Full Text HL-96-022 TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 25, Number 31, September 20, 1996 RFA: HL-96-022 P.T. 34, K.W. Keywords: National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: October 4, 1996 Application Receipt Date: November 1, 1996 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THE FULL 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 Request for Applications (RFA) is to stimulate 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 Mycobacterium tuberculosis (TB) in the United States. 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, Tuberculosis Academic Award, is related to the priority areas of immunization and infectious diseases and HIV Infection. 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 domestic schools of medicine or osteopathy. In this competition, there is an interest in a diversity of types of applications. These include, but are not limited to, applications from any of the following: o established researchers and/or faculty specializing in the field of tuberculosis; o minority faculty members interested in medical education; o minority medical institutions; o institutions serving a high proportion of minority medical students or minority patients; o institutions having other tuberculosis research projects to which this award would be complementary; o institutions located in those areas where there is a high incidence of TB; Candidates A candidate for an award must: o be an established physician and a medical faculty member in an accredited school of medicine or osteopathy in the United States, its territories or possessions; 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 have sufficient clinical training, and practical experience in the control of TB to develop and implement a high quality curriculum in TB encompassing current knowledge and methods applicable to the control of tuberculosis in individuals of all ages and to provide leadership in applied research in control of TB; o be aware of the training and educational needs of health care professionals at all levels who are working in the area of TB control, and be a leader in providing the appropriate instructional programs for these individuals; 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; o commit 30-50 percent effort for a five year period. Individuals who have held another NIH career development award (K series) or a regular research grant (R01) are eligible to apply for the Tuberculosis Academic Award. 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. It is anticipated that support for this program will begin July 1, 1997. 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 standard PHS 398 application kit. FUNDS AVAILABLE Awards will be limited to a maximum of $62,000 for the salary of the PI, plus applicable fringe benefits, and a maximum of $20,000 for technical support. Indirect costs may not exceed 8 percent The estimated funds (total costs) for this fiscal year will be $300,000. It is anticipated that three new grants will be awarded. The specific number, however, will depend upon the merit and scope of the applications received and the availability of funds. The total TBAA program will be advertised for competition each year through 1997. RESEARCH OBJECTIVES Background Despite major advances in the understanding of the pathogenesis, detection and treatment of tuberculosis, in the early 1990s, more than 25,000 cases/year were reported in the United States. TB was spreading rapidly, especially in some population groups. From 1985 through 1990, the number of TB cases increased by 44 percent in the 25-44 year old age group. There was a 12 percent increase among Asians, a 25 percent increase among non-Hispanic whites, a 55 percent increase among blacks, and a 77 percent increase among Hispanics. There is also a high prevalence of TB among HIV infected patients. It is estimated that about 12 percent of all AIDS cases develop TB. HIV-associated TB has occurred in virtually all age groups, both men and women, all race/ethnic groups and in all HIV-transmission categories, although the largest numbers of cases have occurred in intravenous drug users and homosexual/bisexual men. Other groups at high risk for TB include persons living or working in a group or institutional settings such as hospitals and correctional facilities. Frequent outbreaks of multidrug resistant TB continues to occur. These outbreaks are a dramatic manifestation of serious underlying problems in public and private efforts to control TB. Very recently, the numbers of TB cases have begun to show a slight decline, probably, in large measure, because of the increased efforts in prevention and control. In order to assure that this encouraging trend continues, efforts to educate health care professionals about TB must also continue. Although considered "curable" since the development of effective chemotherapy in 1950, the TB problem has not been dealt with adequately. This has been attributed to a lack of sufficient awareness of the problem and inadequate resources, as well as clinical management errors and patient nonadherence to treatment regimens. The management errors include failing to diagnose and treat the cases in a timely manner, relying heavily on Isoniazid (INH) therapy even in patients likely to have INH-resistant organisms, using a single drug therapy, prescribing inappropriate drug dosages, and failing to isolate patients appropriately with infectious TB thereby missing opportunities to prevent the spread of the disease. Surveillance has often been slow or incomplete. Noncompliance with treatment regimens for chronic diseases has been a major problem with approximately 50 percent not taking their medicine. A study in 1988 in New York City reported 89 percent of the patients at one hospital failed to complete therapy, more than half failed to keep their first clinic appointment, and within twelve months of discharge 27 percent of the patients had been readmitted at least once with confirmed active TB. The concept for this initiative originated with the Tuberculosis Education Planning Committee convened by the NHLBI in December 1991, which emphasized the need for increased efforts to educate health care workers, patients, and the public on tuberculosis. They also recommended that public health officials identify populations and geographic areas in the community where tuberculosis screening programs should be intensified as well as conduct public education campaigns targeted to high risk populations to encourage symptomatic patients to seek prompt treatment. In addition, in 1987 the Department of Health and Human Services established an Advisory Council for the Elimination of TB (ACET), and in 1992 a "National Action Plan to Combat Multidrug Resistant