EXPIRED
DIABETES SELF-MANAGEMENT IN MINORITY POPULATIONS Release Date: June 27, 2000 PA NUMBER: PA-00-113 National Institute of Nursing Research National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE This Program Announcement (PA) solicits applications for investigator- initiated research related to sociocultural, environmental, and behavioral mechanisms and biological/technological factors that contribute to successful and ongoing self-management of diabetes in minority populations. Applications that expand accepted intervention strategies in majority populations to minority populations are encouraged. Testing new interventions designed to promote self-management in minority diabetes populations will also be responsive to the PA. Self-management is defined as client strategies and behaviors that contribute to blood glucose normalization, improved health, and prevention or reduction of complications. The concept is broader than adherence to specific regimen components and incorporates deliberate problem solving and decision making processes. Applications are encouraged for both type 1 and type 2 diabetes and all age groups. 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 Program Announcement (PA), Diabetes Self-Management in Minority Populations, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Research Project Grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Background More research is needed among minority populations to determine whether the same strategies to promote and support healthy lifestyle and diabetes self- management behaviors are effective across ethnic groups. Relatively few behavioral studies are reported that focus on minorities with diabetes. This gap in minority diabetes knowledge applies to all age groups, both genders, and all ethnic minority groups. The increasing incidence and prevalence of diabetes in minority populations underscore the importance of the problem. Diabetes continues to be the seventh leading cause of death in the U.S., with a higher mortality rate for many ethnic minority groups than for whites. The CDC statistics for 1995 indicate that African American, American Indian, and Hispanic ethnic groups had a diabetes death rate ranging from 19.3 to 28.5 compared to 11.7 for Caucasian Americans. Although the prevalence and mortality rates vary by ethnic group, health disparities in minority individuals with diabetes is an increasing public health concern. The rate of diabetes is increasing faster in Blacks than Whites, although the reasons for this are not known. There is speculation about genetic admixtures and environmental factors but scientific data about the role of genetics and the environment are insufficient. African Americans appear to be at less risk for type 1 diabetes (insulin dependent) than White Americans. An increasing concern is the upward trend in type 2 (non insulin-dependent) diabetes in children and adolescents, with African American and Hispanic adolescents appearing to be at greater risk. The prevalence of type 2 diabetes in Hispanics is two to three times that of non-Hispanic Whites. Diabetes is rare in Asian and Pacific Islanders although there is evidence that immigrants to this country are becoming susceptible to type 2 diabetes. This susceptibility is considered to be related to lifestyle behaviors prevalent in Western society, including poor nutrition and decreasing physical activity. The incidence of diabetes in various American Indian tribes ranges from 12% to over 50% with the higher rates documented in ages 35 and over. The Strong Heart Study of American Indians in four western states found prevalence rates of 33% to 72% in state samples of over 4000 individuals. The role of genetics in the risk for type 2 diabetes is evidenced by findings that the prevalence for diabetes in American Indians is much higher if one or both parents are diabetic. Another finding among American Indians is that cardiovascular disease, a common complication of diabetes and formerly rare among this population, is increasing at a time when it is decreasing in other ethnic groups. Coping with a complex chronic illness such as diabetes affects the individual as well as family members throughout the entire lifespan. The daily responsibilities and knowledge of the risk for serious complications such as blindness, amputations, and heart disease, place a heavy burden of self-care on individuals with diabetes. Persons with diabetes are faced with decision making that involves establishing priorities in allocating time, effort, and resources to attain multiple types of health care (e.g., nursing, medical, ophthalmic, dental, nutrition, podiatry, and specialists related to complications). In general, much of the responsibility for managing diabetes falls on the individuals themselves, whose responsibilities, in addition to usual health maintenance, include regimens of meal planning and timing, physical activity, blood glucose monitoring, management of acute complications, and adjustments in therapies and lifestyle behaviors. Family members and family life, however, are also affected by the disease. Family members have greater responsibility for participating in diabetes care when the person with diabetes is a child, adolescent, or dependent older adult. These issues related to diabetes management are understudied in minority populations. Self-management to achieve metabolic control includes, among