ANIMAL MODELS OF ADOLESCENT DRUG ABUSE: INTEGRATIVE STUDIES OF BRAIN AND BEHAVIORAL DEVELOPMENT RELEASE DATE: October 31, 2003 RFA Number: RFA-DA-04-011 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: February 17, 2004 APPLICATION RECEIPT DATE: March 17, 2004 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA There is a growing concern that adolescence marks a period characterized by enhanced vulnerability to the effects of drugs of abuse and the emergence of substance abuse disorders. Recent studies in both animals and humans have demonstrated that a dramatic period in neural development coincides with the unique behavioral changes associated with adolescence. These studies have given us a framework for understanding how the adolescent brain develops and how these alterations affect changes in behavior. The National Institute on Drug Abuse (NIDA) is interested in determining: i) whether, and, if so, how change in the adolescent brain is associated with increased drug taking, and ii) how this dynamic substrate might be altered by drugs of abuse. NIDA seeks to stimulate research that uses an integration of neurobiological and behavioral approaches to study adolescent brain development. Thus applicants are expected to use animal models and an integrated approach to focus on the development of regions of the brain that are: i) involved in drug-taking behavior, and/or ii) altered by acute or chronic exposure to drugs of abuse. The goal of this RFA is to promote the advancement of innovative projects that incorporate multidisciplinary approaches to understand how physical transformations in the adolescent brain are related to the behavioral changes associated with drug abuse. Some of the physical changes that are of interest include structural and functional changes in neurons and glia, and alterations in brain circuitry. Some of the behavioral changes that are of interest include: learning, memory, risk taking, cognitive function, impulsivity, motivation and emotion. The results of these studies should provide novel insight into the causes and effects of adolescent drug use. RESEARCH OBJECTIVES Background Adolescence is marked by the physical changes that occur during puberty, but the changes in behavior typically associated with this developmental period occur over a longer and less definitive period. These behavioral changes are poorly understood, but they can have dramatic effects on developmental trajectories and outcomes. Many forms of risk taking and sensation seeking behaviors (including drug taking) begin during adolescence, and these behaviors can lead to a multitude of health-related problems, including increased rates of automobile accidents, suicide, drug abuse and exposure to HIV and hepatitis C. Additionally, adolescent drug taking could potentially alter subsequent brain maturation, leading to changes in adult behaviors. Until recently, brain development was thought to be largely complete after the first few years of childhood. Thus, animal models (especially those using rodents and nonhuman primates) relied extensively on studies of mature organisms to understand basic neurobiological processes and behavioral phenomena. As such, evaluation of the possible causes and consequences of substance abuse in younger, and perhaps more vulnerable, populations have been guided by the assumption that the adolescent brain is no different from that of the adult. However, recent studies in both humans and animals have demonstrated that the brain continues to develop during adolescence and that this period of neurodevelopment is characterized by dramatic changes in brain growth and connectivity. These structural changes coincide with dramatic shifts in a variety of behavioral and cognitive processes. A complex interplay of genetic and environmental variables is clearly involved in adolescent development. However, our understanding of the relationship between these factors is changing, primarily due to the recent research indicating that adolescence is a unique developmental period. Some of the unique aspects of adolescent brain structure and function are becoming clear. Human imaging studies have shown that a robust amount of brain growth occurs during the early teen years (in the form of axonal branching), and that this period is followed by a dramatic phase of pruning. These changes occur in many regions of the brain (including the cortex, basal ganglia, and cerebellum) but they do not occur simultaneously: different brain regions develop during different phases. Coincident with this growth, many important regions of the brain (e.g. the corpus callosum and the cerebellum) become better myelinated, again with distinct kinetics. Thus, a number of circuits in the adolescent brain are established and refined in a complex and dynamic manner. Similar changes are observed in a variety of animals. Studies using a number of both mammalian and non-mammalian models have identified adolescent developmental periods, and this work has provided a foundation for using many animal species to study this process. As in human adolescents, these brain changes are associated with changes in complex social behaviors. From this work, we are beginning to identify the conserved changes in brain structure and regulation that coincide with the unique patterns of emotion and cognition seen during adolescent development. The influence of these structural and functional changes has not been fully integrated into our understanding of the cognitive, social, and emotional processes that characterize human adolescent development. One limitation of human investigations is the inability to test many hypotheses concerning causation. This limitation has led to a debate over the role of neurodevelopment in behavior. For example, does exuberant axonal growth and pruning in the prefrontal cortex (PFC) permit more abstract cognitive processing, or do the neurological changes simply result from this cognitive maturation? With respect to NIDA’s mission, there is a need