HIV/AIDS AND OTHER INFECTIONS AMONG DRUG USERS IN THE CRIMINAL JUSTICE SYSTEM RELEASE DATE: December 10, 2003 RFA Number: RFA-DA-04-015 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: February 23, 2004 APPLICATION RECEIPT DATE: March 23, 2004 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms 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 This RFA invites epidemiological, prevention, and services research on HIV/AIDS and other blood-borne and sexually transmitted infections (STIs) among adult and juvenile drug users in the criminal justice system receiving legal supervision in community-based settings, such as the drug courts, diversion initiatives, or community re-entry programs. Specifically, NIDA seeks innovative research to advance knowledge and understanding of the epidemiology, prevention, and treatment service needs of drug users in the criminal justice system who have or are at high-risk for HIV and other infectious diseases, and who receive legal supervision in the community setting. Results from these studies are expected to inform future developments in behavioral interventions and services to prevent and treat the spread of HIV/AIDS and other diseases among individuals in the criminal justice system with substance abuse-related problems. Applicants are encouraged to address behavioral, social, medical, systems-level, and environmental factors that impact the epidemiology of HIV/AIDS and other diseases in this population; to design and pilot test behavioral interventions to prevent HIV/AIDS and other comorbid conditions associated with the initiation, resumption, or progression of substance abuse and unsafe sex; and to develop and test systems-level models for integrating strategies to prevent and treat HIV/AIDS and other infectious diseases among drug users in the criminal justice system. The challenge of achieving long-term HIV risk reduction and behavioral change among drug users in the criminal justice system is especially complex given the personal, familial, social, environmental, and criminal diversity of the population. By improving our knowledge and understanding of the epidemiology, prevention, and treatment service needs of criminally-involved drug users who may have, or be at high-risk for, HIV and other infections, this initiative will advance developments in behavioral interventions and services to prevent and treat HIV and other blood-borne and sexually transmitted diseases in this population. It will also lead to new developments in systems-level models for integrating prevention and treatment services for HIV/AIDS and other infectious diseases into the criminal justice system. For the purposes of this RFA, the term drug user in the criminal justice system refers to any drug user who lives in the community and is receiving some form of community-based legal supervision under the auspices of the criminal justice system. Such individuals may be recently released or transitioning from a criminal justice institution into the community. Legal supervision may include, but is not limited to, drug courts, diversion initiatives, probation, parole, or other community re-entry programs. It includes supervision during the transitional phase of an inmate's release from an institution into the community, but not supervision while the inmate is in jails, prisons, or other detention centers. RESEARCH OBJECTIVES Background Drug users are disproportionately involved in criminal activity. According to data from the National Institute of Justice's Arrestee Drug Abuse Monitoring (ADAM), about 66% of adult and more than 50% of juvenile arrestees tested positive for one or more illicit drugs in 1999. In 1998, approximately 36% of jail inmates were under the influence of drugs at the time of their offense. In 1999, an estimated 24% of property offenses and 11% of violent offenses were committed for money to buy drugs. Today, over 6.6 million adults (one of every 32 persons) in the U.S. are on probation, in jail/prison, or on parole. In 1999, 61% of Federal inmates were sentenced for drug offenses, up from 53% in 1990. Among individuals in state prisons, the increase from 1990 to 1999 for drug offenses was even larger at 69%. The proportion of juvenile justice-involved youth has increased 31% from 1989 to 1998 (National Center of Juvenile Justice, 2001). Recent estimates suggest that 60% or more of juveniles in the criminal justice system have substance abuse problems (U.S. Department of Justice, 2000). Since 1999, approximately 600,000 inmates per year have been released from institutional facilities back into the community, and an estimated 33% of these individuals have drug abuse problems, as well as other medical and mental health disorders. Upon release, few have connections in the community to help them access local drug treatment services or HIV/AIDS prevention and treatment programs. Individuals who do have access to community-based drug treatment programs often are or have been involved in the criminal justice system, however. Findings from the Drug Abuse Treatment Outcome Study (DATOS) suggest that more than 50% of cocaine and opioid addicts seeking community-based drug treatment reported involvement in the criminal justice system. Data suggest that the prevalence of HIV and other infectious diseases is high among drug users in the criminal justice system. Cooper (1999) estimated that HIV seropositivity rates in U.S. correctional settings were roughly 8-10 times higher than the general population. Data synthesized from surveys, surveillance, and other reports by Hammett et al (2002) indicate that, during 1997, 20% to 26% of all people living with HIV in the U.S., 29% to 43% of all those infected with HCV, and 40% of all those who had tuberculosis (TB) in that year passed through a correctional facility. While only 3% of the U.S. population spent time in a correctional facility in 1997, between 16% to 43% of the burden of HIV/AIDS, HCV, and TB was found in this relatively small segment of the population, making AIDS about 5 times more prevalent among prisoners, and HCV about 9 times more prevalent (Hammett et al, 2002). The findings for juvenile detainees are equally alarming. For example, Teplin et al (2003) examined HIV/AIDS risk behaviors in a longitudinal study of 1,829 males and females ages 10-18 years in Chicago, and found that 95% of the sample had engaged in 3 or more high-risk behaviors, and 65% had engaged in 10 or more (e.g., alcohol and other substance use, unprotected sex with multiple partners). These and other findings highlight the need for better understanding of the epidemiology, prevention, and treatment service needs of drug users in the community who are involved in the criminal justice system. Applicants are encouraged to consider multidisciplinary approaches, as appropriate, in their study designs, drawing from the behavioral, biomedical, and social sciences, and utilizing both qualitative and quantitative measures and methods. Topics of research interest include, but are not limited, to the following: o Identify behavioral, social, cultural, environmental, and systems-level factors in the epidemiology of substance abuse and behavioral risks for HIV and other infectious diseases among drug users in the criminal justice