MOLECULAR GENETICS OF DRUG ADDICTION VULNERABILITY RELEASE DATE: July 22, 2003 PA NUMBER: PA-03-155 EXPIRATION DATE: July 30, 2006, unless reissued. The R01 portion of this funding opportunity has been replaced by PA-07-073, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA seeks investigator-initiated applications for research projects that identify chromosomal loci and genetic variation in genes and haplotypes that are associated with increased 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 in human beings. Much diagnostic effort has been focused on DSM criteria; we are additionally interested in applications that will examine intermediate phenotypes (endophenotypes) to better assess the molecular genetics of drug addiction and drug addiction vulnerability. Thus, applications examining the genetics of addiction vulnerability to both illicit and legal drugs of abuse are relevant to this PA. This program announcement is a continuation of the program initiated by RFA DA-99-003 and PA-00-115, "Genetics of Drug Addiction Vulnerability," https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-99-003.html. For additional NIDA funding opportunities in genetics, refer to the NIDA Genetics Workgroup homepage http://www.drugabuse.gov/about/organization/Genetics/about_genworkgroup/index.html. 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 variants underlying increased vulnerability to drug addiction are unknown. However, new scientific opportunities may now make it possible to identify and characterize the genetic variants that contribute to addiction vulnerability. This knowledge will increase the prospects of improved 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. Recent advances in statistical genetics, molecular biology, and genomic approaches have greatly accelerated the ability to identify the etiology of diseases that have a genetic basis. 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 these complex diseases. These and related approaches are likely to have applicability to the brain diseases of addiction. 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. Research Scope and Goals This PA encourages applications for research projects that identify chromosomal loci and variations in genes that are associated with increased vulnerability to addiction. Genetic approaches may include but are not limited to linkage, linkage disequilibrium, and association studies. Data may be collected from the general population, population isolates, populations with high rates of consanguinity, 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. Investigators may include, as a component of their project, gene x gene interactions, gene x environment interactions, and non-human models to study the genetics of addiction vulnerability. Phenotype definition of both affected and unaffected individuals is a central issue in the analysis of complex traits such as addiction. The use of phenotypes defined by quantity-frequency criteria and diagnostic criteria (such as the DSM-III-R or DSM-IV criteria) have been shown to have significant heritability in twin and/or adoption studies and are strongly encouraged. Also encouraged are numerous structured or semi-structured assessment instruments with high diagnostic reliability, including the Structured Clinical Interview for DSM-III-R 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). However, alternative phenotype definition may better describe the genetic aspects of addiction. Therefore, investigators may propose the use of other phenotypic information such as the presence or absence of biological markers or exhibition of unique individual traits, as well as combinations of these and/or co-morbid conditions. Justification for the use of proposed alternative phenotypes should be clearly stated and evidence that it is heritable provided. In addition, the use of advanced analytical methods such as principal-components analysis, discriminant analysis, artificial neural networks, spectral analysis of EEG, neuroimaging for drug activity/re- activity, and/or pharmacokinetic/pharmacodynamic genetic profiling may help define groups of phenotypes with a higher heritability for complex traits. Identifying specific genes that mediate addiction or other complex, multi- genic diseases is complicated by the fact that analytical methods developed for single-gene disorders do not necessarily incorporate the effects of gene interactions. Investigators are encouraged to consider using innovative genetic models, pedigree structure, haplotypes, and other methods of statistical analysis for the identification of genetic variations conferring vulnerability to a complex genetics disorder such as drug addiction. Data from laboratory, field and clinical research is beginning to show gender differences in biological factors in drug abuse, the progression and initiation to drug use and abuse, the antecedents and consequences of drug use and abuse, and prevention and treatment. Examination of gender differences in the molecular genetics of addiction vulnerability is also encouraged. The NIDA Genetics Consortium (NGC) The nucleus of the NIDA Genetics Consortium (NGC) are investigators who were awarded grants under the RFA, "Genetics of Drug Addiction Vulnerability" (DA-99-003) as well as those who have modified their projects to conform to the guidelines listed in that RFA to use the resources provided by the NIDA Center for Genetics Studies. The NIDA Center for Genetics Studies is funded by a contract awarded to Rutgers University with a subcontract to Washington University for the purpose of creating databases, cell lines, and DNA samples, and for wide distribution of the data and DNA to the scientific community. After a proprietary period, the NIDA Center for Genetics Studies will, upon proper application and approval, distribute both the data and DNA samples to qualified researchers. Members of the NGC meet two times a year to discuss issues related to the molecular genetics of addiction vulnerability. Data Sharing Plan: Dissemination of Data and Biological Materials Investigators belonging to the NGC have developed detailed plans for the dissemination and distribution of all clinical, diagnostic, and pedigree information, as well as the generation of cell lines and the distribution of DNA, 18 months after the funding period. As part of the sharing plan, the investigators belonging to the NGC agree to send blood samples from study subjects