Full Text HL-96-006 SLEEP ACADEMIC AWARD NIH GUIDE, Volume 24, Number 41, December 1, 1995 RFA: HL-96-006 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 29, 1995 Application Receipt Date: March 12, 1996 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 on 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. In this competition, there is a special interest in institutions sponsoring candidates experienced in medical education and sleep and clinical sleep research. Also, minority institutions and institutions with eligible minority faculty members are encouraged to apply. Candidates A candidate for an award must: o 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. o have knowledge and skills in sleep and sleep disorders medicine; o be an established member of a medical faculty in an accredited school of medicine or osteopathy in the United States, its territories, or its possessions; o have had formal clinical research training or post graduate clinical research training; o have had experience and sufficient training in clinical sleep research, clinical practice, and/or medical education to develop and implement a high quality curriculum in sleep and sleep disorders and provide leadership in clinical research on sleep; o have the unqualified support of the Dean and the educational leadership at the institution and demonstrate knowledge and commitment to medical education for medical students, physicians, patients, nurses, and the public; 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. 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 $62,500 for the salary of the Principal Investigator, plus applicable fringe benefits, and a maximum of $20,000 for technical support. Indirect costs may not exceed 8 percent. It is anticipated that support for this program will begin September 30, 1996. Application instructions have been modified to implement "just-in- time" streamlining efforts being considered by the NIH. This requires an applicant to submit certain information only when and if it is likely that an award will be made. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and NHLBI staff. For this RFA, no 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. In addition, instructions for completing the Biographical Sketch have been modified and no "Other Support" information or "Checklist" page is required in the initial application. If an award is likely, necessary budget, Other Support, and Checklist information will be requested by NHLBI staff. The SPECIAL REQUIREMENTS section of this RFA provides specific modifications to the instructions in the PHS 398 application kit. FUNDS AVAILABLE The estimated funds (total costs) available for this program for fiscal year 1996 will be $300,000. It is anticipated that three to four new grants will be awarded in FY 96 and in each of the next two years through an additional competition in each of fiscal years 1997 and 1998. The actual number 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 about sleep and the diagnosis and treatment of 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 curricula and found that about one third of the medical schools provided one to four hours within the curricula for teaching about 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 of the medical schools reported no formal teaching about sleep. It was estimated that about 30 percent of all medical students receive no instruction about 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 percent had laboratories, but only 29 percent had formal training programs about sleep. Of greater concern was that 90 percent of the trainees diagnosed patients with sleep apnea, but only 33 percent had any 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 percent 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 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, and otolaryngology), 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 stimulate the development and/or improvement of the quality of medical education, patient and community education, high quality clinical research programs, and clinical practice focused on the control of sleep disorders. Awardees will be encouraged to submit objectives and program plans for both health provider education and applied research. Awardees will be encouraged to develop and evaluate complementary educational and research projects as indicated below. Objectives The objectives of the Sleep Academic Award Program are to: o encourage the development of high quality curricula in schools of medicine that will significantly increase the knowledge and skills of students, house staff, and others, including practicing physicians, 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 a curriculum that can be adapted and used by other Institutions; o promote communication among specialists in primary care and other specialties to ensure appropriate treatment strategies; o promote an institutional environment that facilitates an interchange of information and educational evaluation techniques about new diagnostic, therapeutic, and behavioral measures in sleep and sleep disorders; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o enhance the teaching about sleep disorders in minority medical schools and promote community education about sleep in the communities served by these institutions, including providing outreach programs from medical centers to health practitioners in the community; o promote the development of a faculty capable of providing appropriate instruction in the diagnosis and management of sleep disorders, with special emphasis on minority faculties; o contribute to the public health efforts to address sleep disorders in the United States; o facilitate an interchange of ideas among awardee investigators and institutions; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups, such as minorities and the elderly with sleep disorders; o encourage high quality clinical and applied research in the treatment and control of sleep disorders. No one application is expected to address all of these objectives. Applicants should assess the needs in their area and develop a program that most effectively addresses the objectives of this RFA. Of particular interest are programs targeted to inner city and rural populations that may need education about sleep and sleep disorders for the community