INTER-RELATIONSHIPS OF SLEEP, FATIGUE, AND HIV/AIDS RELEASE DATE: October 27, 2003 RFA Number: RFA-HL-04-010 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Heart, Lung, and Blood Institute (NHLBI) ( National Institute of Mental Health (NIMH) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.233, 93.853, 93.837, 93.838, 93.839 LETTER OF INTENT RECEIPT DATE: February 13, 2004 APPLICATION RECEIPT DATE: March 15, 2004 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 Special Requirements 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 primary goal of this initiative is to elucidate the etiology of sleep disturbances and fatigue associated with human immunodeficiency virus (HIV) infection and acquired immunodeficiency disease syndrome (AIDS). An improved understanding of this etiology will help in the development of approaches to improve the sleep and quality of life of HIV-infected patients and improve our fundamental understanding of the relationship between sleep and chronic infections in particular and chronic diseases in general. RESEARCH OBJECTIVES Between 850,000 and 950,000 Americans are living with HIV infection and suffering from devastating effects on health, performance, and overall quality of life (QOL). As new therapies extend life expectancy of HIV patients, long term adverse impacts on QOL become increasingly important. Although relatively unstudied, sleep disturbance and fatigue are highly prevalent and disabling symptoms in a majority of individuals infected with human immunodeficiency virus (HIV). Sleep complaints are among the first symptoms of HIV infection and correlate with decreasing CD4+ lymphocyte counts in otherwise asymptomatic HIV seropositive individuals. Fatigue symptoms are associated with increased napping, diminished alertness, difficulty falling asleep, and frequent awakening during sleep. Polysomnographic studies indicate that HIV infection disrupts the normal cycle of alternating rapid eye movement (REM) and non-REM periods associated with restorative sleep; advanced HIV infection is associated with a loss of normal sleep patterns. These impairments in sleep quality may diminish immunological and cognitive-motor function. The onset of these disturbances in sleep architecture occurs early in the course of HIV disease and appears to be a characteristic of the long clinical latency preceding the development of acquired immunodeficiency disease syndrome (AIDS). For patients with HIV infection, sleep disturbance and fatigue interfere with daily activities, diminish the quality of life, and contribute to a greater risk of unemployment. Advanced HIV infection is associated with a loss of normal sleep patterns. Common complications of advanced HIV infection, such as peripheral neuropathy, can also be a source of sleep disturbance and exacerbate fatigue symptoms. Some findings suggest that symptoms of sleep disturbance and fatigue are independently associated with survival among people with HIV infection. Although relatively little is known about the pathophysiology or etiology of sleep disturbances and fatigue in patients with HIV disease, it is known that there are reciprocal interactions between sleep and neuroendocrine and immune factors. For example, immune molecules alter sleep architecture, sleep deprivation alters neuroendocrine and immune responses, immune system activation and neuroendocrine responses alter sleep, and sleep quality appears to affect the course of and susceptibility to infectious diseases in general. Clarification of the relationships among sleep, fatigue, and HIV/AIDS may yield novel possibilities for new ways to study and manage this disease. Studies are needed to elucidate mechanisms associated with both the presence of HIV infection and decrements in sleep and wakefulness. Early immunological responses to peripheral HIV infection are known to alter the profile of circulating cytokines implicated in the regulation of physiological sleep. These acute phase response cytokines are elevated in the blood of HIV-infected individuals, and produce fatigue when administered in human and animal models. Studies are needed to determine whether blood brain barrier permeability to these cytokines is compromised after HIV infection, and to elucidate central mechanisms by which increased cytokine levels alter sleep, the biological clock, body temperature, and other regulators of sleep and wakefulness. Recent findings from animal studies suggest that shedding of the HIV envelope-coat glycoprotein gp120 may mediate at least some sleep abnormalities. Central mechanisms by which HIV gp120 leads to disturbance of sleep and wakefulness need to be elucidated. Sleep disturbances also produce abnormalities in hypothalamic-pituitary- adrenal (HPA) axis hormone secretions such as cortisol and growth hormone. It is not well understood, however, to what extent these sleep-related abnormalities contribute to the acute phase response of HIV infection, the progressive decline in humoral and cellular immunity, the decline of neuropsychological function in AIDS-related dementia, and the wasting syndrome associated with late-stage AIDS. The severity of sleep disturbance and potential developmental consequences of pediatric and especially infant HIV have also not been studied. Research is needed to elucidate the relationship of peripheral neuropathy and other symptoms of advanced HIV infection to sleep disturbance and fatigue. HIV infection may also increase the risk of sleep disordered breathing. Adenotonsillar hypertrophy is an early manifestation of HIV infection and can lead to reductions in upper airway dimensions that increase the risk for sleep-disordered breathing in HIV-infected adults compared to the general population. Accumulating evidence indicates that mild to moderate sleep-disordered breathing may be an independent risk factor for hypertension, cardiovascular disease, and stroke. Whether HIV infection modifies these risks is unknown. Studies are needed to determine the epidemiological risks, natural history, and causal mechanism(s) linking HIV-related infections, lymphadenopathy, and other complications of HIV infection to an increased risk of sleep-disordered breathing. Screening instruments and optimal treatment regimens for airway obstruction also need to be developed since available surgical treatment approaches indicated in selected patients present significant added risks for HIV-infected adults. Insomnia, independent of drug or alcohol use, appears to be a highly prevalent and under-diagnosed disorder in patients with HIV-infection. It is also a common side-effect of anti-retroviral therapies used in HIV treatment. Epidemiological and clinical research are needed to elucidate the neurological and neurobehavioral characteristics of insomnia in HIV-infected individuals, the role in the progression of HIV infection, and the relationship to other symptoms of HIV infection including pain, anxiety, and depression. Developing biomarkers and imaging techniques that define brain sites associated with insomnia may lead to indicators alerting to potential HIV infection. There are a number of research directions that could be pursued to