RFA-DA-01-010: RESPONDING TO CLUB DRUGS AND OTHER EMERGING AND CURRENT DRUG ABUSE TRENDS

Department of Health
and Human Services (HHS)

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RESPONDING TO CLUB DRUGS AND OTHER EMERGING AND CURRENT DRUG ABUSE TRENDS Release Date: January 25, 2001 RFA: RFA-DA-01-010 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 16, 2001 Application Receipt Date: April 16, 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 THE APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Drug Abuse (NIDA) invites applications for research projects responding to emerging and current drug abuse trends. The recent alarming increase in the use of "club drugs" (such as "ecstasy," methamphetamine, GHB, and Ketamine), increase in the use of anabolic steroids among high school students, and the reported use of heroin among adolescents and young adults illustrate the varied and dynamic nature of contemporary drug abuse trends. National and community-based reporting systems reveal regional and local variation in these trends. "Current" trends are included in this RFA in recognition that a trend that is emerging in one area may be well-entrenched or "current" elsewhere. New drugs of abuse and new patterns of use of drugs may emerge rapidly or may gradually diffuse across communities and populations providing a window of opportunity for intervention to prevent further escalation of the pattern and to reduce the health, social, and behavioral consequences. The current state of scientific knowledge concerning the specific patterns and dynamics of contemporary drug abuse trends and associated consequences is somewhat limited. This information is essential to effective and timely local community-based public health response. This RFA will support research to characterize the nature and extent of emerging/current drug abuse trends within local contexts and identify associated health, social, and behavioral consequences; to elucidate individual, social, cultural, and contextual factors influencing drug using behaviors; to enhance our ability to identify, monitor, and assess emerging drug abuse trends; to reveal processes and patterns of development and diffusion of new drug trends; and to identify community- or context-specific prevention and health services needs and interventions. An RFA, "Research on GHB and its Precursors," DA-01-014, has been issued concurrently with this RFA. Applicants whose research interests appear to be suited to both DA-01-014 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, "Responding to Club Drugs and Other Emerging and Current Drug Abuse Trends," 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. Awards to foreign institutions under R-series awards are generally limited to 3 years. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01), small grant (R03), and exploratory/developmental (R21) award mechanisms. The total project period for an application submitted in response to this RFA may not exceed five years for the R01, two years for the R03, and three years for the R21. 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. For research in methods development, the R03 or R21 mechanisms are particularly appropriate. Both are non-renewable and limited in direct cost amount per year (R03, $50,000; R21, $100,000). The R03 mechanism gives funding priority to newer, less experienced investigators, investigators at institutions without well-developed research traditions and resources, or experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific information on individual research mechanisms can be obtained from the NIDA home page at http://www.nida.nih.gov/Funding.html. FUNDS AVAILABLE NIDA intends to commit approximately $1,500,000 in FY 2001 to fund four to six new and/or competitive continuation awards in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $400,000 per year for R01s. 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 plans 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 The predominant drug abuse trends, which emerged in the 1990's, include a broad range of substances with very different pharmacologic properties, physiologic effects, and potential consequences. The term "club drugs" refers to drugs that are being used at all-night dance parties, such as "raves," and in dance clubs. In its Community Drug Alert on Club Drugs issued in December, 1999 (www.nida.nih.gov/ClubAlert/Clubdrugalert.html), NIDA describes six club drugs including MDMA ("Ecstasy" or "E"), Gamma- hydroxybutyrate (GHB), Ketamine, Rohypnol, Methamphetamine, and Lysergic Acid Diethylamide (LSD). Other substances may also be used in the dance club and rave contexts. The dance club and rave subcultures appear to be characterized by an openness to the use of different types of substances, thus fostering environments for the introduction of new drugs. Drugs may also be combined, either in one administration or in a sequence, to produce a sustained or specific desired effect. Research has shown that use of club drugs can cause serious health problems and, in some cases, death. For example, the stimulant effects of MDMA, which enable users to dance for extended periods, may also lead to dehydration and heart failure. Although the designation "club drugs" suggests a specific context for use, research suggests that these drugs are used in non-club, non-rave contexts as well. In April, 2000, NIDA issued a Community Drug Alert in response to the observed increase in the use of anabolic steroids among adolescents (www.nida.nih.gov/SteroidAlert/SteroidAlert.html). Research shows that over time anabolic steroids can take a heavy toll on health, and abuse of oral or injectable anabolic steroids is associated with increased risk for heart attacks and strokes. Needle sharing or non-sterile injection techniques present risks for contracting infections such as HIV, hepatitis B and C, and bacterial endocarditis. Reports of increases in the use of heroin among high school and college students indicate another current trend of public health concern. The increased availability of consistent high purity heroin suitable for intranasal use along with decreases in price appear to have led to a wider acceptance of this drug in young populations in which heroin had not previously been popular. Evidence in some cities suggests that users may be transitioning from intra-nasal use to injecting. Increases in heroin-related emergency department episodes and deaths have been reported in several cities. "Trend" refers to a change in specific drug use prevalence over time, as well as to style or preferences associated with the use of specific drugs. New drug trends primarily relate to substance specific factors (e.g., the introduction of newly developed substances or substances not previously available, changes in mode of administration, new conventions or styles of use) or population specific factors (e.g., use of a substance in a population where it had previously not been used, use in a new context, etc.). In each of the examples of emerging/current trends cited, while there are indications of the direction of changes in the prevalence of use of specific drugs, there is limited information about the magnitude of changes