HEPATITIS C DIAGNOSIS, TREATMENT AND INTERACTION WITH HIV/AIDS RELEASE DATE: January 23, 2002 RFA: RFA-DA-02-008 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: March 18, 2002 APPLICATION RECEIPT DATE: April 16, 2002 THIS REQUEST FOR APPLICATIONS (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 The NIDA plans to support a new National Drug Abuse Research Initiative for accelerating research on the diagnosis and treatment of Hepatitis C in drug abusing populations, especially those at risk for or infected with HIV/AIDS, including such areas as the development of (1) innovative minimally invasive methods for early diagnosis, (2) improved minimally invasive techniques to predict clinical course, (3) studies elucidating factors that influence clinical course, e.g. patterns of abuse of alcohol and other drugs, nutrition, stress, re-infection, (4) studies of the interaction of hepatitis C with co-morbid conditions, e.g. hepatitis B, HIV/AIDS, (5) treatment regimens for hepatitis C and its co-morbid conditions that are effective and deliverable in drug abusing populations both within and outside of drug abuse treatment, (6) studies that address hepatitis C diagnosis and treatment in special populations of drug abusers, e.g., minorities, women versus men, pregnant women, women with childcare responsibilities, (7) interventions that promote the prevention of medical consequences of hepatitis C, (8) models of delivery of diagnostic and treatment services that address issues of access, cost, organization and management and effectiveness, and (9) interventions for the prevention of transmission by infected drug abusers. These research efforts should involve interdisciplinary collaborations including such areas as basic virological and biological science, immunology, behavioral science, prevention science, epidemiology and clinical trials. It is the intent for this RFA to support research that can demonstrate reciprocal interactions between basic and applied research components to facilitate creative and innovative research along the continuum of disciplines. However, the primary intent of this RFA is to support studies that relate directly to the development and testing of protocols for hepatitis C diagnosis and treatment in drug abusing populations, so as to provide data essential to the formulation of clinical guidelines in these areas. RESEARCH OBJECTIVES Background Previous research has identified the high prevalence of hepatitis C in drug abusing populations and has related that prevalence to injection drug use. However, a previous NIH sponsored Consensus Conference on Hepatitis C recommended that treatment for hepatitis C not be initiated in drug abusing populations prior to the achievement of a full year of sobriety. This recommendation, in the absence of significant data and in the absence of treatment alternatives currently available, expressed concerns that the level of adherence to treatment among injection drug users would not reach the level that would allow treatment to be effective and, that the resulting abbreviated and/or intermittent treatment would promote the development and transmission of resistant viral strains and exhaust the limited resources available to provide treatment to those infected with hepatitis C. Thus, despite a demonstrated high level of early infection with hepatitis C and the known potential of hepatitis C to result in chronic progressive liver disease leading from fibrosis to cirrhosis and liver failure, research on the diagnosis and development and implementation of effective treatment of hepatitis C in drug abusing populations remains an underdeveloped area. The objective of this RFA is to proceed as rapidly as possible towards the developed of data-based clinical guidelines for the diagnosis and treatment of hepatitis C in drug abusing populations and thus minimize the influence of institutionalized pessimism with respect to the possibility of effective, deliverable treatment for drug abusers. Research Goals and Scope The NIDA recognizes the need to encourage the development of new, innovative interventions in the diagnosis and treatment of the medical consequences of drug abuse, including hepatitis C and co-morbid conditions, with a particular emphasis on HIV/AIDS. The overall goal for this RFA is to stimulate the development and testing of diagnostic and treatment interventions, including the possibility of early diagnosis and treatment, that can ultimately be demonstrated to be effective in drug abusing populations, and, hence to prevent the development of the medical consequences of hepatitis C and its co-morbid conditions, especially HIV/AIDS. Intrinsic to this effort is the need to elucidate the underlying mechanisms that determine the effectiveness of these interventions, including factors ranging from the basic biology and virology to those related to adherence and the organization and delivery of health services. The results of these studies should promote the development of diagnostic and treatment interventions that target critical mechanisms in the cycle of transmission, development of infection and progression of hepatitis C in drug abusers at risk for or infected with HIV. Additionally, it is recognized that even the most effective diagnostic and treatment interventions have not benefited all who have been exposed to those interventions. Thus, current challenges in diagnostic and treatment research include the need to better characterize subgroups or individuals who are refractory to existing interventions and develop new paradigms for targeting these resistant populations. It is the intent of this RFA to support interdisciplinary collaborations along a continuum of research, ranging from basic science that can inform or guide the development of novel hepatitis C diagnostic and treatment interventions, through clinical trials and the development of guidelines for clinicians in the area of the diagnosis and treatment of hepatitis C in drug abusing populations at risk for or infected with HIV. Preliminary diagnostic and treatment development, efficacy testing, and effectiveness trials of promising new diagnostic methods and treatment interventions are encouraged. Studies at the following levels of analysis are appropriate and applicants should incorporate more than one level of analysis in the interdisciplinary proposal: (a) Basic research studies, with potential application to the development of innovative diagnostic methods and comprehensive treatment interventions,(b) Research on the development, refinement and pilot testing of new diagnostic methods and treatment interventions, including studies aimed at translating discoveries from basic virological, immunological, behavioral, cognitive, social or health services research into novel or improved diagnostic methods or treatment interventions, (c) Efficacy testing of diagnostic methods or treatment interventions that show promise, including research on the hypothesized mechanisms through which these interventions produce their effects, (d) Effectiveness and cost-effectiveness trials of diagnostic methods and treatment interventions. Applications are encouraged to include the study of racial, ethnic minority group membership, sexual orientation, and effects of gender and culture whenever possible and appropriate. The following provide examples of