SPECIALIZED CENTERS FOR ORAL, DENTAL and CRANIOFACIAL RESEARCH RELEASE DATE: April 21, 2003 RFA Number: DE-04-006 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 LETTER OF INTENT RECEIPT DATE: November 15, 2003 APPLICATION RECEIPT DATE: December 16, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Dental and Craniofacial Research (NIDCR) invites applications for Specialized Centers for Oral, Dental and Craniofacial Research. These Specialized Centers will replace the currently existing Comprehensive Oral Health Research Centers of Discovery (COHRCDs) supported by the NIDCR. While the COHRCDs have been, and continue to be, effective, the required scope of activities has somewhat restricted in depth exploration of certain aspects of the selected themes. With the completion of the Human Genome Project and the rapidly escalating development of new sensitive high-throughput technologies, it is timely for the NIDCR to concentrate on contemporary approaches to areas critical to its mission. Through the establishment of Specialized Centers, emphasis will be placed on four areas: craniofacial biology, orofacial pain, oral infectious diseases (with the exclusion of HIV infections and the systemic consequences of oral infection), and salivary gland biology including Sjögren's syndrome. The Centers will focus on basic research associated with any aspect (except as noted) of these four areas and must be comprised of highly integrated multidisciplinary projects. RESEARCH OBJECTIVES It is becoming increasingly apparent that novel solutions to biomedical problems may best be met by the combined efforts of individuals with diverse scientific backgrounds. The Specialized Center mechanism provides an opportunity to apply this concept to the in depth exploration of various aspects of craniofacial biology, orofacial pain, oral infectious diseases and salivary gland biology including Sjögren's syndrome. Regardless of the selected topic, each Center must be composed of a minimum of three tightly integrated basic science projects and any appropriate cores. Although clinical samples may be used for the basic research projects, Phase I, Phase II or Phase III clinical trials are excluded. Each project in each multidisciplinary Center will be expected to utilize state of the art approaches such as genomics, proteomics, biomimetics, tissue engineering, utilization of stem cells, systems/computational biology, bioimaging to interrogate biological events in real time, etc. It is anticipated that the establishment of these centers will provide new insights into the identification of targets for the prevention, diagnosis and intervention of the diseases and disorders related to the four selected areas. In addition, each Center is expected to provide an excellent environment for training of graduate students, postdoctoral fellows and other health professionals. Craniofacial Biology Craniofacial and dental defects account for the majority of birth defects in infants born in the United States and result in an overwhelming financial and social burden. Cleft lip, cleft palate, ectodermal dysplasia, craniosynostosis, tooth agenesis, dentinogenesis imperfecta, amelogenesis imperfecta, dentin dysplasia, hypophosphatasia, holoproencephaly and hemifacial microsomia are some of the consequences of abnormal craniofacial and/or tooth development. While significant advances have been made in identifying the genetic aberrations that result in a number of these defects, there is a major need for further studies that clearly define their genetic basis. This is particularly true of disorders attributable to multiple susceptibility genes. In addition, investigations are also essential to elucidate the mechanisms by which relevant gene products function in normal craniofacial and tooth development. Centers in this scientific area could include topics such as: o Identification of genes, gene function and protein networks involved in normal craniofacial and tooth development; o Identification of aberrations in primary and regulatory genes and networks involved in the induction of craniofacial and tooth abnormalities; o Development of novel animal models of craniofacial and tooth disorders; and o Application of biomimetics, tissue engineering and/or the use of stem cells for the restoration/regeneration of craniofacial and tooth anomalies. Orofacial Pain The amelioration of both acute and chronic orofacial pain remains a major public health issue. Chronic pain is a disorder of the nervous system that persists for months or years and cannot be fully relieved by standard pain medications. This neuropathic pain can be initiated by nerve injury or by persistent inflammation in the target tissue or along the nerve. Orofacial pain can be sufficiently severe to restrict not only such vital functions as talking, chewing, and swallowing but may force affected individuals to sacrifice their professions and social interactions. Among the more common of these conditions are trigeminal neuralgia and pain associated with temporomandibular muscle and joint disorders. The pathophysiology of these disorders is poorly defined. As a result, the development of rational therapeutic modalities has been significantly hindered. Centers focusing on orofacial pain might incorporate such topics