kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/13/91)
REQUEST FOR APPLICATIONS RFA AVAILABLE: AI-91-03 IMPROVED STRATEGIES FOR DIAGNOSIS OF LYME DISEASE P.T. 34; K.W. 0745020, 0715125, 0710070, 0785035, 0710030, 0755010 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 15, 1991 Application Receipt Date: May 3, 1991 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for research that applies an understanding of the biology of Borrelia burgdorferi and host responses to infection by this organism to studies that will lead to the development of reliable and sensitive diagnostic tests for the detection of Lyme disease. Detection of infections by the etiologic agent of Lyme disease, B. burgdorferi, can theoretically be executed by antigen detection, detection of an immune response, or by detection of some non-antigenic component of the infectious agent such as a specific genomic sequence. Research focusing upon the development of one or more of these approaches is an appropriate subject for an application. Successful applications funded under this Request for Applications (RFA) will be supported through traditional research project grants (R01) that can be awarded to both nonprofit and for-profit organizations and institutions. This RFA solicitation represents a single competition with a specified deadline for receipt of applications. There are no plans to reissue this RFA. All applications received in response to the RFA will be reviewed by the same NIAID Initial Review Group (IRG) and by the National Advisory Allergy and Infectious Diseases Council. The deadline for the receipt of applications in response to this RFA is May 3, 1991. Applications should be prepared and submitted in accordance with the aims and requirements set forth in the remainder of this document. BACKGROUND INFORMATION Currently, Lyme disease is the most common vector-borne disease in the United States. It has been reported in forty-six states and has become a subject of great public concern in the United States and other countries, especially those in Europe. The Division of Microbiology and Infectious Diseases (DMID) has targeted Lyme disease as an area of high priority. DMID sponsors research programs on: epizootiology and transmission of Lyme disease; basic biology of the etiologic agent, B. burgdorferi; mechanisms of pathogenesis; host interactions with B. burgdorferi; and immune response to infection. The long range goal is the effective control, prevention, and treatment of Lyme disease. A major impediment to effective treatment of Lyme disease is the lack of sensitive and reliable diagnostic tests that will allow attending physicians to determine the presence of Lyme disease with a high degree of confidence. Lyme disease is difficult to diagnose on the basis of symptoms alone, because they tend to be protean manifestations and present inconsistently. Therefore, supplementary information, such as culture of the etiologic agent or other diagnostic test results, are often critical in the decision-making process as to whether one treats for Lyme disease or not. Most bacterial diseases are confirmed by culturing the etiologic agent. Unfortunately, B. burgdorferi is very difficult to recover from patients. At present the most likely way to improve our ability to diagnose cases of Lyme disease is to develop better approaches for detection of the etiologic agent or of the host response to it. RESEARCH OBJECTIVES The goal of this RFA is to stimulate programs of multidisciplinary basic and clinical research focused upon determining the most effective approach(es) for diagnosis of Lyme disease. Applications submitted in response to this RFA are expected to focus upon developing and testing new diagnostic strategies that should result in a more reliable and sensitive approach to the detection of Lyme disease in patients. Applications should include innovative approaches to the following: o Identification and characterization of antigens, antibodies, and DNA sequences that are good candidates as reagents, probes, or targets for use as a basis for a Lyme disease diagnostic test. o Identification and recruitment of three patient populations (patients that have a firm diagnosis of Lyme disease, patients that have no history or signs of Lyme disease, and patients that have symptoms of Lyme disease but test negative using a defined set of diagnostic tests currently available); o Evaluation of the sensitivity and specificity of candidate diagnostic assays relative to one another and to selected commercially available diagnostic kits using a standard panel of clinical specimens from each of the individuals in the recruited patient populations described above. However, alternative approaches or additional components may be included in applications if they are directly related to the overall objective of this RFA which is the development of improved strategies for the diagnosis of Lyme disease. MECHANISM OF SUPPORT The support mechanism for this program will be the traditional individual research grant (R01). Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. NIAID anticipates making two awards as a result of this request. However, the number of awards to be made is dependent upon receipt of a sufficient number of applications of high scientific merit and upon the availability of funds. If appropriate, collaboration with other investigators or institutions is encouraged. NIAID staff anticipates that each application would be a comprehensive single project (i.e., not a multiproject application). It is expected that the initial year's awards for successful applications will average $500,000 in total (direct plus indirect) costs for each award, although individual awards may be slightly higher or lower. Awards will be made for a project period of up to five years. (Awards to applicant institutions outside the United States will be limited to three years.) The earliest possible award date is September 30, 1991. NIAID has no plans to reissue this announcement. At the end of the award period, awardees may apply for continuation through the normal competing renewal process for R01 grants. SPECIAL REQUIREMENTS NIAID program staff will organize semi-annual meetings at which the Principal Investigators, and other key members (as designated by the Principal Investigators) of the projects, will discuss their progress. This will facilitate overall program planning and development, evaluation of the feasibility of planned approaches, and will promote productive interactions among the awardees. NIAID program staff will also ensure the participation in these meetings of investigators from other NIAID-supported Lyme disease research projects in order to further promote relevant interactions. Funds for travel to these meetings should be included in the budget. GENERAL REQUIREMENTS 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, together with a rationale for its choice. 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 recognize 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, 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. (For RFAs, change to read: 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 REQUIREMENTS Domestic universities, medical colleges, hospitals, and other public or private research institutions, including State and local government units, are eligible. Applications from minority investigators and women are encouraged. REVIEW PROCEDURES Applications will be received by the NIH Division of Research Grants (DRG) and assigned to NIAID. Applications will be reviewed by NIAID staff to determine administrative and programmatic responsiveness to this RFA; those judged to be non-responsive will be returned to the applicant without review. By mutual agreement between the applicant and NIAID staff, a non-responsive application may also be retained at NIH and processed as an unsolicited R01 application for the next review cycle. Those applications considered responsive to the RFA may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications in response to the RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group to be noncompetitive for award and will notify the applicant Principal Investigator and the institutional business official. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID, during July 1991. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council in September 1991. REVIEW CRITERIA The factors to be considered in scientific evaluation of the applications are: o Originality and scientific merit of research approach, design, and methodology as well as the potential scientific, technical, or medical significance of the proposed research. o Relevance of the proposed research to the stated objectives of this RFA. Specifically, the proposed research should be focused upon the development of a diagnostic assay for Lyme disease with greater reliability and sensitivity than currently available. o Research experience and competence of the Principal Investigator and staff to conduct the proposed studies. The Principal Investigator and key personnel must exhibit appropriate experience and competencies (with respect their specific roles in the research proposed) to conduct research studies on Lyme disease. o Adequacy of time (effort) that the Principal Investigator and staff would devote to the proposed studies. o Adequacy of facilities and access to an appropriate patient population. The applicant must demonstrate access and ability to study adequate numbers of patients to achieve statistically meaningful answers regarding the reliability and specificity of the diagnostic procedures to be evaluated in the proposed research. o Reasonableness of proposed costs. The review criteria listed above will be those used by the initial review group, which will base their evaluation primarily on scientific merit. In selecting applications for funding, while scientific merit is of prime consideration, applications also will be evaluated for programmatic relevance and importance. METHOD OF APPLICATION Letter of Intent: Prospective applicants are asked to submit, by March 15, 1991, a letter of intent that includes a descriptive title of the proposed research, and the names and affiliation(s) of the principal investigator and other key nvestigators. The letter of intent is requested in order to provide review staff with an indication of the number and scope of applications to be reviewed. