COLLABORATIVE CLINICAL TRIALS IN DRUG ABUSE RELEASE DATE: March 9, 2004 PA NUMBER: PAR-04-073 February 23, 2007 - This PA has been reissued as (PAR-07-232). EXPIRATION DATE: October 14, 2006 January 3, 2007 - Effective with the February 5, 2007 submission date, all R01 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, the R01 portion of this funding opportunity expired on October 14, 2006. Unsolicited or investigator-initiated R01 electronic SF424 (R&R) applications may be submitted through the Research Project Grant (Parent R01) announcement. 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 APPLICATION RECEIPT DATES: June 16, 2004; October 13, 2004; February 16, 2005 June 16, 2005; October 13, 2005; February 16, 2006 June 16, 2006; October 13, 2006; February 16, 2007 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 is a reissuance of PAR-01-039, Collaborative Clinical Studies in Drug Abuse, published in the NIH Guide for Contracts and Grants, January 2, 2001 at http://grants.nih.gov/grants/guide/pa-files/PAR-01-039.html. This new announcement replaces PAR-01-039 in its entirety. The National Institute on Drug Abuse (NIDA) seeks to increase the collaboration of investigators at different sites in order to address critical issues in the treatment of substance-related disorders that require sample sizes greater than a single site can reasonably attain. The expectation for the collaborative effort is that there will be implementation of common clinical trials across different sites in order to study patient outcomes, patient factors, provider factors, setting characteristics, interactions of these, or other effects where pooled samples are appropriate and necessary for the hypotheses under consideration. This announcement provides guidelines for the development, review, and funding of Collaborative Clinical Trials in Drug Abuse (CCTDA) projects. RESEARCH OBJECTIVES In order to draw valid conclusions from clinical trials of substance- related disorders, in many cases a large sample size is needed, which frequently can only be obtained through collaboration across multiple study sites. For some research questions, such as clinical trials of relatively infrequent behaviors, the required sample size effectively prohibits a single site from being able to recruit sufficient numbers. In other circumstances, even where the main hypotheses can be addressed with the sample available, interesting hypotheses about subpopulations (based on gender, ethnicity, drug use patterns, age, etc.), interaction effects, or ancillary questions (e.g., such as about therapist characteristics, patient matching to treatment, unexpected outcomes, etc.) can only be examined by studying large samples of subjects. Collaborative clinical trials allow multiple investigators to initiate and submit separate applications, each with a separate PI and applicant institution, that propose timely recruitment of an aggregate sample sufficient to address clinical concerns. By allowing multiple sites to recruit, a sample that otherwise could not be recruited, or could not be recruited within a reasonable time frame, can be enrolled. CCTDA seems ideally suited to foster the efficiency and creativity that can be obtained through investigator initiated research and, at the same time, allows multiple investigators to coordinate a focus on a particular clinical issue relevant to drug abuse. Examples of possible foci for a CCTDA are: o Pharmacological treatments that may include new or already-marketed medications. o Large-scale clinical trials of psychopharmacological treatments, alone or in combination with behavioral therapies. o Clinical trials for relatively low prevalence conditions in drug abusing populations or conditions for which it is difficult to recruit subjects. o Clinical trials involving neuroimaging studies of treatment effects that require multiple sites in order to study sufficient numbers of subjects of interest. o Clinical trials powered to draw conclusions about the impact of interventions associated with gender; racial, ethnic, or linguistic group; sexual orientation; age; or other developmental variables. o Clinical trials of other clinical issues in drug abuse (e.g., HIV/AIDS and other infectious diseases) that require multiple sites to ensure a sufficiently large sample to answer the question posed. MECHANISM OF SUPPORT This PA will use the NIH R01 award mechanism; no other mechanisms may be used. The applicant 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 5 years. This PA uses just-in-time concepts. It also uses the modular budgeting format (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. 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. ELIGIBILE 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 and foreign institutions/organizations The CCTDA requires more than one applicant organization, and each applicant organization must meet the eligibility requirements above. Multiple campuses of a single institution or university system are considered separate organizations for the purposes of eligibility to apply. 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. SPECIAL REQUIREMENTS One of the sites should be the coordinating site for the trial. The application for the coordinating site should explicitly state how it is going to fulfill its function and its interaction with the other sites. Similarly, the participating sites should describe their relationship with the coordinating site. Although a foreign institution may be a participating site, the coordinating site must be a domestic institution. 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: Ivan D. Montoya, M.D., M.P.H. Division of Treatment Research and Development National Institute on Drug Abuse National Institutes of Health/DHHS 6001 Executive Boulevard, Room 4123, MSC 9551 Bethesda, MD 20892-9551 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-8639 Email: imontoya@mail.nih.gov o Direct your questions about peer review to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse National Institutes of Health/DHHS 6101 Executive Boulevard, Room 220, MSC 8401 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 Email: tl25u@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse National Institutes of Health/DHHS 6101 Executive Boulevard, Room 242, MSC 8403 Bethesda, MD 20892-9541 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6710 Email: gf6s@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: All applications (Type 1 and Type 2 or amended) submitted in response to this program announcement will be accepted at: June 16, 2004; October 13, 2004; February 16, 2005; June 16, 2005; October 13, 2005; February 16, 2006; June 16, 2006; October 13, 2006 and February 16, 2007. AIDS applications must comply with the standard AIDS receipt dates; the last AIDS receipt date for this PA will May 1, 2007. Separate applications must be prepared by each applicant institution. Because the CCTDA is expected to address questions that are not addressable in single site clinical trials, competing continuation of single site clinical trials would not be appropriate. