DEVELOPMENT OF IN VITRO MODELS OF HUMAN ORAL MUCOSA RELEVANT TO AIDS AND MUCOSAL INFECTIONS RELEASE DATE: October 31, 2003 RFA Number: RFA-DE-05-002 (This RFA has been reissued, see RFA-DE-06-003) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.121, Oral Diseases and Disorders Research LETTER OF INTENT RECEIPT DATE: July 28, 2004 APPLICATION RECEIPT DATE: August 26, 2004 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 objective of this initiative is to stimulate research that will lead to the development and validation of a practical and physiologically relevant in vitro human model of the oral mucosa that can be used to study HIV infection and the complications associated with AIDS under highly controlled conditions. It is envisioned that the availability of such an in vitro human oral mucosa system will provide opportunities to substantially enhance the fundamental understanding of oral HIV infections. This will establish a scientific basis for exploring and testing diagnostic, treatment and prevention strategies for HIV infections and AIDS associated complications. Such models will be used to study, for example, the biology of viral (HIV, EBV, HHV-8, HPV) infection, pathogenesis of diseases, opportunistic complications and host defense immune responses. RESEARCH OBJECTIVES Background Among the routes of transmission that HIV uses to infect the host is the oral mucosal tissue. This route of infection has been shown in both humans and primates. HIV RNA and proteins can be detected directly in the mucosa, as well as in the saliva from infected subjects. However, infectious HIV virions are rarely found in the saliva, suggesting that the oral mucosa is not permissive for efficient HIV replication. Our understanding of HIV pathogenesis is far from complete as is our understanding of how other opportunistic pathogens (HHV-8, CMV, EBV, HPV and Candida) infect and cause the oral complications associated with AIDS. The ability of the oral cavity to resist HIV while providing a safe haven for other pathogens provides a unique opportunity to dissect the differential patterns of host defense or lack thereof. The oral mucosa is composed of both stratified and non-stratified epithelial cells which form a continuously renewing, protective 100 um layer in the mouth. The mucosa contains immunologically functional cells; including dendritic cells, lymphocytes, monocytes/macrophages and neutrophils; which increase markedly when the tissue is inflamed. Matrix components play a central role in maintaining the structure and function of an intact mucosa. The surface of the mucosa is covered by salivary carbohydrates, lipids and proteins, and interacts directly with the oral environment, containing bacteria, fungi, viruses, food, tobacco products, alcohol etc. In addition, the mucosa produces or is bathed by cytokines, chemokines, antibodies and innate host factors in saliva. As such, these tissues are biologically complex and subject to numerous environmental and host factors that regulate their function and integrity. Compared with vaginal and rectal mucosa, research on oral mucosa has been aided by its relatively easy access. However, research on oral mucosa, particularly in subjects with AIDS, has been very difficult because of the inability to control environmental influences, xerostomia, as well as site- and subject-specific immunological factors. Research on identifying protective or susceptibility factors in the oral mucosa in persons exposed to HIV would be greatly facilitated by the availability of high quality, standardized, and reproducible in vitro models of the mucosal tissue. Such models would lend themselves to advanced research in studying the genomics and proteomics of HIV infection and AIDS associated complications in the oral cavity. Moreover, due to the impossibility of using infectious virions in humans and the failure of animal models to recapitulate human infectious paradigms, the availability of an in vitro human model system is critical to advancing research on oral infection and/or identifying potential regulatory molecules which may provide insight into therapeutic targeting. Recent advances in tissue engineering and molecular and cellular biology have elucidated ways to construct tissues using carefully designed scaffolds on which cells can grow and differentiate. These bioengineered tissues can be manipulated to express phenotypic surface markers and to produce immune modulatory cytokines such as interleukin- 1, tumor necrosis factor and interleukin-8. While it may be feasible to construct a homogeneous epithelial model system, it becomes more of a challenge to develop a system in which stem cells, lymphocytes, epithelial cells, macrophages and dendritic cells, fibroblasts and keratinocytes, etc. can be incorporated to form a mucosal model. Scope The objective of this initiative is to encourage research that will lead to the development and validation of in vitro models of the human oral mucosa that are suitable for studying the pathogenesis of HIV and AIDS-related oral complications in a controlled environment. It is expected that investigators will capitalize on new findings in tissue engineering, cell biology of the oral mucosa, genomics, proteomics, bioimaging and real time analysis of gene expression. Multidisciplinary approaches and collaborations are encouraged. Examples of research topics that are responsive to this RFA are listed below but are by no means all inclusive: Development of the models: o Development of a model that can adequately address the effects of certain cells (e.g., neutrophils) and soluble factors (e.g., cytokines) on the oral mucosa. Such cells and cytokines may be critical for viral adherence and internalization. o Utilization of 3D bioinductive scaffolds that can support growth of the cellular components and deliver essential growth factors. o Isolation, enrichment and characterization of epithelial basal layer stem cells required for maintaining long term survival of an in vitro oral mucosa. Other somatic stem cells, such as mesenchymal or circulating hematopoietic stem cells, might also be evaluated. o Application of bioreactors designed to provide spatially uniform concentrations of cells within scaffolds; control conditions in culture medium (e.g., temperature, pH, osmolarity, levels of oxygen, nutrients ); provide physiological relevant physical signals (e.g., interstitial fluid flow, shear, pressure, mechanical compression) needed to obtain long-term survival of the in vitro oral mucosa. o Establishment of the parameters under which