors. o Studies of the incidence and prevalence of HIV infection and AIDS, including monitoring the trends in HIV infection and AIDS-related diseases among specific subpopulations such as adolescents, women, minorities, and sexual partners and newborns/children of drug abusers. o Research on the natural history of HIV/AIDS, including the natural history of the dynamics of HIV and other blood-borne infectious disease transmission in sexual and drug-using risk networks. o Research on the transmission, incidence, prevalence, and natural history of pharmacotherapy-resistant HIV/AIDS in drug-using populations. o Research on the nature and extent of HIV risk behaviors and factors that affect the propagation of HIV and other diseases in at-risk populations. o Research to develop improved study protocols, research designs, interview and measurement instruments, and biostatistical techniques to detect, measure, and characterize HIV risk behaviors (drug use and unsafe sexual practices) in adolescent and adult populations. o Studies of the nature, extent, and progression of drug use and abuse, which include assessment of knowledge and attitudes regarding HIV/AIDS and/or the incidence, prevalence, and nature of drug-related HIV risk behaviors. Etiology and Pathogenesis o Studies to define interactions between drugs of abuse and the operation of secondary messenger pathways effecting lymphocyte or monocyte function. o 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. o Research on the pharmacokinetics and pharmacodynamics of drugs of abuse as factors with an impact on susceptibility, onset, progression, and treatment of HIV disease. o Studies to further develop and utilize experimental models to study the effects of drugs of abuse on the pathogenesis of central nervous system lentivirus infections. o Studies to investigate the role of drugs of abuse and related endogenous substances and other biological and environmental factors in modulating HIV- induced neuroAIDS. o Studies to identify and elucidate the role of drug abuse on immune susceptibility and the development and progression of AIDS-related opportunistic infections, e.g., smoking drugs of abuse and bacterial pneumonias. o Studies of nutritional, metabolic, endocrine, and gastrointestinal disorders and their underlying pathophysiology in HIV-infected drug abusers. o Research on adulterants/contaminants of drugs of abuse and their roles in the etiology, pathogenesis, and natural history of HIV/AIDS and associated illness in drug abusers. o Studies of the role of patterns of drug abuse in HIV/AIDS progression among women, e.g., in perinatal transmission of HIV and the effects on the fetal and neonate nervous system, immune system, and placenta. o Studies of the effects of drugs of abuse and drug treatment medications on immune function that may increase our knowledge of the immune dysfunction characteristic of HIV infection. o Studies of how drugs of abuse may modulate the immune system through the hypothalamic-pituitary axis and other parts of the central nervous system. o Basic and clinical research on neurobiologic, neurologic, neuropsychological, and psychiatric consequences of drug abuse that have relevance for understanding the natural history of HIV/AIDS-related dementia in drug users. o Studies of dual function receptor systems, e.g., opioid, with activation receptors of immune cells and subsequent induction of immune cell responses, including cytokine responses and other host factors. Therapeutics o 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: a. Strategies to improve adherence with HIV medication regimens (e.g., simultaneous or co-located drug abuse and HIV treatment), b. Recruitment and retention of HIV-infected drug users into drug abuse and HIV/AIDS treatment, c. Delivery of linked medical and drug abuse prevention and treatment services through drug abuse treatment programs and/or other preventive and health services delivery programs (e.g., mobile van services), and d. Strategies to improve the methods in and adherence to disease prevention, detection, and treatment programs (e.g., tuberculosis, hepatitis B and C, STDs, and other infectious diseases). o Evaluation of the safety, efficacy, and acceptability of new agents and approaches, including alternative and complementary therapies (e.g., chemopreventive treatment with micro- and macronutrients such as vitamins and trace elements), in the treatment of wasting syndrome, growth failure, and other complications of HIV infection in drug users. o Research that investigates interactions between approved and investigational medications for drug addiction and HIV pharmacotherapies. o Research on the development, dynamics, prevention, and treatment of pharmacotherapy-resistant HIV strains in drug abusing populations. o Research to test the feasibility of enhancing recruitment of HIV-infected drug users, their sexual partners, and infants into HIV/AIDS-therapeutics clinical trials, including very hard-to-reach risk groups and underrepresented racial and ethnic minority subpopulations. Vaccines o Research on improving behavioral and/or biomedical methods to deliver HIV and other infectious disease vaccines to adolescent and adult drug using populations. o 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. o 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. o Studies of the genital tract immune system and inflammatory activity that might compromise integrity of the genital tract or inductive ability of vaccines. Studies of drugs of abuse and genital