Tuberculosis" was published to complement and supplement the "Strategic Plan for the Elimination of Tuberculosis." These plans indicate the urgency to improve the control of TB in the United States. In summary, in spite of major advances in the ability to diagnose, treat, and prevent TB, this disease remains a major health problem in the U.S. today, largely because of inadequate education of health professionals, patients, their families, and the larger community. Objectives The objectives of the Tuberculosis Academic Award are to: o encourage the development of high quality curricula in schools of medicine or osteopathy that will significantly increase the opportunities for students, house staff, and others, including practicing physicians and nurses, to learn the principles and practice of preventing, managing, and controlling TB; o develop and implement interdepartmental programs with common goals and standardized diagnostic and therapeutic approaches; o promote interdepartmental communication between primary care and other specialists to ensure appropriate control and treatment strategies; o encourage applied research in the control of TB; o promote the development of a faculty capable of providing appropriate instruction in diagnosis and management of TB, with special emphasis on minority faculty, nursing, and infection control personnel; o promote coordinated clinical approaches to the care of patients of various ages and ethnic groups who have TB; o provide for outreach programs from medical centers to health practitioners in the community, especially home care agencies, to enhance optimal care, especially in areas of high TB morbidity; o contribute to updating the knowledge and skills of practicing physicians, nurses and other health care providers in the community; o to focus educational efforts on health care providers in those areas where there is a persistently high incidence of TB, such as in immigrant communities, refugee centers, shelters for the homeless, and in correctional institutions; o enhance the awareness of health care providers of the unique ethnic, cultural, socioeconomic, and medical dimensions of TB; o coordinate and collaborate with other community organizations to control TB in areas with a high incidence of TB; o facilitate an interchange of ideas and methods between awardees and institutions; o enhance tuberculosis education programs in minority medical schools and promote TB education in the communities served by these institutions. Of particular interest are programs targeted to inner city populations and to rural areas that may be in need of education about tuberculosis, and among 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 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: 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. 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. 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. 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. 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 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, to develop collaborative projects, and to 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, 8 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. 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 will be required that summarizes activities relevant to curriculum development at the institution and other elements of the program plan and outlines future plans. 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 Division of Lung Diseases 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 4922B 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 new 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 1115), 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 the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. Although the TB Academic Award is not primarily a mechanism to support research, human subjects may be involved. If so, 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 October 4, 1996, 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 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). Applications kits are available at most institutional offices of sponsored research and may be obtained 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. 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 "Tuberculosis Academic Award" HL-96-022. The RFA label available in form PHS 398 application kit (rev. 5/95) must be affixed to the bottom of the face page of the original completed 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. Send or deliver the completed application and three signed photocopies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 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 November 1, 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 applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will return the application to the applicant. 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 be 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 Tuberculosis Academic Award will be evaluated in terms of the following criteria: o description of the magnitude of the tuberculosis problem and the need for the program in the area to be served; o the overall merit of the proposed five year plan for improving the institution's interdepartmental curricula in tuberculosis control; 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 make innovative tuberculosis curricula, materials, and programs available; o the institution's commitment to implement the proposed curriculum and to maintain a program in education about tuberculosis control 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 tuberculosis in areas with high incidence of TB; o plans for communication and cooperation between specialists in adult and pediatric pulmonary medicine, infectious disease, and community medicine to ensure optimal treatment; o plans for collaborative projects with other organizations that have responsibility for and interest in tuberculosis control, 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 tuberculosis among populations served; o the potential for replication or adaptation of the program at other sites. AWARD CRITERIA The anticipated date of award is July 1, 1997. 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 Tuberculosis Academic Award, the Division of Lung Diseases 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. To obtain a copy of the RFA please contact: Melonie Shine Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: ShineM@NIH.GOV Direct inquiries regarding programmatic issues to: Mary S. Reilly, M.S. Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: ReillyM@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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