THE IMPACT OF CHILD PSYCHOPATHOLOGY AND CHILDHOOD INTERVENTIONS ON SUBSEQUENT DRUG ABUSE RELEASE DATE: October 15, 2002 RFA: DA-03-007 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) LETTER OF INTENT RECEIPT DATE: November 22, 2002 APPLICATION RECEIPT DATE: December 23, 2002 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 by the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH) solicits research applications to study: 1) the relationship between psychopathologic and behavioral conditions in childhood and the risk for later drug use disorders, and 2) the impact of childhood mental health interventions on modifying the risk for later drug use disorders. Although a growing body of research has demonstrated associations between certain psychiatric conditions and substance use disorders (SUDs), the following important questions remain to be addressed: 1) Which children are at greater risk for SUD by virtue of their conditions? 2) What shared or unique characteristics or contextual factors constitute the risk for psychopathology and SUD? 3) Are there effective interventions for such conditions or service delivery changes that can prevent or reduce the risk for later SUD? 4) Do some interventions unintentionally increase vulnerability to later SUD? 5) How do findings regarding interventions and outcomes alter understanding of the etiologic processes of drug abuse? The goal of this announcement is to stimulate both new studies and the addition of drug abuse-related measures to ongoing studies to address the above questions. The ultimate purpose of this work is to provide knowledge that will inform and improve preventive and health services interventions with populations at high risk for SUDs. RESEARCH OBJECTIVES Background Cross-sectional studies of adolescents and adults in both clinical and general populations have found high rates of co-occurrence between SUDs and psychiatric disorders, particularly the conduct/antisocial disorders and the mood disorders. Far fewer longitudinal studies have examined the temporal order or causal relationships, including potentially common pathways, for specific psychiatric disorders and SUDs. Thus, the nature of the relationships among psychiatric and drug use disorders is unclear, particularly given that some drugs have disinhibiting and depressive effects that can mimic or unmask psychiatric disorders. Even when a psychiatric disorder is shown to predate an SUD, a causal relationship is not automatically established nor should it be assumed: the childhood psychiatric condition could be a marker of risk due to common risk factors. Research is needed to clarify common (shared) and unique risk and protective factors and pathways for psychopathology and SUDs and to understand how these factors contribute to adverse outcomes through childhood and adolescence. Because of limited current knowledge about the relationships between psychiatric and substance use disorders and their onsets, there is little data on whether interventions for childhood psychiatric disorders can alter initiation of drug use or SUD trajectories. Thus, understanding the relationships between precursor disorders, characteristics, and conditions and SUD outcomes has important prevention and treatment implications. It is known that individuals in the general population differ in level of risk for substance use and SUD. Identifying those at risk, and the nature of the risk, can facilitate development of prevention interventions targeted to specific risk groups. Once comorbid psychiatric and substance use disorders have developed, understanding the relationship between the disorders can also be used to develop more specific intervention strategies for various subgroups at risk for relapse of both disorders. Research is needed to develop interventions that are sensitive to shared risk factors and that may be capable of reducing multiple adverse outcomes. Studies are needed to address questions such as the following: o Which childhood psychiatric and behavioral conditions render individuals at greater risk for SUD? Research has identified relationships between a number of mental health disorders and SUD. One of the strongest relationships to emerge thus far is that between childhood conduct disorder and adolescent SUD. Data are mixed or lacking for other major disorders, including attention deficit hyperactivity disorder, depression, bipolar disorder, anxiety disorders, and eating disorders. It appears likely that some subgroups of children with these disorders are at increased risk, but the degree of risk, and moderating factors, are not known at this time. Further research is needed to better understand the relationships between different forms of psychopathology and later SUD and to clarify their temporal and potentially causal nature. o How do childhood disorders or conditions render individuals vulnerable to later drug use problems and disorders? What aspects of the disorder contribute to risk? Even when a childhood condition is shown to constitute a risk factor for SUD, we need to understand how the condition affects vulnerability, which in turn has important implications for intervention. Many individual, developmental, familial, social, and environmental factors may interact so that multiple pathways can lead to similar SUD outcomes. On an individual level, research is needed to look beyond symptoms and consider features and subthreshold constellations that may characterize vulnerable subgroups and underlie risks common to several disorders. This