to examine brain development during adolescence in the context of understanding the vulnerability to: i) acquire drug abuse behaviors, ii) escalate to uncontrollable use, iii) abstain from drug taking, and iv) relapse after addiction. Furthermore, this dynamic neurobiological substrate, the adolescent brain, may be differentially altered with exposure to drugs of abuse. To that end, understanding any and all of the consequences of this alteration on normal social, emotional and behavioral maturation is a critical public health issue. Two fundamental questions are: i) Do specific brain changes play a role in generating vulnerability to drug taking? and ii) Does drug exposure change subsequent brain development? The tools to study this important phase of development are now at hand. Objectives and Scope Animal models provide an excellent opportunity to manipulate the adolescent brain. Whereas some aspects of adolescent development are likely to be unique to humans (e.g., the degree of prefrontal cortex growth), many animals undergo similar processes in many, if not all, regions of the brain. Numerous studies demonstrate that adolescence is surprisingly conserved during mammalian development. As such, many aspects of adolescent development can be studied in rodents and nonhuman primates. Non-mammalian animal models with well-defined neurobiological and behavioral transitions are also likely to generate important and unique insights. The neurobiological, molecular, and genetic methods that have been used to uncover animal brain development provide us with powerful tools to understand how adolescent neurodevelopment is linked causally to changes in behavior. Given the evolutionary conservation of many of these processes, this information should generate insight into understanding human adolescent development. NIDA seeks to promote relevant animal research integrating the use of basic neurobiology with behavioral studies. The goals are to: i) establish neurobiological models for understanding the causes and consequences of adolescent behavior associated with drug taking, and ii) identify neurobiological correlates of behaviors associated with, or produced by, drugs of abuse. The best approaches will be those that illuminate the causes and consequences of changes in adolescent brain development, and provide models for understanding behavioral vulnerabilities to, and effects of, drugs of abuse. Two critical themes in this area of investigation should be: i) which events are causal? and ii) to what extent are these influences on the behavior driven by internal (e.g., molecular mechanisms, genetics, or neurotransmitter system interactions) or external (e.g. environmental, rearing, social, context) factors? Emphasis should be placed on understanding the relationship between changes in behavior and changes in brain chemistry and architecture. Some fundamental areas of interest representing a merger of neurobiological and behavioral approaches are listed below (these are provided as examples and this list is not intended to cover the full range of projects of interest): o Understand the temporal and spatial changes in neuroanatomy associated with adolescent maturation, as well as the behavioral consequences of these changes. Particularly important changes include alterations in dendritic growth and branching in the prefrontal cortex (as well as other cortical areas), amygdala basal ganglia, and cerebellum. The changes include, but are not limited to, specific changes in axonal branching, pruning and myelination. Both histological and molecular gene expression studies will be needed to define these changes. One key area of interest is to: i) determine how and when distinct regions of the brain associated with cognitive processes (e.g. inhibition) and subcortical motivational circuits become functionally connected, and ii) link key developmental changes in behavior with these events. These changes could be studied using na ve animals, or animals treated with specific drugs of abuse. o Define the relationship between anatomical and behavioral changes with variations in hormone levels. The interplay between the hypothalamus/pituitary/adrenal (HPA) axis and the developing brain is of particular interest. Studies comparing and contrasting gender differences are encouraged in these and all other studies. o Identify the effects of environmental, behavioral and contextual influences on neurodevelopmental processes. In particular, NIDA is interested in determining if arousal, emotion and stress alter aspects of neural development that lead to increases in drug abuse or addiction. Such studies could identify the neurological substrates for drug-seeking behaviors that affect the central processes of learning, memory, cognition, and/or motivation. o Analyze changes in neurogenesis and apoptosis that occur during adolescence, and identify the behavioral consequences of these changes (especially those that have implications for drug taking). Determination of the role of drug use in altering these processes is encouraged, but not required. Identification of any unique aspects of adolescent neurogenesis or apoptosis is of particular importance. o Characterize the neurobiological effects of drug exposure during adolescence on the development of behaviors, emotions and cognitions that have been demonstrated to be important for understanding drug abuse and addiction. o Compare the behavioral and neurobiological features of drug taking (i.e., initiation, maintenance, escalation, extinction, and relapse) in adolescent and adult animals. One important question is: how do chronic neuroadaptations of dependence, tolerance and sensitization differ between adolescent and adult animals? Furthermore, research could determine: i) how features of drug exposure (e.g., rate, schedules, context, etc.) or drug history affects the development of escalated drug intake, and ii) if the course of behavioral changes in vulnerability is different in adolescent and adult animals. Related