PSYCHOPHARMACOLOGY OF WIDELY AVAILABLE PSYCHOACTIVE NATURAL PRODUCTS RELEASE DATE: April 2, 2004 PA NUMBER: PA-04-084 The R01 portion of this funding opportunity has been replaced by PA-07-108, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. 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. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. A replacement R03 (PAS-06-323) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Expiration DATE for R03 Non-AIDS Applications: March 2, 2006 Expiration DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 Expiration Date for R01 Non-AIDS Applications: November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.279 (NIDA), and 93.242 (NIMH). THIS PROGRAM ANNOUNCEMENT (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 In September 2003, the National Institute on Drug Abuse (NIDA) and the Office of the Director’s Office of Dietary Supplements (ODS) came together and supported a workshop entitled Psychoactive Botanical Products. The presentations and ensuing discussion illustrated how little the scientific community currently knows about the chemistry, biology, pharmacology, and behavioral effects of psychoactive botanical (or natural) products and thus this workshop served to identify gaps in our knowledge outlined in this announcement. A summary for this workshop can be found at: http://www.drugabuse.gov/whatsnew/meetings/psychoactivemtgsumm.html. Under this PA, NIDA, ODS, and the National Institute of Mental Health (NIMH), invite research grant applications that characterize the chemistry, psychopharmacology, and/or toxicology of acute and chronic exposure to psychoactive natural products, as well as the transition in the use of these products to licit or illicit drugs of abuse. For the purposes of this PA, psychoactive natural products are defined as fungus- or plant-derived products that are taken primarily for their effects on the central nervous system (e.g., stimulant, depressant, and/or hallucinogenic effects), rather than for treatment, medicinal or therapeutic effects. RESEARCH OBJECTIVES American consumers encounter a variety of plant-derived psychoactive products in the marketplace and elsewhere. These products vary along several dimensions and range from conventional foods (nutmeg, coffee) to garden seeds (morning glory, devil’s trumpet) to dietary supplements (ephedra, kava) to drugs (morphine). Some of these products have been associated with religious rituals (e.g., peyote, Salvia divinorum) in specific cultural contexts. Seeds of certain weedy plants (e.g. Datura stramonium) are found in the wild and collected by individuals seeking psychoactive experiences. The fact that a web of regulations surrounds these categories of goods does not mean that they are unavailable. In addition, there are products illegally in the marketplace that may claim to fall within one category, but that may not meet regulatory standards for that category. For example, products that claim to be dietary supplements that are to be smoked fail to meet the requirements of DSHEA, the 1994 law that regulates dietary supplements in the United States, as are the unapproved sale of products that purport to be replacements for prescription drugs. These are considered to be midbranded drugs, illegal, yet readily available. Since these products are natural, much of the public may assume that these products are safe. However, the recent experience with ephedra illustrates the potential for serious health consequences from unregulated use of psychoactive natural products. Although it was legally marketed for years, ephedra has only recently been deemed unsafe by the U.S. Food and Drug Administration (FDA). Moreover, the short- and long-term effects of these psychoactive natural products on the brain and other body organ systems are unclear. Given that many consumers are buying and using these psychoactive products and may be unaware of the abuse potential and/or other health risks of some ingredients, we seek to encourage the development of research programs that investigate the psychopharmacology of psychoactive natural products, including the chemical characterization and evaluation, pharmacokinetics and their interaction with active or inactive ingredients, or drugs of abuse. Listed below are examples of areas of research that are of programmatic interest. These examples are not meant to be all-inclusive. Classification/Mechanisms of Action: o Both animal and human research can be used to elucidate drug classification (e.g., stimulant, depressant, hallucinogen) and mechanisms of action of psychoactive natural products. To this end, operant conditioning and drug discrimination procedures in animals or humans could be used to further investigate these areas. Other measures of subjective effects, including effects on psychological, motivational, cognitive and emotional processes are also of interest. o Since current knowledge about natural product psychopharmacology may be limited, it will be especially useful to extract, isolate, and characterize the directly active and indirectly active metabolites of these natural products, and then compare them to well-characterized psychoactive drugs, such as caffeine, nicotine, cocaine, opiates, etc., in terms of their neurobiological, behavioral and cognitive effects. Furthermore, understanding mechanisms of action of active components through binding assays, microdialysis, and other approaches may lead to the discovery of novel ligands and the development of potential pharmacotherapies for treating drug addiction and other diseases. o Investigations into the pharmacokinetic and pharmacodynamic properties of psychoactive natural products are also of interest. These may include, but are not limited to, studies that investigate ligand affinity and efficacy, receptor localization, and investigations into the neural circuitry that underlies the psychoactive effects of these drugs. Chemistry, Distribution, and Metabolism: o Research studies in understanding the chemistry, toxicology, pharmacodynamics, pharmacokinetics and the mechanisms of action of psychoactive natural products is encouraged to better understand their efficacy, usefulness, adverse effects and/or abuse potential, if any. Areas of interest include, but are not limited to: 1) Development of methods to analyze and characterize active and inactive ingredients of psychoactive natural products. 2) Studies on absorption, distribution, metabolism and excretion of active ingredients, and interaction of active ingredients with their metabolites and endogenous substances. 3) Research on changes in cellular metabolic profiling (metabolomics) after administration of psychoactive natural products and their active ingredients. 4) Characterization, standardization, and comparison of efficacy and toxicity of psychoactive natural products with their pharmaceutical formulations (e.g., tablets, capsules, elixir). 5) Screening and identification of target receptors for active ingredients leading to new ligand development and structure activity investigations. 6) Development of ligands by chemical synthesis for structure activity relationship (SAR) studies. 