kristoff@GENBANK.BIO.NET (Dave Kristofferson) (06/11/91)
$$XID RFA DK9111 DK-91-11 P1O1 ***************************************** DIABETES AND ENDOCRINOLOGY RESEARCH CENTERS RFA: DK-91-11 P.T. 04; K.W. 0715075, 0785050, 0710030 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: January 10, 1992 Application Receipt Date: February 11, 1992 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Diabetes and Endocrinology Research Center grants. 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 Request for Applications (RFA), Diabetes and Endocrinology Research Centers, is related to the priority area of diabetes mellitus. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). BACKGROUND The NIDDK-supported Diabetes and Endocrinology Research Centers (DERCs) are part of an integrated program of diabetes-related research support provided by NIDDK. These centers have provided a focus for increasing collaboration and cost effectiveness among groups of successful investigators at institutions with established comprehensive diabetes research bases. OBJECTIVES AND SCOPE The objective of the DERCs is to bring together investigators from relevant disciplines in a manner that will enhance and extend the effectiveness of research related to diabetes and its complications. A diabetes center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the DERC is to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will enrich the effectiveness of diabetes research. An existing program of excellence in biomedical research in the area of diabetes and related metabolic and endocrine disorders is required. This research should be in the form of NIH-funded research projects, program projects, or other peer-reviewed research that is in existence at the time of submission of a center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants should consult with NIDDK staff concerning plans for the development of the center. The DERCs are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the center. Two other types of activities may also be supported with center funding--a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators or established investigators in other research disciplines where their expertise may be applied to diabetes research. The center grant may also include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. MECHANISM OF SUPPORT NIDDK expects to award up to three DERC grants in Fiscal Year 1993 on a competitive basis. The receipt of three competing continuation applications is anticipated that will be in competition with other applications received in response to this announcement. Foreign institutions are not eligible to apply. Awards will be for five years contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $750,000 in direct costs per year. Any application exceeding this amount will be returned to the applicant. REVIEW PROCEDURES Applications for a DERC grant will be evaluated by the NIH grant peer review process. Applications will be reviewed initially by an ad hoc review group convened by the NIDDK and subsequently by the National Diabetes and Digestive and Kidney Diseases Advisory Council. METHOD OF APPLYING Applicants should request a copy of "Guidelines for Diabetes Endocrinology Research Centers (DERCs)". These guidelines contain important additional information on the format, content, and review of applications and review criteria. Letter of Intent: Potential applicants are strongly encouraged to submit a letter of intent by January 10, 1992. The letter of intent may only include names of the Principal Investigator/program director and principal collaborators, descriptive title of the potential application, and identification of the organization(s) involved. The letter of intent is to be sent to the Chief, Review Branch, NIDDK at the address noted below. Format for Application: Applications must be submitted on the form PHS 398 (rev. 10/88) available at most institutional business offices and from the Division of Research Grants, NIH, (301) 496-7441. On item 2 of the face page of the application, applicants must enter: Diabetes Centers, RFA number DK-91-11. The RFA label available in the current revision of application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application to the extent that it may not reach the review committee in time for review. Application Procedures: Applications must be received by February 11, 1992. The original and four copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 Two additional copies of the application under separate cover must be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 Receipt, Review, and Start Dates: Letter of Intent Receipt Date: January 10, 1992 Application Receipt Date: February 11, 1992 Initial Review: June - July 1992 Council Review: September - October 1992 Earliest Start Date: December 1, 1992 INQUIRIES Inquiries and requests for guidelines should be directed to: Dr. Sanford A. Garfield Diabetes Centers Program Director Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 496-7418 For fiscal and administrative matters, contact: Linda Stecklin Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 These programs are described in the Catalog of Federal Domestic Assistance No. 93.847 - Diabetes, Endocrinology and Metabolic Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-4110, as amended: 42 USC 241) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA DK9112 DK-91-12 P1O1 ***************************************** DIABETES RESEARCH AND TRAINING CENTERS RFA: DK-91-12 P.T. 04, 44; K.W. 0715075, 0710030, 0785035, 0403004 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: November 22, 1991 Application Receipt Date: December 20, 1991 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Center grants. NIDDK anticipates the competitive awarding of at least five Diabetes Research and Training Center (DRTC) grants in Fiscal Year 1993. 