PATHWAYS LINKING EDUCATION TO HEALTH RELEASE DATE: January 8, 2003 RFA: OB-03-001 Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) LETTER OF INTENT RECEIPT DATE: February 28, 2003 APPLICATION RECEIPT DATE: March 26, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA A substantial number of epidemiological and social science research studies have consistently found a moderate to strong association between educational attainment and a wide variety of illnesses, health problems, health behaviors and indices of overall health. There is, however, considerably less research on the mechanisms and pathways by which education - particularly for non-health education - influences health. For this RFA, education refers to the comprehensive formal instruction that occurs in any level of schooling from kindergarten or before through graduate studies and includes the social and behavioral processes that are combined with formal instruction in educational environments. The goal of this RFA is to increase the level and diversity of research directed at elucidating the causal pathways and mechanisms that may underlie the association between education and health. Better scientific understanding of the causal pathways between education and health could lead to additional and improved prevention and therapeutic intervention strategies for important health problems. In order to better understand these pathways, validation of specific measures of abilities crucial to educational attainment, such as level of cognitive or language skills, may be needed. Further exploration is needed of intervening neuro- or psychobiological mechanisms, such as impact on frontal lobe structure or function or psychological characteristics, and how these relate to a significant health outcome or important health related behavior or expected outcome. In addition, it will be necessary to explore what components or dimensions of education are important to health. The association or pathway between formal education and either important health behaviors or diseases may not be causal. Instead it may reflect the influence of confounding or co-existing determinants or may be bi-directional. Research considered responsive to this solicitation may involve pilot studies, new analyses of existing data, small-scale intervention studies or innovative approaches tailored for the study hypotheses. It may involve new teams of multidisciplinary teams (e.g., education specialists, developmental psychologist, neurobiologists, and economists). However, This RFA is not directed at studies which limit their focus to the impact of specific health education courses or programs on health behaviors; rather, the focus is on the impact of the more general education experiences. RESEARCH OBJECTIVES Nature of Research Problem and Background: Education along with income and occupation has been used repeatedly to define the social gradient in health that persists despite marked improvement in the health of the American population over the last hundred years. Generally individuals with lower income, less education and lower-status occupation/employment, requiring less education and/or providing less income, have poorer health. The gradient is also generally monotonically related to education, income, or occupationally defined social class. The social gradient as defined by either education or income exists in all of the developed countries of the world, despite markedly different health care financing and the different ethnic/racial composition of these diverse countries. Both of these observations suggest that, regardless of the importance of other factors, education contributes directly and indirectly to the social gradient in health. Studies which have attempted to parcel out the independent contribution of education versus income generally have found that there is an apparent independent contribution of each factor, although it is clear that education also has a major impact on income and wealth. Greater understanding of the nature of the independent [non-income] relationships between education and health depends on increasing knowledge about the mechanisms and pathways that explain the association between education and health. Recent summaries of the scientific information on these possible relationships, however, have concluded that pathways and mechanisms by which education influences health are infrequently studied, poorly delineated, and deserve further study. Presentations from a workshop entitled "Education and Health: Building a Research Agenda," co-sponsored by Center for Health and Wellbeing, Princeton University, MacArthur Network on Socioeconomic Status and Health, and National Institutes of Health are available at http://www.wws.princeton.edu/~chw/conferences/conf1002/Agenda.html A review of the scientific literature shows associations between education and health across a broad range of illnesses, including coronary heart disease, many specific cancers, Alzheimer's disease, some mental illnesses, diabetes, and alcoholism. Some of these diseases, such as asthma, also have a strong environmental determinant. In addition, many important health risk factors for disease, such as use of cigarettes, have been linked to education. While for most diseases, the segments of the population with lower levels of education have higher risks of these diseases; there are a few diseases such as malignant melanoma where the incidence is higher in the most highly educated. However, more often education appears to be a protective factor. In some but not all studies of clinical treatments, those with lower levels of educational attainment demonstrated poorer outcomes. In a few studies of chronic diseases such as HIV or diabetes, the effectiveness of self-management and the adherence to medical treatment appears related to educational attainment. It also appears that some intensive treatment regimes may reduce the education gradient in treatment outcome. In other studies the apparent effectiveness of treatment such as studies of postmenopausal hormone replacement therapy and the primary prevention of cardiovascular disease, the treatment effectiveness was significantly reduced when adjusted for socioeconomic status. There is also little research on what specific aspect of the educational process or experience is linked to health. Therefore, research on education could be focused on either broad measures of health such as mortality or morbidity or focused on specific diseases such as cardiovascular disease, lung cancer, depression, diabetes, Alzheimer's disease, alcoholism, drug