DEVELOPMENT OF TOOLS FOR THE ASSESSMENT OF DEPRESSION RELEASE DATE: July 31, 2002 RFA: MH-03-002 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: September 15, 2002 APPLICATION RECEIPT DATE: October 15, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) invite research applications that apply recent advances in affective science, basic behavioral science, and measurement theory to the development of an instrument or assessment battery to assess depression. The instrument must be psychometrically sound, time-efficient, and suitable for tracking changes in symptoms and functioning as a repeated measure over time or in response to therapeutic intervention. Functional impairments for which treatments would be necessary or beneficial should be defined and assessed in the context of any instrument developed. Measurement development should also aim to reliably and validly distinguish depression from the many other physical disorders with overlapping symptoms, for example, fatigue, sleep problems, and changes in eating behavior. Applications emphasizing method development proximal to the development of a depression assessment tool will also be considered. Collaborations are expected between scientists examining basic behavioral processes, (e.g., emotion, motivation, cognition), researchers studying the behavioral biology of mood disorders, clinical investigators studying the etiology, course or treatment of depression, and experts in contemporary measurement theory. RESEARCH OBJECTIVES Background Depression is a serious mental disorder that ranks as one of the leading causes of disability in developed countries. The core presenting features of depression are essentially psychological in nature, i.e., reports of dysphoric mood, anhedonia, and feelings of hopelessness and guilt. Vegetative signs such as sleep and eating disturbances are also frequently present. While proper assessment is critical to meet the primary purposes of diagnosis (demonstrating presence of pathology, guidance for treatment selection), the assessment of depression has long been difficult due to the subjective nature of reports of disturbed mood and difficulties in knowing which aspects of particular symptoms to emphasize. Historically, diagnostic measures of depression have utilized two modes: patient self-report of symptoms or clinician rating of patient symptoms. Measures in each of these traditions have been widely used for multiple purposes with broad public health implications, including validation of the utility of new medications for treatment and identification of candidates for various treatments of depression. The most widely used instruments in treatment development and clinical settings have relied on global indices of depression (i.e., one summary score of severity of depression), failing to target or provide ratings of specific symptom clusters or dimensions (e.g., sleep difficulties, hopelessness, various forms of cognitive bias) which may reflect more precise targets for treatment. More precise description of symptom clusters derived from empirical advances in the field will likely sharpen the measurement of clinical status and increase the clinical and research utility of depression assessment tools. Advances in depression research and treatment development are highly dependent on the quality of instruments to measure or classify the pathology and its expressed symptomatology. No reliable biological markers or valid behavioral tests exist that could help define the exact nature of depression and disentangle issues of comorbid pathologies, or co-occurring syndromes or clusters of symptomatology. Accordingly, diagnostic and classification systems have principally relied upon clinical description and the naming of behavioral signs and symptoms to define the syndrome (e.g., sad mood, sleep difficulties diminished interest). Recent advances in understanding the nature of depression, its course and treatment, and risk factors for its onset and recurrence invite the development of new tools for assessing components of the disorder. For example, the nature and incidence of depression varies across the lifespan, negative cognitive styles or negative information processing, when coupled with stressful events, place an individual at elevated risk for depression, a ruminative coping style is predictive of longer and more severe episodes of depression and appears to enhance negative cognitions, stressful life events predict the onset of new episodes of depression, hopelessness appears to mediate the relation between the cognitive vulnerability-stress interaction and depressive episodes, and primary depression has been associated with a variety of neuroendocrine, neurochemical, neurophysiological, and neuromorphometric abnormalities. Furthermore, the co-occurrence of major depression with other disorders (e.g., drug/alcohol abuse/dependence) or symptom clusters (e.g., anxiety) tends to be the rule, with "pure" cases of depression presenting in exceptional cases. Theoretical and empirical work in recent years has addressed the co-occurrence of depression and anxiety and there is growing evidence that dimensional factors (e.g., negative and positive affect, physiological arousal) may facilitate our definition of the core components of depression. These recent advances have highlighted a growing realization that depression is not a single entity, but rather a heterogeneous complex of disorders. Assessment tools need to deal effectively with such heterogeneity for several reasons. First, different forms of depression may respond differentially to various treatment modalities, or have a different course. However, the traditional assessment and diagnosis of depression has proved insensitive