DEVELOPMENTAL PSYCHOPHARMACOLOGY RELEASE DATE: April 21, 2003 PA NUMBER: PA-03-113 February 21, 2007 - The R21 portion of this FOA has been reissued as PA-07-222. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. The R01 portion of this announcement has been replaced by PA-06-379. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE: March 2006, unless reissued. National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.242, 93.279, 93.865 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) 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 Program Announcement replaces PA-00-114. The National Institute of Mental Health (NIMH), the National Institute of Child Health and Human Development (NICHD), and the National Institute on Drug Abuse (NIDA) request research grant applications to study the possible clinically significant effects that various psychotropic medications may have on the brain when administered during the developing phase that spans from birth to early adulthood. The purpose of this program announcement is to spur new clinical and basic research on the possible impact of psychotropic pharmacotherapy on the developing brain. The main goal is to generate data that are relevant to the clinical use of psychotherapeutic medications in children and adolescents with respect to safety and/or efficacy within dose ranges, schedules, and routes of administration that are usually employed therapeutically. The ultimate purpose is to increase our knowledge of the safety and effectiveness of psychopharmacological treatments administered to children and adolescents. RESEARCH OBJECTIVES Background Psychotropic medications are prescribed with increased frequency to children and adolescents, often for extended periods of time. Millions of prescriptions of stimulants, antidepressants, and other psychotropic medications are written every year for patients under 18 years of age. These pharmacological compounds act on and through neurotransmitter systems that undergo major developmental changes in humans during the first two decades of life. Interactions between drugs and the developing brain are important considerations in assessing the efficacy and safety of these agents in children and adolescents. As psychopharmacological treatments become more accepted in clinical practice, there is increasing concern over the possibility that long-term exposure of developing children to psychoactive agents might result in subtle but significant long-lasting adverse effects. Thus, experimental data are needed to clarify the nature, extent, and impact of these interactions. In addition, identification of brain regions and physiological mechanisms responsible for both the therapeutic and negative effects of drugs will be useful for the development of more selective psychotherapeutic mechanisms with fewer side effects. For ethical, methodological, and practical reasons, it is often difficult or impossible to conduct this type of experiment in humans. In these cases, research in animals is appropriate. Currently, very limited experimental data indicate that exposure of animals to psychotropic medications such as serotonergic or antidopaminergic agents in early life can result in specific biochemical and molecular changes in the adult CNS. In some cases, these changes can persist upon drug discontinuation and into adulthood. Interpretation of results of these experiments is limited by the compounds, doses, administration regimens and routes employed, and the lack of studies of chronic neurochemical or behavioral drug effects. These and other methodological limitations of previous studies have severely restricted generalizations of the results of small numbers of animal studies to humans. Research Objectives The ultimate goal of this research is to determine the short and long-term consequences of chronic or acute psychotherapeutic drug administration. As such, relevant studies in developing animals will examine behavioral, neurochemical, physiological, and molecular effects of early drug administration in both young and adult animals. Studies should focus on specific behaviors and their relationship to biochemical endpoints within defined brain regions. Research approaches to address these questions could include, but are not limited to the following: a) Develop models of psychotherapeutic medication delivery in normal developing animals - Studies are needed to examine the long-term effects of chronic and acute administration of therapeutic doses of psychotherapeutic medications prescribed in children. Examples of relevant medications include, but are not limited to antidepressants, mood stabilizers, and stimulants (as used in the treatment of ADHD). Examples of relevant research include: o Examine effects of routes of administration that emulate as closely as possible human dosing regimens and plasma drug concentrations across a range of therapeutic doses. Comparisons should assess species, sex, and age differences in the kinetics and metabolism of drugs over the range of therapeutic doses. o Examine effects of age and duration of psychotherapeutic drug administration in animals within and across identified brain regions. o Determine specificity of chronic psychotherapeutic drug effects to developmental periods. Endpoint measures for these studies might include, but are not limited to, neurotransmitters (levels, metabolism, synthesis, release), expression and activity of receptors, transporters, and other signaling molecules, gene regulation, neuroendocrine measures in brain, electrophysiological activity, plasticity, and brain development and growth including neuroanatomical and neurochemical markers of brain development, tropic factor expression and action, circadian rhythms, and hormonal effects on these processes. b) Develop and apply behavioral models in animals to assess long-term effects of psychotherapeutic drug administration during development on cognitive and emotional measures. Examples of relevant research include: o Develop objective and reliable measures to mirror specific clinical behavioral attributes associated with psychiatric disorders occurring in children and that serve as specific markers of psychotherapeutic drug efficacy. o Develop behavioral measures that are applicable over the lifespan including juvenile, adolescent, and aged animals. o Identify specific behavioral measures in young animals that are predictive of adult behavioral responses including, for example, cognitive ability, drug response, attention, and response to environmental challenges. o Develop and apply behavioral measures to genetic models employing regionally and temporally selective manipulations of gene expression in brain to study anatomical, neurochemical, and signaling pathways mediating drug-induced behavioral changes. o Examine the effects of chronic drug administration in developing animals on adult behavioral responses to pharmacological or environmental challenges (i.e., stressors) or reinforcing stimuli. The behavioral models should be amenable to studies of the neural pathways, transmitters, and signaling molecules responsible for therapeutic and negative effects of drugs. Examples of some relevant behavioral measures for examining long-term effects of therapeutic doses of psychotherapeutic medications might include, but are not limited to, cognition, learning and memory, attention, impulsivity, exercise, play, anxiety, fear, response to novelty, and social behavior. Studies of the behavioral effects of stimulant medications used to treat ADHD, for example, might identify