system receiving legal supervision in community-based setting; o Identify gender-based differences in trajectories of HIV and other health consequences of drug use (including relapse, HBV, HCV, mental health outcomes, and violence) among persons newly released from prisons and jails, and their implications for prevention, treatment, and re-entry and integration into the community setting; o Determine the types, accessibility, availability, and effectiveness of community-based HIV prevention programs and treatment services for men and/or women newly released from prison or jail, on probation or parole, or those receiving some form of legal supervision in community-based settings for substance abuse-related problems (e.g., through drug courts, diversion initiatives, or community re-entry programs); o Design innovative behavioral prevention and intervention strategies for pilot testing with community-based drug users in the criminal justice system to reduce HIV/AIDS and other comorbid conditions (including hepatitis B, hepatitis C, and other sexually transmitted diseases) associated with drug abuse and unsafe sex; o Develop and test effective community-based outreach strategies to drug users in the criminal justice system that utilize referrals and improve access to HIV/AIDS and other health-related prevention and treatment services; o Develop, pilot test, and refine novel HIV prevention messages and strategies to reduce high-risk drug use and sexual behaviors associated with the spread of HIV and other infectious diseases among adult and juvenile drug users involved with the criminal justice system who live in community settings; o Develop improved methods to assess adherence to therapeutic regimens among HIV-infected drug users involved in the criminal justice system, including studies to compare and validate adherence measures in the context of linked community-based treatment programs and services (e.g., community-based medical care for HIV, HBV, HCV and drug abuse treatment); o Identify contextual, social, and gender-related factors associated with risks of drug use, HIV, and other blood-borne infections and STIs among drug users in the criminal justice system who live in the community (e.g., health disparities, norms and attitudes about gender roles, and peer influences related to HIV-related risk behaviors, including injecting drug use and unsafe sex), and design and pilot test community-based risk reduction interventions that take these factors into account; o Utilize operational and health services research methods to identify and understand issues related to barriers/facilitators and the implementation/ integration of community-based HIV/AIDS interventions for drug users in the criminal justice system; o Identify characteristics of community-based services (e.g., organizational, financing, management, access, delivery, cost-effectiveness, linkage, and coordination) that can be augmented, enhanced, or modified to improve outreach, HIV/AIDS prevention, and treatment programs and services for drug users in the criminal justice system who live in the community. Applications solicited under this RFA should be conceptually clear and theoretically driven, and should address the purposes and objectives of this RFA. In addition, applications should be sensitive to issues of cost, cost- effectiveness, and the integration of public health and public safety outcomes. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory grant (R21) and the small grant program (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants must clearly specify in the application which mechanism is being requested. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under the R21 mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields are better suited for the R03 small grant mechanism. 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 30, 2004. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). All applications submitted in response to this announcement must use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. Exploratory/developmental grant support is for new projects only; competing continuation applications will not be accepted. Two revisions of a previously reviewed exploratory/developmental grant application may be submitted as defined in NIH Policy at http://grants.nih.gov/grants/policy/amendedapps.htm. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE NIDA intends to commit approximately $1.5 million in FY 2004 to fund a combination of 6-8 R21s and R03s in response to this RFA. For an R21, an applicant may request a project period of 2 years and a budget for up to $275,000 total. For an R03, an applicant may request up to $50,000 in direct costs for each of the 2 years, and the application research plan (items a-d) cannot exceed 10 pages. 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 NIDA provides 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 institutions/organizations 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: Elizabeth Y. Lambert, M.Sc. Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA) National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: 301-402-1933 Email: EL46i@nih.gov o Direct your questions about peer review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Telephone: 301-443-2755 Email: tlevitin@mail.nih.gov Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: 301-443-6710 E-mail: gfleming@mail.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 NIDA 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 Program Review National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) Telephone: 301-443-2755 Fax: 301-443-0538 Email: tlevitin@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://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 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://grants1.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/DHHS 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 and all copies of the appendix material must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 234, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignments within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH 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 appropriate NIH 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Please assess the extent to which the study aims are consistent with the goals of the RFA. Does the study address an important problem consistent with the goals of this 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? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS 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: February 23, 2004 Application Receipt Date: March 23, 2004 Peer Review Date: July/August 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (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 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 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: 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 http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 service for 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. 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. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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