type of inquiry can identify targets for intervention. Examples of such explanatory features include executive cognitive dysfunction, affect dysregulation, difficult temperament, and social skills deficits. Some underlying features may have a psychophysiological substrate that merits study. Another individual attribute, gender, can interact with psychopathology to alter risk; for example, certain disorders less prevalent in one gender appear to confer increased risk for SUD (e.g., conduct disorder in girls, the so-called gender paradox). Given gender differences in rates of childhood behavioral conditions and traumatic experiences, and in responses to family functioning, applicants are encouraged to evaluate gender differences in the association and interaction between these circumstances, psychopathology, and subsequent drug use patterns. Furthermore, psychopathologic conditions need to be considered in their developmental context, with attention to the interplay between individual and environmental characteristics and transactional course. Drug use itself can be considered as a developmental influence on the life-course trajectory, and not simply as an adverse outcome; for example, research has shown associations between substance use in adolescence and reduced autonomy, positive action, and competence in young adulthood. o What role do family factors play in child psychopathology and subsequent SUD? Family history of SUD is a powerful predictor of SUD outcomes in offspring. Characteristics of the family and the family environment that may be associated with the child's psychopathology and SUD include genetic mechanisms, parental SUD, and parental psychopathology, and the interaction of these. Parental and parenting behavior such as extreme conflict, violence, divorce, and physical or sexual abuse or neglect may influence the child's risk for SUD. Some of these factors can affect access to or effectiveness of treatment and preventive interventions. Research is needed to determine the causal, mediating, and moderating nature of relationships between family factors, child psychopathology, and substance use disorders. Stressful environments and traumatic events may also increase risk for vulnerable individuals, and socioeconomic status and ethnicity may have moderating effects on risk. When these types of familial and environmental variables are ignored, there is a risk of attributing later SUD simply to the presenting psychopathology, when the childhood condition actually represents a marker or mediator for other risk factors. Thus, this area of research lends itself to multilevel conceptualization and analysis. o Are there effective interventions for childhood psychiatric and subclinical conditions that can prevent or reduce the risk for later SUD? For example, does early mental health treatment reduce the risk for later SUD? Several effective behavioral, pharmacologic, parent and family interventions for a variety of disorders merit consideration for a possible preventative role. Furthermore, it may be possible to modify some established childhood treatments specifically to prevent later SUD. o Do some interventions unintentionally increase vulnerability to later SUD? For example, while some studies on treating childhood ADHD indicate that stimulant medication may reduce risk for later SUD, others raise doubts about this. Other studies have found that interventions that aggregate conduct disordered adolescents may engender more conduct problems, including substance use. Further research is needed on possible iatrogenic effects of interventions for child psychopathology. o How do findings regarding interventions and outcomes alter etiologic models of SUD? It is hoped that research resulting from this announcement will help inform preventive interventions, so that they can be refined and targeted to specific risk groups. However, reciprocal research is also strongly encouraged: that is, findings from preventive interventions should be used to validate or question etiologic models and help distinguish risk markers from causal risk factors. For example, if an effective intervention for a known precursor disorder is delivered and SUD outcomes are not reduced, this may suggest that that childhood psychiatric disorder is not part of the causal chain for SUD or that the aspect of the disorder addressed by the intervention is not critically linked to SUD. In May of 2000, NIDA, in conjunction with NIMH, held a meeting on Assessing the Impact of Childhood Interventions on Subsequent Drug Abuse. Experts discussed basic background information for embarking on this area of research, exemplar approaches, methodological challenges, and ethical and logistical issues. Written materials from this meeting are available at http://www.drugabuse.gov/Meetings/Childhood/, which may be helpful in preparing applications in response to this announcement. Researchers who have not previously undertaken drug abuse research, as well as experienced drug abuse researchers, are encouraged to apply, and consultation with NIDA and NIMH staff is very welcomed. Applicants are urged to consider a number of methodological challenges in this area of research, including the choice of precursor and outcome variables, instruments, and informants; sampling biases; gender differences; the validity of self report and reporting bias; and inclusion of key variables, particularly family history of SUD and of psychiatric disorder. Consonant with the research literature, it is helpful to distinguish