PAS-03-131: SLEEP DISTURBANCE IN PARKINSON'S DISEASE AND PARKINSON-LIKE CONDITIONS

Department of Health
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SLEEP DISTURBANCE IN PARKINSON'S DISEASE AND PARKINSON-LIKE CONDITIONS RELEASE DATE: June 2, 2003 PA NUMBER: PAS-03-131 EXPIRATION DATE: September 30, 2006 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853, 93.233, 93.837, 93.838, 93.839 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA 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 Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This is a program announcement (PA) with set-aside funds. The PA is designed to stimulate and support research on sleep disorders in Parkinson's disease (PD) and Parkinson's related neurological conditions (PRNC). Support will be for research on PD and PRNC patients as well as patients in appropriate comparison groups and/or healthy control subjects. Responsive applications could deal with the following areas: natural history of symptoms studies, mechanistic studies of the sleep disturbances in PD and PRNC, associated sleep disorders such as Restless Legs Syndrome (RLS) and sleep-disordered breathing (SDB), and studies of the sleep- related effects of pharmacotherapies for PD and PRNC. The timing and scope of this PA are predicated on recent research and clinical findings indicating promising new directions for the diagnosis and care of patients with PD and PRNC. RESEARCH OBJECTIVES Sleep disturbances affect the overwhelming majority of PD patients during the course of their illness. This has significant adverse effects upon quality of life and, in some cases, safety on the road and in the workplace. Medications prescribed for PD may also affect sleep and wakefulness. Drugs that act on dopamine systems can cause or exacerbate underlying daytime sleepiness, and paradoxically, can improve or worsen the quality of nighttime sleep. These problems also extend into the larger population of patients with neurodegenerative disorders that exhibit parkinsonian features collectively referred to in this PA as Parkinson's related neurological conditions (PRNC) and include but are not limited to: Diffuse-Lewy body (DLB) disease, multiple systems atrophy (MSA), and RLS. The wide spectrum and ubiquity of disordered sleep and decrements in daytime arousal in PD and PRNC patients has prompted re-examination of their 24-hour patterns of wake/sleep. Key findings in patients with these conditions are: disrupted nocturnal sleep, greater prevalence of periodic leg movements (PLM) and obstructive and central sleep apnea relative to controls, sleepiness irrespective of their drug therapy, and REM sleep behavior disorder (RBD) as an early manifestation. In RBD, the normal muscle paralysis that occurs during REM sleep is disrupted so that patients retain muscle tone allowing them to "act out" emotionally laden and often violent dreams. RBD, therefore, not only disturbs the sleep of the bed partner, but also can cause injury to patients and others nearby. The natural history of sleep disturbances in PD and PRNC remains unknown, as well as the relationship of sleep disturbances to frequent comorbid conditions such as depression and dementia. Clinical experience and increasing evidence from animal studies and animal-models of these disorders consistently indicate that altered function of dopamine neurons may account for not only the daytime motor symptoms of PD, but also co-morbid disturbances in maintenance of a normal sleep-wake cycle. This PA is intended to encourage and support research on PD patients and appropriate comparison groups, possibly including healthy control subjects. Key objectives of this PA include: (1) a better understanding of the pathophysiological basis of sleep disturbances in treatment-na ve or drug- free PD and PRNC patients, (2) the extent and characteristics of effects on sleep and wakefulness produced by available pharmacotherapies for PD and PRNC, and (3) identification of interventions to reduce the burden of sleep- related symptoms on PD and PRNC patients. Resulting information will improve recognition, diagnosis and treatment of these disorders. Of particular relevance will be studies of mechanisms by which dopamine affects arousal and physiological measures of sleep, investigations of natural history of disturbed sleep in PD, interactions of medical and surgical treatment of PD to disturbed sleep, and neuroimaging or neuropathological characterization of patients with well documented PD-related sleep disturbances. Studies of the relationship between sleep disturbances and commonly prescribed medications that interact either directly or indirectly with dopaminergic systems will also be encouraged. New research has described a previously unknown mesothalamic dopamine system in which the thalamus receives dopaminergic inputs from the same cells as those that degenerate in Parkinson's disease. Another study has found dopamine neurons in the dorsal raphe, a brainstem area rich in serotonin and considered important for the regulation of sleep. These findings suggest heretofore unrecognized mechanisms that may be relevant to sleep disorders in PD. Supportable clinical studies will include patients with other disorders associated with defects in dopaminergic transmission (e.g., DLB, MSA, PLM, and RLS. It is important to better understand the mechanisms by which dopaminergic drugs used outside the realm of PD so profoundly affect sleep and motor function. Such drugs include, but are not limited to, amphetamines and phenothiazines. Since the motor and sleep mechanisms affected by PD seem to interact with other transmitter systems, such as GABA, norepinephrine, serotonin, acetylcholine, histamine, etc., this PA is likely to reveal new understanding of the defects underlying PD as well as new therapeutic approaches. This PA is NOT intended to support clinical trials whose primary aim is to evaluate treatment efficacy for the motor symptoms of PD or PRNC. Examples of research that would be considered relevant to this