as: o Transduction and processing of nociceptive stimuli by peripheral nerves and the central nervous system; o Identification of novel nociceptors and their modulation; o Identification and functional studies of neurotransmitters, neuromodulators and intracellular messengers involved in orofacial pain; o Identification of gene and protein networks implicated in the initiation and persistence of orofacial pain; o Modulation of neurogenic inflammation; o Application of pharmacogenomic approaches to determine responsiveness to therapeutic agents; o Utilization of bioimaging for real-time interrogation of biological events; and o Development of improved model systems for investigation of orofacial pain processing mechanisms and phenotypic characteristics of pain. Oral Infectious Diseases Infectious diseases of the oral cavity (caries and periodontal diseases) continue to be significant public health burdens. Dental caries is the most common chronic infectious disease in the United States and is most prevalent in certain populations including children, the economically disadvantaged and the elderly. Periodontal diseases result in the destruction of the tissues that surround and support the teeth and the severity of these diseases increases with age. While oral microorganisms are the etiologic agents for periodontal diseases, the deleterious inflammation of the oral tissues that ultimately leads to tooth loss is largely attributable to responses of the host to these microbes. In both caries and periodontal diseases, highly organized biofilms serve as reservoirs for the causative microorganisms. Not only are complex interactions involved in the adhesion of microbes to other microbes in these biofilms, but also in the adhesion of oral microbes to host tissues. Although periodontitis has been implicated in such systemic disorders as stroke, atherosclerosis, diabetes and the birth of pre-term low birth weight infants, it is not the intent of these Centers to explore these associations. Rather, the emphasis is to be placed on the oral complications of these infectious processes. However, oral tissues, cells, etc. from individuals with these disorders could be utilized to investigate the influence of these disorders on oral manifestations of microbial infections. Centers in this scientific area could address topics such as: o Determination of genetic diversity among members of different oral microbial species; o Genomic and proteomic approaches to identify the mechanisms implicated in colonization and production of virulence factors; o Development of state of the art technologies for the early detection of caries, evaluation of dental erosion in caries, and determination of remineralization of teeth; o Development of genetic based markers for caries activity and susceptibility; o Elucidation of the microbial initiated mechanisms involved in soft tissue and bone destruction (microbe-host cell communication, cell signaling, production of mediators, apoptosis, etc.); o Delineation of the mechanisms by which oral microbes evade the host innate and acquired immune responses; o Studies on transmission of genetic information between oral microbes and the relationship of this event to pathogenesis; o Development of genetic based markers for early and progressive periodontal disease; o Identification of novel therapeutic targets in caries and periodontal disease; and o Development of novel approaches to dysregulate plaque formation and maturation. Salivary Gland Biology and Sjögren's Syndrome Saliva provides primary protection of the mouth and upper gastrointestinal tract. Perturbations of salivary secretory mechanisms can consequently lead to a number of detrimental sequelae including difficulty speaking, chewing and swallowing; rampant tooth decay; mucosal candida infections; loss of taste and oral discomfort. "Dry mouth" (xerostomia) can be induced by radiation of the head and neck for treatment of cancer or certain medications and is the primary symptom of Sjögren's syndrome, an autoimmune disorder characterized by secretory dysfunction of the salivary and lacrimal glands. In the early stages of Sjögren's syndrome, both the acini and ducts are infiltrated by lymphocytes and subsequently undergo degenerative changes. Studies related to the etiology of this syndrome have revealed the specificities of some of the autoantibodies involved. However, a comprehensive understanding of the multiple factors contributing to the initiation and progression of Sjögren's syndrome is lacking. Centers in this scientific area could include topics such as: o Elucidation of the genetic (including modulatory genes) and molecular basis for normal development and function of salivary glands; o Elucidation of the genetic and molecular basis for loss of salivary gland function; o Application of bioimaging to real time monitoring of biological events occurring in normal and pathologically affected salivary glands; o Development of novel technologies for the early diagnosis of Sjögren's syndrome; o Identification and functional analysis of immunological and antigenic components implicated in the etiology of Sjögren's syndrome; o Identification of molecular targets for intervention of Sjögren's syndrome; o Utilization of stem cell based technologies for salivary gland