addiction, or environmentally related disorders. The research could focus on the pathways from education to the disease incidence, the disease severity, or the effectiveness of treatment in specific diseases. The research could also focus on health behaviors strongly associated with elevated risk of premature mortality or morbidity such as cigarette smoking or risky drinking or obesity. In addition the impact of education or the educational level of family members on health behaviors or disease could be examined at the different stages of the life cycle from childhood to late in adulthood. Because of the large number of associations between educational attainment and diseases or health risk factors, it will be important for research studies to focus on clarifying whether or not the associations that are already known to exist or new associations that are found are causal; such information will be critical in providing a basis for developing possible interventions. The research could also focus on the specific aspect of the educational process or experience that is most strongly linked to health. Several different types of biological, psychological and social pathways have been proposed as possibly explaining the association between education and health. Examples of possible psychological or social pathways include the following: o Education leads to higher incomes which allows the purchase of more health insurance, better housing, and other goods and services. This is one of few well-studied pathways. o Education might lead to greater optimism about the future, self- efficacy sense of control, or different time preferences. Any of these psychological characteristics might alter health behaviors or adherence to medical treatments or ability to self manages chronic illnesses. o Education might improve important cognitive skills including literacy, enhanced decision-making, analytical skills, or other cognitive skills which in turn allow individuals to be more successful in managing their health problems, in interacting with the health care system, or in preventing future health problems. o Education may improve health by laying the foundation for the individual's integration in to society, not only in terms of the learning acquired for effective functioning, but in terms of social competencies and the ability to function in hierarchical, structured settings. o Because formal education often occurs at the stage of the life cycle when significant formation of health behaviors is also occurring, these behaviors may be either directly or indirectly influenced not only by specific formal educational experiences but also by the social context provided by the school. Individuals maybe affected by the behavior and norms of the other students. Education might influence the biological pathways including neurologic, inflammatory, and endocrinologic processes or structures. Examples of possible biological pathways include the following: o Education may influence the level of the allostatic load in adult life by switching the balance between protective and damaging effects of stress mediators. o Education may influence the structure or functioning of the prefrontal cortex, temporal lobe, or other parts of the brain, which in turn might effect stress related changes in the immune, cardiovascular, or endocrine systems. o Education might influence function or structure of these potential pathways during the period of formal education or prior to formal education but these changes might persist in adulthood and only become apparent later in the life cycle. o Education may influence cognitive reserve and thereby influence the risk of neurological diseases such as Alzheimer's Disease. Research Objectives Because of the importance of additional information on the pathways that link education with a variety of diseases and health risk factors, researchers are encouraged but are not required to include in any research project both objectives directed at (1) better understanding the relationship between education and a specific disease or important health risk factor and (2) better understanding the relationship between one or more pathways that explain the association between education and health. Examples of possible relevant topics might include the following (but are in no way limited to this suggested list): o Studies to more accurately or completely characterize or measure education, since it is often measured simply as years of education without regard to the characteristics or nature of the educational experience. Relevant aspects of the educational experience include the quality, content, and style of instruction, the structure of schools, and the socialization experiences associated with formal education. The purposes of these studies would be to increase the understanding of the relationship of education to diseases, health behaviors or prevention/treatment outcomes. Studies might also want to develop improved measures of cognitive, language, or analytical skills, acquired through education, that may mediate the effects of education on health. o Studies of children or adults seeking to determine how education improves the ability of the individual to effectively prevent health problems. Studies might evaluate the relationship between education and health while also examining the impact of education on social networks, social support, skills in obtaining information, or traditional health behaviors e.g., diet) and utilization of preventive services (e.g., cancer screening). However, This RFA is not directed at studies which limit their focus to the impact of specific health education courses or programs on health behaviors; rather, the focus is on the impact of the more general education experiences. o Studies of whether and how education influences a patient's selection of type of treatment, ability to participate in the therapeutic regime, adherence and response to treatment, and health and therapeutic outcomes across different groups in the population, such as those with chronic illnesses or the elderly. o Studies of possible other psychological pathways such as self- efficacy, self-esteem, coping effectiveness, depression, or sense of well-being. o Studies of education's impact on postulated physiological pathways such as those between the stress and cardiovascular disorders or significant change in inflammatory processes or CNS regulation of heart rate. o Studies of the timing of education and it's possible impact on psychological and physiological effects. For example, do the consequences