RFA-DA-04-014: MEDICATIONS DEVELOPMENT FOR CANNABIS-RELATED DISORDER

Department of Health
and Human Services (HHS)

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MEDICATIONS DEVELOPMENT FOR CANNABIS-RELATED DISORDER RELEASE DATE: December 1, 2003 RFA NUMBER: RFA-DA-04-014 - (Reissued as RFA-DA-09-001) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: February 20, 2004 APPLICATION RECEIPT DATE: March 23, 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 The National Institute on Drug Abuse (NIDA) is seeking grant applications focusing on the identification, evaluation and development of safe and effective pharmacological treatments for cannabis-related disorders (CRDs), such as cannabis abuse or dependence, and cannabis- induced disorders (e.g., intoxication, delirium, psychotic disorder, and anxiety disorder), and their comorbidity with other medical and psychiatric disorders (e.g., depression), with special interest in the treatment of children and adolescents. Cannabis use includes marijuana, hashish, and other tetrahydrocannabinol (THC) containing substances. This RFA will support clinical trials to test potential medications in humans, and the preclinical development of new chemical entities (NCEs) for advancement to the clinical development stage. Applications may focus on the pharmacotherapy of cannabis abuse and they may target one or various CRDs or clinical manifestations of the disorders. For example, research may focus on marijuana dependence or specifically on marijuana withdrawal. Clinical applications may include human laboratory studies to develop models for testing medications targeting single or multiple manifestations of the CRDs, and the interaction of cannabinoids with other medications, pharmacokinetic and/or pharmacodynamic studies of potentially therapeutic compounds. Preclinical applications may include pharmacological studies on NCEs leading to the identification of candidates for advanced preclinical or phase I/II IND covered clinical evaluation as potential pharmacotherapies for CRDs. RESEARCH OBJECTIVES Background The treatment of CRDs is an issue of great public health concern. Currently, marijuana is the most commonly used illicit drug in the United States with recent estimates from SAMSHA of 14.6 million users in the past month, with particularly heavy use occurring in adolescent populations (over 20% of all high school seniors). Approximately 2.4 million people use marijuana for the first time every year and two thirds of them are between 12 and 17 years of age. In addition, of the 3.5 million people who met criteria for past-year cannabis abuse or dependence in 2001, more than two thirds were between the ages of 12 and 25 years. An estimated 852,000 individuals reported marijuana as the specific substance for which they received their last or current treatment among persons who received treatments in the past year and approximately one half of those individuals were 25 years old or younger. Sufficient research has been carried out to confirm that the use of cannabis can produce serious physical and psychological consequences. The consequences of cannabis use may be due to the acute effects of the drug or due to the chronic exposure that may ultimately produce abuse or dependence. The use of a large amount in a short period of time may induce hallucinations, delirium, and other perceptual manifestations compatible with a psychotic episode. Chronic users of cannabis may experience difficulty in stopping or controlling drug use, develop tolerance to the subjective and cardiovascular effects, and eventually present withdrawal symptoms after sudden discontinuation of use. Long-term heavy use may also produce cognitive changes that affect memory and learning and, in predisposed individuals, induce psychosis and other perceptual phenomena, anxiety, depression and suicidal ideation. In young people, cannabis use additionally seems to affect the normal development of adolescence, and is associated with poor school performance, early problems with the law, and the use of other drugs and alcohol. Among the medical problems, cannabis use has been associated with cardio-respiratory problems, such as aggravation of asthma, bronchitis, emphysema, hypertension and arrhythmias, and increased risk of sexually transmitted diseases. Given the extent of the use of cannabis in the general population and the medical and psychological consequences of its use, particularly the clinically significant psychosocial impairment, there is a great public health need to develop safe and effective therapeutic interventions. The need to develop treatments targeting adolescents and young adults is particularly relevant in view of their disproportionate use patterns. Unfortunately, there is currently no effective pharmacological treatment for CRDs and there is very limited research focused on the identification and development of medications to treat these disorders. Drug abuse treatment research as a whole has rarely focused on the treatment of CRDs. One indicator is the fact that there are no published randomized controlled clinical trials to evaluate pharmacotherapies for CRD as the primary outcome. There are multiple reasons why it is timely to develop medications to treat CRDs. First, there are newly marketed medications available whose mechanisms of actions may have potential therapeutic effects on the clinical manifestations of CRD. Second, the recent discovery of an endogenous cannabinoid system with specific receptors and endogenous ligands, the availability of genetically engineered knockout mice that lack functional cannabinoid receptors to study genetic predispositions to the effects of cannabinoids, and the subsequent development of reliable preclinical models to study the rewarding and dependence- producing effects of THC, all provide understanding of the basic therapeutic mechanisms. Lastly, there is the discovery and development of new chemical entities, some of them already being investigated at the clinical level, which target the cannabinoid system and have the potential for therapeutic benefit. All these factors are setting the stage for the development of medications to treat CRDs. Objectives and Scope The goal of this RFA is to develop safe and effective medications for the treatment of CRDs. Studies may focus on the treatment of marijuana, hashish or other cannabis derivatives. Medications studied under this RFA may aim to treat cannabis-use disorders, such as abuse and dependence, or cannabis-induced disorders, such as intoxication, delirium, psychosis, and anxiety. They may also focus on the specific symptoms of the disorder such as withdrawal, craving or relapse, complications such as cognitive impairment, sleep disorders/disruption of normal rhythms or the clinical surrogates of their use such as depression and other mood disorders. Research topics of interest include but are not limited to: o Development and testing of human laboratory models to evaluate the effects of medications on cannabinoid drug discrimination, conditioned place preference or aversion, self-administration, reward, tolerance, sensitization, craving, withdrawal, and physiological dependence. o Human laboratory evaluation of medications that may affect the pathophysiological correlates of cannabis-use disorders such as self- administration, reward, tolerance, withdrawal, craving, and