RFA-DA-01-014: RESEARCH ON GHB AND ITS PRECURSORS

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RESEARCH ON GHB AND ITS PRECURSORS Release Date: January 25, 2001 RFA: RFA-DA-01-014 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 19, 2001 Application Receipt Date: April 17, 2001 THIS REQUEST FOR APPLICATIONS (RFA) USES THE "MODULAR GRANT"AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Drug Abuse (NIDA) announces the availability of funds to support research on the drug gamma-hydroxybutyrate (GHB) and its precursors, gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD). This request for applications (RFA) is being issued in response to the recent emergence of GHB, GBL, and 1,4-BD as public health concerns. Abuse of GHB is a novel phenomenon, whose future impact on society is uncertain. NIDA intends to support a broad range of scientific research that is expected to lead to a reduction in the abuse of these sedative-hypnotic "club drugs", and to the development of treatments for GHB abuse. An RFA, "Responding to Club Drugs and Other Emerging and Current Drug Abuse Trends," DA-01-010, has been issued concurrently with this RFA. Applicants whose research interests appear to be suited to both DA-01-010 and the present RFA may wish to contact NIDA program staff listed under INQUIRIES. 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, Research On GHB and its Precursors, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Foreign institutions are not eligible for R03 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) traditional research project (R01), small grant (R03), and exploratory/developmental grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2001. Support may be requested for a period of up to five years for R01 grant, two years for R03 grant (http://grants.nih.gov/grants/guide/pa-files/PAR-97-038.html), and three years for R21 grant (http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html). FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2001 to fund 6 to 10 new and/or competitive continuation grants in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plan of NIDA provides support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background GHB abuse is a recent phenomenon with uncertain medical, behavioral, and social outcomes. GHB is also associated with novel production and drug trafficking and distribution systems. GBL and 1,4-BD are industrial solvents, and like other abused solvents, their supply is difficult to control. Because of this difficulty, the need for effective demand reduction approaches is great. GHB and its precursors were legally available to consumers for many years in the U.S. as dietary supplement products, but recently GHB was scheduled under the Controlled Substances Act, and GBL became a List I chemical. 1,4-BD is not scheduled under federal guidelines, however, the Food and Drug Administration (FDA) has declared 1,4-BD a Class I Health Hazard. GHB has a distinct neuropharmacology, a specific receptor, unique metabolic and regulatory relationships to major neurotransmitters in the central nervous system (CNS), and unique discriminative stimulus effects. While GHB is naturally present in the brain, and appears to have vital physiological roles, the ingestion of GHB can readily achieve concentrations in the brain several orders of magnitude greater than normal. Both 1,4-BD and GBL are readily metabolized to GHB, therefore, the term "GHB" is used in most instances in this RFA to encompass all three related substances. When GHB or its precursors are abused, the resulting high concentrations of GHB obtained in the brain impact on brain systems not normally involved in GHB physiology, and may result in adverse acute (e.g., coma, aspiration pneumonia, death) and chronic (e.g., tolerance, addiction, severe withdrawal) consequences. Moreover, given the recent changes in the availability of lactone solvents, it is not known what contaminants are present in illicit sources of GHB. Improved prevention and treatment of GHB abuse will result from a better understanding of normal GHB system physiology, biochemistry, and ontogeny, analytic methods to assess GHB in the body, GHB (and precursor) pharmacology and toxicology, epidemiological patterns and trends of GHB abuse, vulnerability and resiliency factors for GHB abuse, and long-term neurobiological, behavioral, and medical consequences of GHB abuse. Cross-disciplinary and multi-disciplinary approaches are encouraged in responding to this RFA (e.g., ethnographic approaches, epidemiological investigations, genetic, pharmacological, behavioral, and neurobiological studies), as are collaborative research endeavors between basic and clinical investigators. NIDA invites researchers to consider a broad range of scientific studies using human subjects and preclinical models in the basic science, prevention, and treatment of GHB abuse, as illustrated in the examples listed below. In all these examples, researchers are encouraged to incorporate a gender analysis in their research design. Studies within a developmental context are of particular interest, since most GHB abusers are young. Moreover, a pharmacological antagonist of the GHB receptor, NCS-382 (6,7,8,9-tetrahydro-5-[H]benzocycloheptene-5-ol-4-ylidene acetic acid), is available through NIDA’s Drug Supply Program and may be particularly useful in pharmacological studies. GHB and its precursors may have specific, legitimate medical uses in selected patient populations, e.g., for the treatment of narcolepsy. Research involving therapeutic applications or putative therapeutic applications of GHB or related substances is not within the scope of this RFA. Research related to the possible utility of using GHB or related substances in the treatment of drug dependence on other substances (e.g., opiates, alcohol) is not within the scope of this RFA. Research Areas In particular, research is needed in the following areas: o abuse liability, reinforcing properties, and subjective effects, o long-term consequences (e.g., tolerance, dependence, withdrawal), o patterns of abuse and population trends, o effects of Internet marketing and distribution on abuse, o basic pharmacology and physiology of GHB, o overdose and toxicity, and o prevention and treatment strategies. The research gaps and issues outlined below are examples suggested to assist investigators in research on the problems and consequences of GHB abuse. Researchers are invited to address other issues and problems associated with GHB abuse that are not specifically outlined in the examples below. Epidemiological Studies o Characterize trends in GHB abuse by geographic area and according to demographic and other subpopulation variables (e.g., use by bodybuilders, use at raves or circuit parties). o