and substance- and population-specific factors. Very little is known about the characteristics of users of particular drugs; drug use behaviors, contexts, and norms; factors influencing specific trends; and the health, social, and behavioral consequences. This information is essential to the identification of services needs and for the development of timely interventions. A major objective of this RFA is to address these gaps in our knowledge about emerging and current trends in order to facilitate the provision of needed health services and to develop timely and effective interventions tailored to specific drug using behaviors and contexts. While this RFA encourages research proposals on the three trends mentioned in this RFA, studies need not be limited to investigation of these trends. The identification of emerging trends is affected by the sensitivity of methods to detect new trends in different populations and across various locations. New trends have emerged in a broad range of social contexts. Drug abuse monitoring, timely assessment, and intervention approaches may be influenced by a range of variables including characteristics of drug users, pharmacologic and health effects of abused drugs, drug using contexts, conventions of use of different drugs, and environmental and community factors. This RFA will support research on models to better understand the emergence, development, and diffusion of drug trends; and methods for the early detection and timely assessment of new trends and consequences in various population subgroups and settings. This RFA will support community- and context-based epidemiologic (including ethnographic), prevention, and health services studies on key components of public health research and response relevant to emerging and current drug use trends. Researchers are encouraged to incorporate gender analyses, as appropriate, in the research plan. Studies limited to describing drug use subcultures without addressing the relevance for health are not within the scope of this RFA. Areas of Research Focus Illustrative examples of research areas within the scope of this RFA are outlined below. The following examples serve as a guide and are not meant to subsume all research topics that would be appropriate to the study of emerging and current trends under this RFA. o Characterize the nature and extent of specific drug use trends within local community and/or drug use contexts. Describe context-specific drug use behaviors, including routes of administration of specific drugs, use of drugs singly or in combination, timing or sequencing of multiple administrations or combinations, and/or patterns of social interaction associated with use of the drug/s. Explore the range of contexts/settings in which drugs are used (e.g., for club drugs, investigations of use in other settings). o Describe health, social, and behavioral consequences of use of specific drugs, drug combinations, and associated behaviors (e.g., continuous dancing and dehydration). Assess the influence of contextual factors (e.g., in clubs, outdoor raves, gyms) on consequences. o Assess the influence of community and contextual factors on drug use and associated risk behaviors. o Study the emergence and development of drug trends, and describe processes of diffusion of drug trends across communities. Particularly of interest is whether and how club drugs are diffusing out of clubs and specialized sub- cultural contexts, such as raves, into other contexts and populations. o Examine the roles of youth social networks, subcultures, and technology (e.g., Internet) in the development and diffusion of drug trends and in the dissemination of information about benefits, risks, effects, and consequences of use of specific drugs and drug combinations. o Explore how social networks and technology (e.g., Internet) might be used in preventing use of club drugs. o Investigate the knowledge, perceptions, attitudes, and norms of drug users and vulnerable populations with respect to specific drugs and drug use behaviors. Determine the sources of information on drugs and associated consequences utilized by drug users, and explore reasons for use and non-use of specific drugs. o Examine the marketing, distribution, and sales of drugs, including the roles of social networks, technology (e.g., Internet, cell phones), and street-based and situation-based (e.g., clubs, gyms) transactions. o Develop brief targeted interventions that are population or context specific; particularly, approaches which can be implemented and administered quickly and at low cost. o Develop models for community-based information dissemination. Studies should assess the role of community and service delivery factors in the effective and rapid dissemination of public health information and should result in practical guidance that can be utilized by communities. Assess the impact of the availability of this public health information on drug use patterns. o Assess health services needs and factors impacting provision of services, particularly as they relate to acute health consequences and the provision of emergency services. o Develop models and methods for identification and monitoring of emerging and current trends (and associated consequences) in different populations and settings. Studies should consider the impact of various factors such as location (e.g., urban, rural, suburban), community structure (e.g., geographic or political community boundaries; shared identity such as sexual orientation, ethnicity, recreational preference), and drug using context on the feasibility of models. o Develop models and methods for timely verification and assessment of emerging trends in different populations and contexts. o Methodological studies on collection of data in different populations and contexts. SPECIAL REQUIREMENTS Meeting Principal Investigators of grants resulting from this RFA will be asked to participate in meetings to be convened during the second and third (if applicable) funding years to report progress, discuss problems, and share information on emerging and current trends related to the conduct of their grants. Requests for funds to support attendance at these meetings, to be held in the Washington, D.C. area, should be included in the budget request. 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 these policies. 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. 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. 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 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 Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA 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 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 methods? 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. Schedule Letter of Intent Receipt Date: March 16, 2001 Application Receipt Date: April 16, 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: Moira O Brien, M.Phil. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 402-1881 FAX: (301) 443-2636 E-mail: mobrien@nida.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 E-mail: 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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