kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/22/91)
NOTE from D.K. - Because of the large amount of RFA/RFP material this mailing has been spaced out over several days to try to minimize mailbox congestion and the resulting bounced mail problems. Part 1 was posted a few days ago. ---------------------------------------------------------------------- REQUEST FOR APPLICATIONS RFA: CA-91-07 MOLECULAR ANALYSES OF RADIATION-INDUCED GENETIC DAMAGE P.T. 34; K.W. 1002028, 0725015, 1002019, 1002004 National Cancer Institute Letter of Intent Receipt Date: April 24, 1991 Application Receipt Date: May 24, 1991 I. INTRODUCTION The Division of Cancer Etiology of the National Cancer Institute (NCI) invites grant applications from interested investigators through an announcement of Request for Applications (RFA) for molecular studies on the mutagenic effects of ionizing radiation on mammalian DNA, in vitro and in vivo. II. BACKGROUND The nature and frequency of mutations induced by exposure of mammalian cells to ionizing radiation is not well characterized for low linear energy transfer (LET) radiations (e.g., gamma and x-rays); it is even less well characterized for high-LET radiations (e.g., neutrons and alpha particles). In particular, it is not known if mutations induced by ionizing radiations are preferentially distributed at the molecular level into characteristic mutation spectra as appears to be the case for point mutations induced by chemical mutagens and by ultraviolet light. If characteristic or unique mutation spectra could be demonstrated in mammalian cells exposed to the various forms of ionizing radiation, they would be candidates as molecular markers for radiation exposure and a possible means of distinguishing radiation-induced genetic damage from that which occurs spontaneously or is induced by other mutagens. III. RESEARCH GOALS AND SCOPE The purpose of this RFA is to encourage research to characterize the distributions of mutations induced in the DNA of mammalian cells exposed to ionizing radiations in vitro and in vivo. The objective will be the quantitative analyses of mutations by location and frequency of occurrence in defined DNA targets (or chromosomal location for large-scale genetic events) with sufficient sensitivity and precision to be applied directly to small populations of somatic cells. Primary emphasis should be placed on basic studies with cultured mammalian cells, including human cells. Such research could involve a variety of genetic endpoints and techniques including the use of specific gene targets, repetitive DNA sequences, and chromosome-specific DNA probes. This RFA will permit a wide range of research activities, including, but not limited to, the following studies: o To determine if mutation spectra based on point mutations, deletions, and/or other mutational endpoints may be uniquely characteristic of radiation exposure and can be used to discriminate between cellular exposures to the different forms of ionizing radiation, between exposures to ionizing radiations versus exposure to other types of mutagens, or between mutations induced by exposure to ionizing radiation and those of spontaneous origin. o To determine the feasibility and merit of amplifying mutations directly from somatic cells without using genetic selection and subculturing to amplify mutated DNA for molecular analysis. In vivo studies should consider the possible complications that may result from the clonal expansion of mutations in progenitor cells into populations of somatic cells. o To investigate mutational responses in radiation- exposed somatic cells as functions of varying doses and dose rates. o To compare and validate radiation-induced mutation spectra obtained with cultured cells exposed in vitro with mutation spectra obtained from somatic cells exposed in vivo. IV. MECHANISM OF SUPPORT This program will be supported through the National Institutes of Health (NIH) traditional research project grant (R01). The applicant will have the sole responsibility for planning, directing, and executing the proposed research. Awards will be administered under Public Health Service grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. The total project period for applications submitted in response to the present RFA should not exceed four (4) years. The intent of this research initiative is to fund approximately 6 individual research grants, with total program costs not to exceed $950,000 in total costs for the first year. This funding level is dependent on receipt of a sufficient number of grant proposals of high scientific merit. Support for this RFA is provided for in the financial plans of the NCI. However, award of grants responding to this RFA will be contingent on the availability of funds at the time the awards are made. Non-profit, for- profit, and both foreign and domestic institutions are eligible to apply. Renewal applications will compete with all other unsolicited applications and will be reviewed by a standing Division of Research Grants (DRG) study section. However, should the NCI determine that there is a sufficient need for programmatic support related to the RFA, the NCI may announce a request for renewal applications. V. REVIEW PROCEDURES AND CRITERIA a. Review Procedures Upon receipt, applications will be initially reviewed by DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Review of the responsiveness of applications will be carried out by NCI program staff. If a grant application to the RFA is judged to be nonresponsive, the applicant will be contacted by program staff and given an opportunity to have the proposal considered along with unsolicited grant applications received. Applications responsive to the RFA solicitation will be reviewed by a review group convened by the Division of Extramural Activities of the NCI for that purpose. The initial review will be for scientific merit. A second level of review will be carried out by the National Cancer Advisory Board where qualified applications will be considered with respect to the needs and priorities of the NCI. b. Review Criteria Applications should be responsive to the stated purpose and objective of the RFA. Those factors considered to be important for review will include: 1. A demonstrated knowledge of the applicable science and competence with relevant methodology. 