mucosal inflammation induced by drug use behaviors, which facilitate HIV transmission in injection and non-injection drug users. o In collaboration with institutions and communities being targeted, explore behavioral and social issues and prevention activities that might have a substantial impact on the design or conduct of a trial, including: a. Evaluation of other biomedical and behavioral interventions that could prove of benefit in decreasing the incidence of HIV infection in the populations identified for future vaccine efficacy trials and assessment of their potential impact on the evaluation of vaccine efficacy, b. Conduct of behavioral research in populations at high risk for HIV infection to determine, for example, appropriate risk-reduction interventions and to estimate risk behavior and recruitment, adherence, and retention strategies pertinent to the design and execution of a successful efficacy trial, especially for populations that have been historically underrepresented in clinical trials, c. Determination of possible adverse social, economic, behavioral, or legal consequences of participation in clinical trials and development of broadly applicable strategies for mitigating potential harm, d. Determination of optimal methods of achieving informed consent for vaccine efficacy trials, and e. Evaluation of ethical issues and challenges, and the behaviors and conduct of health care workers, peer counselors, outreach workers, and prevention scientists in performing drug use and HIV-related studies. Behavioral and Social Sciences Research o 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 behaviors (e.g., among adolescents, in perinatal transmission in drug-abusing mothers, and in commercial sex work). Such research may include, but is not limited to: a. Community-based behavioral and social intervention studies to stop or reduce the reuse and sharing of needles and unsafe sexual behaviors among injection drug users, crack cocaine users, and methamphetamine users and their sexual partners, b. Behavioral studies on multicomponent prevention and intervention strategies, such as improving compliance with barrier methods, vaccine regimens, and HIV therapeutics, c. Studies to develop and enhance prevention of HIV among high risk adolescents and youth, including ethnographic and epidemiologic studies of runaways and street children at risk for initiating drug use and injecting drug use and/or for exchanging sex for money, drugs, or subsistence, and d. Development of new or improved HIV-risk and drug-use risk screening questionnaires that are developmentally appropriate for use with specific target populations in diverse settings (e.g., among street youth and adolescents, in communities of older adults, and among ethnic and cultural subgroups) and that serve as valid and reliable predictors of immediate and future exposure to HIV and other infectious diseases where preventive interventions do not occur. o Studies of the determinants and correlates of HIV risk behaviors and risk behavior change among adolescents who have initiated or recently transitioned to injecting drug use and who engage in unsafe sex in association with their drug use. o Studies of simultaneous and serial treatment interventions for drug dependence and comorbid conditions that meet the following criteria: a. Determines the efficacy or effectiveness of psychosocial and/or pharmacological treatment interventions for drug dependence and have a high probability of leading to reductions in transmission of infectious diseases associated with drug use, e.g., HIV, viral hepatitis, and other medical consequences of drug use and addiction (e.g., pneumonitis, osteomyelitis, cutaneous abscesses and cellulitis, hypertension, bacterial endocarditis, and diabetes mellitus), b. Reduces the risks of acquiring or transmitting HIV and other blood-borne infections among drug users who are in or out of drug treatment and at risk for HIV or HIV seropositive, c. Includes the assessment of drug use injection and non-injection practices and/or sexual AIDS risk, d. Evaluates HIV risk reduction counseling being provided either (1) during the course of the study or (2) as part of the intervention under study. o Studies of the impact of HIV/AIDS on the drug abuse treatment delivery system and on the HIV/AIDS services provided within drug treatment programs, including those provided under managed care. o Studies of the cost, cost-benefit, and cost-effectiveness of interventions to reduce HIV risk behaviors and prevent the transmission of HIV and other blood-borne infections. o Studies of the organization and management of services for HIV-positive drug abusers, including studies of the barriers to service access and utilization and strategies for overcoming them. o Studies of the organization and management of drug use and medical services provided by mobile care systems (e.g., vans) as a method for improving the effectiveness of community-based outreach, prevention, and health care access. o Research to enhance the effectiveness of other community-based HIV prevention interventions, such as studies to enhance entry and retention of new initiates to injecting drug use, persons at risk of transitioning to injecting drug use, and high-risk non-injecting drug users into drug abuse treatment and prevention programs. o 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 o 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. o 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 o 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 in 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). International Research Collaboration o 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). 