This Program Announcement expires on December 15, 2003, unless reissued. DRUG ABUSE ASPECTS OF HIV/AIDS AND OTHER INFECTIONS Release Date: November 30, 2000 PA NUMBER: PA-01-023 National Institute on Drug Abuse (http://www.nida.nih.gov) 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) supports research on the natural history, epidemiology, etiology, pathogenesis, prevention, and treatment of drug abuse and drug abuse aspects of HIV/AIDS and other infectious agents [e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), other sexually transmitted diseases (STDs), and tuberculosis (TB)]. AIDS was first recognized as a growing epidemic among men who have sex with men (MSM) and injection drug users (IDUs) and their sexual partners in the early 1980s. While considerable scientific progress has been made since then in understanding, preventing, and treating the intertwined epidemics of drug abuse and HIV/AIDS, much remains unknown or poorly understood today. Emerging drugs of abuse, such as the club drugs ecstasy, GHB, ketamine, and methamphetamine, as well as more potent supplies of heroin, cocaine, and marijuana, are rapidly changing the profiles of populations at risk. In the United States, over 48,000 women have been diagnosed with AIDS attributed to injection drug use, and more than a third of AIDS cases in adult/adolescent women diagnosed from July 1998 through June 1999 reported injection drug use as their risk exposure. Racial and ethnic minority populations of both genders have been deeply affected by drug abuse, HIV/AIDS, and other infectious diseases in recent years, with new HIV infections continuing at an alarming rate in the U.S. and in other nations. This PA seeks to stimulate a range of investigator-initiated studies to advance the scientific knowledge base on drug abuse aspects of HIV/AIDS and other serious infections. Researchers are invited to address diverse and cross-cutting issues in multiple disciplines, including virology, etiology, therapeutics and vaccines, ethnography and epidemiology, and the behavioral and social sciences. HEALTHY 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 PA, "Drug Abuse Aspects of HIV/AIDS and Other Infections," is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project (R01), small grant (R03), and exploratory/developmental (R21) award mechanisms. 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 for the R01, two years for the R03, and three years for the R21. RESEARCH OBJECTIVES Background and Significance In the early 1980s, HIV and AIDS were first identified in the U.S. among MSM, IDUs, and the sexual partners of IDUs. It later became clear that the same risk behaviors for HIV (i.e., injecting drug use and unprotected sex) are associated with other blood-borne and sexually transmitted infections, such as HBV and HCV, and with the spread of TB. Sharing syringes and other equipment for drug injection is a primary route of HIV transmission, yet injection drug use contributes to the spread of HIV/AIDS beyond the circle of those who inject, e.g., to persons who have sex with an IDU and to children born to HIV-infected mothers who acquired the infection from sharing needles or having sex with an infected IDU. IDU-associated AIDS accounts for a larger proportion of cases among women than among men. Since the epidemic began, 59% of all AIDS cases among women have been attributed to injection drug use or sex with partners who inject drugs, compared with 31% of cases among men. Racial and ethnic minority populations in the U.S. have experienced a disproportionate burden of HIV/AIDS cases, most profoundly from IDU-associated AIDS. In 1998, IDUs accounted for 36% of all AIDS cases among both African American and Hispanic adults and adolescents, compared with 22% of all cases among White adults/adolescents. Since the start of the epidemic, injection drug use has directly or indirectly accounted for more than 36% of the AIDS cases in the U.S., and the trend continues today. The Centers for Disease Control and Prevention (CDC) reports that 15,024 (31%) of the 48,269 new cases of AIDS in the U.S. in 1998 were associated with injection drug use. IDUs also have one of the highest HBV seroincidence rates compared to other risk groups, and at least 60% of incident HCV cases are among IDUs. Acquisition of HBV and HCV can occur rapidly following initiation of injection, with reported prevalence rates of 50% for HBV and 65% for HCV among persons injecting for less than one year. Co-infections of HBV, HCV, and HIV often cluster in IDUs and are endemic among experienced IDUs. IDUs are at very high risk for pneumonia, septic pulmonary emboli, and TB. In 1998, for example, CDC estimated that 50% of HIV-infected persons with TB had injection drug use as an HIV exposure. Other infectious diseases pose major risks to IDUs, including Human T- Lymphotropic Viruses (HTLV) and hepatitis D virus (HDV). Combined HBV and HDV infection is associated with hepatitis outbreaks and high mortality among IDUs. IDUs are at risk for other serious health complications, such as rhabdomyolysis and delirium, as well as a variety of bacteremic infections, including endocarditis, skin/soft tissue infection, mycotic aneurysm, septic arthritis, septic