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. The letter of intent should be sent to: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Program and Project Review Branch National Institute of Allergy and Infectious Diseases National Institutes of Health Westwood Building, Room 3A10 Bethesda, MD 20892 Telephone: (301) 496-8208 Format of Applications: Applications must be submitted on form PHS 398 (Rev. 10/88), the application form for research grants. Application kits are available at most institutional business offices and may be obtained from the Office of Grants Inquiries, Room 449, Westwood Building, Division of Research Grants, NIH. The format and detail applicable to research grant applications should be followed, and the requirements specified under Review Criteria (VII.C.) must be fulfilled. For purposes of identification and processing, mark "yes" in item 2 on the face page of the application and type in the words IMPROVED STRATEGIES FOR DIAGNOSIS OF LYME DISEASE and the RFA number AI-91-03. The RFA label available in the form PHS-398 (rev. 10/88) must be affixed to the bottom of the face page of the original signed application. Failure to use this label could result in delayed processing of the application such that it may not reach the committee in time for review. The research proposed should describe plans to accommodate the RFA research program requirements. Application Procedure: The completed original application and four (4) exact copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** TWO (2) ADDITIONAL COPIES MUST BE SENT TO: Dr. Olivia Preble Chief, Microbiology and Immunology Review Section Program and Project Review Branch National Institute of Allergy and Infectious Diseases National Institutes of Health Westwood Building, Room 3A10 Bethesda, MD 20892 Telephone: (301) 496-8208 CONSEQUENCES OF LATE APPLICATIONS AND DUPLICATE SUBMISSIONS To ensure their review, applications must be received by both DRG and Dr. Olivia Preble by May 3, 1991. Applications received after the above date will be returned without review. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. FUTURE FUNDING This is a one-time RFA. NIAID has no plans to reissue this announcement at any future date. Continuation of research projects funded through this RFA, beyond the time period awarded, can be applied for through the usual competitive renewal process for R01 research grants. INQUIRIES Investigators seeking information relevant to scientific/programmatic aspects of this RFA should contact Dr. Robert L. Quackenbush at the address below. Questions of a business or administrative nature should be directed to Todd Ball at the address below. Questions regarding review procedures should be addressed to Dr. Preble, at the address given above. Dr. Robert L. Quackenbush Chief, Bacteriology and Mycology Branch Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Westwood Building, Room 738 Bethesda, MD 20892 Telephone: (301) 496-7728 Mr. Todd Ball Chief, Microbiology and Infectious Diseases Grants Management Section Westwood Building, Room 718 GMB, DEA, NIAID, NIH Bethesda, MD 20892 Telephone: (301) 496-7075 This program is described in the Catalog of Federal Domestic Assistance No. 93.856 - Microbiology and Infectious Disease Research. Grants are awarded under the authority of the Public Health Service Act, Title IV, Section 301 as amended, Public Law 78-410; Public Law 97-219; Public Law 99-158; Public Law 99-500; and Report 99-711 to accompany HR 5233 and administered under PHS grant 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 Health Systems Agency review. REQUEST FOR APPLICATIONS RFA NUMBER: DK-NR-91-09 RESEARCH PLANNING GRANT: DIABETES IN MINORITY POPULATIONS P.T. National Institute of Diabetes and Digestive and Kidney Diseases National Center for Nursing Research Letter of Intent Receipt Date: May 16, 1991 Application Receipt Date: July 16, 1991 PURPOSE, SCOPE, AND OBJECTIVE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Center for Nursing Research (NCNR) invite applications for Research Planning Grants to support the development of plans for research projects that address critical questions related to the etiology, pathogenesis, diagnosis, treatment, cure, and prevention of diabetes mellitus and its complications in minority populations, including Blacks, Native Hawaiians, Hispanics, Pacific Islanders, and Asian Americans. Comparisons among these populations and the Caucasian population of the U.S., including ethnic/religious subsets, and with populations in the country of origin would be welcome. American Indians and Alaskan Natives are not encouraged in this Request for Applications (RFA), because a similar initiative limited to these populations was announced in the NIH Guide for Grants and Contracts, Vol. 19, No. 40, November 9, 1990. DISCIPLINES AND EXPERTISE Research proposed in response to this RFA may involve basic, clinical, behavioral, and epidemiologic studies. Basic research may be designed to elucidate biochemical alterations responsible for increased suceptibility to diabetes mellitus or to the complications of diabetes. Clinical research may be oriented to the cellular, organ, or human level and may include metabolic studies and comparisons. Behavioral studies, particularly those focused on prevention of diabetes through weight control programs, are encouraged. Epidemiologic designs that might be considered include observational and natural history studies, case-control studies of racial/ethnic differences, studies of migrant populations in the U.S. versus in their country of origin, urban/rural comparisons, acculturation of the minorities to the U.S. lifestyle and environment, and longitudinal studies. Issues of obesity, effects of aging on chronic disease, and multiple chronic diseases (such as diabetes and hypertension) are particularly encouraged. Research directed toward improving methodologies for population-based studies of minority ethnic/racial groups is also encouraged. Innovative approaches that involve new inter- disciplinary collaborations are particularly desirable. Whenever possible, studies should make cost-effective use of existing resources to help improve the health status of these populations. Accordingly, the applicant research team should include individuals with the appropriate scientific, medical, and