and integrated neurobiological substrate questions could target events at the cellular or molecular level. Those that have been demonstrated to be significant for important transitions in animal models of drug abuse behavior with adult animals could be used to verify and compare their significance in adolescent models of drug abuse. o Identify critical periods during adolescent brain development for drug effects on cognitive, emotional or social behaviors. These periods should be linked to changes in rates of acquisition and continuation of drug taking. These behavioral changes should be tied to specific neurological changes during these critical periods. o Examine the behavioral consequences of neuroadaptations to repeated drug administration in adolescent animals. Potential questions include: Are these neuroadapatations and the ensuing behavioral changes different from those that have been characterized in adults? and What are the types of neuroadaptations that lead to rapid progression of excessive, uncontrollable intake? Behavioral changes of interest include those indicating shifting central motivational processes, and responses to natural rewards, alterations in species-specific behavioral patterns, narrowing of behavioral repertoire, and changes in drug responsivity or sensitivity. Some of the tools available to answer these questions include the following (these are provided as examples and this list is not intended to cover the full range of projects of interest): o Pharmacological tools to probe the neurotransmitter substrates of behavior, motivation and cognition, as well as to assess drug responsivity or sensitivity. o Animal behavioral models of motivation for drug and natural rewards, (including, but not limited to, i.v. drug self-administration) and conditioned place preference. Especially encouraged is the use of choice procedures that provide alternative reinforcers or behaviors, and paradigms that allow for the development of dynamic behavioral typographies (e.g., sensitization, escalation, changing behavioral repertoires, etc.). o Genetic tools to determine the role of individual gene products in directing adolescent development and behavior. While this work is perhaps most obviously performed using mice (i.e., mutants and transgenics), recent advances such as RNAi should allow researchers using a variety of animal models to understand the roles of individual gene products in particular brain regions. o Approaches and candidates adapted from embryonic and early perinatal research. Such approaches have defined a variety of candidate molecules that regulate earlier neural development (e.g. the Wnt, BMP, GDNF, and FGF ligands). Recent research suggests that these molecules are also likely to function during adolescence. As such, they are prime candidates to begin to understand the molecular basis of adolescent brain development. o Comparative approaches that exploit species-specific differences in life histories and behavioral development during the adolescent period. For example, species differences or specialization in social interaction, pair- bonding and mating, territoriality, aggression, and communication behaviors may be useful for identifying the neurobiological basis of behaviors that are relevant for understanding the development of drug abuse and addiction. MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01) and the exploratory/development (R21) award mechanisms ( As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at FUNDS AVAILABLE NIDA intends to commit approximately $1.5 million in FY 2004 to fund 4- 8 new and/or competitive continuation grants in response to this RFA. An applicant may request for the R01 a project period of up to 5 years. For the R21, the project period is 2 years and up to $275,000 in direct costs for the two-year period. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA provide 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. At this time, it is not known if this RFA will be reissued. 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 institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Robert Riddle, Ph.D. Genetics and Molecular Neurobiology Branch Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4258, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-6300 FAX: (301) 594-6043 Email: o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 234, MSC 8401 Bethesda, Maryland 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 234, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 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 RFA label is also available at: SENDING AN APPLICATION TO THE NIH: 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/DHHS 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 and all copies of the appendix material must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 234, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignments within 8 weeks. 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. However, when a previously unfounded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Council on Drug Abuse REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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? Does the study address an important problem consistent with the goals of this RFA? (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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following item will be considered in the determination of scientific merit and the priority score: 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 REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 17, 2004 Application Receipt Date: March 17, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, 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 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 ( 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 URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy
NIH... Turning Discovery Into Health®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.