thrombophlebitis, respiratory infections, and osteomyelitis. Risks for these infections are particularly high among IDUs exposed to infected blood from multiperson use of syringes and other injecting equipment. Noninjecting drug use, particularly the use of crack cocaine, is another major transmission risk for HIV and other infectious diseases. Research has shown that crack smokers may be three or more times more likely to be infected with HIV than non-smokers. The context of risk, including crack use and drug-for-sex exchanges or risky, unprotected sex with multiple partners, is significantly associated with the rapid spread of HIV through drug and sex networks. Age-discrepant relations also have implications for HIV transmission, young women and adolescents who use crack and other drugs are at high risk for HIV infection at an early age, especially when they use drugs and have sex with older, HIV-infected partners. Largely because of substantial gains in early diagnosis and therapeutic care, there are now more people living with HIV in the U.S. than ever before. Moreover, today’s HIV prevention programs have benefited considerably from the empirical knowledge accrued over more than 15 years of NIDA-supported research on preventing the spread of HIV and other infections among drug users. While the number of new HIV infections in the U.S. has declined significantly from the 150,000 a year in the late 1980s, there are still an estimated 40,000 new infections every year. In addition, the CDC estimates that, of the 900,000 people currently living with HIV in the U.S., up to a third are unaware that they have the infection. Today, the profile of the individual at risk in the U.S. is largely urban and involves multiple and simultaneous risk-taking behaviors, including injecting and noninjecting drug use (particularly use of crack cocaine), unprotected sex with multiple partners, and exchange of sex for drugs or money. The intertwined epidemics of drug abuse, HIV/AIDS, and other infectious diseases have evolved over time. HBV and HCV have become more prevalent in injecting and noninjecting drug-using populations, as have drug-resistant strains of gonorrhea and TB. HCV is now considered an opportunistic infection in HIV-positive persons, according to the U.S. Public Health Service (1999). An estimated 80% of HIV-infected persons in the U.S. today are co-infected with HCV. Although no vaccine is available for HIV or HCV, epidemiological data on the HBV vaccine indicate that successful immunization of injecting and noninjecting drug users is possible. Multidisciplinary, biomedical, and behavioral research is critically needed today to address the public health challenges of these intertwined, drug use-associated epidemics in all ethnic and racial groups, adolescents and young adults, and persons of all sexual orientations. Areas of Interest NIDA seeks multi-disciplinary, cross-cultural research studies on drug abuse aspects of HIV/AIDS, other blood-borne and sexually transmitted infections, and TB. Included are studies that inform our understanding of the causes and consequences of differentials in HIV-associated risks, morbidity, and mortality in men and women, adolescents and adults, and in majority and minority populations. Researchers are encouraged to utilize and integrate complementary methodological approaches in their study designs, including epidemiology, ethnography, behavioral and prevention science, virology, and clinical medicine. This PA envisions a range of national and international research projects within and across the priority areas for NIH research on HIV/AIDS (http://www.nih.gov/od/oar/index.htm), including but not limited to the types of studies and issues described below. Natural History and Epidemiology o Studies of the epidemiology and natural history of HIV and blood-borne infections, STDs, and TB in injecting and noninjecting drug users and their sexual partners, including studies of women, racial and ethnic minorities, specific subpopulations (e.g., adolescents and young adults, runaways, street youth, men who have sex with men and use drugs), and the risk, peer, and social networks of drug users and their sexual partners. Studies are encouraged to understand potential cofactors and mediators of these diseases, their progression, and their outcomes in active drug users. o Studies of new and improved approaches to access and recruit hard-to- reach, active drug users to participate in biomedical and behavioral interventions to reduce drug use-related risk behaviors, disease transmission, comorbidity, and mortality. Researchers are encouraged to develop new strategies to link community-based outreach to drug users with referrals and access to services for HIV counseling and testing, diagnostic screening for other diseases, drug treatment, and medical care. o Research involving the development and evaluation of (a) new study protocols, sampling and survey methods, and biostatistical techniques, and (b) rapid diagnostic assays to measure and monitor drug abuse and sex-related risk behaviors, seroincidence and seroprevalence rates for HIV, HBV, HCV, other blood-borne and sexually transmitted infections, and TB, and disease progression and outcomes. Etiology and