physiological dependence. o Design and implementation of FDA defined Phase I clinical trials to assess the medical safety and tolerability of medications when treating patients with CRDs. o Interaction studies focused on the effects of medications to treat CRDs and the concurrent use of cannabis derivatives, including pharmacokinetic and/or pharmacodynamic studies. o Testing medications that may affect the interaction between cannabinoid, opioid and dopamine systems, and which may have therapeutic effect not only for CRDs but also for other medical conditions such as pain and other drug dependencies. o Exploratory/developmental pilot studies to evaluate the preliminary efficacy of medications to treat single or multiple clinical manifestations of CRDs. o Randomized clinical trials, defined by FDA as Phase II, to evaluate the efficacy of new or already marketed medication for the treatment of single or multiple CRDs, or any of their clinical manifestations. For example, studies may focus on the treatment of marijuana dependence or marijuana withdrawal. o Development of medications to block withdrawal symptoms. o Studies focusing on the treatment of comorbid psychiatric conditions that may negatively affect the outcome of the disorders or their treatment. For example, studies may focus on treating the clinical depression associated with the use of cannabis. o Studies focusing on interactions of medications developed for CRDs with those treating comorbid mental disorders. o Brain imaging studies to determine the effects of treatments on brain processes and to determine surrogate markers of treatment efficacy. o Clinical studies aimed at preventing or reducing the medical consequences of cannabis use, including HIV and other infections. o Pharmacological testing of potential medications which would act as full agonists, partial agonists, or antagonists (or prodrugs whose metabolism would result in such desired activity). o Identification and testing of potential medications which would produce one or more of the following effects in pharmacological studies: a relatively long duration of action; mild reinforcement when compared to cannabinoids; and/or blockade of cannabinoid’s effects in behavioral assays and on cognitive, spatial/motor and/or learning/memory functions. o Design and synthesis of novel radioligands targeting the cannabinoid receptors for use as tools to study both the neurobiology of ligand- receptor interaction as well as targets for treatments. The rationale for choosing the medication(s) to be investigated can be based on a top-down approach, a bottom-up approach, or both approaches combined. The top-down approach would be the testing of marketed medications that are available for other indications and which may be promising candidates for the treatment of CRDs. For example, an FDA approved antidepressant may be chosen as a target medication. The bottom-up approach involves the identification and testing of new chemical entities that, because of their chemical characteristics and mechanism of action, could be candidates to be developed specifically for CRDs. The testing of combinations of medications is within the scope of this RFA. Medications may target one or more neurochemical mechanisms implicated in the physiopathology of CRDs by direct or indirect modulation of the systems, or by producing synergistic or antagonist effects. The treatment of CRDs usually requires a multidisciplinary approach, including behavioral treatment strategies. Therefore, it is expected that the medication treatment studies proposed under this RFA should have a behavioral intervention platform or propose the concurrent evaluation of medications and behavioral interventions in a 2X2 design. MECHANISM OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) and the exploratory/development (R21) (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) 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 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. FUNDS AVAILABLE NIDA intends to commit approximately $3 million in FY 2004 to fund 4-7 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 and up to $400,000 in direct costs per year. For the R03, the project period is 2 years and direct costs up to $50,000 for each of those 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. The size of individual awards will vary as a function of the nature and scope of the research proposed. It is anticipated that the upper limit of each award will be $400,000 in direct costs, and applications over this amount will not be accepted for review. Budget requests should be carefully justified and commensurate with the complexity of the project. 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 categories: Scientific/research, peer review, and financial or grant management issues: o Direct your questions about scientific/research issues to: Iv n D. Montoya, M.D., M.P.H. Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4143, MSC 9551 Bethesda, MD 20892-9551 Phone: (301) 443-8639 Fax: (301) 443-2599 Email: imontoya@mail.nih.gov 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, Room 220, MSC 8401 Bethesda, MD 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov 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, Room 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov 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 Name 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 should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Room 220, MSC 8401 Bethesda, MD 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@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 document 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. 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. 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 220, 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 and/or nonresponsive applications will not be reviewed. 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. For the regular project applications (R01) 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: Please assess the extent to which the study aims are consistent with the goals of the RFA. 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? (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 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The R03 and R21 applications will be evaluated based on the review criteria specified in the respective R03 and R21 announcement. The applicants should read the appropriate announcement before preparing the application. They can be found at the following web addresses: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html and http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html, respectively. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 20, 2004 Application Receipt Date: March 23, 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 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 SAFETY AND 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 Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "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. 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. 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. 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 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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