regeneration; o Restoration of salivary gland function including restoration of the biologically active molecules present in saliva; and o Development of an artificial salivary gland. MECHANISM OF SUPPORT This RFA will use NIH P50 (Specialized Center Grant) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is August 2004. This RFA uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDCR intends to commit approximately $10.0 million total costs in FY 2004 to fund up to six new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for total costs (direct plus facilities and administrative (F&A) costs) of up to $1.5 million per year. This amount may be exceeded by a request of up to $200,000 for F&A costs associated with subcontracts. Funds may not be utilized for training but each Center is expected to provide an environment for the training of graduate students, post doctoral fellows and health professionals. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application 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 o Faith-based or community-based organizations Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants should request funds for one trip per year by the PI and one project leader for an annual meeting to be held at NIH in Bethesda, MD. The purpose of these meetings is to discuss scientific advances and the potential for collaborations. All applications will be expected to address data sharing as indicated at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Ann L. Sandberg, Ph.D. Acting Director, Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AN-12B Bethesda, MD 20892 Telephone: (301) 594-2419 FAX: (301) 480-8319 Email: ann.sandberg@nih.gov o Direct your questions about peer review issues to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44F Bethesda, MD 20892 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Chief Grants Management Officer Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44B Bethesda, MD 20892 Telephone: (301) 594-4808 FAX: (301) 480-3562 Email: md74u@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Ann L. Sandberg, Ph.D. Acting Director, Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AN-12B Bethesda, MD 20892 Telephone: (301) 594-2419 FAX: (301) 480-8319 Email: ann.sandberg@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. SUPPLEMENTAL INSTRUCTIONS The following page limitations will apply: Overview describing the Center as an entity-5 pages Individual projects-25 pages Cores-10 pages The applicants should include, in the Overview, a discussion of the synergistic interactions that will be achieved through the establishment of multi-disciplinary teams, the utilization of novel approaches and the integration of the various projects. No appendices, with the exception of color figures, and no journal reprints will be accepted. All essential information must be in the submitted application. No corrections or updated information will be accepted after the application has been submitted. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F, MSC 6402 Bethesda, MD 20892-6402 APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the NIDCR National Advisory 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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)? 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: ADMINISTRATION: Are the quality control of the research, managerial oversight, internal communication, cooperation between the investigators and contractual agreements adequately addressed? MULTIDISCIPLINARY APPROACH: Is the Center comprised of collaborative efforts between individuals from different scientific disciplines? INTEGRATION OF PROJECTS: Are the proposed projects and cores well integrated in addressing the selected Center theme? UTILIZATION OF CONTEMPORARY TECHNOLOGIES: Are state of the art technologies applied to the exploration of the selected topic? TRAINING ENVIRONMENT: Does the Center provide an environment conducive to the training of graduate students, postdoctoral fellows and other health professionals? Each project will be reviewed according to the criteria indicated above. The review of the Cores will be based on the justification for and usefulness of the core facilities to the various research projects (each core should provide essential facilities or services for two or more individual projects). The review of all submitted projects will be included in the overall review and final score. Weak components will not be recommended for deletion prior to scoring. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 15, 2003 Application Receipt Date: December 16, 2003 Peer Review Date: May 2004 Council Review: August 2004 Earliest Anticipated Start Date: August 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 (https://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 https://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 https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 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 https://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 https://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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://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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