Pathogenesis o Studies of viral and host mechanisms involved in the transmission, establishment, and spread of HIV in IDUs, noninjecting drug users, and their sexual partners, including research on the mechanisms by which viral hepatitis, STDs, and other infections may influence HIV transmission in drug users. Research is encouraged to identify the etiologic and interactive biologic, behavioral, environmental, sociocultural, and gender-related factors that determine the relative transmission efficiency of HIV and other diseases in diverse populations of drug users and others at risk. o Studies that define the role of drugs of abuse and related compounds (including adulterants and contaminants of drugs of abuse) or drug abuse treatment medications on susceptibility, onset, and progression of HIV disease, latent HIV infection, pharmacotherapy-resistant HIV strains, AIDS- associated opportunistic infections, TB, and other blood-borne and sexually transmitted diseases in drug-abusing populations. o Research on drug abuse-related risk factors associated with nutritional, metabolic, endocrine, and gastrointestinal disorders and their underlying pathophysiology in persons infected/co-infected with HIV, HIV/AIDS-associated opportunistic infections, TB, viral hepatitis, and other blood-borne and sexually transmitted infections. o Basic and clinical research on the neuropathogenesis of HIV and the relationship of nervous system infection to disease progression in drug users, including studies of the relationship(s) of virologic, host, pharmacologic, and environmental factors to HIV-associated central nervous system dysfunction and AIDS dementia complex. Therapeutics o Clinical trials research which reflects the changing demographics of drug abuse, HIV/AIDS, TB, viral hepatitis, and other blood-borne and sexually transmitted infections, including studies that recruit and retain multi- ethnic/racial populations of injecting and noninjecting drug users, their sexual partners, and their children in the evaluation of potential therapies for the treatment of drug abuse, HIV infection, serious HIV-associated complications, and other diseases. o Basic and applied research to advance therapeutic entities and strategies to prevent and treat HIV, HIV/AIDS-related complications, and potential co- infections in drug users and their sexual partners. Of interest are studies of drug interactions among commonly used treatments for HIV and HIV-related disease and other substances that may be used by HIV-infected drug users (such as drug addiction treatment medications and over-the-counter drugs). Investigators are encouraged to evaluate the acceptability and use of new compounds (e.g., topical microbicides and other agents) to reduce and prevent sexual transmission of HIV and other infectious diseases in high-risk, sexually active, drug-using populations. o Studies that select and investigate biologic markers, surrogates, and/or other outcomes to evaluate the safety and clinical efficacy of new agents and approaches in the treatment of HIV-associated opportunistic infections and neurologic complications of HIV disease in injecting and noninjecting drug users. In particular, clinical research is needed to develop and evaluate interventions that facilitate better adherence to therapies among drug users infected with HIV and other diseases in drug abuse treatment. o Studies of adherence to multidrug regimens in HIV-infected injecting and noninjecting drug users, including the development of improved methods to assess adherence to therapeutic regimens in this diverse and changing population. Better methods are also needed to compare and validate adherence measures in the context of linked HIV care/drug abuse treatment services for HIV-infected drug users, and to evaluate the impact of improved adherence on the clinical effectiveness of HIV care/drug abuse treatment (and, potentially, of therapeutic regimens for other infectious diseases, such as HBV and HCV). Vaccines o Basic research to advance the design and development of candidate vaccines and other biomedical interventions to prevent the spread of HIV in at-risk, drug-using populations, including studies that, for example, monitor and model effects on immune activation from drug abuse and STDs in HIV-infected and seronegative injecting and noninjecting drug users and their sexual partners. o Basic virologic and immunologic research to model, develop, and evaluate safe and effective HIV vaccine strategies and passive immune interventions to interrupt HIV transmission from mother to infant, with special focus on high risk, sexually active and/or pregnant women who use drugs or are the sexual partners of IDUs. o Epidemiologic and behavioral research to monitor changes in the risk behaviors and HIV seroincidence rates of persons participating in vaccine clinical trials and to improve methods for identifying and evaluating emerging risk groups likely to participate in HIV vaccine efficacy trials. Behavioral and biomedical intervention studies are needed to improve the recruitment, adherence, and retention of high-risk populations in HIV vaccine efficacy trials and to minimize potential adverse social, economic, behavioral, and legal consequences of participation. o