sociocultural expertise to pursue the proposed research project. Special consideration should be given to including team members with demonstrated access, knowledge, and cultural sensitivity to the specified study population. Although new research projects are desired, applicants are urged to make cost-efficient use of current or recently terminated studies that contain large components of populations that are minorities in the U.S. Examples of studies that may have been conceived for reasons other than for research on U.S. minorities or for studies on the diseases listed above are the Barbados Eye Study, the Trinidad St. James Study, Honolulu Heart Study, Puerto Rico Heart Study, Bogalusa Heart Study, Evan County Study, Tecumseh Study, Rochester Epidemiology Program, National Survey of Black Americans, Lipid Research Clinics Program, Meharry Cohort Study, Kaiser Permanente Twin Registry, Early Treatment of Diabetic Retinopathy Study, Consolidated End Stage Renal Disease Data System, and the various national surveys of the National Center for Health Statistics (e.g., Health and Nutrition Examination Surveys, Hispanic HANES, Health Interview Survey, and others). GENERAL BACKGROUND The Report of the Secretary of Health and Human Services Task Force on Black and Minority Health (1) identified noninsulin-dependent diabetes (NIDDM) and its complications as major public health problems in several minority populations. Until 1940, diabetes was less common in the Black population than in the general population. Today, the prevalence of NIDDM is 33 percent higher in Blacks than in the Caucasian population. Diabetes is the third leading cause of death from disease in Blacks. Hispanic-Americans suffer from diabetes to a degree disproportionate to their representation in the U.S. population as a whole. In all populations, the rate of diagnosed diabetes rises with age and plateaus at 9-10 percent among those 65 years of age and older. Rates in men and women are virtually equal. Among those 65 to 74 years of age and those 75 and older, the rate has increased approximately 2.5-fold in the past 30 years. In the United States, approximately half of the people with NIDDM do not know they have the disease. Obesity is a well-established risk factor for diabetes. For Hispanics, the rate of diabetes increases with each higher level of percent desirable weight (PDW). At obesity levels of PDW over 100, rates of diabetes are higher in Hispanic populations than in Black populations, and rates are higher in Blacks than in Caucasians. Most adults with diabetes in both Hispanic and Black populations are overweight, and women are particularly obese (20 percent or more above desirable weight). The prevalence of diabetes in the Black population is about 50 percent higher than in non-Hispanic whites and the occurrence in Hispanics is about double that of non- Hispanic whites. Obesity in children is a major concern. One in five American children is obese. Younger children weigh more and have more body fat than children the same age did 20 years ago. While the role of genes in predisposing people to diabetes is important, almost all obesity studies have found family influences significant. MECHANISM OF SUPPORT This RFA is a one-time solicitation by NIDDK and NCNR for applications for Research Planning Grants (R21) to help support the unique short-term needs of investigators planning research studies related to diabetes in minority populations. It is anticipated that five to ten Research Planning Grant awards will be made in response to this solicitation, contingent on the receipt of meritorious applications and the availability of appropriated funds. The award of these Research Planning Grants will be followed within approximately one year by an RFA for investigator-initiated research project grant applications (RO1) related to this same program area. This subsequent RFA will provide the opportunity for investigators to obtain support for periods up to five years for meritorious research projects that address critical questions related specifically to the etiology, pathogenesis, diagnosis, treatment, cure, and prevention of diabetes and its complications in minority populations. PROVISIONS OF THE AWARD Approved Research Planning Grant applications should request no more than one year of funding for up to $25,000 direct costs. Examples of the allowed uses of these funds include: paying travel expenses of scientists, clinicians, epidemiologists, and other essential personnel who will assist in the preparation of the research plan; supporting retrieval and analysis of extant data; supporting preliminary studies to refine procedures, document recruitment potential; paying for secretarial assistance, telephone, postage, and office supplies. In addition, the study team should also have access to individuals with appropriate expertise in statistics and data management, and consultant fees may be paid for biostatisticians and epidemiologists (but not generally for other personnel). SPECIAL REQUIREMENTS A. 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. 