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 Request for Applications (RFA), Diabetes Research and Training Centers, is related to the priority area of diabetes mellitus. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). BACKGROUND At the present time, the NIDDK supports six DRTCs. These centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. OBJECTIVES AND SCOPE The objective of the DRTCs is to bring together investigators from relevant disciplines in a manner that will enhance and extend the effectiveness of research and training being conducted in the field of diabetes and its complications. It should be stressed that a DRTC, although containing all of the elements present in a Diabetes Endocrinology Research Center (DERC, see RFA DK-91-11), contains substantial additional components described here. Diabetes Centers must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the DRTC is to bring together, on a cooperative basis, clinical and basic science investigators and those involved in diabetes training and information transfer in a manner that will enrich the effectiveness of diabetes research, training, and information transfer. When fully developed, the DRTCs are expected to encompass the following: (1) facilitating and strengthening basic and clinical research related to diabetes and its complications; (2) training health professionals about diabetes and its management; (3) developing a model demonstration facility to contribute to the above endeavors; and (4) transferring advances in the field of diabetes into improved care for people with diabetes through activities that identify and then overcome barriers to the application of new science to diabetes management and treatment. All of these areas need not be developed to the same degree. However, a strong base of biomedical research is the most important function of a center. Accordingly, a program of excellence in biomedical research in the area of diabetes and related metabolic and endocrine disorders in the form of NIH-funded research projects, program projects, or other peer-reviewed research must be in existence at the time of submission of a Center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants should request a copy of the DRTC guidelines and consult with NIDDK staff concerning plans for the development of the Center. The DRTCs are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the Center. Two other types of activities may also be supported with center funding - a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new initiatives or feasibility research studies for new investigators or for established investigators in other research disciplines where their expertise may be applied to diabetes research. These include biomedical, epidemiologic, behavioral, and health care research as it pertains to the Center's mandate for the training of primarily health care professionals. The Center grant may also include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. ELIGIBILITY Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT NIDDK expects to award up to five DRTC grants in Fiscal Year 1993 on a competitive basis. The receipt of five competitive continuation applications is anticipated, and these will be in competition together with other applications received in response to this announcement. Awards will be for five years contingent upon the availability of appropriated funds. Requests for support must not exceed $1,250,000 per year in direct costs. Any application exceeding this amount will be returned to the applicant. REVIEW PROCEDURES Applications for a DRTC grant will be evaluated in national competition by the NIH grant peer review process. Applications will be reviewed initially by an ad hoc review group convened by the NIDDK and subsequently by the National Diabetes and Digestive and Kidney Diseases Advisory Council. METHOD OF APPLYING Applicants should request a copy of "Guidelines for Diabetes Research and Training Centers (DRTCs)." These guidelines contain important additional information on the format, content, and review of applications and review criteria. Letter of Intent: Potential applicants are strongly encouraged to submit a letter of intent by November 22, 1991. The letter of intent may only include names of the Principal Investigator/program director and principal collaborators, descriptive title of the potential application, and identification of the organization(s) involved. The letter of intent is to be sent to the Chief, Review Branch, NIDDK at the address noted below. Format for Application: Applications must be submitted on the form PHS 398 (rev. 10/88) available at most institutional business offices and from the Division of Research Grants, NIH, (301) 496-7441. On item 2 of the face page of the application, applicants must enter: Diabetes Centers, RFA number DK-91-12. The RFA label available in the current revision of application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application to the extent that it may not reach the review committee in time for review. Application Procedures: Applications must be received by December 20, 1991. The original and four copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application under separate cover must be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 Receipt, Review, and Start Dates: Letter of Intent Receipt Date: November 22, 1991 Application Receipt Date: December 20, 1991 Initial Review: June - July 1992 Council Review: September - October 