other things, monitoring blood glucose levels, balancing insulin dosage with food intake and physical activity, prevention and treatment of hypoglycemia, and an active partnership with health care providers. Self-management involves daily problem solving and decision making about actions relevant to glucose-medication titration. Healthy lifestyle behaviors are also an important part of effective diabetes self-management. A satisfying quality of life and full participation in work or school are also important to effective self-management of diabetes. The acceptance and application of these self-management responsibilities in minority populations are not well described. The outcomes of effective diabetes control are now well known. Clinical trials consistently show that intensive health care and self management make a positive difference. Results from the Diabetes Control and Complications Trial (DCCT) have shown that improving blood glucose control in type 1 diabetes, in which the body produces no insulin to regulate blood glucose levels, markedly reduces related complications of the eyes, kidneys, and nerves. Results from the United Kingdom Prospective Diabetes Study (UKPDS) have similarly demonstrated that improved control of blood glucose in type 2 diabetes also reduces diabetes related complications. Although more effective medications, delivery devices, and methods for diabetes self-monitoring have improved the ability to control glycemia, normal metabolic control remains difficult to achieve for all populations. Focusing research on groups that have disproportionate health problems compared to the overall population is important to society as a whole in terms of social and economic benefits. The results of previous research on self- management strategies for diabetes can not be assumed to be effective for minority groups if their representation constituted a small proportion of the sample. Research that emphasizes minority populations must be increased if health disparities among varying ethnic groups with diabetes are to be reduced by 2010. A Congressionally-established Diabetes Research Working Group developed a comprehensive plan for diabetes research priorities in 1999. The recommendations include studies related to the optimization of glucose control and the need for behavioral research. The report notes that in many cases, successful metabolic control and prevention of complications depends on changing the behaviors of patients, providers, and persons at risk for development of diabetes. The DCCT, UKDPS, and a recent meeting at NIH on behavioral science research in diabetes all stress the need to extend research on self-management, adherence, and other biopsychosocial aspects of diabetes management to assist persons with diabetes to achieve normal blood glucose levels, to reduce complications, and to improve their quality of life. The investigation of factors associated with effective and long-term diabetes self-management is critical to improving diabetes health outcomes. This announcement is aimed at meeting the diabetes self-management research needs in minority populations. NIA Statement. NIA in interested in understanding biological, behavioral, and social factors which affect the aging process and the health and quality of life of older persons. We are especially interested in the interaction of disease and care factors with proposed studies explicitly examining the role of aging and life-course factors in disease onset, progression and/or management. NIEHS. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate. The NIEHS is interested in supporting collaborative partnerships between academic investigators and community based organizations that address physical and social environmental influences on diabetes self management protocols, (please visit http://www.niehs.nih.gov/dert/programs/translat/envjust/envjust.htm and http://www.niehs.nih.gov/dert/programs/translat/cbpir/cbpir.htm). Scope Research on self-management for diabetes that affects psychosocial and physiological outcomes in minority populations is solicited through this program announcement. This announcement solicits proposals on both type 1 and type 2 diabetes populations and all age groups. The target populations are ethnic minorities although comparison studies may include a Caucasian group when warranted and when sample sizes are proportionate. Intervention proposals are solicited, especially those to test accepted strategies not adequately evaluated in minority populations. Applications with a focus on majority populations will not be considered responsive to this PA. Another current program announcement (PA-00-49) titled Enhancing Adherence to Diabetes Self- Management Behaviors is appropriate for all ethnic populations and can be viewed at http://grants.nih.gov/grants/guide/pa-files/PA-00-049.html. The following research topics are provided as examples that would extend research currently funded by NIH. They are not listed in any priority order and are not intended to be inclusive or restrictive. o Determine ways to accurately measure cultural/ethnic differences in self- management behaviors, o Determine the influence of particular cultural/ethnic group differences in diabetes self-management behaviors and outcomes (examples: variations in blood glucose testing, symptom management, healthy behaviors), o Evaluate interventions for minority children or adolescents