Full Text HL-97-015 SLEEP ACADEMIC AWARD NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: HL-97-015 P.T. Keywords: National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: November 20, 1997 Application Receipt Date: December 23, 1997 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The primary objective of this initiative is to encourage the development and/or improvement of the quality of medical curricula, physician/patient/nurse and community education, and clinical practice for the prevention, management, and control of sleep disorders. A secondary objective is to promote high quality clinical research in sleep. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Sleep Academic Award, is related to the priority areas of heart disease and stroke, diabetes, chronic disabling conditions, mental health and disorders, and clinical prevention services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by any domestic university or school of medicine or osteopathy. Institutions that have not yet developed a curriculum in sleep medicine are especially encouraged to apply. Eligible institutions may submit only one application in each competition. Institutions that are already receiving support from the Sleep Academic Award program may not apply for this competition. Institutions may sponsor a candidate experienced in both medical education and clinical sleep research or a candidate experienced in clinical sleep research if supported by faculty with expertise in medical education. Institutions should also be committed to implementing the curricula development and educational research programs proposed by candidates. In this competition, there is a special interest in receiving applications from minority institutions and institutions with eligible minority faculty members. Candidates A candidate for the Sleep Academic Award must have the following credentials: o knowledge and skills in sleep and sleep disorders medicine and a demonstrated commitment to one or more areas of medical education for students, physicians, patients, nurses, or the public; o sufficient post graduate training and experience in clinical sleep research, clinical practice, and/or medical education to develop and implement a high quality curriculum in sleep and sleep disorders and to provide leadership in clinical research on sleep; o established appointment on the faculty of an accredited school of medicine or osteopathy in the United States, its territories or its possessions; o unqualified support from the Dean and educational leadership of the institution and; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application. Individuals who have or have had another NIH career development award (K series) or a regular research grant (R01) are eligible for a Sleep Academic Award if the individual meets the requirements of the Sleep Academic Award program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years and is non-renewable. Awards will be limited to a maximum of $50,000 for the salary of the Principal Investigator, plus applicable fringe benefits, and a maximum of $30,000 for technical support. Facilities and administrative (indirect) costs may not exceed 8 percent. It is anticipated that support for this program will begin September 1, 1998. Application instructions have been modified to reflect "just-in-time" streamlining efforts being considered by the NIH. The just-in-time concept requires applicants to submit certain materials only when there is the possibility of an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and NHLBI staff. For this RFA, only limited budgetary information is required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and key personnel must be included in the research plan. Instructions for completing the Biographical Sketch have been modified. In addition, the Other Support information and application "Checklist" page are not required as part of the initial application. If the possibility of an award exists, the Budget, Other Support, and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of these modifications to the standard PHS 398 application kit. FUNDS AVAILABLE It is anticipated that in fiscal year 1998, support will be available for total costs of approximately $300,000 and that approximately three to four grants will be awarded under this program. The actual number of awards each year, however, will depend upon the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background Recent estimates suggest that as many as 40 million people may suffer from chronic or intermittent disorders of sleep. Many remain undiagnosed and untreated, the consequences of which include reduced productivity, lowered cognitive performance, increased likelihood of accidents, higher risk of morbidity and mortality and decreased quality of life. It is now apparent that sleep disorders, disturbances of sleep, and sleep deprivation are major public health concerns. Sleep problems occur in both genders, in all races and socioeconomic groups, and increase with age. National attention has been directed to this problem. The National Commission on Sleep Disorders Research submitted their report entitled "Wake Up America: A National Sleep Alert" to the United States Congress in January 1993. The Commission's recommendations include encouraging broader awareness of sleep and training in sleep and sleep disorders, spanning the full range of health care professions, particularly at the primary care level. Several surveys have documented that physician training and knowledge about sleep and sleep disorders is minimal. For example, in 1978 the American Sleep Disorders Association (ASDA) conducted a survey of medical school teaching and found about one third of the medical schools provided between 1-4 hours of teaching in sleep. A more recent (1990) survey found that less than two hours were allocated to teaching about sleep at one third of the medical schools and one third reported no formal teaching about sleep. It was estimated that about 30% of medical students receive no instruction in sleep. These results would suggest that there actually has been a decrease in the amount of medical school training about sleep. The American Thoracic Society (ATS) surveyed pulmonary residency training programs and found that 70% had laboratories, but only 29% had formal training programs about sleep. Of greater concern was that 90% of the trainees diagnosed patients with sleep apnea, but only 33% of the trainees had formal training on how to conduct sleep studies. The major obstacles cited for increasing the attention to sleep in medical schools included low administrative priority, lack of qualified faculty, and limited curriculum time. Given the limited medical school training about sleep and sleep disorders, it is not surprising that several surveys have reported that health practitioners rarely diagnose sleep disorders. In fact, primary care physicians scored less than 