optimal HIV infection/transcytosis of the mucosal epithelium occurs in the in vitro models. o Determination of the optimal conditions for infection of the in vitro models with other relevant oral mucosal pathogens. o Utilization of a mucosal model to study the mechanisms by which pathogens that are associated with oral complications in HIV infection, such as EBV, HHV-8, HPV, CMV, HSV and Candida impact HIV permissiveness and vice versa. Validation of the in vitro human models: o Use of sophisticated histological techniques and analysis of specific tissue markers to show that the in vitro oral mucosa is physiologically relevant to in vivo mucosa. o Studies on transmembrane signaling pathways that are activated during HIV-host cell interaction. o Analysis of structural proteins involved in viral adsorption, internalization and endocytosis to cells in the model system. o Identification or function of proteins and other molecules (e.g., lipids, mRNA) involved in cross talk between HIV infected and non- infected host cells. o Comparison of gene expression in infected and uninfected oral mucosal tissues. o Gene and protein expression profiles of cells infected with orally- relevant microbes and opportunistic pathogens (CMV, EBV, HPV etc.), prior to and during progression of simulated AIDS conditions; identification of factors which promote or inhibit the virus in this context. o Analysis of the gene and protein expression profiles of HIV and host cells under quiescent and stress (pH, oxygen, heat) conditions. o Gene and protein profiles of host leukocytes recruited to HIV infected oral mucosal tissues; use of laser confocal microscopy to identify and characterize infected cells. o Studies on HIV inhibitory factors using in situ and real time techniques. o Development of assays applicable to the in vitro model for analyzing the effect of natural or pharmaceutical interventional agents. o Development and testing of potential agents that would impede, HIV and/or opportunistic oral pathogen amplification and dissemination within the mucosa. Applications using animal cells or tissue will not be responsive to this RFA. MECHANISM OF SUPPORT This RFA will use NIH Individual Research Project Grant (R01) and the Exploratory/Development Research Grant (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. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see 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 FUNDS AVAILABLE The NIDCR intends to commit $2,000,000 total costs in FY 2005 to fund 6 to 8 new and/or competitive continuation grants in response to this RFA. An R01 applicant may request a project period of up to 4 years and a budget for direct costs of up to $499,999 per year. An R21 applicant may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. This R21 cap may be exceeded by $25,000, direct costs per year to accommodate the facilities and administrative (indirect) costs associated with collaborative research at another institution. 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 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 Grantees will meet annually at or near NIH, Bethesda, MD, to share results, to ensure that the NIDCR has a coherent view of the advances in the field, and to have an opportunity for collective problem solving among investigators. Applicants should budget for travel in their requested budget for the principal investigator and one additional junior investigator to attend this annual meeting. 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: Mostafa Nokta, MD, PhD. Division of Basic and Translational Sciences National Institute of Dental and Craniofacial research Building 45, Room 4AN-18H 45 Center Drive Bethesda MD, 20892-6402 Telephone: (301) 594-7985 Fax (301) 480-8319 Email: 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 45 Center Drive Bethesda, MD 20892-6402 Telephone: (301) 594-2904 Fax: (301) 480-8303 Email: o Direct your questions about financial or grants management matters to: Mary Daley Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44B 45 Center Drive Bethesda, MD 20892-6402 Telephone: (301)-594-4808 Fax: (301)-480-3562 Email: 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. George 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). 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 The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTARY 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. 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. o 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: (include if appropriate) Applications requesting up to $250,000 per year in direct costs 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 includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at 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: 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, send two additional copies of the application and all appendix material to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44F 45 Center Drive Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: APPLICATION PROCESSING: Applications must be received on or before August 26, 2004. 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 from the previous unfunded version of the application. 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 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 written critique o Receive a second level review by the NIDCR National Advisory Council or Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to 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. 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. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). 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 REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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 28, 2004 Application Receipt Date: August 26, 2004 Peer Review Date: October 2004 Council Review: January/February 2005 Earliest Anticipated Start Date: February 2005 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. 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: 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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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 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 ( 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 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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 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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