MULTIDISCIPLINARY APPROACH FOR RESEARCH ON ORAL COMPLICATIONS OF HIV INFECTION RELEASE DATE: December 3, 2003 RFA Number: RFA-DE-05-003 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institute of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.121, Oral diseases and Disorders Research LETTER OF INTENT RECEIPT DATE: August 17, 2004 APPLICATION RECEIPT DATE: September 14, 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 This initiative is designed to encourage multidisciplinary research on the oral complications of HIV infection and their prevention that crosses several academic disciplines (e.g., virology, immunology, cell biology, pathology, epidemiology, biochemistry, pharmacology, medical imaging, etc.) It is anticipated that this research will increase our knowledge of the basic mechanisms involved in the pathogenesis of the oral disorders associated with AIDS and that it will identify novel strategies for prevention, treatment and diagnosis of the oral manifestations of AIDS. RESEARCH OBJECTIVES Background: HIV infection is a major public health problem throughout the world. The major hallmark of this infection is a gradual depletion of CD 4+ T cells which eventually lead to a state of immunosuppression. This immunosuppression makes patients vulnerable to several oral complications, including oral tumors, oral candidiasis, oral viral infections, HIV related salivary gland disorders, and oral ulcerations of diverse etiologies. The majority of infections associated with HIV disease are initiated at mucosal surfaces, occurring as a result of the passage of the pathogens across mucosal membranes. The oral mucosa is more resistant to HIV infection than other mucosal sites in the body. The reasons for this resistance are far from understood, and the factors underlying such resistance may be the basis for novel rational prevention strategies against HIV/AIDS and HIV associated opportunistic infections. The oral cavity is rich in immune cells, such as CD4+ and CD8+ T cells and their Th1/Th2 subpopulations, Langerhans cells and dendritic cells. The cascade of events triggered by HIV and HIV-associated oral pathogens in the oral mucosa may affect local and systemic innate and adaptive host immune responses. Elucidating the sequence of events, and the immunological and virological factors involved, are likely to shed light on how HIV and the associated oral viral pathogens evade the host immune response. The oral mucosa is bathed with saliva, which lubricates the oral cavity and provides protection against many pathogens. Mucosal secretions contain several non specific inhibitors that target bacteria, viruses and fungi. Those with significant inhibitory activity to HIV, include lactoferrin, secretory leukocyte protease inhibitor, proline rich proteins, defensins, salivary agglutinin and cystatins. These innate immunity effectors are rapidly available and ready to kill or neutralize their pathogens within minutes. The role of these immune factors in the resistance to oral transmission of HIV is not well defined. Understanding the coordination of the innate and adaptive immunity to HIV would yield information that will lead to novel therapeutic strategies and protective vaccine designs. The immunosuppression characteristic of AIDS, predisposes the patients to cancers, warts and preneoplastic oral lesions. Some of the neoplasms are aggressive, hard to treat and can affect the quality of life of the patients. Oral malignancies and tumors affect up to 25% of patients with AIDS. The most frequent oral malignancies are Kaposi’s sarcoma (KS) and non-Hodgkin’s lymphoma. Oral warts and oral hairy leukoplakia (OHL), a benign epithelial hyperplasia of the lingual squamous epithelium, are also reported. Interestingly, the genome of some of the viruses that are associated with the oral complications of HIV infection have sequence homology with some human cytokines and/or chemokines. For example, a cytomegalovirus gene encodes vIL-10 and CXC1&2, an EBV gene encodes vIL-10 and a HHV-8 gene encodes vIL-6. The role of this mimicry with mammalian cell cytokines in disease pathogenesis is not known. IL-10 and IL-6 mediate Th2 cell responses and inhibit Th1 immune responses. IL-6 also stimulates lymphocyte proliferation. Patients with HIV-related salivary gland disease present with signs and symptoms similar to those of patients with Sj gren’s syndrome. This condition is characterized by lymphocytic infiltration of the salivary glands and lymphoepithelial cysts of the major salivary glands. Occasionally lymphomas may develop within the salivary glands. The search for an etiology for these lymphomas is inconclusive. The incidence of salivary gland disease among HIV infected patients appears to have increased following the introduction of HAART. The cause of this increase is not known at the present time. A multidisciplinary comprehensive approach for study of the oral complications of HIV disease will expedite and enhance our knowledge of the field and will provide new insights and solutions to an ever growing list of unanswered questions that continue to emerge. Scope The aim of this initiative is to encourage the submission of multidisciplinary proposals with at least three (3) tightly integrated projects and any necessary cores that address the existing gaps in our knowledge of the pathogenesis of the oral complications of HIV infection. Examples of topics include, but are not limited to: o Determining how HIV and viruses with oncogenic potential interact