PAR-04-025: PHASE III CLINICAL TRIALS IN ORAL INFECTIOUS DISEASES

Department of Health
and Human Services (HHS)

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PHASE III CLINICAL TRIALS IN ORAL INFECTIOUS DISEASES RELEASE DATE: November 20, 2003 PA NUMBER: PAR-04-025 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(S): 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 The National Institute of Dental and Craniofacial Research (NIDCR) encourages submission of investigator-initiated grant applications for Phase III clinical trials to assess the efficacy and safety of preventive or therapeutic interventions for oral infectious diseases. Such interventions should have high potential for translation into clinical practice and for improving the oral health status of all Americans. NIDCR’s prior support for basic and clinical research has shown that dental caries, periodontal diseases, and many other oral diseases involve infectious processes that result from the interplay of infectious agents, environmental influences (e.g., diet), genetic factors, and host response. This initiative seeks to accelerate the translation of such findings into well-documented, cost- effective interventions of proven efficacy for preventing and treating oral infectious diseases. Clinical trials focusing on the periodontal diseases and dental caries are particularly encouraged given the uniquely prominent role that these disorders have in the delivery and cost of oral health care as well as their widespread prevalence in the population. However, clinical trials involving other oral conditions with an infectious cause bacterial, viral, or fungal will also be considered responsive to this PA. Applications that address novel interventions, higher risk population groups with oral health care disparities, research gaps, and common pathologic mechanisms are particularly encouraged. RESEARCH OBJECTIVES To ensure that the scientific advances of the post-genomic era enter the mouth, the NIDCR must enhance the translation of basic science findings into clinical trials. Clinically relevant evidence must be obtained from definitive clinical trials in order to define optimally effective clinical practices. Such practices require extending current paradigms of preventive, surgical, and reparative dental care to paradigms that emphasize prevention/earlier detection/and novel interventions based on a more thorough biologic understanding of oral health and disease. Therefore, the NIDCR recognizes the need to encourage and support high quality definitive clinical trials that address significant clinical problems. These clinical trials need to be appropriately designed and of sufficient power to have an impact on the public health and future clinical practice. Thus, the specific goal of this program announcement is to encourage investigators to design and submit high quality Phase III randomized clinical trials to improve the prevention and treatment of infectious oral diseases. Oral infectious diseases are endemic in the population and are the most prevalent chronic infections in humans. Periodontal diseases and dental caries are the most common infectious oral conditions. Both are the result of infections caused by bacteria in the dental plaque biofilm. Periodontal diseases range from mild forms such as gingivitis to severe forms of periodontitis that result in destruction of periodontal support and tooth loss. Approximately half of the U.S. adult population aged 35 to 44 have gingivitis and about one-fourth have severe periodontitis. Although pathogenic bacteria in dental plaque are the primary etiologic agents for periodontal disease, diabetes and tobacco use increase risk for this infectious disease. Accumulating evidence also indicates a potential link between maternal periodontal disease and the incidence of preterm birth and /or low-birth weight babies and between periodontal disease and both cardiovascular disease and pulmonary disease. Even though many more children and adolescents remain caries free today than previously, dental caries is still the most common chronic infectious disease of childhood in the United States. Early childhood caries (ECC) affects the primary dentition and is seen in about 18% of children aged 2 to 4. Children whose parents or caregivers have less than a high school education or who are Mexican American, American Indian, or Alaska Native appear to be at a highest risk for developing ECC. Maternal oral infections and their transmission to infants and young children are known to play an important role in ECC. The majority (51.6%) of children aged 5 to 9 years have at least one carious lesion or dental restoration in the primary of permanent dentition. This prevalence increases to 77.9% at 17 years of age and to 84.7% in adults 18 or older. Furthermore, 49.7% of people 75 years or older have root caries. Medically compromised patients receiving radiation and chemotherapy are particularly vulnerable to dental caries. Treatment for the periodontal diseases and dental caries accounted for much of the estimated $60 billion Americans spent for dental services in 2001. In addition to encouraging Phase III clinical trials to prevent or treat caries and periodontal disease, this program announcement also applies to clinical trials that focus on other oral diseases or conditions (e.g., salivary diseases, oral mucosal lesions) associated with bacterial, viral, or fungal infections. For example, the human papilloma virus (HPV) is found in a variety of oral lesions and candidiasis, a fungal infection caused by Candida albicans, often causes oral symptoms of burning and soreness as well as sensitivity to acidic and spicy foods. In most cases, candidiasis can be controlled with local or systemic antifungal medications, but control of this fungal infection can be difficult in patients with compromised immune systems. SCOPE The purpose of this PA is to encourage Phase III clinical trials that address the efficacy and safety of biologically-based preventive or therapeutic interventions for oral infectious diseases. These studies should be sufficiently powered to provide definitive results with clinically meaningful outcomes. Examples of studies that would be responsive to this program announcement are listed below. These are only illustrative examples and applicants are encouraged to propose other topics that are consistent with the goals of this program announcement. o Clinical trials involving, chemotherapeutic, pharmacologic, passive immunotherapy, or other interventions to prevent and/or treat the periodontal diseases and various types of dental caries (e.g., ECC, root caries), particularly in population subgroups with known risk factors and who are at risk for disparities in oral health care; o Clinical trials focusing on the prevention or treatment of oral manifestations or complications of infections caused by herpes viruses, human papilloma virus, Human Immunodeficient Virus (HIV), enteroviruses or other human viruses; o Clinical trials testing new therapeutics or management strategies for oral candidiasis and other fungal infections; o Clinical trials testing interventions for noma and other disfiguring or debilitating oral infections; o Clinical trials on interventions for managing and treating mucosal infections in patients with AIDS or immune dysfunction secondary to cancer therapy. MECHANISM(S) OF SUPPORT This PA will use the NIH U01 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. 