CLINICAL GENETICS OF CRANIOFACIAL AND ORAL DISORDERS RELEASE DATE: May 8, 2003 RFA Number: DE-04-004 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: October 20, 2003 APPLICATION RECEIPT DATE: November 18, 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 goal of this Request for Applications (RFA) is to promote research that will enhance clinical genetics studies of the genes and environmental factors that cause or modify susceptibility to craniofacial, oral and dental disorders and diseases. Currently, a major hindrance to progress in clinical genetics research has been the variation that exists between individuals with the same craniofacial disorder and the lack of consensus in the clinical community regarding phenotypic definitions. Specifically, this initiative is focused on developing well-characterized patient populations with distinct craniofacial disorders by fostering unique partnerships between clinicians and basic scientists to develop rigorous diagnostic criteria. Research studies are encouraged to refine clinical characterization, to identify diagnostic biomarkers, to establish reliable subphenotypes, and to develop standardized and comprehensive phenotypic definitions that extend to associated anomalies beyond the head and neck. Because of the interdisciplinary nature of this research, collaborative projects are encouraged among clinicians, geneticists, epidemiologists, molecular and developmental biologists, and other researchers. RESEARCH OBJECTIVES Background: There are more than 300 genetic syndromes that have an associated craniofacial, oral or dental component. In addition there are many isolated, or non-syndromic, craniofacial defects that are not part of a genetic syndrome. Craniofacial disorders require surgical, dental, speech, medical and behavioral interventions and they impose a substantial burden on patients and their families. Clefts of the lip and palate affect about 1/700 births and show a wide variability related to geographic regions. Craniofacial disorders are often rare disorders and many have complex etiologies involving the interaction of both genetic and environmental factors. Increased risk for craniofacial disorders has been associated with variables such as maternal use of prescription drugs, alcohol, and tobacco, maternal nutritional status, and occupational exposures during pregnancy. A major barrier to progress in clinical genetics studies of craniofacial disorders has been the process of accruing well-defined patient populations with a rigorous phenotypic characterization. Diagnostic criteria for many rare craniofacial disorders are often imprecise or poorly defined. In addition, the variation that currently exists in the phenotypic characteristics or clinical manifestations among individuals with the same craniofacial disorder and the lack of consensus in the clinical community regarding phenotypic definitions hampers efforts to combine data from different patient samples and efforts to replicate research findings. The completion of the Human Genome Project and the development of genome wide high-throughput technologies provide important new tools for facilitating progress in clinical genetics studies of craniofacial disorders. In order to take advantage of these new approaches and accelerate the rate of research progress, there are several obstacles that must be overcome. Development of rigorous and comprehensive diagnostic criteria and accrual of well-defined patient populations are essential for implementing high-throughput technologies to identify genetic and environmental factors that contribute to oral and craniofacial disorders. The ability to distinguish reliable subphenotypes within a broader phenotype will greatly increase the power of gene mapping studies by permitting subsets of cases to be analyzed from within larger data sets. Scope: Applications submitted in response to this announcement should focus on methodologies to standardize diagnostic criteria and to enhance the accrual of well-defined patient populations with specific oral and craniofacial disorders. Applications may focus on either single gene or multigenic disorders relevant to the research mission of NIDCR. A partial listing of dental, oral and craniofacial genetic diseases and disorders of interest to NIDCR is provided in Appendix 4 of the NIDCR Genetics Workgroup Report (http://www.nidr.nih.gov/about/strat- plan/Genetics_Rpt.pdf). Definitive diagnostic criteria are currently lacking for many of these target disorders and diseases. Research supported by this RFA will promote the collection of pedigrees, the detailed characterization of clinical phenotypes, the generation of reliable subphenotypes, and the standardization of comprehensive diagnostic criteria for craniofacial disorders. It is anticipated that research proposed in response to this initiative will involve the formation of multidisciplinary collaborations between clinicians, geneticists, epidemiologists, molecular biologists, developmental biologists and other researchers. Studies focused on gene discovery are not considered responsive to the RFA. The following is a non- inclusive list of research topics considered appropriate for response to this initiative: o Accrual of well-characterized patient populations, including the collection of biomaterials (e.g. DNA, cell lines, and affected tissue samples), clinical information, and laboratory tests; o Development of comprehensive diagnostic criteria based on a synthesis of patient information including history, laboratory procedures, medical records and clinical interviews; o Phenotypic assessment utilizing state of the art methodologies such as morphometry, MRI and other imaging techniques; assessment may include associated anomalies beyond the head and neck as well as behavioral, psychological, cognitive and other characteristics; o Generation of reliable subphenotypes within broader diagnostic classifications; o Analyses of genotype/phenotype correlation; o Association of dental anomalies with orofacial clefts and other craniofacial disorders; o Standardization of protocols for patient data records and for sample collection and storage; o Longitudinal studies describing the natural history and clinical course of craniofacial disorders; o Identification of diagnostic biomarkers and biomarkers that predict severity, progression and response to clinical interventions; studies to develop biomarkers may include the application of cDNA and protein microarray technologies; o Development of a controlled vocabulary to describe phenotypes and subphenotypes; o Identification of phenotypic features that distinguish heterogeneous genetic subgroups; o Studies to identify factors that account for phenotypic variability that is associated with a mutation in a specific gene; o Studies to determine the range of phenotypes associated with a particular genetic mutation. MECHANISMS OF SUPPORT This RFA will use the NIH R01 Individual Research Project Grant and the R21 Exploratory/Developmental Grant 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 anticipated award date is July 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 budgeting format. (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. 