RFA-AA-02-003: DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS

Department of Health
and Human Services (HHS)

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DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS Release Date: October 11, 2001 RFA: RFA-AA-02-003 National Institute on Alcohol Abuse and Alcoholism (http://www.niaaa.nih.gov/) Letter of Intent Receipt Date: December 28, 2001 Application Receipt Date: January 23, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and testing of alcohol-related HIV preventive interventions that have the potential for reducing the risk of transmission of HIV in alcohol using, abusing, and dependent populations. This Request for Applications (RFA) is responsive to a proposed HIV Prevention Science Initiative by the Office of AIDS Research that seeks to stimulate further research on the impact of "... early identification (of HIV infection), counseling, and other behavioral interventions, and HIV treatment on risk behaviors, the utilization of HIV prevention services, and the transmission of HIV." It also advances the mission of the NIAAA Office of Collaborative Research, which includes the promotion and coordination of trans-Institute collaborative programs related to HIV/AIDS and other illnesses which disproportionately affect minority populations. The focus of this priority area is on intervening to change alcohol-related behavior of HIV-infected individuals as it relates to further transmission of HIV between individuals and diminished health outcomes among those infected. Because these risk behaviors occur in the context of drinking situations, drinking networks, and wet communities, the interplay between these social/environmental factors and individual level factors is of particular interest with regard to potential targets for intervention. A commitment to multidisciplinary, collaborative research, and to research that focuses on a range of population groups that combine alcohol and HIV/AIDS risks is implicit in this priority. Investigators are encouraged to move beyond basic behavioral studies to implement a continuum (from efficacy to effectiveness) of substance use risk- reduction interventions in populations at risk for both alcohol problems and HIV infection. This RFA on prevention research in the alcohol/AIDS area continues the previous focus of the NIAAA Prevention Research Branch on primary prevention of HIV and alcohol abuse among male and female alcohol users. However, A new emphasis on collaborative approaches between researchers and communities for translating prevention research to practice in community settings has also been identified. In addition, this RFA addresses secondary prevention issues (including alcohol treatment and risk reduction) among HIV infected male and female alcoholics who may be more likely than other HIV infected individuals to engage in high-risk sexual behavior, to use unclean needles, and to have problems adhering to therapeutic treatments for HIV and AIDS. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS- led national activity for setting priority areas. This RFA is related to the priority area of AIDS prevention. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No.017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512- 1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non- profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and the NIAAA exploratory/developmental (R21) 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 a research project grant (R01) application submitted in response to this RFA may not exceed 5 years. Exploratory/developmental grants (R21) are limited to 3 years for up to $100,000/year for direct costs. (See Program Announcement PA-99-131, NIAAA Exploratory/Developmental Grant Program, http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a complete description of the R21 mechanism.) Applicants are also encouraged to submit applications for Investigator- Initiated Interactive Research Project Grants (IRPG) which is available at http://grants.nih.gov/grants/guide/pa-files/PA-96-001.html. The IRPG mechanism requires the coordinated submission of related research project grants (R01) from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross- referenced individual R01 applications. Applicants may be from one or several institutions. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2002. FUNDS AVAILABLE It is estimated that up to $3.0 million will be available to fund approximately 10 to 15 grants under this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Alcohol consumption has been identified as an important behavioral cofactor for HIV infection and has been consistently associated with HIV-risk behaviors over time. Significantly higher rates of HIV infection are found among clinical samples of male and female alcoholics and nonclinical samples of individuals who meet criteria for alcohol dependence than in the general public. In addition, reduction in alcohol use in treatment samples is associated with reduced sexual risk taking. Higher levels of alcohol use has also been shown to predict higher incidence of infection and reduced time to seroconversion among gay men, and non-adherence to medical regimens among infected individuals. Although, there is limited research among minority and impoverished women who are at increasing risk for HIV infection, alcohol use by women and their partners has been linked to increased sexual violence and susceptibility to HIV infection. Alcohol-related HIV interventions are being tested among gay and bisexual men, Native American youth, incarcerated young adults, and persons in alcoholism treatment. Initial results after intervention and at follow-up suggest that a wide range of HIV-risk behaviors can be reduced, particularly among gay men and in alcohol treatment contexts. This research suggests that substance abuse prevention and treatment programs that include HIV components are more effective in reducing alcohol consumption and risky sexual practice than those that do not contain these components. Similarly, it appears that HIV prevention programs that include an alcohol