for health outcomes differ if education is obtained in adulthood as compared to during the more traditional educational trajectory of grade school and high school? o Studies of how specific aspects, components, or dimensions of the educational process affect health. For example, the relationship among school "tracking" policies, peer networks, and health-related behaviors in adolescence; the relationship between instructional styles and quality of teaching and health outcomes. o Studies to determine whether the strength of the association between quantity and quality of education and better health varies across the population, time periods, and countries. o Studies to determine the unique or independent contribution of education on mortality or morbidity, separate from other measures of socioeconomic status such as family income, wealth, occupation or social class during the different periods of life. Similarly studies of whether education is a marker for some other causal factor such as pre-school experiences or health status. o Studies to determine the role of education in the intergenerational transmission of disease and the pre-disposition to disease over the life course. In summary the goal of this RFA is to increase the level and diversity of research directed at elucidating the causal pathways and mechanisms that may underlie the association of educational attainment and health. In order to advance the field, this type of research should include valid measures of education, assessments of key intervening mechanisms or pathways, and one or more significant health outcome or important health related behavior. Research in response to this RFA may include pilot or preliminary studies, new analyses of existing data, innovative approaches or comparisons between countries. It may involve teams of multidisciplinary researchers ranging from education or economics to molecular biology or neurobiology. It may involve one or more than one stage of the life course. A better scientific understanding of the causal relationship between education and health, such as that which this solicitation seeks to support, could lead to additional prevention and therapeutic strategies for a wide range of important health problems. MECHANISM OF SUPPORT This RFA will use NIH RO1 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. 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 September 30, 2003 to March 31, 2004. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The participating IC(s) intends to commit approximately one and half million dollars in FY 2003 and an additional one million in FY 2004 to fund 5 to 10 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 4 years and a budget for direct costs of up to $350,000 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 IC(s) 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 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 The applications should include sufficient funds for one annual two-day trip for one or two investigators from the research team to meet with other funded investigators from this RFA in the Washington DC area. While there is no requirement for any coordination among funded projects from this RFA, because of the paucity of past research in this area, ongoing discussions among funded researchers should strengthen the overall research program and will be useful for NIH. 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: Lawrence J. Fine MD, Dr.PH. Office of Behavioral and Social Science Research, Office of Director National Institute of Health Building 1 Room 256 MSC 0183 Bethesda, MD 20892 Telephone: (301) 435-6780 FAX: 301-402-1150 Email: Finel@od.nih.gov Georgeanne E. Patmios National Institute on Aging, Behavioral and Social Research Program NIH GATEWAY Building Room 533 Bethesda, MD 20892 Telephone: (301) 496-3138 FAX: 301-402-0051 Email: PatmiosG@nia.nih.gov Helen I. Meissner, Ph.D., Chief Applied Cancer Screening Research Branch Behavioral Research Program Division of Cancer Control and Population Sciences National Cancer Institute Executive Plaza North, Suite 4102 6130 Executive Boulevard, MSC 7331 Bethesda, MD 20892-7331 Rockville, MD 20852 (for express mail) Telephone: (301) 435-2836 FAX: (301) 480-6637 Email: hm36d@nih.gov V. Jeffery Evans Ph.D., J.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1176 FAX: (301) 496-0962 Email: evansvj@mail.nih.gov o Direct your questions about peer review issues to: Yvette M. Davis, V.M.D., M.P.H. Center for Scientific Review, NIH/DHHS 6701 ROCKLEDGE Drive, Rm. 3152, MSC 7770 Bethesda, MD 20892 Telephone: (301) 435-0906 Fax: (301) 480-3962 Email: DavisY@csr.NIH.GOV o Direct your questions about financial or grants management matters to: Lawrence J. Fine MD, Dr.PH. Office of Behavioral and Social Science Research, Office of Director National Institute of Health Building 1 Room 256 Bethesda, MD 20892 Telephone: (301) 435-6780 FAX: 301-402-1150 Email: Finel@od.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Lawrence J. Fine MD, Dr.PH. Office of Behavioral and Social Science Research, Office of Director National Institute of Health Building 1 Room 256 Bethesda, MD 20892 Telephone: (301) 435-6780 FAX: 301-402-1150 Email: Finel@od.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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 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 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 five 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) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the (IC). Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR 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. 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 an appropriate 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: The research must include at least one clearly defined measure of education, a potential pathway, and one or more risky or beneficial health behavior, or disease(s) endpoint. The research may be of a pilot or preliminary nature. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 28, 2003 Application Receipt Date: March 26, 2003 Peer Review Date: May 2003 Council Review: September or October 2003 or February 2004 Earliest Anticipated Start Date: October 2003 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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 No. 93.866, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under 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. 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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