substance use initiation and lower levels of use from higher levels of use and the SUDs throughout the study (background, hypotheses, measures, analyses, reporting). Depending on the proposed study approach, careful consideration needs to be given to power analyses, particularly for low prevalence disorders or conditions, and for interactions between variables, e.g. gender and psychopathology. Both categorical and dimensional approaches to psychopathology are encouraged; while a particular disorder may constitute a clear risk factor (categorical approach), sometimes it is the severity of impairment associated with disorder, rather than simple presence of a disorder, that is associated with increased risk for SUD (dimensional approach). Possible approaches Examples of research approaches responsive to this program announcement include, but are not limited to, the following: o The addition of appropriate precursor or outcome measures to ongoing longitudinal studies, including genetic epidemiologic studies, using community-based or clinical samples, to illuminate the temporal ordering and nature of the relationships between child psychopathologic conditions and SUD o Secondary data analyses and meta-analyses of existing longitudinal data sets that include child psychopathologic and SUD data, to explore temporal and etiologic relationships among the disorders o Follow up and recapture studies of mental health treatment and prevention samples, to study whether childhood interventions targeted at psychiatric and behavioral disorders and their symptoms altered drug abuse and other behavioral outcomes in adolescence o Studies of electrophysiologic or other biobehavior markers of potential vulnerability to both child psychopathologic or subdiagnostic conditions and SUD, to better identify high risk children and possible foci for intervention o Addition and evaluation of an SUD assessment or prevention component to current clinical and prevention trials of interventions addressing child or adolescent psychiatric disorders o Studies of possible iatrogenic adverse effects as well as positive or protective effects of childhood interventions on subsequent SUD and other behavioral and developmental outcomes o Research that uses data from intervention studies to propose and test etiologic models for adolescent SUD and other outcomes in adolescence, incorporating childhood psychopathology precursors MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01), small grant (R03) and the exploratory/developmental (R21) award mechanisms. 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 July 2003. The total project period for an R01 application submitted in response to this RFA may not exceed 5 years. For R21 applications, the project period cannot exceed 3 years and $100,000 in direct costs in each of those years. For R03 applications, the project period cannot exceed 2 years and $50,000 in direct costs in each of those years, and the application research plan (items a-d) cannot exceed 10 pages. 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 NIDA intends to commit approximately $2.0 million in FY 2003 to fund 8 to 10 new and/or competitive continuation grants in response to this RFA. NIMH intends to commit approximately $1.0 million in FY 2003 to fund 4 to 5 new and/or competitive continuation grants in response to this RFA. 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 and NIMH 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. At this time, it is not known if this RFA will be reissued. 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 (Foreign applicants are not eligible for the small grant (R03) mechanism) 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 inquiries regarding scientific/research issues to: Naimah Weinberg, M.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-6637 Fax: (301) 443-2636 Email: nw46w@nih.gov Farris Tuma, Sc.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 5197, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 443-5944 Fax: (301) 480-4415 Email: ftuma@nih.gov o Direct your questions about peer review matters 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: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, Maryland 20892-9541 Telephone: (301) 443-6710 Fax: (301) 594-6849 E-mail: gfleming@mail.nih.gov Brian Albertini Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: albertinib2@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 Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 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). 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. It is expected that most of the applications responding to this announcement will fall under the modular grant format. 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: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 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 NIDA and NIMH. 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 NIDA or NIMH 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 and/or the National Advisory Mental Health 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 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: November 22, 2002 Application Receipt Date: December 23, 2002 Peer Review Date: February/March 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. 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. 93.279 (NIDA) and 93.242 (NIMH) 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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