Identify subpopulations of GHB abusers, their reasons for use, and associated patterns of use, including combination with other abused substances, and adverse consequences. o Identify the individual and environmental factors associated with vulnerability to begin and continue GHB abuse and to experience the adverse consequences of abuse. o Determine the roles of social networks and group dynamics in leading to diffusion of use and in maintaining long-term use,. o Determine the role for GHB withdrawal symptoms in continued GHB abuse. o Measure vulnerability, protective, and resiliency factors for GHB abuse and addiction at the individual, situational, and community levels. o Describe the health, behavioral, and social consequences of GHB abuse. o Determine the extent and basis of public perceptions and knowledge of GHB. o Characterize the role and influence of the Internet on patterns and trends of GHB production, marketing, distribution, and abuse. o Perform research to evaluate the impact of the recent FDA scheduling on GHB abuse and illicit drug choice. Preclinical Studies o Examine GHB’s pharmacological mechanisms, toxicology, pharmacokinetics, and interactions with ethanol and other drugs. o Characterize the normal biochemistry, molecular and cell biology, physiology, and function of endogenous GHB systems, and their pathophysiology, as may relate to GHB abuse. o Develop animal models to study motivational processes, environmental influences, and genetic factors that influence the acquisition and maintenance of GHB abuse, and identify associated neural substrates. o Identify consequences of acute and chronic GHB administration on sensory/perceptual, behavioral and cognitive processes. o Characterize GHB tolerance, dependence, and relapse, and study the mechanisms and dynamics underlying these phenomena. o Determine if acute or long-term administration of GHB induces neurotoxicity. o Examine possible ontogenetic consequences of GHB exposure, and characterize effects of GHB at various stages of development. o Identify relative reinforcing and subjective properties of GHB in comparison with other, better-characterized, drugs of abuse, using self- administration and other animal behavioral models. o Examine the mechanisms underlying the GHB withdrawal syndrome, including the study of potential treatments to ameliorate this withdrawal syndrome and determine if the precursors of GHB induce a different withdrawal syndrome. o Determine the effects of contaminants present in illicit sources of GHB. Clinical Investigations o Characterize the relative subjective, affective, cognitive and performance effects of acute GHB in human subjects. o Examine how GHB abuse affects choices to engage in high-risk behaviors (e.g., sexual risk taking, HIV exposure). o Examine tolerance, dependence and withdrawal and identify strategies for the management of withdrawal syndromes in clinical populations. o Explore both behavioral and pharmacological approaches to treating GHB addiction, or addiction with GHB-polydrug combinations, and the consequences of addiction. o Develop and improve methods for diagnosing, treating, and increasing physician awareness of GHB overdose and poisoning, including research aimed at developing and improving rapid analyses for GHB that can be used in medical emergency care settings. o Develop and improve assays for detecting previous exposure to GHB that might be useful following GHB-facilitated assault. o Examine pharmacokinetics and characterize pharmacological actions (including receptor binding profiles and effects on brain function) of acute and chronic GHB in GHB and GHB-polydrug abusers. o Determine if there are persistent effects of GHB abuse on cognitive processes including learning and memory. o Study potential neurotoxic effects using neuroimaging, post-mortem investigations, or other approaches. Prevention Studies o Use epidemiological and etiological data to identify potential preventive intervention strategies that target GHB abuse (i.e., hypothesis development research). o Conduct qualitative research to identify strategies communities are using to prevent GHB abuse and to assess the efficacy of these approaches. o Evaluate the efficacy for preventing GHB abuse of existing drug abuse prevention programs designed to target other drugs of abuse. o Evaluate universal preventive interventions adapted to target GHB abuse, and the unique predictors of GHB abuse, including, for example, brief, context-specific interventions delivered in settings where the drug is often used. o Study selective and indicated interventions targeted at high-risk groups (e.g., participants at rave or circuit parties, men who have sex with men, etc.). o Assess the impact of policy change on GHB use, including identification of the types of policies communities are developing, the impact of policy change and policy enforcement on use, and identification of the strategies used to implement policy in contexts where GHB is used (e.g., demands placed on clubs to ensure a GHB-free environment, club staff training programs). o Explore the use of the Internet as a vehicle for innovative dissemination of prevention interventions. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA"s Home Page at http://www.nida.nih.gov under Funding or may be obtained by calling (301) 443-2755. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. Send the letter of intent (by receipt date listed in the heading of this RFA) to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier/express service) Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions). The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and their role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) 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 Research (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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDA. 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 review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: 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? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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 The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: March 19, 2001 Application Receipt Date: April 17, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 30, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit (as determined by peer review), availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jerry Frankenheim, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-1312 FAX: (301) 594-6043 Email: jfranken@mail.nih.gov Direct inquiries regarding review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 E-mail: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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