50% correctly on factual items for diagnosis and management of sleep disorders. A 1991 Gallup survey showed that primary care physicians failed to correctly diagnose one in three adults with insomnia. Most narcoleptics contact as many as five physicians before a proper diagnosis is made. Clearly, physicians are not well trained or knowledgeable about sleep and sleep disorders. Sleep disorders cut across several medical specialties (e.g., neurology, psychiatry, internal medicine, pulmonary medicine, and otolaryngology etc.), which complicates the development of effective treatment guidelines and research. Although most sleep disorders can be controlled with medical treatment, many patients are not being diagnosed or receiving state-of-the-art medical care. This may be because many people believe that no effective treatments exist and therefore do not seek medical help. Multidimensional research is clearly necessary to improve clinical practice and patient education. Therefore, the aim of this program is to improve the quality of medical education and to stimulate the development of patient and community education, high quality clinical research programs, and clinical practice focused on the control of sleep disorders. Applicants are encouraged to submit program plans in sleep education and applied research that complement each other. Objectives The objectives of the Sleep Academic Award program include the following: o develop high quality curricula in schools of medicine that will significantly increase the knowledge and skills of students, house staff, practicing physicians, and others needed to apply state-of-the-art principles and practice to the prevention, management, and control of sleep disorders; o evaluate the impact of the proposed program and assemble curricular materials that can be adapted and used by other Institutions; o improve communication among specialists in primary care and other specialties to ensure appropriate strategies for the treatment of sleep disorders in patients of various ages and ethnic groups; o foster development of institutional environments facilitating the interchange of information on advances in sleep research and the implementation of improved interdepartmental programs with standardized diagnostic and therapeutic approaches to sleep medicine; o educate community health practitioners and the public about sleep and sleep disorders through the development of outreach programs, especially through the enhancement of sleep education programs in minority medical schools and the communities they serve; o develop the sleep medicine skills of faculty to provide high quality instruction in the diagnosis and management of sleep disorders, with special emphasis on minority faculties; o establish channels of communication between medical educators, institutions, sleep researchers, and community agencies to enhance the transfer of knowledge and ideas on educational requirements and optimal approaches to the prevention and management of sleep disorders; o contribute to public health efforts to address sleep disorders in the United States; o encourage the development of high quality clinical and applied research in the treatment and control of sleep disorders. In this competition, programs targeted to inner city populations and to rural areas needing education about sleep and sleep disorders and to community physicians, nurses, and other health care workers caring for medically undeserved populations are of particular interest. SPECIAL REQUIREMENTS Applicants should develop a comprehensive program that effectively addresses the needs in their area and the objectives of this RFA. The primary focus must be on plans to improve the quality of medical school education on sleep and sleep disorders for students and physicians. Plans and educational materials for curricular improvements must be of a design that facilitates replication at other sites. All applications must also include plans to evaluate the outcome of educational and research initiatives. The responsibilities of the Principal Investigator and key personnel must be specifically stated at the beginning of the research plan and placed in the context of other institutional and research commitments. Since the Sleep Academic Award primarily provides support for the salary of the Principal Investigator, applications that are contingent on receiving support from other agencies and institutions must specifically identify these resources in relationship to the program plan. For revised applications, the comments of the previous review committee should be specifically addressed in a preface to the program plan. 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 is 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) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The policy contains some provisions that are substantially different from the 1990 policies. 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, (F 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies of the policy from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. Although the Sleep Academic Award is not primarily a mechanism to support research, it is likely that human subjects will be involved. Therefore, protection for human subjects must be addressed, and the approximate percent of women and each minority group that you expect in the total population must be included. LETTER OF INTENT Prospective applicants are asked to submit, by November 20, 1997, a letter of intent that includes a descriptive title of the proposed program plan, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be faxed or sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research and from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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, to identify the application as a response to this RFA, check "YES" in item 2 of application page 1 and enter the title "Sleep Academic Award NIH HL-97-015". Use the following modifications in completing the standard PHS 398 application instructions: o BUDGET INFORMATION - No current/future year budgets or justifications (Form Pages 4 and 5) are required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and all key personnel must be specifically stated at the beginning of the research plan. Necessary budget information will be requested by NHLBI staff if there is a possibility for an award. o BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant should provide the title and source of any sponsored support relevant to the proposed research. o OTHER SUPPORT - No other support information is required on the "Other Support" page (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o FACE PAGE - Currently, the Division of Research Grants requires that requested costs be reflected on the face page for computer system tracking purposes. Because no budgetary information is required as part of the "streamlined" application, we are