and disrupt the cellular regulatory networks to induce neoplastic changes of mucosal cells; o Evaluating the role of cytokine and chemokine mimicry of viruses associated with the pathogenesis of oral complications of HIV infection; o Identification of anti-HIV factors in saliva. Determine the usefulness of such factors for early HIV diagnosis and identify factors that may predict disease progression; o Studies on salivary gland complications in HIV infection including basic research on the etiology, pathogenesis, and prevention as well as high throughput analyses of gene expression in health and disease; o Genetic therapies to induce salivary glands to secrete anti-viral factors against HHV-8, HPV, EBV and CMV; o Studies on oral mycotic pathogens associated with HIV infection that involve their pathogenesis; strain variability and virulence; mechanisms of anti-fungal resistance; and identification of novel targets for antifungal therapy; o Studies on oral mucosal immunity including research on innate and adaptive immunity; novel immunological approaches for interfering with oropharyngeal HIV transmission; novel vaccine approaches for HIV that make use of the buccal or the nasopharyngeal mucosa as a portal for inoculation; o Oral complications associated with the prolonged use of HAART in patients with HIV including etiology, host susceptibility, early detection and prevention; and, o Development of animal and in vitro cell- based models for AIDS- related oral complications. This initiative is not designed to support clinical trials. However, the use of clinical samples from patients is allowable and encouraged. MECHANISM OF SUPPORT This RFA will use NIH Research Program Project (P01) award mechanism. Program Project grants support broadly based, multi-disciplinary research programs that have a well-defined, central research focus or objective. An important feature is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects (four or more are recommended) that contribute to the program objective. This type of award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. The total project period may not exceed five years. Applicants will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is March of 2005. This RFA uses just-in-time concepts. It also uses the non-modular budgeting formats and 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 $3.3 million total cost (direct cost and applicable facilities and administrative F&A costs) in FY 2005 to fund up to 3 grants new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget of up to $1.1 million total cost (direct cost and applicable facilities and administrative F&A costs) per year. 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. 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 institutions/organizations o 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 http://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: Mostafa Nokta, M.D., Ph.D. Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research, Building 45, Room 4AN-18H Bethesda MD, 20892-6402 Telephone: (301) 594-7985 Fax: (301) 480-8319 Email: Mostafa.Nokta@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 20892-6402 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 Grants Management Branch National Institute of Dental and Craniofacial Research 45 Center Drive MSC 6402 Building 45, Room 4AN-44B Bethesda, MD 20892-6402 Phone: (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 Institute 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: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS The applicants should include an Overview 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. The following page limitations will apply: Overview describing the Program Project synergy -5 pages Cores - 10 pages Individual projects - 25 pages (Research Plan sections a-d of the PHS398 form) Appendix- All essential information must be in the submitted application. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts previously accepted for publication may be included per individual project. All components of the appendix should be single sided and unbound. 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: http://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, send two additional copies of the application 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 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 Undergo a process in which all applications will be reviewed, 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: ADMINISTRATION: Are, for example, equipment calibration and maintenance, personnel oversight, internal communication, and synergistic interactions between investigators adequately addressed? Will there be an external review committee? MULTIDISCIPLINARY APPROACH: Is the Program comprised of collaborative efforts between individuals from different scientific disciplines? INTEGRATION OF PROJECTS: Are the proposed projects and cores well integrated? 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? 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 Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html. 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: August 17, 2004 Application Receipt Date: September 14, 2004 Peer Review Date: November 2004 Council Review: January 2005 Earliest Anticipated Start Date: March 1, 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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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