7) Development of bioavailability studies of active ingredients. Behavioral, Physiological, and Toxicological Effects: o Little is known about the subjective effects of psychoactive natural products that are marketed or used as psychedelics, stimulants, euphoriogenics, or anxiolytics. Many drugs of abuse produce a change in either magnitude or duration of their subjective effects with repeated exposure. As such, it is important to investigate both the acute and chronic subjective effects of these products. o It is important to investigate possible physiological effects, such as cardiovascular effects, endocrine effects, etc., following both acute and chronic exposure to psychoactive natural products. Gender differences are also of interest, especially as they relate to endocrine effects. o Psychoactive natural products may affect cognitive ability. Studies designed to understand the acute effects of psychoactive natural products on cognition, learning and memory, and motivation (e.g., conditioned reinforcement or incentive motivation) are needed. o Although the acute toxicological effects associated with psychoactive natural products have been studied, there has been little or no research into the possible long-term neurotoxicity or psychological/functional consequences of these agents. Such studies are needed. o Little is known about the short- and long-term effect of using psychoactive natural products in combination with other psychoactive natural products, or with drugs of abuse. For example, combining sedative and hallucinogenic natural products may result in a different set of health or abuse risks as compared to a single psychoactive natural product taken separately. Additionally, multiple psychoactive natural products may be marketed (and thus taken) as a single product. It is therefore important to investigate the short- and long-term effects of psychoactive natural products alone and in combination with other psychoactive drugs or products. Prenatal or Developmental Effects: o Since psychoactive natural products are widely available and may be used by pregnant women, animal models investigating the physiological, behavioral, and toxicological effects of these products on both pregnant mother and offspring are needed. o Little is known of how stage of development interacts with the effects of psychoactive natural products. These products may produce different subjective, physiological, and cognitive effects occurring in children, adolescents and adults. Issues related to vulnerability of children and adolescents to both the reinforcing and adverse consequences of psychoactive natural product use are of interest. The effects of dose should also be investigated, as it is not known how dosages intended for adults will affect younger users. It is expected that these studies will employ epidemiological methods, survey data, animal models, or other approaches that do not involve administering these products to children or adolescents. o Investigations focused on the maternal-fetal pharmacokinetics and pharmacodynamics, and how placental formation and function may be altered by use of psychoactive natural products, including placental transport of these agents, are encouraged. These types of studies would shed light on how the growth and development of the fetus and offspring are affected by these psychoactive natural products. Research in this area could focus on studies of transfer of drug to fetus through placenta, biochemical and pharmacokinetic effects on placenta and fetus such as receptor binding, interaction with transporters, and enzymes, drug absorption, distribution, metabolism and elimination. It is expected that these studies will employ epidemiological methods, survey data, animal models, or other approaches that do not involve administering these products to pregnant mothers. o Development of methodologies for analyzing drug concentration in fetal fluids, meconium and fetal hairs, as well as placental transfer of drugs, concentration of drugs and their metabolites in fetal circulation, and their possible effects on fetuses and offspring are needed. Appropriate animal model studies on fetal exposure to psychoactive natural products are also encouraged. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) R03 (small research grant, see http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html) mechanism, and R01 (research project grant) mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed five years for an RO1 and two years for the R03. This PA uses just-in-time concepts. It also uses the modular budgeting 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 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 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 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 your inquiries concerning this PA 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: Allison Chausmer, Ph.D. Translational Research Branch Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-5088 FAX: (301) 594-6043 Email: achausme@nida.nih.gov Matthew Rudorfer, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: mrudorphe@nida.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D. National Institute on Drug Abuse 6101 Executive Boulevard, Room 250, MSC 8403 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.nih.gov Joy Knipple National Institute of Mental Health 6001 Executive Boulevard, Room 6131, MSC 9605 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: knipple@mail.nih.gov 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 http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. 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 at the 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 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 written critique 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 evaluate 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. 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? 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? 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? 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 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to 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. 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $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. http://grants.nih.gov/grants/policy/data_sharing. 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. 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://stemcells.nih.gov/index.asp 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, 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. 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 http://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 http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. 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.healthypeople.gov/. 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 Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and established within the Office of the Director, National Institutes of Health (NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law 103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to establish standards with respect to dietary supplements." This law authorized the establishment of the ODS. 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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