and specific diagnostic and descriptive data to a repository (NIDA Center for Genetics Studies). These specific diagnostic and descriptive data include 1) subject ID #; 2) family ID #; 3) site ID #; 4) parental ID #s; 5) sex; 6) death status; 7) ethnicity or geographic origin of ancestry; 8) age and/or year of birth; 9) twin status; 10) DSM-III-R diagnoses; 11) DSM-IV diagnoses; 12) instrument used to establish diagnoses; 13) answers to all of the questions in the structured interview or, minimally, the answers to those questions from which the addiction diagnoses were established; 14) age of onset of drug dependence and quantity-frequency of peak lifetime use of all addictive substances; and 15) Proband. Applicants responding to this announcement are strongly encouraged to join the NGC. Applicants wishing to join the NGC are expected to follow the stipulations under special requirements in the RFA "Genetics of Drug Addiction Vulnerability" https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-99-003.html and to seek the advice of program staff. By joining the NIDA Genetics Consortium the applicant will: o Increase statistical power of the samples being collected; o Enhance quality control of the data collected; o Facilitate and enhance opportunities for collaboration; o Have access to a data management facility to create extensively documented files at no cost; o Have high quality cell lines produced upon receipt of blood samples; o Have aliquots of high quality DNA extracted from the cell lines and returned at no cost; o Have an unlimited supply of DNA; and o Be able to devote more resources to data collection and data analysis. Investigators with a currently funded NIH grant with specific aims related to the genetics of addiction who would like to join the NIDA Genetics Consortium should also contact the program official listed at the end of the announcement. For further information on the NGC, please see http://www.drugabuse.gov/about/organization/Genetics/consortium/index.html. 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 must 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 (PRINCIPLES AND GUIDELINES FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS ON OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES; published on December 23, 1999 in the Federal Register http://www.ott.nih.gov/policy/rt_guide_final.html). 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 PA to develop and propose detailed plans for sharing the data and materials generated through the grant. See NIDA Human Molecular Genetics Research: Frequently Asked Questions (FAQs) http://www.drugabuse.gov/about/organization/Genetics/about_genworkgroup/index.html and Frequently asked questions about the NIDA Center for Genetic Studies http://www.nida.nih.gov/about/organization/genetics/FAQ_GeneticStudies.html 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, and 4) a timetable specifying when various elements of the database (e.g., diagnostic, assessment, or genetic data) will be available for distribution. Available Genotyping Resources Investigators should note that an existing resource available to investigators for genotyping is the Center for Inherited Disease Research (CIDR), which is supported by a contract to Johns Hopkins University by eight NIH institutes including NIDA. CIDR was established in 1996 to provide high- throughput 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 who are supported by one of the eight supporting NIH institutes (including NIDA). Thus, projects supported by this PA 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 before the requested start date of the grant. The deadlines for submission of applications requesting CIDR access are November 1, February 1, and June 1. For more information about CIDR, see the CIDR Web site at http://www.cidr.jhmi.edu or contact Dr. Jerry Roberts at 301-402-0838 or at firstname.lastname@example.org. Alternatively, investigators may wish to use the Mammalian Genotyping Service (http://research.marshfieldclinic.org/genetics/) at the Marshfield Medical Research Foundation in Marshfield, Wisconsin. This facility is sponsored by the National Heart, Lung, and Blood Institute (NHLBI) at NIH and is provided at no cost to investigators whose projects are approved for genotyping by the Scientific Advisory Panel of the Mammalian Genotyping Service. For submission dates, investigators should contact the Mammalian Genotyping Service at (715) 387-9150. MECHANISMS OF SUPPORT This PA will use the NIH research project grant (R01) and the program project (P01) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting format (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. 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 ("cores") that provide funds for tasks common to two or more projects within the award. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations Foreign institutions are not eligible for program project (P01) grants. 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. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Joni L. Rutter, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse, NIH, DHHS 6001 Executive Blvd., Rm 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-0298 Fax: (301) 443-594-6093 Email: email@example.com o Direct inquiries regarding fiscal or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: firstname.lastname@example.org SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at https://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: Contact NIDA program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the NIDA staff that the NIDA will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and NIDA who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at https://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse. REVIEW CRITERIA The information in this section pertains to R01 applications; those interested in a P01 submission should refer to NIDA's "Program Projects Guidelines found at http://www.drugabuse.gov/Funding/P01.html. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. Please also see http://www.nida.nih.gov/about/organization/genetics/FAQ_DataSharing.html and the previous section on The NIDA Genetics Consortium (NGC). BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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 of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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