PA-03-159: CHRONIC ILLNESS SELF-MANAGEMENT IN CHILDREN

Department of Health
and Human Services (HHS)

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CHRONIC ILLNESS SELF-MANAGEMENT IN CHILDREN RELEASE DATE: August 6, 2003 PA NUMBER: PA-03-159 (Reissued as PA-07-098[R03], PA-07-099[R21] and PA-07-097[R01]) March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for R01 Non-AIDS Applications: November 2, 2006 EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007 National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.361 (NINR), 93.865 (NICHD); 93.849 (NIDDK), 93.837 (NHLBI) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this initiative is to solicit research to improve self- management and quality of life in children and adolescents with chronic diseases. The study of children within the context of family and family- community dynamics is encouraged. Children with a chronic disease and their families have a long-term responsibility for self-management of their health and illness. The child with the disease will have a life-long responsibility to maintain and promote health and prevent complications of the chronic disease. Research related to sociocultural, environmental, and behavioral mechanisms as well as biological/technological factors that contribute to successful and ongoing self-management of particular chronic diseases in children is encouraged. Proposals that include factors specific to age, developmental stage, family, community, culture, race/ethnicity, or social- contextual issues are also encouraged. RESEARCH OBJECTIVES Chronic diseases, for this announcement, are defined as illnesses that are lifelong in duration, treatable but rarely cured completely, and require persistent self-management behaviors that are shared by the child and family. The disease and health self-management behaviors required are ongoing rather than infrequent and intermittent. Note also that the NIH definition of children is anyone under the age of 21. The first goal of Healthy People 2010 is to help individuals of all ages increase life expectancy and improve their quality of life. Chronic diseases that begin in childhood present a special challenge to both quality of life (QOL) and life expectancy. For example, severely obese children and adolescents have lower health-related QOL than children and adolescents who are healthy. Overweight is a chronic health condition that often begins in childhood, contributes to the risk of disease-associated morbidity, and requires self-management activities. The prevalence of overweight among children in the United States is continuing to increase in most populations, and especially among Mexican-American and non-Hispanic black children and adolescents. Chronic diseases and other chronic health conditions are estimated to occur in 20 to 30%, or 12 to 18 million, of the children and adolescents in this country. Seven to eight percent of children aged 5 to 17 have activity limitations due to one or more chronic health conditions. These limitations often go beyond the physical state. There can be a social stigma among affected children who often are socially ostracized. This tends to intensify the underlying psychosocial determinants that lead to inappropriate self-management behaviors. Enhanced awareness and greater self-management early on could help prevent exacerbation of the chronic illness or condition, and the associated adverse health outcomes. Children are affected by numerous chronic conditions, including, but not limited to, diabetes, chronic kidney disease, juvenile rheumatoid arthritis, epilepsy, cystic fibrosis, asthma, developmental disabilities, obesity, cerebral palsy, sickle cell disease, hemophilia, congenital heart disease, HIV/AIDS, genetic and other birth defects, low birth weight sequelae, and traumatic injuries. Although each chronic illness has distinct biological processes, there are numerous commonalities with respect to psychosocial, lifestyle, economic, quality of individual and family life, and health that have impacts on the child and family. Chronic illnesses affect the child throughout his/her life and also affect the family unit. The impact of day-to-day requirements, complexity of disease management activities, lifestyle, and family dynamics all may influence the effectiveness and long-term success of self-management and the health outcomes. Furthermore, chronic health conditions may affect the financial status, and social, community, and school interactions of the child and the family. The effectiveness of the management of the chronic illness, and its related health outcomes, depends on many family and health care system factors. The child or adolescent is affected personally by the pathology of the disease and by the required lifestyle and health management adaptations. The family are involved in the child's chronic illness management through requirements for care assistance, supervision/guidance, travel and time from work for health visits or hospitalizations, cost of care, and the impact of these requirements on family dynamics and lifestyle. It may be that health care providers have underestimated the complexity of the child and family needs related to personal responsibility and self-management actions. Although there has been a focus in recent years on the self-management of chronic illness, most of this research has occurred in adult populations. Adherence studies that focus on a subset of the self-management process in children are most evident in the areas of asthma, diabetes, and HIV/AIDS. More research is needed on chronic illness self/family management in children and adolescents and intervention testing for relevance in this population, including diverse groups within the larger population of children with chronic diseases. This section describes a few examples of the many chronic health conditions that occur in children and require long-term self-management to reduce associated morbidity and mortality. The Health and Retirement Study, conducted in 1996, found that poor childhood health increases morbidity in later life. This association was found for lung disease, cardiovascular conditions, arthritis/rheumatism, and cancer. There is other evidence that children with poorly controlled diabetes could be included in this list as well. While there are little sound epidemiological data on childhood chronic illnesses as a group, there are data for individual diseases. In the US, asthma is the most common chronic disease of childhood and, in 1999, the estimated annual cost of treating asthma in children in the US was $3.2 billion. Children with asthma miss about 10 million school days each year. The prevalence of asthma in children aged 0 to 17 years is reported in MMWR (2000) as 68% with increases of 5% per year for the years 1980-1995. About 1.6 million children have diabetes. There is a significant increase in type 2 diabetes in children and adolescents. Data culled from diabetes clinics in several locations suggest that the percentage of children diagnosed with diabetes who are classified as having type 2 diabetes has risen from less than 5 percent (prior to 1994) to 20 to 30 percent (after 1994). Children who go undiagnosed until they become symptomatic may have been hyperglycemic for many years and are at high risk of