ALCOHOL ABUSE AND HIV/AIDS IN RESOURCE-POOR SOCIETIES RELEASE DATE: January 14, 2003 RFA: AA-03-009 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) LETTER OF INTENT RECEIPT DATE: March 25, 2003 APPLICATION RECEIPT DATE: April 25, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Alcohol Abuse and Alcoholism seeks applications for international, cross-disciplinary research on HIV/AIDS, other blood-borne infections [i.e., hepatitis B virus (HBV), and hepatitis C virus (HCV)], tuberculosis (TB), and comorbid conditions and consequences in alcohol abusing and dependent individuals, their sexual partners, and their children. This RFA is intended to build on lessons learned in developed countries in response to the interrelated epidemics of alcohol and HIV/AIDS and other infectious diseases. It seeks to foster cross-national and international research collaborations that, through both independent research and the recruitment, training, and mentoring of new, multi- disciplinary researchers, lead to the development, adaptation, replication, and evaluation of effective interventions and approaches to slow or reverse the spread of HIV and other infections in vulnerable heavy drinking populations. Epidemiologic studies on the dynamics of alcohol abuse and HIV demonstrate a continual need to reach new and emerging risk groups in diverse geographic settings with effective prevention interventions. Data from the WHO indicate that while alcohol consumption is declining in most of the developed countries, it is rising in many resource-poor countries and the countries of Central and Eastern Europe. Males do most of the drinking in these countries, and evidence available regarding patterns of drinking suggests that heavy drinking is prevalent in these countries. The contribution of alcohol to the global burden of disease is significant and growing in some regions, to the point that in parts of Central and Eastern Europe, alcohol use is contributing to an unprecedented decline in male life expectancy. These same parts of the world have seen significant increases in rates of HIV infection over recent years, and there is growing evidence that escalating rates of alcohol abuse and HIV infection are closely related. For example, while the epidemic in sub-Saharan Africa, home of two-thirds (23.3 million) of the 33.6 million people in the world living with HIV/AIDS in 1999, has been largely driven by heterosexual transmission, there, as elsewhere, alcohol use is becoming increasingly important as rates of alcohol use continue to rise. It is well known that alcohol use increases the risk of exposure to HIV through its association with high risk sexual and substance abuse behaviors. However, there is also growing evidence that alcohol consumption may play an important role in susceptibility to infection and the progression of HIV disease. This latter includes the occurrence and course of comorbid conditions such as HCV and TB. Research also suggests that alcohol use has important influences on adherence to medications and provider advice, provider and patient attitudes towards treatment, and survival. Challenges for cross- national and international HIV research efforts lie in the diversity of risk groups and communities of alcohol users; the rapidly changing alcohol, Alcohol- and sex-related risk profiles of susceptible populations; the variability in global alcohol use patterns; the complex interactions among behavioral, ethnic/racial, sociocultural, environmental, and biomedical factors that influence the initiation and progression of alcohol abuse and the spread of HIV and other infections; and the differences among resource-abundant and resource- poor countries as to their understanding of the interrelationship of alcohol abuse and HIV, their public health knowledge and experience, and their capacities to respond with durable, effective measures to contain the epidemic. This RFA will support cross-national and international multidisciplinary research on the intersection of alcohol consumption and the HIV epidemic. Investigators representing a broad array of academic disciplines and engaged in cross-cutting fields of science are encouraged to consider designing hypotheses-driven studies that utilize rigorous methodologies from epidemiological, biomedical and behavioral research traditions. Special emphasis areas include: the prevention and treatment of HIV and other blood-borne infections in sexually active populations of alcohol users; the clinical course and consequences of HIV and related health conditions in diverse communities of alcohol users, their sexual partners, and their children; the causes and consequences of differences in HIV-associated risks, morbidity, and mortality between men and women, adults and adolescents, and majority and minority populations who consume alcohol at various levels; and the design, development, and evaluation of behavioral and biomedical prevention measures to reduce the impact of alcohol use and sex-related risk behaviors on the primary and secondary transmission of HIV and other infectious diseases. Community-level interventions which address related social and health policy issues (e.g., alcohol outlet density, alcohol taxation policies, prevention and treatment service distribution) are also of interest. Researchers are encouraged to utilize integrative, multi-method approaches in their study designs. Examples of newer technologies which may be employed include but are not limited to geospatial coding