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. The NIH (U01) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award" The total project period for an application submitted in response to this PA may not exceed five years. The award may be competitively renewed for a second period, up to five years, based on peer review of a renewal application and the availability of funds. The NIDCR does not envision more than one renewal period. 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 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 This PA solicits fully developed Phase III clinical trials. This PA will be of special interest to investigators who already have data and other preliminary requisites specified by NIDCR for all Phase III clinical trials. For a complete description of the NIDCR’s clinical trial program and specific requirements for Phase III clinical trials to be supported by NIDCR see Information for Investigators at http://www.nidcr.nih.gov under the heading Clinical Trials. To obtain preliminary data to support the development of a Phase III clinical trial you may wish to consider submitting an application in response to PAR- 03-043/NIDCR Clinical Pilot Data Grant (http://grants.nih.gov/grants/guide/pa-files/par-03-043.html). If you have preliminary data but wish to refine the trial’s protocol and procedures before applying under this PA, it may be appropriate to submit an application in response to PAR-03-042/NIDCR Clinical Trial Planning Grant (http://grants.nih.gov/grants/guide/pa-files/par-03-042.html). The Phase III clinical trial application should consist of a minimum of two grant applications: one from the Study Chair and one from the Data Coordinating Center. Applications for participating clinical sites may be submitted as separate grant applications or as subcontracts to the Study Chair or Data Coordinating Center applications. Given the complexity of Phase III clinical trials, NIDCR encourages the use of a Data Coordinating Center as an integral part of the clinical trial organization. As part of the Study Chairs application, NIDCR requires the submission of a detailed Manual of Operations (MOP, see http://www.nidr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp for a model MOP), plans for establishing a Data and Safety Monitoring Board (DSMB), plans for regular meetings of the clinical trial steering committee, and documentation of the ability to enroll the specified number of patients. All applications with direct costs $500,000 or more in any year of the proposed research, must have a data sharing plan. Prior to submitting an application in response to this PA or for a Clinical Trial Planning Grant or a Clinical Pilot Data Grant, investigators are requested to submit a brief description of the proposed Phase III clinical trial for programmatic review by NIDCR. This review is designed to provide assistance and program advice to prospective applicants for clinical trials. This brief description should not exceed 2 pages in length. See http://www.nidr.nih.gov/clinicalTrials/proposalProcedure.asp for details on topics to be covered plus review criteria to be used by NIDCR in conducting the programmatic review. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD Under the cooperative agreement, there will be substantial NIDCR scientific and/or programmatic involvement with the awardee. The NIDCR’s purpose is to assist, support, and/or stimulate the recipient's activity by facilitating performance of the effort as a partner. The NIDCR will not assume direction, prime responsibility, nor a dominant role in the activity. For details of the responsibilities, relationships and governance of the study to be funded as U01s (cooperative agreements) please refer to http://www.nidcr.nih.gov/clinicalTrials/terms_conditions.asp. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and the NIDCR’s clinical trial program 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: Dr. Richard Mowery Clinical, Epidemiology and Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4As43F, MSC 6401 Bethesda, MD 20892-6401 Telephone: (301) 594-4848 FAX: (301) 480-8322 Email: rm33a@nih.gov Or Dr. Bruce Pihlstrom Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4As43H, MSC 6401 Bethesda, MD 20892-6401 Telephone: (301) 594-4830 FAX: (301) 480-8322 Email: pihlstrb@mail.nih.gov o Direct your questions about peer review issues to: Dr. George Hausch Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301480-8303 Email: George.Hausch@nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44B Bethesda, MD 20892-6402 Telephone: 301-594-4800 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 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 three 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) In order to facilitate the review of applications assigned to the NIDCR, the applicant must, at the same time, mail or deliver two copies of the application and all copies of the appendix material to: Dr. George Hausch Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F MSC 6402 Bethesda, MD 20892-6402 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 the National Advisory Dental and Craniofacial Research Council. 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, specific review criteria for Phase III clinical trials to be used by the Special Review Panel have been developed for the Administrative Center/Chair application, Coordinating Center application, Clinical Center applications, and Laboratory/Testing Center application. These criteria can be found at http://www.nidr.nih.gov/clinicalTrials/reviewCriteria.asp 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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