developing diabetic micro- and macrovascular complications. These potential long-term and serious complications support the need for proactive self-management from diagnosis onward. Children who have insulin-requiring diabetes are three times more likely than their classmates to be hospitalized. About 285,000 children have juvenile arthritis. Juvenile arthritis has long- term functional ability implications that may be improved with appropriate self-management behaviors. The incidence of end-stage renal disease (ESRD) in patients age 0 19 years in the United States is 15 per million people, according to the 2002 USRDS Annual Data Report. Exact numbers for patients who have chronic kidney disease, but do not yet require dialysis are not available, but are certainly higher than for those with ESRD. Children with a chronic disease face a lifetime of careful health management requirements and lifestyle adaptations to prevent or manage related health complications. Interventions that make a difference in childhood disease self-management may set the stage for health outcomes later in life. Scope This announcement invites proposals for research focused on self-management in children with chronic diseases. Within this larger population of interest, it is desirable to see a range of study populations including representative as well as understudied groups including, but not limited to, specific racial or ethnic, rural, or economically disadvantaged groups. The chronic diseases identified in this announcement should not be viewed as the only chronic diseases of interest. Interventions that have broad application across child and adolescent populations and chronic diseases are of particular interest. Understanding of heretofore unexplained cultural meanings/behaviors, family, child viewpoint, socio-contextual, psychosocial, and other factors relevant to child and adolescent chronic disease self-management are also of interest. This announcement is open to descriptive studies that address important gaps in knowledge in order to provide direction for future interventions and to interventional studies that have strong translation potential for diverse settings and groups. Areas in which such scientific opportunities exist include but are not limited to: o Examine the influence of common management factors such as quality of life, psychosocial, culture, ethnicity, age, socioeconomic status, developmental stage, or social-contextual issues on chronic disease self-management in children. o Examine factors that promote the transfer of different levels of self- management responsibility to the child, including the relationship of age or stage of development. o Determine whether approaches to self-management established in adults may be adapted to children with chronic diseases (examples: improved self- efficacy, cognitive strategies, social support, provider/child/family partnership). o Test interventions that improve child and family functioning, self- management, quality of life, biologic status, and health outcomes with management requirements of a child's chronic condition. o Test self-management interventions for children in rural areas, medically underserved settings, and in racial/ethnic groups or explore factors that create barriers to self-management in these groups. o Examine factors that are effective in sustaining proactive self-management behaviors and integrating them into routine lifestyle (school, home, community) activity across developmental stages of the child. o Explore the impact of a child having a chronic illness on peer relationships, siblings, parents, and on family member roles and how that impact may affect self-management effectiveness. o Examine whether, or in what ways, diverse family constellations such as single parent, extended families, grandparents as guardians, or same-sex parents affect self-management of the child's chronic illness. o Evaluate the impact of advances in treatment and technology on the management of chronic illness conditions in childhood and adolescence. o Test interventions for family coping in chronic conditions that result in periodic acute illnesses, hospitalizations, or invasive therapies in regard to seamless care, coping during acute phases, and the child/family/provider partnership. MECHANISMS OF SUPPORT This PA will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The objective of the R01 mechanism is to support a discrete, specified circumscribed project. The objective of the exploratory/developmental mechanism (R21) is to encourage applications from individuals who are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of self- management for children with chronic diseases. Investigators are encouraged to explore the feasibility of an innovative research question or approach that will provide a basis for future research projects. Exploratory/developmental grants (R21) are limited to 2 years of support with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. Please see the NIH-wide R21 program announcement (PA-03-107) (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the "Submitting an Application" section for more details. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Nell Armstrong Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: armstrongn@mail.nih.gov Dr. Lynne M. Haverkos Behavioral Pediatrics and Health Promotion Research Program National Institute of Child Health and Human Development 6100 Executive Blvd., Rm. 4B05, MSC 7510 Bethesda, MD 20892-7510 (Rockville, MD 20852 for Fed Ex or UPS) Phone: (301) 435-6881 FAX: (301) 480-0230 E-mail: haverkol@mail.nih.gov Dr. Marva Moxey-Mims Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 639, MSC 5458 Bethesda, MD 20892-5458 Phone: (301) 594-7717 FAX: (301) 480-3510 E-mail: Moxey-MimsM@extra.niddk.nih.gov Dr. Susan Czajkowski Behavioral Medicine Research Group Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Rockledge 2, Room 8114 6701 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0406 FAX: (301) 480-1773 E-mail: CzajkowS@nih.gov o Direct your questions about financial or grants management matters to: Ms. Diane Drew Office of Grants and Contracts Management National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-2807 FAX: (301) 451-5651 Email: dianedrew@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) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions for R21 applications: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. Appendix. 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. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the 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 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 groups 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? 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: The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications. 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 will be assessed. 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 adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY 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 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 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 PA 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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