EPIDEMIOLOGICAL AND BEHAVIORAL RESEARCH IN ORAL HEALTH RELEASE DATE: November 14, 2003 PA NUMBER: PA-04-022 The R01 portion of this funding opportunity has been replaced by PA-07-169, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. EXPIRATION DATE: November 1, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 (Oral Diseases and Disorders) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA seeks to stimulate epidemiological and behavioral research to improve oral health or increase the understanding of the determinants of oral health. This initiative addresses specific research opportunities identified in the NIDCR Strategic Plan (http://www.nidcr.nih.gov/about/strat-plan/) issued in 2003 and in NIDCR’s Plan to Eliminate Oral Health Disparities (http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf. Such research projects will contribute to the Institute’s clinical research programs by providing a clearer understanding of behavioral and environmental factors influencing oral health, oral health care, and the prevention, diagnosis, and treatment of specific oral diseases/conditions. RESEARCH OBJECTIVES Background: Oral, dental, and craniofacial diseases are among the most common health problems affecting individuals in the US (Oral Health in American: A Report of the Surgeon General, 2001). The prevalence of most oral diseases is influenced by biological, behavioral, and environmental factors. Such factors include, for example, diet, personal self care behavior, tobacco and alcohol use, environmental influences such as the availability of fluoridated community water, access and motivation to seek preventive and therapeutic professional oral health care, health care providers decisions and practice behaviors, genetic influences, bacterial exposures, and immunological status. A better understanding of risk factors for oral diseases, and of the behavioral and environmental influences on oral health and dental treatment outcomes is needed. Over the past three decades, oral health in the US overall has improved. Among most age groups, the average number of teeth per person affected by dental caries has decreased and more US adults are keeping their natural teeth. Nevertheless, as noted in Oral Health In America: A Report of the Surgeon General and in the recent NIDCR Strategic Plan, profound differences in the prevalence of oral diseases persist. Dental caries and the periodontal diseases are very prevalent in the US. Both are caused by bacteria in dental plaque (biofilm) and are influenced by environmental, genetic and behavioral factors. While the prevalence of dental caries has declined in the past three decades, it remains the most common chronic childhood disease in the U.S. By age 17, more than 80 percent of U.S. adolescents are affected by this disease. The poor and uninsured, the very young and the elderly, and those with compromising medical conditions or disabilities are at increased risk for dental caries. The periodontal diseases range from mild forms of gingivitis to severe forms of periodontitis that results in tooth loss. Almost half of US adults age 35 to 44 have gingivitis, a reversible inflammation of the gingiva. Approximately one- fourth has periodontitis with clinical attachment loss of at least 4 millimeters. Severe periodontal disease (6 millimeters or more of clinical attachment loss) affects 14 percent of adults ages 45 to 54, and 23 percent of 65- to 74-years old. Tobacco use is a major risk factor for the development and progression of periodontal diseases. Diabetes, particularly if poorly controlled, increases the risk for periodontal disease. Sj gren’s syndrome is an autoimmune condition involving the salivary glands. It affects between 1 and 4 million Americans, mostly middle age women. Individuals with cystic fibrosis are also at high risk for salivary gland dysfunction, as are the estimated 40,000 people per year who lose salivary gland function as a result of radiation treatment for head and neck cancer. Individuals lacking adequate saliva commonly experience rampant tooth decay, mucosal infections such as candidiasis, loss of taste, and oral discomfort. Acute or chronic dental or craniofacial pain afflicts approximately ten per cent of the adult population. Sources of orofacial pain include caries, periodontal diseases, and neuropathic and musculoskeletal conditions. Orofacial pain is a major symptom of temporomandibular muscle and joint disorders (TMJD), currently estimated to affect at least ten million people in the United States. Craniofacial anomalies are among the most common of all birth defects. Cleft lip and cleft palate occur in about 1 to 2 out of 1,000 births in the United States. Many other rarer disorders, such as the ectodermal dysplasias, Treacher Collins syndrome, Apert’s syndrome, and Waardenburg syndrome include oral and craniofacial manifestations and share with cleft lip/palate the potential for producing significant functional, esthetic and social consequences across the entire life span. In addition, oral facial injuries can lead to serious disfigurement or problems with speech or chewing. Oral and craniofacial injuries occur throughout life and can result from a variety of causes such as athletic activities, failure to use appropriate protective equipment, interpersonal violence, falls, and vehicular accidents. To date, only limited research has addressed the epidemiology, prevention, and behavioral concomitants of craniofacial injuries. Numerous studies indicate that poorer individuals in the US are significantly more likely to have fewer diagnostic and preventive dental visits compared with persons with more economic resources. Minorities, the elderly, and children on Medicaid and other low-income children have fewer preventive dental visits. A lack of preventive care is correlated with poorer oral health. For example, more than a third (36.8 percent) of poor children aged 2 to 10 were found to have untreated decayed teeth compared to 17.3 per cent of nonpoor US children. Rural residents are less likely to receive preventive dental care than their urban counterparts. Predisposing and enabling factors (e.g., attitudes, health literacy, access to insurance) are strongly predictive of use of dental services. For many medical conditions, individuals who are sick are more likely to seek and receive medical