risk-reduction component may be more effective in reducing HIV risk behaviors than those that do not. Preventive interventions may be initiated and implemented by the investigators themselves for the specific purpose of testing effects of the strategies, or the interventions may occur naturally through the actions of public and private organizations (e.g., reduction in availability and accessibility of alcohol, increased distribution of condoms at bars, health promotion campaigns that highlight linkages between alcohol use and AIDS). Investigator-initiated alcohol-focused interventions may also be nested within the context of naturally occurring HIV interventions, such as vaccine trials, permitting the effects of both types of interventions to be studied simultaneously. These alcohol-focused interventions can be aimed at individuals, social networks, institutions, and specific alcohol settings such as bars and clubs, to change alcohol-related sexual expectancies, behavioral norms, and HIV risk-taking behaviors. Populations at risk for HIV who also abuse or are dependent on alcohol are most in need of study. These special subgroups include alcohol abusing women and minorities, gay or bisexual men, male and female alcoholics in treatment, and adolescents initiating sexual behavior in the context of drinking networks, in which HIV is prevalent. Other groups of interest that may be indirectly affected by alcohol use include partners and families of HIV-infected alcoholics. In addition to developing and testing new investigator-initiated interventions or measuring effects of naturally-occurring preventive policies or programs, timely and cost-effective approaches may include: a) developing additional HIV interventions within the context of clinical studies to address alcohol-related problems (e.g., improving adherence of alcohol abusers to therapeutic regimens involving antiretrovirals, microbicides, vaccines, etc). b) augmenting ongoing alcohol-problem intervention studies to include HIV infected or at-risk populations and adapting the intervention to address HIV issues in this subgroup (e.g., including HIV-risk populations in comparisons of brief motivational counseling and cognitive-behavioral interventions). Several areas of emphasis for particular high-risk groups or innovative approaches to multidisciplinary research may be appropriate for proposed intervention studies. These include, but are not limited to: Collaborative Community-Based Research: As behavioral researchers focus on problems of substance abuse and AIDS they are increasingly involved in the communities that are most affected. Urban ethnic and racial minority neighborhoods are particularly affected and often hard to access. To overcome barriers to access, behavioral scientists have formed productive collaborative alliances with organizations within these community environments, including non-government organizations (NGOs). In the case of this RFA, researchers and NGOs are encouraged to collaborate in developing and testing interventions for alcohol abuse and HIV problems. Where appropriate, proposed community-based research should provide support for researchers within the NGO, to promote joint participation in a scientific knowledge-building process. Effective collaborative relationships should facilitate rigorous scientific evaluation of intervention outcomes. Suggested areas of research include but are not limited to: - studies that develop and test different modes for transferring effective research-based Alcohol/HIV prevention interventions into ethnically diverse communities. - studies of mechanisms that would enable community-based organizations to advise and communicate with the research community on needed research to improve responses to ongoing or emerging alcohol-related HIV public health issues. - studies which identify and evaluate outcome measures appropriate to the evaluation of research-based alcohol/HIV prevention interventions implemented in community settings. - research on the characteristics of community-based organizations and coalitions most likely to be successful in implementing research-based prevention interventions in at-risk communities. - develop and validate effective models for the translation of research-based alcohol/HIV prevention interventions into the community. - studies of the cost-effectiveness of research-based alcohol/HIV prevention interventions when implemented in different health and community settings. Medically Underserved Populations Including Women and Families: Alcohol abusers often delay entering medical settings where they could be identified as needing appropriate interventions and are often difficult to retain in controlled clinical trials. Such difficulties in attracting and retaining alcohol-abusing individuals may have particular significance for the testing and evaluation of HIV vaccines and therapeutics. In addition, alcohol may be a primary substance of abuse by those with multiple co-occuring psychiatric and AIDS-related medical diagnoses. New interventions need to be developed to attract and retain these individuals at extremely high-risk for negative health outcomes, and new research designs and analytic strategies need to be developed to adequately evaluate these interventions in settings in which high rates of attrition may occur. Intervention strategies may include, for example, more informal and culturally relevant drop-in clinics. Another approach may include the development of different research procedures, such as case-control or case-based designs which may be necessary to test the effects of these interventions on such variables as HIV exposure, interactions with alcohol abuse, and disease outcomes. In recent years there have been significant advances in our understanding of the ways in which the causes and consequences of alcohol misuse differ in men and women. However, much remains to be learned about how those differences impact HIV transmission, disease progression and clinical outcomes. Research efforts are needed develop alcohol/AIDS interventions to: - develop methods to promote routine screening of women and other