scientific themes in the area of diagnosis and treatment of hepatitis C in drug abusing populations that might benefit from interdisciplinary collaborations within the context of this RFA. However, the list is not intended to be all-inclusive, and many other significant topics of scientific inquiry may be appropriate: o Studies of the effects of drug and alcohol abuse patterns, including drug abuse history, continued drug abuse, and relapse to drug abuse in, for example, dropouts from drug abuse treatment, on (1) the onset and progression of hepatitis C, including basic studies of effects of drugs of abuse on the viral replication and/or the development of unique viral isolates, (2) immune processes related to disease transmission and course, and (3) response to treatment regimens. Studies examining the possible effects of repeated or re- infection among drug abusers in treatment for hepatitis C may be included. o Studies of the effects/side effects of treatment of hepatitis C, e.g., the development and treatment of depression during the course of treatment with interferon, and development of ways of dealing with such side effects so as to minimize dropouts from treatment or other forms of non-adherence. o Development of minimally invasive ways of predicting the course of hepatitis C and monitoring the effectiveness of treatment intervention, e.g., ways of ascertaining levels of fibrosis of the liver that do not involve the need for liver biopsy. o Development and testing of minimally invasive diagnostic methods that allow the very early identification of infection so as to facilitate tests of early treatment intervention, since at least one study suggests that such early treatment may lead to higher rates of treatment success. o Effects of metabolic, endocrine and gastrointestinal factors, including macro and micro nutrient deficiency in the course and treatment of hepatitis C. o Elucidation of the basic mechanisms at the cellular and sub-cellular, e.g., mitochondrial, levels of the pathogenesis of hepatitis C infection in drug abusing populations, emphasizing the influences of factors unique or predominant in drug abusers and including mechanisms effecting response to treatment. o Studies of the influence of alcohol as a cofactor in processes related to the acquisition and treatment of hepatitis C in drug abusing populations. o Studies of the drug-abuse-related factors and mechanisms that influence the pathogenesis of hepatitis C disease. Examples include studies of (1) effects of host and viral genetics on resistance, course of hepatitis C infection and response to treatment and (2) proteomic issues related to the aforementioned. o Research elucidating factors important in addressing diagnostic and treatment issues for hepatitis C and its co-morbid conditions among special populations, e.g., minorities, gender differences, pregnant women. For example, questions of why African Americans seem to do worse than Caucasians in results of treatment for hepatitis C may be explored. o Examination of co-factors that increase the risk of acquisition of hepatitis C in non-injection drug users, e.g., some data indicates a prevalence of up to 20-35%. o Examination of the influence of co-infection with other forms of hepatitis, e.g., hepatitis B, hepatitis G, and other infectious diseases, e.g., HIV, on the disease course and treatment of hepatitis C. o Study of drug interactions among medications used to treat hepatitis C and those used to treat (1) drug abuse, e.g., methadone, buprenorphine/naloxone, (2) co-morbid mental disorders, e.g., antidepressants, and (3) co-morbid infectious diseases, e.g., HIV, hepatitis B, tuberculosis. o Development of methods to maximize adherence to treatment in drug abusing populations both in and out of drug abuse treatment and study of the effects of degrees of non-adherence on the effectiveness of treatment. o Research on the most effective ways of organizing, delivering, (e.g., linkage to primary care and/or drug abuse treatment, other outpatient models for care delivery), and financing health service systems to maximize ability to deliver effective treatment for hepatitis C and it co-morbid conditions to drug abusing populations, including special populations as minorities, women versus men, pregnant women, injection versus non-injection drug users. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01), small grant (R03) (http://grants.nih.gov/grants/guide/pa-files/PAR-00-059.html), and exploratory/developmental grant (R21) (http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The 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 September 30, 2002. The exploratory/developmental (R21) grants are limited to 3 years and small grants (R03) are limited to 2 years. Both are non-renewable and limited in direct cost amount per year (R03, $50,000, R21, $100,000). The R03 mechanism is intended for newer, less experienced investigators, for investigators at institutions without well-developed research traditions and resources, or for experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. FUNDS AVAILABLE NIDA intends to commit approximately $2 million in FY 2002. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is anticipated that approximately 3-6 awards will be made under this announcement. Although the financial plans of NIDA 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. ELIGIBILITY 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 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: Sander Genser, M.D., M.P.H. 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) 443-1801 FAX: (301) 594-6566 Email: SG73F@NIH.GOV o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 IC 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: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 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 http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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: http://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: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov 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 NIDA. 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 (IC) 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 National Advisory Council on Drug Abuse. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches or method? 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? (6) RELEVANCE: The relevance of the proposed work to the purpose of the RFA. 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 (including data safety monitoring plans), 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 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 18, 2002 Application Receipt Date: April 16, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITIERIA 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 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. 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. 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. 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. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA"s Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. 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. 93.279. 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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