PERIODONTAL DISEASES: MICROBIAL AND HOST GENOMICS/PROTEOMICS RELEASE DATE: April 24, 2003 RFA: DE-04-001 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 LETTER OF INTENT RECEIPT DATE: July 29, 2003 APPLICATION RECEIPT DATE: August 26, 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 purpose of this RFA is to stimulate research that will employ prokaryotic/eukaryotic genomic and proteomic techniques to analyze the molecular interactions that occur between oral bacteria and host cells (i.e. bacteria-bacteria, bacteria-host cell, and host cell-host cell) associated with the pathogenesis of periodontal diseases. The ultimate goal is to use this information to prevent, treat or diagnose periodontal diseases. RESEARCH OBJECTIVES Background Periodontitis is a chronic inflammatory disease that destroys the tissues that surround and support the teeth. These diseases are complex, with genetic, microbial, immunological and environmental factors determining disease risk, progression, and course. Periodontal diseases are a significant public health burden in the United States. Total expenditure on periodontal and preventive periodontal procedures (dental cleaning and oral hygiene instruction) was $14.3 billion in 1999. Severe periodontal diseases (having 4mm or more of attachment loss) increase in prevalence with age, with approximately 50% of 55-64 years old having evidence of severe disease. By age 75, roughly two thirds of all adults have severe periodontitis and one third of them have 6 mm or more of attachment loss. Males are more likely than females to have at least one tooth with 6 mm or more of attachment loss, and severe periodontal diseases are higher in non-Hispanic blacks and persons in low socioeconomic groups at each age group. Early onset periodontitis, a severe and rapidly progressive disease occurring in individuals under the age of 35, is far more common in African American blacks (10.0%), than Hispanics (3.0%) and whites (1.3%). Some forms of periodontal diseases progress very rapidly, destroying the tissues that surround and support the teeth. Risk factors for periodontal diseases include smoking, colonization of the subgingival plaque with pathogenic bacteria, diabetes, race and age. Periodontitis has been associated with systemic diseases and conditions, such as stroke, atherosclerosis, diabetes, respiratory disease, and adverse pregnancy outcomes. During the last five years, periodontal research supported by the NIDCR has led to significant advances including identification of hundreds of species of uncultured bacteria by 16S ribosomal RNA genetic techniques, complete or partial sequencing of many periodontopathic bacterial strains, a more complete appreciation of the importance and complexity of the microbial biofilms, host immune responses involved in chronic inflammation, molecular analysis of alveolar bone loss, and the biological basis for accelerated tissue regeneration. Periodontal diseases are initiated by a complex network of molecular interactions between bacteria growing as a biofilm in the subgingival crevice and the host tissues that surround and support the teeth. The damage to host soft and hard tissues appears to be largely the result of multiple factors produced during the destructive chronic inflammatory response to the bacteria and their products, as well as bacterial proteinases and cytotoxins released from subgingival biofilms. Genomics refers to the study of the identity of all genes within the chromosome of a cell. Functional genomics research is directed towards elucidating the organization of the genes and their expression patterns under highly defined conditions. The human, animal and microbial genome sequencing projects are providing a rich genetic resource to better understand periodontal diseases. The development of high throughput analyses of genomic data makes it possible to explore patterns of gene expression in cells of the periodontium (both eukaryotic and prokaryotic), and thus better define the precise pathogenesis of diseases. DNA microarray technologies provide investigators with the ability to assess changes in gene expression on a genome-wide basis, providing a "global" perspective of how an organism responds to a specific stress, drug or toxicant. Proteomics, the study of the proteome (i.e., the complete set of proteins expressed by the genome of an organism, cell or tissue type), seeks to unravel the biological complexity encoded by the genome. Proteomics builds on and complements the knowledge gained from genomics by revealing the levels, activities, regulation and interactions of every protein in the cell. Study of the proteome is more complex than that of the genome. It is estimated that the number of proteins to be examined is at least an order of magnitude greater than the number of genes, in part because proteins can undergo a variety of post- translational modifications. Moreover, the composition of the proteome is dynamic and constantly changing in response to the environment and there are multiple possible interactions among proteins. Protein chips that can simultaneously identify large numbers of proteins, although more difficult to produce and to handle than DNA microarrays, offer insight into the patterns of proteins associated with health and disease. High throughput structure determination using x-ray crystallography and identification using nuclear magnetic resonance spectrometry are providing exciting insight into host and microbial proteins under different environmental conditions. Importantly, the data generated by these research projects are becoming more manageable through impressive developments in the field of bioinformatics. Genomics and proteomics provide a new gateway to understanding the etiology and pathogenesis of periodontal diseases. For example, complete transcriptional profiling of microbes isolated directly from human subgingival biofilms, can show gene expression patterns required for nutrient acquisition, motility and production of virulence factors. Recent studies also show that microbial and host proteins are modified posttranslationally by cellular proteases, resulting in unexpected structure and biological functions. Such global information about genes and proteins provides a rational basis for identification of molecular targets that could be used for better diagnoses, prevention, or treatment of these diseases. The identification of single nucleotide polymorphisms involved in allelic variants of genes, can lead to information on patient-specific genes involved in disease pathogenesis. Genomic and proteomic information can define cellular networks of response genes, identify target molecules of toxicity, provide future biomarkers, and identify individuals with varied susceptibility to infection, inflammation, the environment and/or drugs. The application of these tools to oral health research is causing a paradigm shift in the study and understanding of periodontal diseases. Integration of information from the genome sequencing projects, comparative and microbial genomics, proteomics, bioinformatics, and related technologies will provide the basis for proactive approaches for prevention, diagnosis and treatment. Scope The objective of this RFA is to stimulate research to use contemporary high-throughput technology to identify and characterize genes (genomics) and proteins (proteomics) that are associated with periodontal diseases and health. Findings from these studies will establish a scientific basis for identification of logical targets for the prevention, diagnosis and treatment of