GENETICS OF DRUG ADDICTION VULNERABILITY Release Date: September 15, 1998 RFA: DA-99-003 P.T. National Institute on Drug Abuse Letter of Intent Receipt Date: December 28, 1998 Application Receipt Date: January 27, 1999 PURPOSE This Request for Applications (RFA) solicits investigator-initiated applications for research projects that identify genetic variation that increase vulnerability to addiction, or dependence on, stimulants (e.g., cocaine and amphetamine), narcotics (e.g., opiates), nicotine, benzodiazepines, barbiturates, cannabis, hallucinogens and/or multiple drugs of abuse. Thus, applications examining the genetics of addiction vulnerability to both illicit and legal drugs of abuse are relevant to this RFA. Genetic approaches within the scope of this RFA are linkage, linkage disequilibrium, and association studies. Data may be collected from the general population, population isolates, and/or recent admixed populations. Standard and novel methods of analysis for the identification of genetic variation conferring vulnerability to a complex genetics disorder such as drug addiction are highly encouraged. The creation of new diagnostic instruments is not within the scope of this RFA. Investigators proposing such a goal will be deemed unresponsive to this RFA. Priority will be given to applications with sufficient statistical power to identify genetic variations or chromosomal locations of the genetic variations associated with increased addiction vulnerability. Another priority consideration is the speed at which data collection and genetic analysis take place. To achieve sufficient statistical power, efficient data collection, and rapid genetic analysis, investigators may need to establish multidisciplinary and multisite efforts. Interested investigators are advised to discuss their plans with National Institute on Drug Abuse (NIDA) staff and visit the NIDA Genetics Workgroup homepage for more details: http://www.drugabuse.gov/about/organization/Genetics/about_genworkgroup/index.html". To facilitate the development of collaborations among drug addiction researchers and scientists with expertise in genetics and molecular biology prior to the submission of applications, a moderated bulletin board has been established on the NIDA Genetics Workgroup home page. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Genetics of Drug Addiction Vulnerability, is related to many priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit, public and private organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. The collection of clinically well characterized samples of sufficient size for linkage analyses and for linkage disequilibrium mapping studies in genetically isolated populations may be facilitated by the establishment of international consortia. Collaborations among U.S. scientists and scientists at foreign institutions are encouraged, when scientifically appropriate. In these cases, awards may be made to foreign institutions or to domestic applications that include foreign components. Foreign institutions are not eligible for program project (P01) grants. MECHANISM OF SUPPORT Applicants may apply for a regular research project (R01) grant or program project (P01) grant. The P01 mechanism supports broadly based multidisciplinary research programs that have a well defined, central research focus or objective. An important feature is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The P01 consists of a minimum of three interrelated individual research projects that contribute to the overall program objective. To achieve sufficient statistical power or needed expertise these projects may be located at more than one institution. This type of award can also provide support for certain shared resources, termed cores, that provide funds for tasks common to two or more projects within the award. NIH limits the time period for P01 grants to 5 years. The cover letter and abstract should indicate the type of mechanism for which the applicant is applying. Specific information on individual research mechanisms can be obtained from the NIDA home page at http://www.nida.nih.gov/Funding.html. FUNDS AVAILABLE This RFA is a one-time solicitation. It is anticipated that $7.0 million (including direct and indirect costs) will be available for this initiative in Fiscal Year 1999 and Fiscal Year 2000. Funding in future years will be subject to the availability of funds. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will also vary. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Future unsolicited competing continuation applications will compete with all investigator-initiated applications, and will be reviewed according to the customary peer review procedures. RESEARCH OBJECTIVES Background Evidence from adoption and twin studies, from genetic strains of rodents, and from induced mutations in mice, suggests that heritability may play a role in vulnerability to addiction. The genetic variation underlying increased vulnerability to drug addiction is as of yet unknown. However, new scientific opportunities may now make it possible to identify and characterize the genetic variations that contribute to addiction vulnerability. This knowledge will improve diagnosis, prevention, and treatment of drug addiction. By better understanding the genetic factors involved in the addiction process, the environmental contributions to this disease can also be better understood. Significant advances in molecular and statistical genetics have now made it possible to identify the etiology of a disease through genetic means without any other biological knowledge. The power of the genetic approach for neuroscience is evidenced by the recent positional cloning of genetic variations associated with many cases of Alzheimer's Disease and rare forms of Parkinson's Disease. Animal models of these genetic disorders are now being created using transgenic technology. These models provide a greater understanding of the underlying biology of the disease. These and related approaches are likely to have applicability to the brain disease of addiction, even though no evidence documents that it follows a strictly Mendelian pattern of inheritance in humans. The challenge for the molecular genetics of addiction, like many other complex genetic disorders lacking simple patterns of Mendelian inheritance in humans, is addressing the complexity of polygenic disorders with substantial