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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: All applications (Type 1 and Type 2, or amended) must be bundled together and mailed on or before the receipt dates of June 16, 2004; October 13, 2004; February 16, 2005; June 16, 2005; October 13, 2005; February 16, 2006; June 16, 2006; October 13, 2006 and February 16, 2007. AIDS applications must comply with the standard AIDS receipt dates; the last AIDS receipt date for this PA will be May 1, 2007. 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 unfunded version 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. The application must be organized in accordance with standard PHS Form 398 instructions, with the following modifications: Each application in a CCTDA group should be essentially identical to the others, with the exception of expected differences in elements such as numbers of available subjects, resources and environment, budgetary requirements, and staff. Each application must include an overview section that is no longer than 2 pages and constitutes the first pages of the RESEARCH PLAN section (i.e., immediately precedes the Specific Aims). This overview should list the individual applicant organizations participating in the CCTDA and the Principal Investigator for each. It should establish the need for applying as a CCTDA and justify the role for each applicant organization in the CCTDA. The investigators may also wish to identify one individual as the contact person for the group for the purposes of facilitating communication. If so, that should be noted in the overview. Sections A-D of the research plan should describe those aspects of the project that are common to all sites. The research procedures and protocol should be presented in detail, along with description of the study population from which samples are drawn, the anticipated samples themselves, resources, plans for data analysis, and characteristics that support each site’s (i.e., not simply the applicant’s site) role in the project. Where there are minor variations in plans, these should be noted in the text and then summarized in a separate subheading in Section D (which counts toward the 25 page limit) titled ELEMENTS UNIQUE TO THIS SITE. The research plan should describe a feasible strategy for integration of research procedures, managerial and administrative responsibilities, and training across sites to ensure the integrity of the research effort. The Principal Investigators may wish to designate a Steering Committee or other decision-making body. If so, the biosketches of these individuals should be included. If not, a feasible strategy for decision-making must be detailed. Plans for ensuring access to data by all sites, analytic resources, publication and authorship procedures, public use of data, dissemination of results, and means of arbitrating disagreements should be addressed. Any site that contracts out elements of the research should note this as an element unique to the site, both in the main body of the research plan and in the separate section on unique elements. The nature, purpose, and oversight of the contractual arrangement should be fully described. Revised submissions of CSDAs must include an introduction to the revision that highlights changes in the research plan and how delays in initiating the project will affect the work. This is particularly important in cases where some but not all of the CCTDA sites have already begun work on a project. All applications submitted as part of the CCTDA should be mailed together in one package, in order to assure that they are processed as CCTDA submissions. All of the applications constituting the proposed CCTDA group must be submitted in a single package, whether or not the applications are from the same institution. A cover letter must list the total number of applications submitted for the CCTDA group, clearly identifying each application and the principal investigator of each. For each component application in the CCTDA group, the original, five copies, and the appendix material must be bundled together and clearly identified PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened by NIDA 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 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? RATIONALE AND FEASIBILITY OF THE COLLABORATION: How well is the use of collaborating sites justified? How necessary is collaboration to address the scientific issues? How well does this application establish, through preliminary data or other means that other sites will be able to contribute to the study? MANAGEMENT PLANS: How well developed and reasonable are the plans for coordination, decision-making, quality control, and arbitration? In particular, how well have other administrative and managerial issues been addressed with respect to: o the reliability and accuracy of the main administrative site's past performance and the potential of the main administrative site's future performance in clinical trials; o the experience of the Principal Investigator and other key personnel in conducting clinical trials; o the ability of the main administrative site to manage and analyze data for the clinical trial; and, o the appropriateness of the proposed procedures for data management, data storage, and analytical activities. 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 REVIEW 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 Funding decisions will also consider whether there are sufficient high quality collaborating sites for the CCTDA project. 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 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). 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. 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. 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. 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 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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