and to physicians, nurses, and other health care workers who are or who will be caring for medically underserved populations. Because this is a medical education program, funds may be requested for technical support staff who have complementary expertise to that of the principal investigator. Such personnel may include medical educators, curricula specialists, program evaluators, or other specialists. SPECIAL REQUIREMENTS Use the following modifications in completing the standard PHS 398 application: 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 has the option of providing 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 "just-in-time" application process, we are requesting that standard amounts be shown on the face page. IT IS UNDERSTOOD THAT THESE LEVELS ARE STRICTLY FOR ADMINISTRATIVE PURPOSES AND THAT ACTUAL AWARD LEVELS ARE SUBJECT TO NEGOTIATION, PRIOR TO AWARD. The following amounts must be entered on the face page: 7a. Direct Costs for Initial Budget Period - $70,000; 7b. Total Costs for Initial Budget Period - $75,000; 8a. Direct Costs for Proposed Period of Support - $350,000 and; 8b. Total Costs for Proposed Period of Support - $375,000. The applicant should be prepared to 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. In the event that budget information, Other Support pages and/or Checklist pages are submitted with the application, they will be removed prior to review to allow for consistency with other applications. 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 $62,500 for 50 percent effort). A candidate must plan to devote at least 30 percent effort and no greater than 50 percent effort to this award. A Principal Investigator may devote up to a combined total of 100 percent effort on the Academic Award and as an investigator on any other NIH-supported grant(s) or contract(s) and may receive remuneration from such sources accordingly. 2. Program Support Technical support will be provided up to a maximum of $20,000 per year for the following: o personnel other than the PI if requested for the development, implementation, and evaluation of the program. Salaries will be allowable for technical and support staff and consultants, e.g., educational and evaluation specialists. 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 travel for the Principal Investigator to meet with other investigators and NHLBI staff to exchange ideas, develop collaborative projects, and provide 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. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award. 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 may apply for an award 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 being made in meeting the program's objectives. An annual report that summarizes to curriculum development at the institution and other elements of the program plan and outlines 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 an awardee 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. 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 new 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 new 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 also 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 expected to be in the total population must be included. LETTER OF INTENT Prospective applicants are asked to submit, by December 29, 1995, a letter of intent that includes the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and 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 NIH 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 Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone (301) 710-0267, email: GIRG@DRGPO.DRG.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 page 1 of the application and enter the title "Sleep Academic Award" HL-96-006. 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) Send two additional copies of the application to the Chief, Review Branch, DEA at the address listed under INQUIRIES. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants, otherwise, the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by March 12, 1996. 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 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by the NHLBI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be noncompetitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria. Applications for this Sleep Academic Award will be evaluated in terms of the following criteria: o the magnitude of sleep and sleep disorders and the need for the program in the area to be served; o the overall merit of the proposed five year plan for developing or improving the institution's interdepartmental curricula in sleep; o the qualifications and background of the candidate, including experience in teaching, curriculum development, and administration in a medical school, planning and conduct of research, and level of effort; o the ability and commitment to work cooperatively with other investigators to develop innovative sleep curricula, materials, and programs; o the institution's commitment to implement the proposed curriculum and maintain a program in education about sleep and sleep disorders after the termination of the award; o the significant involvement of appropriate disciplines in the development, implementation, and evaluation of the program; o design and evaluation of educational interventions for health care providers and for patients with sleep disorders; o plans for communication and cooperation among specialists in internal medicine, psychiatry, pulmonary, neurology, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in sleep disorders; for example, health departments, medical and nursing associations, voluntary health agencies, and home care agencies; o plans for and availability of expertise to implement and evaluate the proposed program, including strategies for both process and impact evaluation; o the potential of the program for making an impact on the control of sleep disorders; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is September 30, 1996. 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, and the opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 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 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, 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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