for the identification of likely responders to existing psychosocial and psychopharmacological treatments. Second, the complete mapping of the human genome raises the possibility of relating disorder subtypes to specific genetic vulnerabilities. Third, advances in techniques to study neuropathophysiological processes facilitate the study of associations between clinical phenomena and the neural substrates of mood and emotion. Refined measurement is a prerequisite for studies that examine such associations, link genetic diatheses to particular forms of disorder, or guide the precise tailoring of future therapeutics. Advancing the field of depression research will require the talents of investigators from diverse traditions working together. In the past decade, investigators in the fields of basic behavioral science and cognitive neuroscience have made significant advances in understanding fundamentals of behavior and brain functioning relevant to mood disorders. For example, there is a well-established literature on the effects of mood on information processing in normal subjects and a complementary literature on information processing abnormalities observed in depressed individuals. Simultaneously, notable advances have been made in the field of measurement theory and psychometrics. Methodological advances in the field of educational psychology, for example, could be particularly informative to investigators developing tools for psychopathology assessment. Also, the use of item response theory would allow depression measurement investigators to examine item bias or differential item functioning in order to develop a tool best protected against group biases. However, there have been limited opportunities for collaboration among scientists with expertise in clinical psychopathology, basic behavior and cognition, and psychometrics. Thus, there exists great opportunity and need for the interdisciplinary collaboration of scientists in the service of advancing the assessment of depression. Investigators responsive to this RFA will assemble an interdisciplinary team (e.g., clinical psychopathology investigators, behavioral scientists, cognitive neuroscientists, psychometricians, and statisticians) appropriate for the development of a measure or assessment battery for depression in the context of recent advances in relevant research areas. This team will use their complementary skills and advanced psychometric techniques, such as item response theory, adaptive testing, and computational modelling, to develop an optimal measure or set of measures for depression. Studies responsive to this RFA will incorporate recent advances in measurement theory and methods when developing the measure and evaluating the instrument"s psychometric characteristics (e.g., construct validity, internal consistency, inter-rater reliability, and test- retest stability), and screening properties (e.g., sensitivity, specificity, and predictive power). The measure must demonstrably be: (1) suitable for tracking changes in symptoms and functioning as a repeated measure over time or in response to therapeutic intervention, (2) time-efficient, and (3) cost-efficient. The tools developed should address validated components of depression such as: depressed mood, hopelessness, anhedonia, psychomotor retardation, sleep disruption, fatigue or loss of energy, diminished ability to think or concentrate, disturbed self-image (i.e., feelings of worthlessness or excessive guilt) and suicidal ideation. Since the number and type of items that are included in a scale will likely obviously influence the total score value, it is expected that the research will include efforts to define core components or dimensions of depression that are supported by empirical data, and which may be useful in assessing severity, guiding treatment decisions, or predicting outcome. To the extent that individual differences in the patterning of severity or impairment across these different dimensions may provide an avenue for addressing the heterogeneity of depression and offering specific targets for treatment, strong consideration should be given to the possibility of batteries with validated subscales in addition to a single, overall depression score. Any measure developed needs to be appropriate for both sexes, individuals of diverse cultural backgrounds, valid for individuals at various stages of development (i.e., children, adults, elderly), and sensitive to individuals with various co-morbid medical conditions. Tools developed must also be suitable for use in diverse settings including clinical trials based in academic centers, community-based mental health centers, drug/alcohol treatment programs and institutions (e.g., jails/prisons). Applications must feature the types of translational partnerships described in the report of the National Advisory Mental Health Council"s Behavioral Science Workgroup, "Translating Behavioral Science into Action" (http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm). An example for this particular initiative would be a partnership between experts in advanced psychometric techniques and clinical psychopathology. Below are examples of research areas and questions that could advance scientific knowledge regarding the description and assessment of depression. The list is not exhaustive, and it is expected that additional important research topics may be identified. o Development of an instrument or set of measures with one or more subscales based upon a theoretical model of depression substantiated by behavioral, psychophysiological, cognitive, self-report, and/or biological measures of the fundamental "core" components of the disorder o Development of a new rating scale to assess