ORAL HEALTH OF SPECIAL NEEDS AND OLDER POPULATIONS RELEASE DATE: December 8, 2003 PA NUMBER: PA-04-031 The R01 portion of this funding opportunity has been replaced by PA-07-151, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.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) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.121, Oral Diseases and Disorders 93.866, Aging Research THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement is to encourage investigator-initiated clinical research focused on the oral health of special needs populations, including those with developmental or acquired physical or mental disabilities, people with mental retardation (MR), people living with HIV/AIDS, and frail or functionally dependent elders. The types of clinical research welcomed are epidemiologic, behavioral/social sciences, health care, patient-oriented and community-based studies aimed at understanding and improving the oral, dental and craniofacial health status, quality of life and health outcomes among elders and other special needs populations. Given the complexity of factors that may contribute to oral health disparities of these populations the use of multiple approaches and interdisciplinary teams is anticipated. Studies that nest oral health projects into ongoing, funded research are encouraged. The research interests of the National Institute of Dental and Craniofacial Research are described in the NIDCR Strategic Plan (http://www.nidcr.nih.gov/about/strat-plan/) and in A Plan to Eliminate Oral Health Disparities (http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf). RESEARCH OBJECTIVES Oral Health in America: A Report of the U.S. Surgeon General indicates that oral, dental and craniofacial diseases and disorders are among the most common health problems affecting the general population. The U.S. Surgeon General’s Report and the NIDCR’s Plan to Eliminate Oral Health Disparities note that certain segments of our society have significant disparities in oral health. This program announcement encourages the submission of clinical research applications that focus on improving the oral health status and quality of life of a specific segment of the population those with special needs. Special needs populations, for the purposes of this program announcement, include people with developmental or acquired physical or mental disabilities, people with mental retardation (MR), people living with HIV/AIDS, and frail and functionally dependent elders. As a group, Americans are aging and by 2030 one-fifth of the population or approximately 70 million people will be 65 years and older. An estimated 30 percent of elders have limited mobility, are homebound, live in nursing homes or are functionally dependent on others in their daily life. The impact of oral, dental and craniofacial diseases and conditions on the health and quality of life of frail and functionally dependent elders may be considerable. National surveys indicate that serious oral health problems exist even among many older adults who are non-institutionalized or non- homebound. These oral health problems may have an impact on general health, social well-being, and quality of life. Studies conducted in a variety of settings indicate that older people with impaired dentitions have trouble sleeping because of dental problems, avoid social contact and conversation, and may be too embarrassed to laugh or smile. The psychosocial impacts of oral diseases and conditions are of concern given the growing evidence that social support is related to general health. Many older adults suffer from severe periodontal disease and there is evidence that periodontal disease or tooth loss may be associated with poor diabetic control, respiratory disease, cardiovascular disease, and stroke. Nationally representative surveys indicate that the loss of teeth is associated with lower intakes of nutrient rich foods and dietary fiber and lower levels of important biochemical analytes. The U.S. Surgeon General’s Report states that people who are missing teeth would have difficulty complying with the healthful diet recommendation of the 5-A-Day campaign for intake of fiber-rich fruits and vegetables. Prosthetic replacement of lost teeth using current approaches does not appear to significantly improve nutritional outcomes. Few studies have explored innovative approaches to oral care aimed at improving quality of life, nutritional status and health outcomes. Great strides have been made in the prevention and treatment of oral diseases and conditions in segments of the general population, but these achievements may not be applicable to people with developmental and acquired disabilities. Despite the fact that as many as one in five persons in the United States has some level of disability, that is developmental (e.g. mental retardation, cerebral palsy, syndromic disorders) or acquired (such as head or spinal cord injuries, HIV/AIDS, degenerative neurological disorders, psychiatric disorders) little clinical research related to their oral health has been conducted. For example, data on the prevalence, incidence and determinants of oral health is almost non-existent for people with disabilities. Information regarding the types and severity of oral diseases and conditions; the biological, behavioral and environmental factors related to oral health; documentation of inequalities of oral health and oral health care within various populations with disabilities; and impact of oral health on social well being, quality of life and general health is needed to guide the development of effective and appropriate prevention and treatment of oral disease for people with developmental and acquired disabilities. Factors of particular importance to special needs populations may include dietary and special feeding practices; use of medications for chronic conditions; ability to perform self-care procedures; access to health information; health literacy of patients or their care givers; professional care approaches; and interactions between environmental, behavioral and biological factors that increase vulnerability. Small-scale studies, such as screening examinations conducted by the Special Olympics Special Smiles Program, give clues to the burden of disease and suffering experienced by people with MR or other disabilities. Using a very conservative protocol, dental examiners found that nearly 40% of Special Olympics participants showed signs of gingival infection, a fourth had untreated decay, and nearly 13% reported some form of oral pain. These data are even more significant when it is considered that The U.S. Surgeon General’s Report: Oral Health in America noted that those participating in Special Olympics tend to be from higher-income families. Another Surgeon General’s Report, The Surgeon General’s Conference on Health Disparities and Mental Retardation acknowledged that challenges of people with MR from minority and low-income communities may be magnified. This may well be the case for oral health given the documented disproportionate burden for oral disease that exists for racial and ethnic minorities, the poor, and those with less education in the general population. The disparities in oral health and its impact on the quality of life of these populations and their caregivers may be substantial. Frail and functionally dependent elders may be at particular risk for oral diseases, conditions and discomfort due to side effects of medications and complications from medical or surgical care. Many prescription and over-the- counter drugs are associated with oral side effects