these diseases. Examples of responsive projects include, but are not limited to: o Studies of the intracellular signaling pathways activated during bacteria-host cell interactions; o Analysis of all structural proteins involved in microbial attachment to host tissue cells; o Application of innovative proteomic technologies such as isotope- coded affinity tag (ICAT) peptide labeling, SELDI-TOF, multi- dimensional chromatographic technologies (such as coupling LC-LC with MS/MS), antibody arrays, protein chips, and yeast two-hybrid or phage- display assays to study host and microbial proteins involved in periodontal diseases; o Identification of proteins and other molecules involved in cross talk between bacteria and host cells; o Studies on total gene expression by bacterial growing in "normal" versus "pathogenic" biofilms; o Analysis of the gene and protein profiles to establish an objective definition of active versus quiescent periodontal disease; o Total gene expression in subgingival plaque bacteria exposed to host innate and acquired immune factors; o Gene and protein profiles of host leukocytes recruited to gingival/periodontal lesions; o Molecular profiles of alveolar bone cells in healthy versus chronically inflamed tissues; o Microbial gene expression in mixed microbial ecosystems; o Contact-induced gene expression in bacteria; o Computational models to understand the roles of gene-environment interactions in disease; o Epithelial cell gene expression resulting from interactions with microbes and microbial soluble factors; o Studies on molecular bacterial physiology using real time technologies; o Studies characterizing protein-protein interactions and their consequences on inflammation in the gingiva. o Quantitative studies focused on protein modifications that will enhance our knowledge of periodontal disease pathogenesis; o Studies characterizing the molecular mechanisms controlling temporal and spatial regulation of protein expression networks in a cell; and, o Studies to identify and characterize the relationship between gene expression profiling and protein interaction networks for cellular processes. Applications that propose only to survey and catalog gene or protein expression patterns in response to exposure to environmental conditions will be considered non-responsive to this RFA. Applications should focus on enhancing our understanding of the mechanisms and pathways by which genes and proteins contribute to the prevention, diagnosis and treatment of periodontal diseases. MECHANISM OF SUPPORT This RFA will use NIH R01 and R21 award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The earliest anticipated award date is April 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non-modular 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. FUNDS AVAILABLE The NIDCR intends to commit approximately $2.0 million total cost (direct cost and applicable facilities and administrative F&A cost) in FY2004 or FY2005 to fund six to eight new and/or competitive continuation grants in response to this RFA. An R01 applicant may request a project period of up to four (4) years and a budget for direct costs up to $500,000 per year. An R21 applicant may request direct costs up to $275,000 over a two year period. 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(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 o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants should request funds for one trip per year for an annual meeting to be held at NIH in Bethesda, MD. The purpose for these meetings is to discuss scientific advances in the genomics and proteomics of periodontal diseases, and to discuss the potential for collaborations, data sharing, data repositories and other research opportunities. 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: Dennis F. Mangan, Ph.D. Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AN-12J Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 480-8319 Email: Dennis.Mangan@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 National Institutes of Health Building 45, Room 4AN-44F Bethesda, MD 20892-6402 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 Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-55 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8303 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 NIDCR 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 Dr. Hausch at the address listed above. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS: All application instructions outlined in the PHS 398 application kit are to be followed with the following modifications for R21 applications: 1. FACE PAGE, Item 6: Up to a total of two years of support may be requested. Total direct costs for the two years may not exceed $275,000. Normally, no more than $200,000 may be requested in any single year. 2. RESEARCH PLAN: Items a-d may not exceed fifteen (15) pages, including tables and figures. The following information should be taken into account for items a, b and c: o Item a, SPECIFIC AIMS--The instructions for this section suggest that the applicant state "the hypotheses to be tested". Since some applications submitted in response to this RFA may also be design- or problem-driven (e.g., development of novel technologies), or need- driven (initial research to develop a body of data upon which future research will build), hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. The application should state the hypotheses, design, problem and/or need which will drive the proposed research. o Item b, BACKGROUND AND SIGNIFICANCE--In this section, it is important to identify clearly how the application addresses the specific objectives of this RFA and the purpose of the R21 mechanism. Item c, PRELIMINARY STUDIES/PROGRESS REPORT—No preliminary data are required for an R21 application. 3. APPENDIX. Up to five articles may be submitted as appendix materials. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: R01 applications requesting up to $250,000 per year in direct costs and all R21 applications must be submitted in a modular grant format. The modular 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. 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed 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 by 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 your 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 your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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). 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 o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o R21 APPLICATIONS: The potential for ground-breaking, precedent- setting research, with particular emphasis on novel and innovative approaches; and the potential to stimulate new concepts or approaches regarding important biomedical/behavioral problems, or provide a technique/system of wide applicability. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 29, 2003 Application Receipt Date: August 26, 2003 Peer Review Date: November 2003 Council Review: January 20-21, 2004 Earliest Anticipated Start Date: April 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. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "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://grants.nih.gov/grants/stem_cells.htm 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 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 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 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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