environmental influences. Continued advances during the next 5-10 years will enhance the study of the molecular genetics of addiction vulnerability. SPECIAL REQUIREMENTS 1) Phenotype(s) For purposes of recruitment, applicants are expected to select affected probands and to define unaffected individuals on the basis of criteria documented as significantly heritable by current twin and/or adoption studies. Information about drug use, quantity, frequency criteria, and diagnostic criteria (such as the DSM-III-R or DSM-IV criteria) that have been shown to have significant heritability in twin and/or adoption studies could provide one approach to defining phenotypes of affected and unaffected individuals. The rationale for selecting unaffected as well as affected individuals must be clearly justified. Diagnoses should be established from clinical information obtained with structured or semi-structured assessment instruments with high diagnostic reliability, e.g., the Structured Clinical Interview for DSM-IIIR or IV (SCID), the Psychiatric Research Interview for Substance and Mental Disorders (PRISM), the Structure Clinical Assessment for Neuropsychiatry (SCAN), the composite International Diagnostic Interview (CIDI), the CIDI-Substance Abuse Module (CIDI- SAM), the Diagnostic Interview Schedule (DIS), and the Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS). The inclusion of other phenotypic markers is highly encouraged. The characterization of a phenotype is to be based on sound scientific evidence and reasoning. Examples of possible phenotypes include specific diagnostic categorizations, presence or absence of biological markers, or exhibition of unique individual traits, as well as combinations of these or co-morbid conditions and other phenotypic markers. The creation of new diagnostic instruments is not within the scope of this RFA. Investigators proposing such a goal will be deemed unresponsive to this announcement. 2) Subjects and Samples Subjects may be recruited from treatment facilities, the general population, genetically isolated populations, or from a recently admixed population to implement case-control, nuclear family or extended pedigree research designs. Applications employing genome wide scan and/or association strategies are encouraged. The employment of innovative genetic models, pedigree structure, and methods of analysis for the identification of genetic variations conferring vulnerability to a complex genetics disorder such as drug addiction is highly encouraged. Applicants must justify the adequacy of the proposed target sample size as feasible and adequate for the identification or localization of genetic variation for the addictive disorder under study, given the assumptions underlying the genetic model being used and the proposed methods of analysis. 3) Management Since quality control and consistency across sites are of utmost importance, applications that include multiple sites must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross site comparability of training to assure reliability and quality control. Likewise, a data management plan by a single investigator at a single site using a R01 type mechanism should be described. 4)Electronic Databases. It is expected that applicants will have developed, or have access to, a high quality, computerized database for data entry, storage, and analyses of large amounts of data including clinical information, family structure, diagnostic criteria, and genotype data. As a condition of award, it is expected that the Principal Investigator provide a plan for dissemination of these data as described below. The minimum data set for each subject must include unique family and individual identification numbers (such that access to the database will not reveal the true identity of the subjects), sex, date of birth, ethnicity/geographical origin of ancestry (including, if possible, ethnicity of both parents and grandparents), MZ/DZ twin status (if appropriate), DSM-IIIR and DSM-IV diagnoses, quantity and frequency of peak lifetime use of all addictive substances, age of onset, comprehensive clinical information with individual item scores obtained through a structured interview, and other relevant phenotypic data. Other data may be included. Associated with these data will be all genotype information, including but not limited to, DNA marker names, allele size in base pairs and corresponding frequencies, and relative map distances. These data will be widely distributed to the scientific community, according to a plan proposed by the Principal Investigator and approved by NIDA. 5) Cell Lines and DNA Extraction It is expected that investigators will obtain blood samples from all individuals entered into the study and create immortalized cell lines, unless strong scientific justification can be provided for exemption of the study design from this requirement. DNA is to be extracted from these lines for wide dissemination to qualified investigators in the scientific community and for use in genetic analysis in accordance with the Data Sharing Plan (see below). Applicants may request funds to defray the costs of this task. Exemption from the requirement of creating immortalized cell lines may be granted if scientifically justified. 6) Quality Control Since quality control of data accuracy is essential to the execution of genetic analyses, applicants are expected to provide details of how the data can be verified and updated throughout the project. The methods of verification are also to be included in the Data Sharing Plan. 7) Molecular, Genetic, and Statistical Analysis An existing resource available to investigators for genotyping is the Center for Inherited Disease Research (CIDR) supported by a contract to Johns Hopkins University by eight NIH institutes including NIDA. CIDR was established in 1996 to provide high throughput of genotyping and statistical services for complex genetic diseases to the scientific community at large. Introductory no cost access to CIDR resources is available to investigators who have been approved by the CIDR Access Committee (CAC) and are supported by one of the eight, supporting NIH institutes (including NIDA). Thus, projects supported by this RFA are eligible for no cost access to CIDR resources following CAC approval. Investigators should request access to CIDR resources if needed and obtain CIDR approval by April 1. Deadline for submission of applications requesting CIDR access is November 1. For more information about CIDR, see the CIDR web site at http://www.cidr.jhmi.edu. A detailed scientific plan for conducting a high throughput genomic scan and statistical analysis at a central facility is needed if approval to use the CIDR facility is not obtained. The proposed costs and time frame for genotyping are expected to be justified (e.g., comparable with the genotyping costs at CIDR or the average cost for a commercial facility). 