that incorporate family, health care providers, school staff, support systems, and psychosocial factors, o Identify culture/ethnic-specific facilitators and barriers relevant to self-management across the lifespan, o Investigate the influence of age, diet, education, environment, financial status, and physical activity in diabetes self-management in minority ethnic groups, o Investigate the efficacy of academic or health care provider agency collaborations with community-based organizations in the implementation of and adherence to self management protocols, as this relates to social support mechanisms, i.e., social capital. Social capital may be defined as social interactions that positively impact individuals/communities, o Determine the influence of social support, burden of care, coping skills, quality of life, and self-efficacy on diabetes self-management in minority groups, o Test interventions previously shown to be effective and efficacious in majority populations within or across minority ethnic populations, o Test interventions and delivery systems that involve minority populations in active participation in self-management and related problem solving, o Examine physiological, genetic, and environmental factors that affect response to metabolic control and self-management in minority populations, o Determine the efficacy of technologies associated with self-management in minority populations (examples: glucose monitoring, computer based communications/strategies, insulin pump), and o Evaluate the influence of neighborhood characteristics on self-management capabilities, e.g., available venues for safe indoor and outdoor exercise and accessibility of fresh produce and other health promoting foods. 1. Congressionally-Established Diabetes Research Working Group. (1999). Conquering Diabetes: A Strategic Plan for the 21st Century. Bethesda, MD: NIH Publication No. 99-4398. 2. National Institutes of Health (November, 1999) Behavioral Science Research in Diabetes meeting. Presented by National Institute of Diabetes and Digestive and Kidney Diseases and the Office of Behavioral and Social Sciences Branch, NIH. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided 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 research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 and is available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH Some applications received in response to this program announcement are expected to focus on scientific issues related to aging and to aging-related aspects of disease. In describing the plan to recruit human subjects, investigators may cite a focus on aging or on aging-related aspects of disease as the justification for why children will be excluded from such applications. In this regard, applicants may use Justification 1, the research topic to be studied is irrelevant to children, from the policy announcement. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that 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. (1) 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? (2) 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? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. Additional scientific/technical merit criteria specific to the objectives of the PA and the mechanism used must be included if they are to be used in the review. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding GENERAL ISSUES to: Dr. Nell Armstrong Division of Extramural Activities National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: [email protected] Direct inquiries regarding specific PROGRAMMATIC ISSUES to the staff of the appropriate Institute/Center: Dr. Nell Armstrong Division of Extramural Activities National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: [email protected] Dr. Marcia G. Ory Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Room 533 MSC 9025 Bethesda, MD 20892-9205 Telephone: 301-402-4156 FAX: 301-402-0051 Email: [email protected] Dr. Sanford A. Garfield Senior Advisor for Biometry & Biomedical Research National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 685 Bethesda, MD 20892-5460 Telephone: 301-594-8803 FAX: 301-402-6271 Email: [email protected] Dr. Frederick L. Tyson Program Administrator Chemical Exposures and Molecular Biology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-0176 FAX: (919) 316-4606 Email: [email protected] Direct inquiries regarding FISCAL MATTERS to: Mr. Robert Tarwater Office of Grants and Contracts Management National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-2807 FAX: (301) 480-8260 Email: [email protected] Mr. David Reiter Grants Specialist Grants Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892 Tel: 30l-496-1472 FAX: 301-402-3672 Email: [email protected] Ms. Cheryl Chick Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 606 Bethesda, MD 20892-5456 (FEDEX Zip Code 20817) Telephone: 301-594-8825 FAX: 301-480-3504 Email: [email protected] Ms. Jacqueline M. Russell Grants Management Specialist Grants Management Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences Telephone: (919) 541-0751 Fax: (919) 541-2860 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.361 (NINR), 93.866 (NIA), 93.849 (NIDDK), and 93.3, 93.113, 93.114 and 93.866 (NIEHS). 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and 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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