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. B. The research team, composed of the Principal Investigator, Co-Investigator(s), and/or collaborators must include individual(s) who are experienced in health science research. Involvement of individuals who have demonstrated experience working with or delivering health services to minority populations is highly desirable. The application should include a succinct discussion of previous relevant investigational and health care activities. Letters of collaboration should be included for all proposed consultants. C. The applicant must demonstrate that the research team has an understanding of and is sensitive to the target population. Where specific language or cultural barriers are important, the applicant must provide a plan for addressing these barriers. D. NIH staff may take into account demographic and geographic distribution of peer reviewed and approved applications in the final selection process in order to support the development of research projects involving an appropriate distribution of populations of concern. ELIGIBILITY REQUIREMENTS Applicants may be non-profit or for-profit organizations, including universities, public health departments, voluntary organizations, or combinations thereof, both foreign and domestic. Among a team of applicants, one institution must be proposed as the lead organization to serve as the Grantee Institution and assume responsibility for the fiscal and programmatic conduct of the project. Other members of the team should be proposed based on individual consortium agreements (subcontracts) with those organizations. The Grantee Institution and any proposed consortium must have the staff and facilities required for the proposed program. REVIEW PROCEDURE Applications must be received by July 16, 1991, and will be reviewed initially by the Division of Research Grants (DRG) for completeness. Grants will be assigned to the relevant participating Institute for possible funding. Evaluation for responsiveness to the program requirements and criteria stated in the RFA will be conducted by NIH program staff. Applications that are judged incomplete or non-responsive will be returned. Those applications judged to be responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NIDDK. Subsequently, a second level of review will be performed by staff of each participating Institute to consider the special needs and priorities of that Institute. Applications recommended for approval will be considered for funding beginning February 1, 1992. REVIEW CRITERIA Applicants are encouraged to submit and describe their own ideas on how best to meet the objectives of this RFA. Applications will be judged primarily on (1) the likelihood that the new knowledge that may be gained will subsequently help to reduce the burden of diabetes and its complications on the health status of minority populations; (2) the potential scientific and technical merit of the proposed project, including the significance of the scientific question(s), rationale, appropriateness of the proposed planning process, consideration of appropriate ethical issues, and availability of preliminary data; (3) the potential to establish collaborations with groups and other agencies involved in health care of the selected populations; and (4) the qualifications and experience of the proposed investigators. Applicants are strongly encouraged to note these criteria and to include sufficient information in their Research Planning Grant Application so that these aspects of their proposal can be adequately assessed. The review group will also critically examine the requested budget and will recommend an appropriate budget and period of support for each approved application. LETTER OF INTENT Prospective applicants are requested to submit a letter of intent by May 16, 1991, that includes a descriptive title of the proposed research; the name, telephone number and mailing address of the Principal Investigator; the names of other key personnel; the name of the applicant institution and other collaborating entities; and the number and title of this RFA. Although a letter of intent is not required, it allows NIDDK Review Staff to estimate the potential review workload and to avoid possible conflict of interest in selecting reviewers. This letter of intent must be sent to: Dr. Robert D. Hammond Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases, NIH Westwood Building, Room 406 Bethesda, MD 20892 INQUIRIES The participating Institutes welcome inquiries from potential applicants to clarify any issues or questions regarding this RFA. Inquiries should be directed to the following NIDDK or NCNR program staff: NIDDK Dr. Lois F. Lipsett National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Westwood Building, Room 620 Bethesda, MD 20892 Telephone: (301) 496-7433 NCNR Dr. Mary D. Lucas National Center for Nursing Research National Institutes of Health Building 31, Room 5B03 Bethesda, MD 20892 Telephone: (301) 496-0523 METHOD OF APPLYING The regular research grant application form PHS 398 (revised 10/88) must be used. This form is available from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, Maryland 20892. The RFA label available in the 10/88 revision of Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the title of the RFA and the number should be typed on line 2 of the face page on the application form. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies in one package to DRG at the address below. The photocopies must be clear and single sided. Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two (2) additional copies of the application to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases, NIH Westwood Building, Room 406 Bethesda, MD 20892 Applications must be received by July 16, 1991. If an application is received after that date, it will be returned to the applicant. REFERENCES 1. U.S. Department of Health and Human Services. Report of the Secretary's Task Force on Black and Minority Health. Vol. VII, U.S. Government Printing Office, Washington, D.C., January 1986.