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. R21 Applications: Objectives of the R21 Exploratory/Developmental Grant award mechanism include: the support of innovative, high risk/high impact research requiring preliminary testing or development; exploration and development of new approaches and concepts; research and development of new technologies, techniques or methods; or initial research and development of data upon which significant future research may be built. While minimal preliminary data are expected to be described in the R21 proposal, applications should clearly indicate that the proposed research and/or development is scientifically sound, that the qualifications of the investigators are appropriate, and that resources available to the investigators are adequate. Investigators with expertise in fields other than craniofacial clinical genetics who wish to establish new research programs in this area are also encouraged to apply. Applicants are encouraged to contact program staff for advice about choosing the appropriate grant mechanism. FUNDS AVAILABLE The NIDCR intends to commit approximately $2,500.000 total cost in FY 2004 or FY2005 to fund 3 to 4 new R01 grants and 5 to 7 new R21 grants in response to this RFA. An R01 applicant may request a project period of up to 3 years and a budget for direct costs of up to $250,000 per year. An R21 applicant may request a project period of up to 3 years and a budget for direct costs of up to $125,000 per year. Funding caps may be exceeded by a request for one additional module for indirect costs associated with subcontracts on R21 applications or two additional modules for indirect costs associated with subcontracts on R01 applications. 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(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 In order to enhance investigator progress and to promote the process of achieving agreement on comprehensive standardized diagnostic criteria for craniofacial disorders, principal investigators are expected to attend an annual conference that will be held at or near the NIH, Bethesda MD. Applicants are advised to include funds to support travel of the PI and one other investigator in each year's budget. The sharing of biomaterials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in the genetic analysis of human diseases. NIH policy requires that investigators make unique research resources produced with DHHS funding available for research purposes to qualified individuals within the scientific community. A draft NIH Statement on sharing research data that describes these policies is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html. Applicants who respond to this RFA must develop and propose detailed plans for sharing and disseminating the data and biomaterials generated through the grant. It is expected that the information to be shared will include clinical, diagnostic, and pedigree structure information, in addition to cell lines and DNA. When possible, it is preferable that data and biomaterials generated through grants funded through this RFA be placed in common, public access databases or repositories that are widely accessible to investigators throughout the scientific community. Rapid sharing of data and biomaterials is strongly encouraged. The scientific review group will evaluate the adequacy of the proposed plans for sharing data. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. The adequacy of the plan will be considered by NIDCR program staff and will be important in determining whether the grant shall be awarded. The sharing plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. Evaluation of non- competing continuation applications will include assessment of the effectiveness and timeliness of research resource release. 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: Rochelle Small, PhD Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research National Institutes of Health Natcher Bldg. 45, Room 4AN-18D Bethesda, MD 20892 Telephone: 301) 594-9898 FAX: (301) 480-8318 Email: rochelle.small@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 Natcher Bldg. 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 Grants Management National Institute of Dental and Craniofacial Research National Institutes of Health Natcher Bldg. 45, Room 4AN-44B Bethesda, MD 20892 Telephone: (301) 594-4808 FAX: (301) 480-8303 Email: daleym@mail.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: Rochelle Small, PhD Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Natcher Bldg. 45, Room 4AN-18D Bethesda, MD 20892 Telephone: 301) 594-9898 FAX: (301) 480-8318 Email: rochelle.small@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at 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: 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 three years of support may be requested. 2. Items a-d of the Research Plan for the R21 application 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—Minimal preliminary data are required for an R21 application. 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, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: H. George Hausch, Ph.D. Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Natcher Bldg. 45, Room 4AN-44F, MSC 6402 Bethesda, MD 20892-6402 APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 National Advisory Dental and Craniofacial Research Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (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? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The scientific review group will evaluate the adequacy of the proposed plans for sharing data. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. BUDGET: The reasonableness of the proposed budget and the requested period of support will be evaluated in relation to the proposed research. Budget requests should include funds to support travel of the PI and one other investigator to attend an annual conference to be held at or near the NIH, Bethesda MD. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 20, 2003 Application Receipt Date: November 18, 2003 Peer Review Date: February/March 2004 Council Review: June 2004 Earliest Anticipated Start Date: July 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 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. 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 administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm 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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