1992 Earliest Start Date: December 1, 1992 INQUIRIES Inquiries and requests for guidelines should be directed to: Dr. Sanford A. Garfield Diabetes Center Program Director Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 496-7418 For fiscal and administrative matters, contact: Linda Stecklin Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 These programs are described in the Catalog of Federal Domestic Assistance No. 93.847 - Diabetes, Endocrinology and Metabolic Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-4110, as amended: 42 USC 241) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA DE9105 DE-91-05 P1O1 ***************************************** NATIONAL RESEARCH SERVICE AWARD - INSTITUTIONAL TRAINING APPLICATIONS RFA: DE-91-05 P.T. 44; K.W. 0715148, 0404000, 0785040, 0715008 National Institute of Dental Research Letter of Intent Receipt Date: October 21, 1991 Application Receipt Date: November 20, 1991 PURPOSE The National Institute of Dental Research (NIDR) invites applications from domestic, private or public, nonprofit institutions proposing institutional training programs in basic and clinical sciences pertaining to: (1) oral soft tissue diseases including oral cancer, oral manifestations of AIDS, and oral herpes simplex virus (HSV) infection; and (2) behavioral science research in dentistry. Applications pertaining to other areas of oral health research are also acceptable. Proposed training must be relevant to the goals of the NIDR, as described in the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope". The primary objective of these training programs is to develop highly qualified, clinical investigators by supporting postdoctoral training of individuals with DDS, DMD, or equivalent clinical degrees, who are committed to a career in oral health research. Applications may include pre- and postdoctoral training for basic scientists and/or short-term training for dental students in the proposed programs. 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 Request for Applications (RFA) is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). The NIDR expects to make five new and/or renewal institutional training awards in response to this RFA. This RFA is for a single competition with a receipt date of November 20, 1991. LEVELS OF TRAINING AND TRAINEE ELIGIBILITY Several studies and advisory panels have emphasized the importance of graduate-level training leading to the Ph.D. degree in order prepare dentists for productive careers in oral health research. However, training in oral health research is also appropriate for pre- and postdoctoral basic scientists and for dental students during their professional education. Applications will be accepted to provide training at one or more of the following levels, given in priority order: (1) dentists pursuing a Ph.D. or equivalent degree in basic science; (2) dentists pursuing postdoctoral research training; (3) baccalaureate degree holders pursuing a Ph.D. or equivalent degree; (4) Ph.D. degree holders pursuing postdoctoral research training; (5) pre-dental degree students pursuing a short-term research experience, usually during, but not limited to, the summer months. Preference must be given to individuals who have received, as of the beginning of an appointment, a D.D.S., D.M.D., or equivalent dental degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is acceptable. Predoctoral trainees must have received a baccalaureate degree as of the beginning date of their appointment and must be enrolled in a graduate program leading to the award of a Ph.D. or an equivalent degree in biomedical or behavioral oral health research. Trainees for short-term research experiences must be enrolled in a program leading to a D.D.S. or equivalent degree. Individuals who wish to interrupt their dental school studies for one or more years to engage in full-time research training before completing their professional degrees are eligible; however, prior approval by the NIDR is required before an appointment can be offered. Individuals with a Ph.D. or equivalent degree may be appointed to the training grant. However, in general, they are expected to apply for a National Research Service Award (NRSA), individual postdoctoral fellowship award (F32). Trainees must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Individuals on temporary or student visas are not eligible. RECRUITMENT AND APPOINTMENT OF WOMEN AND MINORITY TRAINEES Attention must be given to recruiting women and individuals from minority groups that are underrepresented, nationally, in these sciences. A plan must be included for the recruitment of these individuals. PROGRAM CHARACTERISTICS The training program must provide opportunities for individuals to carry out supervised biomedical or behavioral oral health research and develop research skills. Clinical programs must have strong relationships with basic scientists that will ensure that the dentists have the opportunity to acquire the necessary foundation for future independent research. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Applicants may request as many postdoctoral, predoctoral, or short-term trainee positions as can be justified. However, five or more positions for postdoctoral trainees over the five-year period must be proposed. Acceptance of postdoctoral trainees must be limited to the first three years of the five-year award, i.e., two trainees the first year, two the second year, and one the third year. A similar pattern is to be proposed by applicants requesting more than five positions. The number and types of positions will be determined by peer review, program needs, and the availability of funds. Only one training award will be made to an institution unless the training programs are in distinctly different areas of oral health research. PERIOD OF SUPPORT Institutional training grant awards are made for five years and are renewable. Trainees may receive up to five years of support at the predoctoral level and three years of support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Extensions beyond these periods require a waiver from the NIH. Dentists requiring additional time to complete training as a participant in a Ph.D. program may anticipate favorable consideration of a waiver request, contingent upon certification of the recipient's good academic standing. STIPENDS AND OTHER TRAINING COSTS For predoctoral and the short-term trainees, at all levels of experience, the stipend is $8,800 per year ($734 per month). For postdoctoral trainees, the stipend is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research (including industrial), teaching, internship, residency, clinical practice, and other time spent in a health-related field beyond that of the qualifying doctoral degree. The postdoctoral stipends are as follows: Years of Relevant Experience Stipend 0 $18,600 1 19,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 Stipends may be supplemented by an institution from non-Federal funds. Federal funds may be used for stipend supplementation only if specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or V.A. benefits if permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Degree trainees may exclude only required course tuition, fees, books, supplies, and equipment. Non-degree trainees will be required to report stipends and all monies paid on their behalf for tuition and fees. These statutory requirements went into force as of January 1, 1987. NIH is not in a position to advise students or institutions about their tax liability. In any event, changes in the taxability of stipends in no way alter the relationship between NRSA fellows, trainees, and institutions. NRSA stipends are not now, and never have been, salaries. Trainees supported under the NRSA are not in any employer-employee relationship with NIH or the institution at which they are pursuing research training. Tuition and fees, including medical insurance, are allowable trainee costs if such charges are required of all persons in a similar training status at the institution, without regard to their source of support. Tuition at the postdoctoral level, if justifiable, is limited to that required for specific courses in support of the approved training program. Annual increments in tuition costs beyond the first year of a five-year award may not exceed six percent. Trainee travel, including attendance at scientific meetings, that the institution determines to be necessary to the individual's training, is an allowable trainee cost. Institutional costs of $1,500 per year per predoctoral trainee and $2,500 per year per postdoctoral trainee and $125 per month per short-term trainee may be requested to defray the cost of training-related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. Indirect costs based on 8 percent of total direct costs less tuition and fees, or actual indirect costs, whichever is less, may be requested. Applications from state and local government agencies may request full indirect cost reimbursement. PAYBACK PROVISIONS Trainees, other than the short-term trainees, must sign an agreement that they will fulfill the payback requirements. Trainees agree to engage in biomedical or health-related behavioral research and/or teaching for a period equal to the period of support in excess of 12 months. Trainees must undertake the obligated service on a continuous basis within two years after termination of support. Individuals who fail to fulfill their obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. Under certain conditions, the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. REVIEW PROCESS AND CRITERIA Applications will be evaluated for scientific and technical merit by the NIDR Special Grants Review Committee (SGRC), a standing NIH initial review group. Site visits may be involved. The following review criteria will be applied: o The proposed research training and program design; core curriculum; prescribed set of courses or seminars; the manner in which individual guided research activities will be selected; procedures for monitoring trainee progress; the existence of a true training program, as contrasted with fellowship training for an individual trainee; the combination of different levels of training; the appropriateness of the proposed number of trainees; the unique and/or innovative nature of the training program; resources and facilities. o The qualifications of the program director and participating faculty including the roles of specific preceptors; their time commitment; current research grant holdings, and pending research grant activities; specific experience in graduate research training. o Training environment: evidence of a high level of ongoing fundamental and clinical research activity; availability of equipment, facilities, and clinical resources. o Selection of trainees: plans for recruitment and criteria for the selection of trainees, including minorities and women; how trainees are assigned to preceptors. o Provisions for protection of human subjects; efforts to include women and minorities in study populations (see below); and provisions for the ethical treatment of animals. After review of the training grant application for scientific and technical merit and assignment of a priority score, the SGRC will comment on plans for attracting women and individuals from underrepresented minority groups to the training