announcement include, but are not limited to, the following: o Studies on the natural history of sleep and wakefulness symptoms in PD and PRNC. o Studies to elucidate mechanisms by which these conditions affect sleep and wakefulness. o Studies on the inter-relationship between disturbed sleep and impaired wakefulness. For example, to what extent, in these patient groups, do sleep disturbances cause impaired waking function? To what extent are disturbed sleep and impaired wakefulness joint manifestations of the same CNS defect? o Studies to define possible sub-populations of PD and PRNC appropriate for adjuvant pharmacotherapy or modified primary pharmacotherapy, aimed at reducing problems with sleep and/or wakefulness. o Studies to define the extent to which SDB or other sleep disorders contribute to impaired wakefulness in PD and PRNC, including studies of upper airway motorneuron function. o Studies to elucidate abnormalities in the neurobiology of hypocretin and leptin associated with PD or PRNC and leading to altered chemosensitivity or increased upper airway resistance during sleep. o Preliminary/pilot studies to elucidate mechanisms by which pharmacotherapies for these conditions affect sleep and wakefulness. o Preliminary/pilot studies to identify promising interventions to improve the sleep and wakefulness of PD and PRNC patients. o Preliminary/pilot studies to optimize the intervention strategy (e.g., dose, duration, frequency of dosing). For example, studies designed to investigate dose-concentration, dose-response, or concentration-response relationships may contribute to optimal dosage selection to minimize adverse effects on sleep and wakefulness. o Preliminary/pilot studies to assess the appropriate delivery system or parameter settings of an electronic device or surgical technique. o Preliminary/pilot studies to assess the safety and tolerability at various doses or concentrations of a specific intervention. o Preliminary/pilot studies designed to explore pharmacokinetic and pharmacodynamic relationships. Prospective applicants should be aware that, in some cases, especially in connection with protocol and experimental design, there may be convergent objectives between the present PA and the PA entitled, "PILOT STUDIES FOR CLINICAL TRIALS IN NEUROLOGICAL DISORDERS". See: http://grants.nih.gov/grants/guide/pa-files/PAR-01-119.html. It is strongly encouraged that prospective applicants, who are considering a response to the present PA that entails pharmacotherpeutic intervention, discuss the proposal with the Clinical Trials Group at NINDS prior to the submission of the application (contact below). Dr. Scott Janis Clinical Trials Group National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 2210 6001 Executive Blvd Bethesda, MD 20892 301-496-9135 (phone) janisS@ninds.nih.gov MECHANISMS OF SUPPORT This PA will use the NIH research project grant (R01) and the program project grant (P01) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NINDS has set aside $1,500,000 in total costs to fund applications that do not score within the NINDS payline (see NINDS Funding Strategy http://www.ninds.nih.gov/funding/ninds_funding_strategy.htm). The amount and timing of awards paid from set aside funds will depend on the overall scientific merit of the applications and the availability of funds throughout the duration of this solicitation (3 years). NHLBI anticipates funding 1-3 applications with sufficient merit at levels of support similar to NINDS. Assignment will be based on customary NIH referral guidelines. Although the National Institute on Aging (NIA) is not a co-sponsor of this PA, it is interested in the support of research on the disorders of sleep that afflict the older population. As such, the NIA would be interested in meritorious applications submitted in response to this announcement that are relevant to its mission and competitive within its funding plan. 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 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 your inquiries concerning this PA 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: Merrill M. Mitler, Ph.D. Program Director Systems and Cognitive Neuroscience National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 2116 6001 Executive Blvd Bethesda, MD 20892 301-496-9964 (phone) 301-402-2060 (fax) mitlerm@ninds.nih.gov Carl E. Hunt, M.D. Director, National Center on Sleep Disorders Research National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10038 Bethesda, MD 20892-7920 301-435-0199 (phone) 301-480-3451 (fax) huntc@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Karen D. Shields National Institute of Neurological Disorders & Stroke Senior Grants Management Specialist 6001 Executive Blvd, Suite 3290 Bethesda, Maryland 20892 (Regular Mail) Rockville, Maryland 20852 (Courier Service) (301)496-7393 Direct Line (301)496-9231 Main Line (301)402-0219 Fax ks26n@nih.gov Robert Pike National Heart, Lung, and Blood Institute Section Chief, Grants Operations Branch 6701 Rockledge Drive MSC 7926 Bethesda, Maryland 20852 (Courier Service 20817) 301-435-0166 301-480-3310 Fax piker@nhlbi.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) The title, SLEEP DISTURBANCE IN PARKINSON'S DISEASE AND PARKINSON-LIKE CONDITIONS, and the number of this announcement (PAS-03-131) must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the 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 discuss the following aspects of the 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 the application's overall score, weighting them as appropriate for each application. 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 will be assessed. 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 CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. MONITORING PLAN AND DATA AND SAFETY 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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_ 2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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