of alcohol-related events and alcohol prevention and treatment resources and medical informatics systems with the capacity to integrate multiple clinical databases. Established researchers are urged to recruit new, domestic and foreign researchers to work on their projects, to provide training and mentoring to help achieve their project's specific aims, and to nurture the career development and independence of new researchers with potential to enrich the multiple disciplines involved in preventing HIV and other infections in high-risk alcohol-using populations. RESEARCH OBJECTIVES BACKGROUND Alcohol consumption and its consequences together with HIV/AIDS are major public health burdens in many parts of the world. Chronic abusive alcohol use can lead to life threatening organ system damage. Light to moderate consumption can induce behavioral and organ system changes which may influence HIV transmission, pathogenesis, and disease progression. There is an overlap between persons at risk for alcohol- related problems and individuals at risk for HIV infection. Regardless of the level consumed, alcohol is likely to influence the health status of persons infected with HIV and those whose behaviors place them at risk for acquiring the virus. In addition to being a risk factor in the contraction and progression of HIV disease, alcohol misuse affects adherence to complex HIV medication regimens and to physician advice. Recent evidence has indicated interactive effects of alcohol use and HIV infection on brain functioning and cognitive processes. Whether alcohol consumption increases susceptibility to opportunistic infections in HIV+ patients and whether alcohol-induced immunosuppression affects pathogenesis and disease progression are important questions. However, carrying out research on the effects of alcohol consumption and drinking behaviors on HIV-related health outcomes is challenging. While clinical findings have associated increased levels of chronic alcohol consumption with diminished immune function, as evidenced by reduced levels of CD4 and CD8 activity, many questions about the relationship between alcohol consumption, increased susceptibility to HIV infection, and accelerated progression to AIDS remain unanswered. Strain variations of HIV, individual differences in susceptibility, long incubation time following seroconversion, and varying patterns of adherence to HIV medications are only some of the challenges in studying disease progression. Comorbid mental and somatic illnesses and environmental stress are additional confounding factors, each of which may vary in its impact across cultures and subcultures. Cumulative research on alcohol and HIV/AIDS has shown that reductions in alcohol consumption are associated with declining incidence in HIV and other blood-borne infections in at-risk populations. Despite the significant advances that have been made, however, HIV and other infectious diseases continue to spread among alcohol-using populations in the U.S. and worldwide. The cumulative evidence from research on prevention and treatment programs for alcohol use disorders shows that no single approach is sufficient to avert new HIV and other infections in all alcohol users and their sexual partners. Research gaps remain in a number of key areas, including but not limited to: our understanding of the epidemiology of risks for HIV/AIDS in alcohol- using populations and others at risk; the clinical course and consequences of HIV and co-occurring infections associated with continual risky alcohol use and sexual practices; the individual (e.g., age, gender, race/ethnicity) and environmental (e.g., social, economic, cultural) factors that influence attitudes, beliefs, and behaviors related to alcohol use and risky sex; and the impact of alcohol abuse, HIV/AIDS, and related infectious diseases on diverse community populations throughout the world. It is therefore of continuing importance to conduct cross-national and international research which seeks to clarify the role of alcohol in HIV transmission and disease progression, and to develop and test comprehensive, cost-effective preventive interventions which both reduce the risk of alcohol-related HIV transmission and improve the treatment of HIV infected alcohol abusing and/or alcohol dependent individuals. Areas of Research Focus This initiative will support cross-national and international research that includes but is not limited to the following interrelated areas: 1) Adaptation, replication, and evaluation of community-based prevention interventions to reduce risk behaviors and avert incident HIV and other infections in high-risk populations. This includes studies of the effectiveness of such interventions and their adaptability and diffusion to societies and cultures different from those in which they were originally developed. 2) Comparative effectiveness and sustainability of prevention and treatment interventions among alcohol-abusing populations in diverse international settings, including studies of environmental factors affecting availability, access and adherence to multiple types of behavioral and therapeutic interventions, the development of improved, accessible clinical management approaches, and research on models for facilitating cooperation among research and service professionals in international settings. Studies examining community-level interventions which address related social and health policy issues (e.g., alcohol outlet density, alcohol taxation policies, prevention and treatment service distribution, etc.) are of particular interest. 