mechanisms responsible for drug effects on attention, eating, or sleep. c) Apply pharmacological and behavioral animal models to assess drug mechanisms and brain sites responsible for therapeutic and adverse drug effects in developing animals. Relevant questions include but are not limited to the following: o Examine long-term effects of chronic psychotherapeutic medication administration in developing animals (i.e., antidepressants, stimulants, mood stabilizers, and antipsychotics agents) on brain and behavior. Identify developmental stages that may be uniquely sensitive to drug effects. o Identify brain regions responsible for the therapeutic and negative effects of therapeutic doses of psychotherapeutic medications on behavior. o Determine neurochemicals responsible for the beneficial and adverse effects of psychotherapeutic medications in developing animals. Identify cellular mechanisms. o Develop strategies for identifying novel psychotherapeutic medications with fewer adverse effects. o Examine the combined consequences of early environmental experience and psychotherapeutic drug administration on brain and behavioral measures in adult animals. Integrative studies in both non-human primates and preliminary studies in other species are encouraged. Brain imaging and gene targeting approaches to identify molecules and brain regions responsible for behavioral effects of drugs are also appropriate. d) Develop and expand clinical studies to examine possible effects of psychotherapeutic administration on the development of children as assessed by behavioral and brain measures obtained during childhood and/or in adults. Examples of relevant research include: o Study the possible impact of psychopharmacological treatment on developmentally relevant clinical parameters, such as, physical growth, sexual maturation, and cognitive development. o Study possible toxicities of psychotropic medications, which are specific or more common in certain phases of development as compared with adulthood. o Utilize non-invasive imaging techniques to study the effects on the brain of psychotropic medication in children. o Employ brain imaging techniques to assess the effects of childhood drug administration on brain development and adult brain function. o Identify brain regions responsible for the therapeutic and negative effects of therapeutic doses of psychotherapeutic medications. o Develop valid biochemical, imaging, or pharmacogenetic biomarkers or objective behavioral outcome measures for assessing clinical efficacy and safety of psychotherapeutic medications. e) Study the possible effects of development on the pharmacokinetics, metabolism, disposition, and pharmacodynamics of psychotropic medications commonly used in children and adolescents. Examine gender and ethnic differences in these measures. Examples of possible relevant research: o Study the pharmacokinetics, pharmacodynamics, and/or pharmacokinetic/ pharmacodynamic correlations of medications commonly used in the treatment of children with mental disorders. o Study developmentally mediated changes in the ability to metabolize psychotropic medications in children. o Study the bioavailability of liquid formulations of psychotropic medications used in young children. o Study the effects of drug-drug interactions when combined therapies of psychotropic medications are used. o Study the effect of development on the bio-distribution of psychoactive agents. MECHANISM(S) OF SUPPORT This PA will use the NIH Research Project Grant (R01), NIH Exploratory/Developmental Research Grant Award (R21), and NIH Small Research Grant Program (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. Information on the requirements for the NIH small grant program may be obtained at: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html. The Exploratory/Developmental Grant (R21) provides up to two years of funding with a maximum of $275,000 direct costs over the entire budget period. It is intended for development and pilot testing of novel models, sensitive neurochemical measurements, interventions and other aspects of intervention development. Information on the requirements for the NIH Exploratory/Developmental Grant may be obtained at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. The total project period for an R01 application submitted in response to this PA may not exceed five years. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://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. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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 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 Questions regarding scientific/research issues about basic or clinical neuroscience research including sites and mechanisms of drug action may be directed to: Lois Winsky, Ph.D. Division of Neuroscience and Basic Behavioral Research National Institute of Mental Health 6001 Executive Boulevard, Room, 7184, MSC 9641 Bethesda, MD 20892-9641 Telephone: (301) 443-5288 FAX: (301) 402-4740 Email: lois@helix.nih.gov o Questions regarding scientific/research issues about research focused on clinical outcomes may be directed to: Benedetto Vitiello, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7147, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: bvitiell@nih.gov o Questions regarding psychotropic medication interactions with child growth may be directed to: George P. Giacoia, M.D. Center for Research in Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11B Bethesda, MD 20982-5288 Telephone: (301) 496-5589 FAX: (301) 480-9791 Email: gg65m@NIH.GOV o Questions regarding applications relevant to drug abuse may be directed to: Nancy S. Pilotte, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-1317 FAX: (301) 594-6043 Email: npilotte@mail.nih.gov o Direct your questions about financial or grants management matters to: Carol J. Robinson Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: crobinso@mail.nih.gov Mary E. Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03D, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 Email: md74u@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.nih.gov 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 http://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 http://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 http://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 http://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: 1) Contact the IC 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 IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC 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 http://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 http://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 appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your 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 your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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 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 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001 .html); a complete copy of the updated Guidelines are available at http://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 http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://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 http://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 http://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 http://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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