under served individuals for alcohol misuse, high risk sexual practices, and other HIV risk behaviors in health care settings - enhance understanding of the impact of coexisting alcohol use disorders and HIV/AIDS on families, particularly single parent families, - measure the combined impact of treatment for alcohol use disorders and HIV/AIDS on vertical transmission of HIV and on other pregnancy outcomes (e.g. SIDS, premature birth) - improve linkage of general medical services, alcohol and other substance abuse treatment, and reproductive health services - enhance medical communication strategies between treatment providers to improve care of groups at highest risk for alcohol abuse and HIV-infection, which include impoverished youth and women, selected ethnic minorities, gay and bisexual men, and male and female partners of HIV-infected individuals. Community-based Institutional Approaches to Improving HIV and Alcohol Abuse Prevention: Community-level activities are critically important components of the national strategy to prevent alcohol and other drug (AOD) abuse and HIV infection. When community institutions are involved in AOD and HIV prevention, they may engage in activities such as providing educational intervention, distributing condoms, sponsoring community outreach activities such as street ministries or public awareness campaigns, or coordinating with other community organizations in service-delivery or fund-raising activities. Despite the impressive involvement of many community institutions in prevention activities, little research exists that systematically examines the diverse ways in which these organizations can contribute to HIV prevention and the factors that make them effective or ineffective in doing so. This initiative seeks to build a body of social science knowledge that will lead to innovative and effective approaches to preventing alcohol and other drug (AOD) misuse and HIV by expanding thinking on how community institutions affect risk and prevention of AOD abuse and HIV infection. For the purposes of this initiative, an institution is defined as a formal organization that is located in a community, engaged with community residents, and focused around a mission or activity. Examples of community institutions include churches, grocery stores, schools, and voluntary associations. Important research objectives regarding the role of community organizations and coalitions in the prevention of AOD and HIV/AIDS include, but are not limited to: - engaging community institutions to effectively reach out to HIV-positive and at-risk individuals and to implement effective prevention interventions? Promoting linkage between prevention and health care services, - improving mechanisms through which community institutions influence health and well being, generally, and health behaviors and AOD and HIV risk and protection specifically, - improving the effectiveness of institutions in shaping and enforcing community norms relevant to HIV and AOD risk. Promoting understanding of how the influence of institutions differs by type, structure of institution, relationships among institutions, and community context, - identifying and reinforcing characteristics of institutional norms, structure, operation, and activities which are associated with effective AOD and HIV prevention in particular communities and settings, - changing organizational environments and facilitating the implementation of research-based HIV prevention interventions, - using new technologies to inform, train and assist community-based organizations to implement and sustain efficacious AOD and HIV prevention interventions, Such new technologies may include use of the internet, CD- ROMS or other potentially cost-effective modalities. HIV/AIDS and Alcohol Use Among Adolescents: In contrast to the attenuation of the infant AIDS epidemic in the United States, there is evidence that HIV infection rates are increasing tin the adolescent population. This expanding adolescent HIV epidemic is increasingly female, minority, and related to sexual transmission (i.e., heterosexual activity in females and homosexual activity in males). Use of alcohol and illicit drugs by youth is related to early sexual experience. These risky behaviors may lead to unprotected sexual intercourse and are related to the acquisition and transmission of HIV among adolescents. Certain sub-populations of adolescents, in addition to females and minorities, are particularly at high risk for HIV infection. Examples are homeless, runaway, and street youth who engage in unsafe sex as a means of obtaining drugs or money, especially in urban area with high HIV rates, adolescents in juvenile detention centers where there is frequent HIV- associated risk-taking behavior, and alcohol and other drug-using adolescents in rural communities with increasing HIV seroprevalence. Within the broad areas of HIV prevention, transmission, disease progression, consequences, and treatment, there is a great need for research on specific concerns arising from the convergence of adolescence, AOD use and abuse, and HIV/AIDS. Studies are needed to develop, test, and disseminate prevention strategies to reduce the incidence of alcohol-related HIV infection, including: - community-based behavioral and social intervention strategies to reduce alcohol use and high-risk sexual behavior among adolescents and their sexual partners - primary prevention programs that include both HIV and alcohol abuse prevention (especially the integration of HIV risk components with existing alcohol abuse prevention programs) in school, juvenile detention, and street settings - family and other group-based intervention strategies to reduce alcohol use and high-risk sexual behavior among adolescents and their sexual partners - screening procedures for use by healthcare providers to identify youth at risk for alcohol abuse and exposure to HIV, particularly those in elementary and middle schools. - programs to improve access to and utilization of health services by alcohol-using HIV-infected adolescents, including strategies to improve adherence with HIV medications, recruit and