proposed core components of depression (e.g., mood lability, guilt and worthlessness, and loss of capacity to experience pleasure). The identification of core components should be guided by empirical evidence of the validity of such components. o Development of an instrument appropriate for children and/or adolescents which is sensitive to developmental stages and relies on multiple informants. o Development of methods for assessing affect regulation which will inform our understanding of the activation and termination of negative affect. o Development of one or more procedures to assess cognitive regulation in depression, such as measures of attention or memory, which demonstrate disorder- related biases. o Development of instruments/procedures to assess fluctuations in vulnerability to depression, such as that resulting from stressful life events, drug/alcohol abuse and medical illness. o Development of new approaches to conceptualizing and measuring depression that incorporate the inherent co-occurrence of various anxiety symptom clusters or disorders (somatic anxiety, social anxiety disorder, generalized anxiety disorder, etc.) o Development of new approaches to conceptualizing and measuring depression in the context of co-morbid medical conditions and their treatment (e.g., hepatitis C, HIV/AIDS). o Development of scales to measure impairment in functioning or quality of life in mood disorders. o Development of new approaches to conceptualizing and measuring depression and vulnerability to depression in the context of drug/alcohol abuse/dependence, including maintenance use, states of intoxication/withdrawal, and enrollment in drug/alcohol treatment. o Development of new approaches to conceptualizing and measuring the relationship of depression to drug/alcohol abuse patterns, (e.g., drugs of choice, polydrug use, bingeing, injection use) and drug/alcohol relapse in individuals with periods of sobriety. MECHANISM OF SUPPORT This RFA will use NIH Research Project Grant (R01) and the Exploratory/ Developmental Grant (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 1, 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. FUNDS AVAILABLE The NIMH intends to commit approximately $1,500,000 in FY 2003 to fund 4 to 7 new and/or competitive continuation grants in response to this RFA. The NIDA intends to commit approximately $500,000 in FY 2003 to fund 2 to 3 new grants in response to this RFA. NIDA"s R21 Exploratory/Developmental announcement can be found at https://grants.nih.gov/grants/guide/pa-files/PA-01-012.html. A research project grant (R01) may involve either a single Principal Investigator or a group of investigators using the Collaborative R01 mechanism, applicants may request a project period of up to 5 years, with a budget determined by the work proposed. Applicants for the Collaborative R01 Grant are strongly encouraged to familiarize themselves with the NIMH announcement (https://grants.nih.gov/grants/guide/pa-files/PA-01-123.html) and direct questions to program staff listed in this announcement. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $125,000 per year for a Developmental/Exploratory Grant (R21). For those applications that include a subcontractual/consortium arrangement, direct costs of up to $150,000 per year may be requested to allow for F&A costs on those consortium arrangements. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) 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 o Faith-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 two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Regina T. Dolan-Sewell, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6183, MSC 9625 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: rdolan@mail.nih.gov Sander G. 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 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-1801 FAX: (301) 594-6566 Email: sgenser@mail.nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: albertib2@mail.nih.gov Gary Fleming, J.D., M.A. Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3119, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.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: Regina T. Dolan-Sewell, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health, NIH 6001 Executive Boulevard, Room 6183, MSC 9625 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: rdolan@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. 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: Jean Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9625 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@mail.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 the participating ICs. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next 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 the 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 Mental Health Council and 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 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: September 15, 2002 Application Receipt Date: October 15, 2002 Peer Review Date: February 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 1, 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 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 http://grants1.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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://web.health.gov/healthypeople/About/ AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH) and 93.279 (NIDA) 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)(or other authorizations) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm (cite other relevant policies) 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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