3) Comparative studies of the single and combined components of various prevention/ intervention strategies and services among alcohol- using men and women and their sexual partners in diverse international settings, including studies of their differential impacts on the incidence, prevalence, and transmission of HIV and other blood-borne infections, their cost-effectiveness, and the nature and extent of their linkages to other social, health, and medical services. 4) Studies which identify and evaluate outcome measures and data collection systems appropriate to the evaluation of research-based HIV prevention interventions for reducing alcohol-related HIV exposure implemented in international settings. 5) Research on the integration of alcohol treatment services with other medical services provided to AIDS patients. This includes studies of access to alcoholism treatment services, outcomes and cost effectiveness of integrated treatment, organizational configurations that best facilitate the delivery of combined services, and cross training of both addiction and other medical care specialists to increase competence in delivering combined care. 6) Studies of the translation of research findings into improved clinical practice for HIV patients. Especially relevant are studies of the international diffusion and cross-cultural adaptation of improved treatment practices. 7) Development of innovative, comprehensive interventions to improve access to and delivery of HIV vaccines, antiretroviral and other therapeutic agents, routine screening services for sexually transmitted diseases (STDs), and HIV testing and counseling services to alcohol- using populations. 8) Bioethical considerations in research methodologies, and in the design and implementation of culturally appropriate, available, and affordable prevention interventions for alcohol use and HIV risk, including counseling and testing services, medical care, and alcohol treatment services to men and women with alcohol abuse/dependence, their sexual partners, and their children infected with HIV and other infectious diseases. 9) Risk-factor epidemiology of HIV and co-occurring blood-borne infections in alcohol-using men and women, in their sexual partners, and in their children. 10) Behavioral dynamics and alcohol use-related processes associated with the acquisition and transmission of HIV and other infections, including individual, social, environmental, cultural, economic, gender-based, and other factors which influence alcohol-related risk behaviors. 11) Socioeconomic and demographic characteristics, sexual and alcohol- using behaviors, health care utilization and treatment seeking, HIV virologic and immunologic status, and the health and medical consequences of HIV and other blood-borne infections in alcohol-using populations. 12) Virologic, immunologic, genetic, and alcohol use factors and the mechanisms by which they may influence susceptibility, recovery and persistence, and progression of HIV and other diseases in alcohol-using men and women, in their sexual partners, and in their children. 13 Research on the characteristics of community-based organizations and coalitions most likely to be successful in implementing effective science-based interventions for reducing alcohol-related HIV exposure in at-risk communities. MECHANISM OF SUPPORT This RFA will use NIH (NIH) Exploratory/Developmental Grant (R21) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator- initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 29, 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. FUNDS AVAILABLE The NIAAA intends to commit approximately $2 million in FY 2003 to fund 8 to 16 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $250,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Michael Hilton, Ph.D. Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism Willco Bldg, Suite 302 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 402-9402 FAX: (301) 443-480-2358 Email: mhilton@niaaa.nih.gov o Direct your questions about peer review issues to: Eugene Hayunga, Ph.D. Chief, Scientific Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Bldg, Suite 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 o Direct your questions about financial or grants management matters to: Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-2434 FAX: 301- 443-0788 Email: jfox@willco.niaaa.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: - Descriptive title of the proposed research - Name, address, and telephone number of the Principal Investigator - Names of other key personnel - Participating institutions - Number and title of this RFA 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 by the date listed at the beginning of this document. The letter of intent should be sent to: RFA-AA-03-009 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Bldg, Suite 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: RFA-AA-03-009 Extramural Project Review Branch Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the NIAAA National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 25, 2003 Application Receipt Date: April 25, 2003 Peer Review Date: June-July 2003 Council Review: September 17, 2003 Earliest Anticipated Start Date: September 29, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.273 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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