retain participants in HIV/AIDS treatment, and deliver linked medical and drug abuse treatment services - strategies to support the transition from pediatric to adolescent and from adolescent to adult health care settings that focus on reducing alcohol and sexual risk behaviors. International Studies on Alcohol Abuse and HIV/AIDS: Although some developing countries have implemented successful HIV/STD prevention programs and policies, there is an urgent need to enhance these efforts and to find low- resource, cost-effective prevention programs. According to the World Bank, AIDS has eradicated a half-century of development in most affected countries. The impact on life expectancy among adults between the ages of 25 to 44 in staggering, and one child in ten is orphaned in Africa. Recent data indicate that alcohol and other drug use, particularly when combined with high-risk unprotected sex, have contributed significantly to the spread of HIV in many parts of the world. Epidemiologic studies on the dynamics of alcohol and other drug abuse and HIV demonstrate a continual need to reach new and emerging risk groups in diverse geographic settings with effective prevention interventions. This initiative encourages new and expanded collaborative efforts between U.S.-supported researchers and researchers in other nations to test behavioral interventions to arrest the spread of HIV infection and its consequences. Suggested areas of focus include but are not limited to: - development and testing of innovative, durable, and cost-effective interventions targeting individuals with co-occurring alcohol abuse/dependence and HIV/AIDS in diverse international settings to reduce their alcohol consumption and other high-risk behaviors. - testing of comprehensive school-based education programs that include components of life skills and ways to prevent alcohol and other substance abuse and other high risk behaviors in pre-adolescent, adolescent, and young adult populations in developing countries. - development and testing of combined AOD, HIV/STD and reproductive health programs to reduce HIV risk behaviors. - identification of gender roles in acquisition and transmission of AOD- related HIV and the development of preventive interventions that address these factors. - developing interventions to change formal and informal communication patterns, including mass and local media, through which information regarding the relationship between AOD use and abuse and HIV/AIDS may be disseminated in high risk communities. 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 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 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 are 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 of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. DATA AND SAFETY MONITORING PLAN (applies if you have proposed a clinical trial): As of the October 2000 receipt date, applicants must supply a general description of the Data and Safety Monitoring Plan for ALL clinical trials, this must be included in the application http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html The degree of monitoring should be commensurate with risk. NIH Policy for Data and Safety Monitoring requires establishment of formal Data and Safety Monitoring Boards for multi-site clinical trials involving interventions that entail potential risk to the participants. The absence of this information will negatively affect your priority score. 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 RFA 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIAAA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: RFA-AA-02-003 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-4375 FAX: (301) 443-6077 by the letter of intent receipt date indicated. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: RFA-AA-02-003 Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Bldg, Suite 409 6000 Executive Blvd, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Applications must be received by January 23, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of the research grant applications will include the following: Significance: Does the study address the goals of the RFA? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, 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 designs? 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? Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work 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 studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Budget: Is the requested budget and estimation of time to completion of the project appropriate for the proposed research? In addition, plans for the recruitment and retention of subjects will be evaluated as will the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goal of the research. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. Schedule Letter of Intent Receipt Date: December 28, 2001 Application Receipt Date: January 23, 2002 Peer Review Date: March-April 2002 Council Review: May 2002 Earliest Anticipated Start Date: July 1, 2002 AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Potential applicants are strongly encouraged to seek pre-application consultation, for which purpose they may contact the individuals listed below. Direct inquiries regarding the proposed research to: Deidra Roach, M.D. Collaborative and Special Health Programs Branch - CSHPB Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-5820 FAX: (301) 480-2358 Email: droach@mail.nih.gov Kendall Bryant, Ph.D. Chief, Collaborative and Special Health Programs Branch - CSHPB Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 402-9379 FAX: (301) 480-2358 Email: kbryant@niaaa.nih.gov Direct inquiries regarding fiscal matters to: Judy Simons Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 FAX: (301) 443-3891 Email: jsimons@niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," Title 45 CFR Parts 74 and 92, "Administration of Grants," and 45 CFR Part 46, "Protections of Human Subjects." 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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