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 sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1983 (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, that were published in the Federal Register on March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: 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 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. 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 Contract, March 6, 1998, and is available at the following website: http://grants.nih.gov/grants/guide/notice-files/not98-024.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 before submitting an application that will administer compounds to human subjects. The guidelines are available on the NIDA Home Page at http://www.nida.nih.gov/, or may be obtained by calling 301-443-2755. 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, clinics, 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 include injection drug users, crack cocaine users, and sexually active drug users and their sexual partners. SPECIAL REQUIREMENTS Budget/Administrative Issues NIDA will set aside $500,000 total costs into this program for FY 2000. Applicants should request only what is necessary to do the proposed work and should request no more than $100,000 in direct costs. Competing supplements are provided for expansion of a project"s scope or the research protocol. Supplements are treated as new applications for purposes of the review requirements and competition for funds and are reviewed in accordance with NIH standard procedures, i.e., peer review/council review. Competing supplement requests should be submitted to the Center for Scientific Review on the standard AIDS receipt date of May 1, 2000. Applications submitted for the other NIH AIDS application receipt dates will not be considered for these funds and will compete for funds with other unsolicited applications. Supplements may not exceed the stated life of the parent project. Parent grants that would require or be in the status of no-additional-cost extension during the supplement period will not be eligible for supplementation. Supplements may not represent changes in the basic goals or intent of the project. AIDS-related competing supplement requests to either non-AIDS or AIDS-related grants will receive expedited review, according to Section 301 of the Public Health Service Act (42 USC241). APPLICATION PROCEDURES Supplement applications are to be submitted in the grant application form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, E-mail: GrantsInfo@nih.gov. The kit contains detailed instructions on page limits, appendix material, and other matters related to preparation and submission of the application. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Applications will use the modular grant format, requesting direct costs in $25,000 modules, up to a total direct cost request of $100,000 per year. 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 (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total 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 http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total Direct Costs requested for each year. This is not a Form page. Under Personnel, list key project personnel, including their names, percent of effort, and role in the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role in the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the Form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, 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. Submit a signed typewritten original of the application, including the Checklist, and five signed photocopies 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) As noted, to be eligible for consideration for these FY 2000 supplement funds, competing supplement applications must be received by May 1, 2000. REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. 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. 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 the study on the concept or methods that drive this field? 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? Innovation: Does the project employ novel concept, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: - The adequacy of plans to include 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. - The reasonableness of the proposed budget and duration in relation to the proposed research. - The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely effected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries concerning this notice are encouraged. The opportunity to clarify any 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, Rm. 5198, MSC 9593 Bethesda, MD 20892-9593 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-1801 FAX: (301) 594-6566 Email: sg73f@nih.gov Direct fiscal inquiries to: Gary Fleming, J.D. Chief, Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Rm. 3131, MSC 9541 Bethesda, MD 20892-9541 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6710 FAX: (301) 594-6849 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 the Public Health Service Act, as amended by Sections 301 and 405 (42 USC 241 and 284) and are administered under NIH 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 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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