8) Data Sharing Plan: Dissemination of Data and Biological Materials The sharing of biological materials, interview and other assessment data, and genotype information (including software) in a timely manner has been an essential element in the rapid progress that has been made in the genetic analysis of human diseases. PHS policy is that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when first results based on these resources have been published (PHS Grants Policy Statement in the July 12, 1996 issue of the NIH Guide to Grants and Contracts). Accordingly, to address the interests of the research community and government in promoting the science of the genetic basis of drug addiction vulnerability, NIDA expects applicants who respond to this RFA to develop and propose detailed plans for sharing the data and materials generated through the grant. It is expected that the information to be shared will include all clinical, diagnostic, and pedigree structure information, in addition to cell lines and DNA. It is expected that the Data Sharing Plan will specify the following elements: 1) creation of comprehensive and verified databases that contain all clinical, diagnostic, pedigree structure, and genotypic information collected and produced by the grant, 2) establishment of cell lines (from which DNA will be extracted and stored) from all protocol subjects from whom blood samples have been obtained, 3) a mechanism or protocol by which all databases and biological materials (DNA samples, cell lines) can be widely searched or distributed to qualified investigators in the scientific community, 4) a timetable specifying when various elements of the database (e.g., diagnostic, assessment, or genetic data) will be available for distribution. The Scientific Review Group will be asked to make an administrative comment on the proposed plan for data sharing and access and, the adequacy of the plan will be considered by NIDA in funding decisions. The plan must be approved by NIDA (after negotiation with the applicant if necessary) before an award will be made. NIDA staff will review implementation of the plan for each Application for Continuation of Grant. Failure in compliance may result in reduction of the amount awarded in the Continuation of Grant. 9) Human Subjects Issues Proper safeguards are required to protect the welfare and rights of subjects who participate in genetic research. Subjects who participate in research projects funded under this RFA need to be fully informed of important issues such as data collected from them will be included in a large database for research distribution only after all information that can reasonably identify them is removed. Study participants must also be informed that their biological material (DNA) will be stored and available to other researchers. Subjects also need to be informed that some qualified investigators who will have access to these (unidentifiable) data may have commercial interests. Some identifying information may remain with Principal Investigators in their own research files, in which case appropriate Informed Consent must be obtained from the subjects. Under circumstances of unique genotypes, it may be possible that enough information eventually might be developed to allow individuals to be identified and, consequently, become subject to any risk(s) that might arise as a result of that identification. Subjects must thus be informed about the risk of identification. Applicants should address any special human subject issues that arise as a result of the proposed research. (NIH is currently working to develop a model consent form for human genetic research, and this will be provided to applicants whose projects are funded under this RFA when it becomes available. This may then serve as a template that is subject to modification and/or approval by local institutional review boards.) 10) Post Award Management During the course of the project period, while the original approved scope of work will be maintained, it is anticipated that technologies will improve and the rate of progress and focus of work supported by the grant(s) may change. Accordingly, it is expected that the principal investigator(s) will be allowed reasonable latitude, in consultation with program staff, to make necessary adjustments in scientific direction to accommodate such changes. Most importantly, it is essential to the achievement of the study aims that subject recruitment proceed as rapidly and efficiently as possible. Thus, principal investigators may need to be flexible in modifying recruitment strategies to assure that the targeted sample size is achieved. During the course of the award period, the principal investigators will be invited to meet with NIDA program staff in the Washington, D.C. area, to review scientific progress. Other scientists external to and knowledgeable about these studies may also be invited to participate. Budget requests should include travel funds for the principal investigator to meet annually in the Washington, D.C. area. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES, who may also provide additional relevant information. NIH POLICY AND GUIDELINES ON THE 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 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. 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 these recommendations 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 "What's New" or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are strongly encouraged to discuss their research objectives with NIDA staff early in their planning process. Prospective applicants are asked to submit, by December 28, 1998, 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 this RFA. Although a letter of intent is not required, is not binding, and does not influence the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained 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 RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. 