Multidisciplinary research to improve the design and efficiency of HIV vaccine efficacy studies involving high-risk drug-using populations, including research to establish and strengthen linkages between HIV vaccine preparedness and other prevention and treatment research activities (e.g., research on HIV outreach interventions that integrate counseling and testing for HIV with screening and medical services for viral hepatitis and other STDs, and with referrals and access to drug abuse treatment). Behavioral and Social Sciences Research o Research to design and test single components (and/or their combinations) of prevention interventions for HIV and other diseases in sexually active, drug-using populations, including evaluation studies to determine the effectiveness, cost-effectiveness, and sustainability of interventions in demographically and culturally diverse community contexts. This may include developing interventions that have linkages to a variety of ancillary services (e.g., rapid diagnostic assays, HIV counseling and testing, and medical and drug treatment) or that are adapted to special populations, such as drug injecting women, the sex partners of drug injectors, or men who use drugs and have sex with men. o Interdisciplinary research on the behavioral, cultural, and social determinants of injection drug use and risky sex as they relate to the transmission of HIV and other infections. Studies are needed to understand the diverse and dynamic contexts of risk associated with the transmission of blood-borne infections and STDs, including HIV. Such studies may address, for example, relationships between peer influences, beliefs about gender roles, the composition of social networks, and transitions from noninjecting to injecting drug use or from unsafe drug use and unsafe sex. o Intervention studies to improve outreach, recruitment, adherence, and retention of HIV-infected drug users, especially hard-to-reach IDUs, in clinical trials on HIV/AIDS and drug abuse prevention and treatment. Research is encouraged on improving strategies to prevent and minimize adverse social, psychological, and physical consequences of HIV/AIDS and drug abuse addiction, including the stigmatization so often associated with these diseases. o Research that advances qualitative and quantitative methodologies in behavioral and social science investigations of drug abuse, HIV/AIDS, and other infectious diseases. This may include studies to: improve measurement instruments for special populations (e.g., HIV-infected drug injecting women, prisoners), refine techniques for measuring the social mixing patterns of high-risk networks, develop outcome measures and indicators for evaluating the social impact of HIV prevention interventions, and formulate new strategies that facilitate multisite, intercultural, and international research projects. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS - UPDATED AUGUST 2, 2000 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 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age 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 Contract, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations 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 IDUs, crack cocaine users, and sexually active drug users and their sexual partners. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and IC that agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance from both for any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (revised 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) 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 o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) 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. o 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. o 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. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form Page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap 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 facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o 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. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application including the Checklist, and 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) REVIEW CONSIDERATIONS Applications 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, will evaluate applications for scientific and technical merit. 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 our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (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? In addition to the above criteria, in accordance with NIH policy, all applications also will be reviewed with respect to the following: o 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 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, or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elizabeth Lambert, M.Sc. or Helen Cesari, M.Sc. 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) 402-1933 or 402-1918 FAX: 301-443-4100 Email: HC30X@nih.gov or EL46i@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX : (301) 594-6847 E-mail: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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