including xerostomia, gingival enlargement and altered taste perception. Some medications contain sucrose that when coupled with xerostomia and poor oral hygiene may increase risk for dental caries. Medical and surgical treatment for conditions such as head and neck cancer can result in painful and debilitating oral pathosis. Some people with special needs have problems swallowing or mastication and require special diets or feeding that may increase risk for dental caries. Strategies to overcome these and other challenges requires additional research. Innovative strategies using state-of-the art technology may be helpful in overcoming barriers to care and access to information that confronts people with special needs and their caregivers. The application of technology such as telehealth and telemedicine in oral health care has the potential for increasing health literacy and information transfer, implementing tailored interventions, assessing health and monitoring compliance with recommendations for with oral health care. Development of novel approaches and adaptation of existing technology for the oral health care of people with special needs are needed. The development of assistive devices for the oral health care of special needs populations with disabilities has received little attention. The use of interdisciplinary health care provider and caregiver teams warrants exploration. Listed below are examples of studies that would be responsive to this program announcement. These are only illustrative examples and are not listed in priority order. Applicants are encouraged to propose other topics consistent with the goals of this program announcement to address the oral, dental and craniofacial health of elders and other special needs populations. Applicants are encouraged to consider nesting oral health projects in ongoing, funded observational studies of community-dwelling and institutionalized populations. o Documentation of the prevalence, incidence and determinants of oral, dental and craniofacial diseases and conditions in special populations where insufficient information is available. o Documentation of the impact of oral, dental and craniofacial health on the quality of life across multiple domains such as comfort and well-being, function (eating, chewing, food selection), social and personal interaction (talking, smiling, communicating), and self-image. o Documentation of the impact of oral health-related quality of life on general health. o Development and testing of strategies to improve oral health-related quality of life and its impact on general health. o Identification and testing of innovative strategies to improve oral health that are self- or caregiver provided across the spectrum of physical and cognitive conditions of people with special needs. o Exploration of innovative approaches to improve or maintain oral health and quality of life of people with needs by increasing the ability and willingness of health care professionals and other caregivers to provide oral care. o Exploration of innovative health promotion approaches (social, educational, legal, fiscal) to address environmental, behavioral and biological determinants of oral health and oral health-related quality of life. o Identification of strategies to improve dissemination and implementation of research findings to people with special needs, their caregivers, and health care professionals. o Exploration of innovative and appropriate technology to diagnose and prevent disease and improve or maintain oral health and quality of life of people with special needs. o Exploration of physical and psychosocial factors that influence perceptions of oral health and care needs of people with special needs and their caregivers. o Development and testing assistive devices for use by people with disabilities or their caregivers. o Development and testing novel approaches to prevent or mitigate the effects of medications, treatments or feeding practices on oral health including dental caries, xerostomia, mucositis, and periodontal disease. o Identification and testing of novel use of technology to improve dissemination of oral health information, compliance with recommendations for oral health care, oral health literacy, and oral health. o Assessment of the degree to which oral health practices or decision making practices regarding oral health are similar to other health practices or economic decisions in older individuals, and/or the degree to which practices and decisions are related to such changing cognitive functions in old age as memory, executive function (ability to plan and carry out behavior), or emotion. Investigators are encouraged to form multidisciplinary research teams to address the prevention and treatment of oral, dental and craniofacial diseases and conditions and to address the improvement in quality of life for people with special needs. People with special needs or their advocates should be included in all phases of the research whenever possible. Social science, behavioral, and other patient-oriented research with outcome assessments may be conducted within the scope of this PA. Investigators interested in conducting developmental research in preparation for R01 level research are referred to Request for Applications number DE-04-009 NIDCR Exploratory and Developmental Grants in Clinical Research at http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-04-009.html. Applications for clinical trials will NOT be accepted under this Program Announcement. If an investigator wishes to propose a clinical trial in oral health of special needs and older populations, she/he must follow the NIDCR’s guidelines for submitting a clinical trial that are found at http://www.nidr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp. MECHANISM(S) OF SUPPORT This PA will use the NIH R01 award mechanism. 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. 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 oral health disparities research related to elders and other special needs populations to: Ruth Nowjack-Raymer, MPH, PhD Director, Health Disparities Research Program Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS-43J Bethesda, MD 20892-6401 Telephone: (301) 594-5394 FAX: (301) 480-8322 Email: Ruth.Nowjack-Raymer@nih.gov o Direct your questions about behavioral, social science, or health services research issues to: Pat Bryant, PhD Director, Behavioral Research Program Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS-43A Bethesda, MD 20892-6401 Telephone: (301) 594-2095 FAX: (301) 480-8319 Email: Patricia.Bryant@nih.gov o Direct your questions about epidemiology research issues to: Maria Teresa Canto DDS, MPH Director, Population Sciences Research Program Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS-43B Bethesda, MD 20892-6401 Telephone: (301)594-2095 FAX: (301)480-8322 Email: Maria.Canto@nih.gov o For questions related to cognitive changes and aging, or decision making and dental health planning in older individuals contact: Jeffrey Elias, PhD Behavioral and Social Research Program National Institute on Aging Gateway Building, Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 Email: eliasj@nia.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 4AN-44B Bethesda, Maryland 20892-6402 Telephone: (301) 594-4808 FAX: (301) 594-3562 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 title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR 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 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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