care than are those who are healthy. In contrast, people who have the most dental needs often are the same people who seek or receive the least dental care. Studies are needed to identify determinants of seeking dental care and elucidate processes through which appropriate preventive oral health care can be encouraged among all people. NIDCR’s Strategic Plan The NIDCR’s Strategic Plan supports studies that expand and enhance the integration of population-based, genetic, social, and behavioral research. Specific research activities highlighted in the Strategic Plan and relevant to this PA include but are not limited to: o Further the understanding of how genetic, behavioral and environmental factors interact to contribute to disease susceptibility or resistance; o Assess and bridge gaps in the knowledge, opinions, and practices of the public, educators, and health care professionals about oral diseases and their prevention; o Identify risk factors and markers for the progression of disease to oral, dental and craniofacial diseases and disorders; o Improve oral health literacy; o Develop more effective strategies to encourage the appropriate and timely adoption of research findings into clinical practice. Examples of studies that may be responsive to this program announcement are given below. The list is only for illustrative purposes and is not exhaustive. Examples are not listed in priority order. Applicants are encouraged to propose other topics consistent with the goals of this program announcement. o Conduct epidemiological studies to clarify the relation between caries in the primary dentition and subsequent caries in the permanent dentition; o Conduct longitudinal studies on incidence and risk factors for diseases/conditions such as coronal and root caries, and periodontal diseases, persistent orofacial pain, salivary gland disease, and oral conditions associated with diabetes; o Conduct case-control studies to assess risk for orofacial pain or craniofacial deformities; o Investigate links between biologic, behavioral, environmental, and genetic factors associated with the incidence of oral cancer and survival; o Assess knowledge, attitudes, and behaviors of the public and health care providers as related to the oral effects of tobacco use, prevention of craniofacial injury, and between aging and oral disease or compromised oral function; o Develop and test methods to encourage attitudes and behaviors which support oral health and that can be accepted and sustained in community settings; o Study determinants of therapeutic adherence; test and develop methods to enhance compliance with therapeutic or preventive oral health care recommendations and compliance in clinical trials; o Develop and assess measures to increase oral health literacy and enhance effective transfer of knowledge to consumers regarding effective prevention and treatment of oral disease; o Conduct studies to assess the relation of oral health literacy and language skills to oral health status and/or treatment outcomes; o Conduct studies to enhance communication of oral health information and to improve oral health outcomes within disadvantaged and underserved populations; o Conduct epidemiological studies to investigate environmental and behavioral factors that contribute to higher prevalence of oral diseases/conditions in disadvantaged and underserved populations; o Develop and test community-based approaches for reducing oral diseases/conditions, such as oral-facial trauma in adolescents or other high risk groups; o Develop improved methods to assess personal and social outcomes of dental care and identify determinants of motivation to seek professional oral health care; o Determine the incidence and prevalence of oral and craniofacial diseases and conditions in disadvantaged, high risk, and underserved populations for whom nationally representative data are unavailable. MECHANISM OF SUPPORT This PA will use the NIH R01 award mechanism. However, if a clinical trial is proposed under this PA, the U01 award mechanism will be used. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. 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. SPECIAL REQUIREMENTS Intervention studies may be conducted within the scope of this PA. NIDCR has established special requirements for applications involving research conducted through randomized clinical trials as outlined on NIDCR’s home page under the section titled Clinical Trials (http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp ). WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: Direct your scientific questions about epidemiology research issues to: Maria Teresa Canto, DDS, MPH Director, Population Sciences Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS43B Bethesda, MD 20892-6401 Telephone:(301) 594-5497 Fax: (301) 480-8319 E-mail: maria.canto@nih.gov Direct your scientific questions about behavioral, social science, or health services research issues to: Patricia S. Bryant, PhD Director, Behavioral and Social Science Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS43A Bethesda, MD 20892-6401 Telephone:(301) 594-2095 Fax: (301) 480-8319 E-mail: patricia.bryant@nih.gov o Direct your scientific questions about oral health disparities research issues to: Ruth Nowjack-Raymer, MPH, PhD Director, Health Disparities Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS43J Bethesda, MD 20892-6401 Telephone:(301) 594-5394 Fax: (301) 480-8319 E-mail: ruth.nowjack-raymer@nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN44B Bethesda, MD 20892-6402 Telephone: (301) 594-4808 FAX: 301-480-3562 Email: daleym@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 tilte 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 marked. 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 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 $500,000 or more in direct costs for any year must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 an 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 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 methods? 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? 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 $500,000 or more 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. 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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