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 Item 2 of the face page of the application form and the "YES" box must be marked. Applications should state in a cover letter and in the Abstract Section which mechanism (Regular Research (R01) or Program Project (P01) is being proposed. Submit a signed original copy 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 Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Applications in response to this RFA must be received by January 27, 1999. If an application in response to this RFA is received after that date, the application 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 revisions of applications already reviewed, but such applications must include an introduction responding to the previous critique. The applicants should also ensure that their revised applications respond to the review criteria by which applications in response to this RFA will be evaluated. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness to this RFA by NIDA staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIH staff will 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 this RFA will be evaluated for scientific and technical merit by a peer review group convened by the NIDA in accordance to NIH procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of 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. The reviewers will comment on the following aspects of the application in their written critiques to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria will be addressed and considered by the reviewers 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 a 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 the 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? Will the proposed study significantly advance knowledge about identification of genetic variation that confers susceptibility to drug addiction? Is the scope of work for the molecular genetic studies focused exclusively on efforts to establish the chromosomal locations of susceptibility loci, and not focused on fine mapping, sequencing, or mutation analyses? (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? Does the sample size have sufficient statistical power to identify genetic variations or chromosomal regions that harbor genetic variations conferring susceptibility to the disorder under investigation? Does the applicant address potential problems in recruitment and consider alternatives? If multiple sites are involved, is there adequate coordination and oversight among the various groups? Is phenotyping being done in a highly reliable, rigorous and comprehensive fashion? Is data collection reliable from site to site? Will genotyping be accomplished in a rapid and cost-effective fashion? (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? Does the project foster new analytic approaches for identifying chromosomal regions of interest? (4) Investigator: Is the investigator or are the investigators 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)? Is there sufficient expertise in the area of drug addiction, molecular genetics, statistics, and bioinformatics to carry out the data collection and genetic analyses? (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? Does the applicant have access to sufficient resources to obtain the targeted sample size? 6) Scalability: What is the likelihood that the data collected in the project will be rapidly collected and available for analysis by a broad range of qualified investigators? 7) Integration with other resources: Are comprehensive diagnostic assessment instruments and currently available software utilized in the project? Are appropriate criteria used to select a minimum number of affected individuals with the core phenotype, for the purpose of pedigree ascertainment? 8) Budget and duration: Are the proposed budget and duration appropriate in relation to the proposed research? Are the costs and time frames for molecular and statistical analyses generally comparable to those at CIDR and other high- throughput genotyping facilities? The review committee will also evaluate the provisions for the protection of human and subjects, and the safety of the research environment as well as the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Also, the committee will evaluate the Data Sharing Plan in n administrative note, using criteria such as: Will the applicant's data management plans permit creation of a highly efficient and organized electronic database? Will these plans facilitate the creation of databases containing final best estimate diagnostic data, family structure information, and clinical data that is accessible to the scientific community? Will data provided to the data management facility and cell repository be in a highly exportable format that will permit rapid integration with comparable resources maintained by other investigators? Does the investigator's quality control plans assure that databases provided to the scientific community are accurate and up-to-date, and that cell lines and DNA samples are of high-quality? Schedule Letter of Intent Receipt Date: December 28, 1998 Application Receipt Date January 27, 1999 Peer Review Date April/May 1999 Council Review September 1999 Earliest Start Date September 30, 1999 AWARD CRITERIA Awards will be made on the basis of scientific and technical merit as determined by peer review. Other factors that will be used to make award decisions are: o Adequacy of plans to make all data and biological materials collected and produced as a result of the proposed research widely accessible in a timely manner to the biomedical research community o Programmatic considerations o Availability of funds INQUIRIES Written, telephone, and email inquiries concerning this RFA are strongly encouraged. NIDA staff welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issue to: Jonathan D. Pollock, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A19 Rockville, MD 20857 Telephone: (301) 443-6300 FAX: (301) 594-6043 Email: firstname.lastname@example.org Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: email@example.com AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285), and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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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