program. In the case of renewal applications, this will cover accomplishments in recruiting women and individuals from underrepresented minority groups and in training them for research positions. o Past training record: for both new and renewal applications, the past performance of the program director and preceptors in training scientists; reviewers will look for accomplishments, or potential, of the faculty in the training of scientists who will make major contributions to dental research, as indicated by success in obtaining individual research grant support, recognition for outstanding scientific accomplishment, and involvement of former trainees in academic, clinically oriented, and laboratory research and their ongoing productivity. For renewal applications, the record in filling trainee positions and the completion record of trainees will be considered. Cumulative information on the career development of all former trainees, including information about their minority status, will be evaluated. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the SGRC on the plans for, and success in, recruitment of women and individuals from underrepresented minority groups. The NIDR will notify the applicant of the Council's action shortly after its meeting. Funding decisions will be made based on the SGRC and Council recommendation, the need for research personnel in specified program areas, and the availability of funds. The earliest award date will be July 1, 1992. ADDITIONAL INFORMATION SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan and summarized in Section 2, E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort must be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. Copies of the NIDR Long-Range Research Plan for the Nineties, "Broadening the Scope," are available by a written request to NIDR, P.O. Box 54793, Washington, D.C. 20032 Training grants may not be used to support studies leading to a D.D.S. or other similar professional degrees, or to support residencies, i.e., postgraduate training for dentists providing health care directly to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the training grant may support such research training if the trainee has shown a clear interest in a research career. Since recently graduated dentists usually have little or no prior research training, their training must include a minimum of two years of basic research training. All competing institutional training grant applications must include a description of formal and informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. No awards will be made to applications lacking this component. This announcement was published in the NIH Guide for Grants and Contracts, Vol. 18, No. 45, December 22, 1989. For additional information, including the grounds for approving extensions of support and payback provisions, please refer to the announcement in the NIH Guide for Grants and Contracts, entitled, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13 (1), dated January 6, 1984. These are available in the business or grants office of most academic institutions and from: Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 496-7441 REVIEW SCHEDULE Applications will be processed according to the following schedule: Application Initial Review Council Earliest Receipt Date Group Meeting Meeting Award Date November 20 Feb/March May/June July 1991 1992 1992 1992 APPLICATION PROCEDURES It is recommended that prospective applicants contact program staff early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. It is suggested that prospective applicants submit a letter of intent no later than October 21, 1991, giving a descriptive title of the proposed training; the name, address and telephone number of the Program Director; and the names of key personnel and collaborating institutions. A letter of intent is not binding nor is it a prerequisite for acceptance of an application but it will assist staff in planning for timely review of applications. Applications must be prepared on grant application form PHS 398 (rev. 10/88). Application forms may be obtained from most institutional business or grants office and from the Office of Grants Inquiries at the above address. Applications received after November 20, 1991, and those deemed nonresponsive to the RFA will be returned to the applicant. To identify the application as a response to this RFA, check "yes" on item 2 of page 1 of the application and enter "RFA: DE-91-05, NRSA - INSTITUTIONAL TRAINING APPLICATIONS." The RFA label available in application form PHS 398 must be affixed to the bottom of the face page. 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. An original and four copies of the application must be received by November 20, 1991 at: Grant Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** Two additional copies must be sent to: H. George Hausch, Ph.D. Chief, Scientific Review Branch Extramural Program National Institute of Dental Research National Institutes of Health Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 496-7658 Inquiries concerning this RFA and letters of intent should be directed to: Thomas M. Valega, Ph.D. Special Assistant for Manpower Development and Training Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 496-6324 For fiscal and administrative matters, contact: Theresa Ringler Grants Management Officer National Institute of Dental Research Westwood Building, Room 518 Bethesda, MD 20892 Telephone: (301) 496-7437 This program is described in the Catalog of Federal Domestic Assistance No. 93.122. National Research Service Awards are made under authorization of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program.