elucidate the etiology of sleep disturbances and fatigue associated with HIV infection and AIDS. Clinical and animal model based research using mechanistic neurophysiological, neuroanatomical, and pharmacological approaches are encouraged. Examples of studies that would be responsive to this program include but are not restricted to the following: o Elucidate mechanisms underlying sleep abnormalities and circadian dysrhythmia in human HIV/AIDS, or in animal models infected with viruses comparable to HIV. o Elucidate the cellular or neural basis for changes in the regulation of biological clock and homeostatic sleep mechanisms responsible for entrained and free running circadian rhythms as a function of infection with viruses comparable to HIV. o Identify potential exacerbating effects of sleep and circadian disturbance on the severity of HIV infection and progression to AIDS, or in animal models infected with viruses comparable to HIV. o Identify abnormalities in restorative functions of sleep contributing to symptoms of fatigue and excessive daytime sleepiness as a function of HIV infection and AIDS. o Elucidate mechanisms linking sleep and circadian disturbances in HIV/AIDS to cardiopulmonary, endocrine, immunological, and other pathophysiological sequalae of HIV infection and AIDS. o Elucidate sleep abnormalities contributing to HIV-related neurocognitive dysfunction and excessive daytime sleepiness. o Identify differences in sleep/alertness among HIV/AIDS patient groups that vary with respect to peripheral nerve pathology. o Elucidate biological, cellular, and molecular mechanisms by which HIV or HIV viral proteins interact with the host to disturb normal sleeping patterns, and the interactions between the HIV proteins and primary and secondary targets in the central nervous system. o Elucidate the effects of sleep disturbance and fatigue on HIV disease progression, as indicated by immunological and clinical indicators of disease progression, and identify biological mediators and biomarkers of such interactions. MECHANISM OF SUPPORT This RFA will use NIH R01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgetingas well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at FUNDS AVAILABLE The NHLBI intends to commit approximately $2,000,000 and NIMH approximately $500,000 in FY 2004 to fund four to five new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to four years and a budget for direct costs of up to $350,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application 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. SPECIAL REQUIREMENTS In order to be considered responsive to this announcement, applications must propose hypothesis-driven studies that focus on elucidating the etiology of sleep disturbances and fatigue associated with HIV infection and AIDS. Studies of sleep disorders must be closely coupled to the goal of elucidating pathophysiology associated with HIV infection and AIDS in order to be considered responsive to this RFA. Applications focused on the transfer of established methods or overcoming technical barriers such as the measurement of sleep will not be accepted. Applications centered on developing large cohorts for epidemiology or interventions for HIV/AIDS or sleep disorders would not be appropriate. Collaborations and consortia promoting interdisciplinary approaches between scientists studying the pathophysiology of HIV infection and AIDS and sleep or circadian researchers are strongly encouraged. In such cases, each participant's contribution should be identified and well-integrated into the overall experimental design. Applications proposing to include data collection from normal human subjects or animal models must provide a strong rationale that is clearly relevant to the goal of elucidating the etiology of sleep disturbance and fatigue associated with HIV infection and AIDS. Upon initiation of the program, the sponsoring Institutes may organize periodic meetings to encourage the exchange of information among investigators who participate in this program. Travel funds for a two day meeting each year, most likely to be held in Bethesda, Maryland, must be included in the budget calculation. Applicants must include a statement indicating their willingness to participate in these meetings. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Michael J. Twery, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: Kathy Kopnisky, Ph.D. Center for Mental Health Research on AIDs National Institute of Mental Health 6001 Executive Boulevard, Room 6199 Bethesda, MD 20892-9619 Telephone: (301) 443-7726 FAX: (301) 443-9719 Email: o Direct your questions about peer review issues to: Anne Clark, Ph.D. Chief, Review Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7214, MSC 7924 Bethesda, MD 20892 (20817 for express/courier service) Telephone: (301) 435-0270 FAX: (301) 480-3541 Email: o Direct your questions about financial or grants management matters to: Robert Pike Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: 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 by mail or E-mail to Anne Clark at the above address. 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 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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at 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: 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 and all five collated sets of appendix material must be sent to Anne Clark at the above address for peer review questions. 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 assignment 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 the NHLBI and NIMH. Incomplete and/or nonresponsive applications will not be reviewed. 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 National Heart, Lung, and Blood Institute 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 an appropriate national advisory council or board. 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 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 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? 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? 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)? 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). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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 13, 2004 Application Receipt Date: March 15, 2004 Peer Review Date: May-June, 2004 Council Review: September, 2004 Earliest Anticipated Start Date: September, 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. DATA AND SAFETY 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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 "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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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 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 ( 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 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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 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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