requesting that the following amounts be entered on the face page: 7a. Direct Costs for Initial Budget Period - $80,000; 7b. Total Costs for Initial Budget Period - $86,400; 8a. Direct Costs for Proposed Period of Support - $400,000 and; 8b. Total Costs for Proposed Period of Support - $432,000. It is understood that these levels are strictly for administrative purposes and that actual award levels are subject to negotiation, prior to award. The applicant should provide the name, phone number, and facsimile phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. Applications must be received by December 23, 1997. If an application is received after this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 DRG will also 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. o If an application is determined to be unresponsive to the RFA, the principal investigator will be notified and the application returned. The following sections are specific cost guidelines that will apply to those applications selected for award consideration. 1. Principal Investigator's Salary The salary for the Principal Investigator must not exceed the actual institutional salary rates for the effort being devoted to the Academic Award. In addition, salary rates must not exceed an annual salary level of $125,000 plus fringe benefits (a maximum of $50,000 plus fringe benefits for 40 percent effort). A candidate must devote at least 30 percent effort and no greater than 40 percent effort to this award. The combined efforts of any individual, Principal Investigator or key personnel, on the Sleep Academic Award and any other non-NIH or NIH-supported grant(s) or contract(s) must not exceed 100 percent. 2. Program Support Technical support will be provided up to a maximum of $30,000 per year for the following: o personnel, other than the Principal Investigator, if requested for the development, implementation, and evaluation of the program. Collaborations with consultants possessing medical, educational, or evaluative expertise complementary to that of the principal investigator are strongly encouraged. Salaries and the associated costs for any personnel other than the Principal Investigator are limited to the $30,000 per year allowed for technical support. o consumable supplies essential to the proposed program are allowable, but equipment costs are not allowable; o funds for educational development to enable the awardee to develop educational skills; o funds for the Principal Investigator to travel and meet with other investigators and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Investigators may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Facilities and Administrative Costs Facilities and administrative costs will be provided at eight percent of the total direct costs of each award excluding equipment. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution is expected to apply on behalf of a named individual meeting the criteria for this award. Only one application may be submitted from each eligible institution in each competition. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a noncompetitive basis depending upon progress in meeting the program's objectives and the availability of funds. An annual report that summarizes curriculum development at the institution, other elements of the program plan, and the outline of future plans will be required. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If a principal investigator moves to another institution, the award will continue at the original institution only upon acceptance by the National Heart, Lung and Blood Institute of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by NHLBI. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI. The roster of the review panel may be found on the NHLBI home page (gopher://fido.nhlbi.nih.gov:70/11/nhlbi/about/meet/sep/irsep) approximately one month prior to the review date. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI and participating Institutes anticipate funding under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria Applications for this Sleep Academic Award will be evaluated in terms of the following criteria: o qualifications and effort level of the candidate and key personnel, including pertinent experience in teaching, curriculum development, program evaluation, administration, and clinical research program planning and conduct; o plans to develop, improve, and integrate an interdepartmental curricula in sleep medicine with existing institutional training programs for medical students, graduates, and post-graduates; o plans to evaluate all proposed educational interventions, including strategies for both process and impact evaluation; o plans for communication and interdepartmental collaboration between medical specialists in appropriate disciplines to ensure the development, implementation, and evaluation of optimal treatment and educational programs; o plans and ability to work cooperatively with other investigators developing innovative and portable curricular materials in sleep medicine for replication at other sites; o the potential impact of the program on the degree of sleep medicine training and on the prevention, management, and control of sleep disorders within the population to be served; o plans for community outreach or collaborative projects with organizations having responsibility for or interest in sleep disorders, such as community centers, health departments, medical and nursing associations, voluntary health agencies, and home care agencies; o description of the need for this program and the magnitude of sleep disorders within the population to be served; o overall merit and feasibility of the proposed five year plan; o institutional commitment to implement the proposed curriculum and to maintain a program in education about sleep and sleep disorders after the termination of the award. AWARD CRITERIA The anticipated date of award is September 1, 1998. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Sleep Academic Award, the NHLBI will provide funds for a project period up to five years. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify issues or answer questions from potential applicants is also welcomed. Direct inquiries regarding programmatic issues to: Michael J. Twery, Ph.D. Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: TweryM@gwgate.nhlbi.nih.gov James P. Kiley, Ph.D. National Center on Sleep Disorders Research 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: KileyJ@nih.gov Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: ScheireJ@NIH.GOV Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: ZimmermR@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to a review by a Health Systems Agency. The PHS strongly encourages all grant 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, 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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