2. The scientific merit and innovation of proposed research. 3. Adequacy of facilities and special resources relevant to the RFA. 4. Cost effectiveness of the proposal and quality of scientific collaboration. VI. METHOD OF APPLYING Applications must be submitted on PHS 398, revised 10/88, available at most institutional business offices and may be obtained from the Office of Grants Inquires, DRG, NIH, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland 20892. The format and instructions applicable to individual research grant applications should be followed in preparing a grant in response to the RFA. 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 a grant application, and could prevent it from reaching the review committee in time for review. In addition, the number and title of the RFA must be typed on line 2 of the face page of the application and YES must be checked. A signed, typewritten original grant application, including the checklist, and four (4) signed, exact photocopies, must be mailed, in one package, to the Division of Research Grants at the address below. The photocopies must be clear and single-sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two (2) additional copies of the application must also be sent to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Westwood Building, Room 848 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 24, 1991. If an application is received after that date, it will be returned to the applicant. 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. Animal and human subject approval clearances, when applicable, should be submitted with the application to expedite the review process. Letter of Intent Prospective applicants are requested to submit a letter of intent to respond to the RFA that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. The letter of intent helps NCI staff to estimate the review workload and to avoid possible conflict of interest in the review. The request for a letter of intent does not bind the respondent to respond formally to the RFA, nor is it a requirement to apply. The letter of intent does not enter into the review of applications. The letter of intent must be sent to: Richard A. Pelroy, Ph.D. Radiation Effects Branch National Cancer Institute Executive Plaza North, Suite 530 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-9326 VII. INQUIRIES Written or telephone inquires concerning the objectives and scope of this RFA are encouraged and may be directed to Dr. Richard A. Pelroy at the above address. This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention Research. Awards are under authorization of Public Health Service Act, Section 301(c) and Section 402 (Public Law 78-410, as amended; 42 USC 241; 42 USC 282) and administered under PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program in not subject to the intergovernmental review requirements of Executive Order 12372 and Health Systems Agency review. REQUEST FOR APPLICATIONS RFA NUMBER: AR-91-02 BASIC RESEARCH ON OSTEOPOROSIS P.T. 34; K.W. 0705050, 0785050, 0760020, 0765030, 0760025, 0760075 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 1, 1991 Application Receipt Date: May 15, 1991 INTRODUCTION Osteoporosis, a condition in which bone mass is low, represents a major public health problem in the United States, exacting an enormous societal toll annually in morbidity and mortality. It affects more than 24 million Americans and is responsible for at least 1.3 million fractures each year. Moreover, the frequency of osteoporosis and osteoporosis-related fractures is expected to increase with the expansion of the elderly population in the upcoming decades. Bone remodeling is regulated by a complex interplay of bone cells and factors that modulate the growth and functional activity of the cells. After the age of forty, and particularly after menopause in women, the balance of bone formation and bone resorption is disturbed leading to bone loss. Although there has been an explosion of information on the nature of the bone forming and bone resorbing cells and numerous bone-active factors have been identified, the regulation of bone remodeling by mechanical, endocrine, and local factors, especially as they relate to osteoporosis, remains poorly understood. BACKGROUND A national scientific conference on RESEARCH ADVANCES IN OSTEOPOROSIS, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute on Aging, was held in February 1990. Following the general meeting, the NIAMS convened a meeting of leaders in basic and clinical osteoporosis research to develop future research directions and opportunities. These research directions became part of a report that was requested last year by the Senate Appropriations Committee. The Report on HHS-wide Research, Education, and Health Promotion Activities in Osteoporosis also contained information on the status of current research in osteoporosis throughout the Department of Health and Human Services. A copy of this report may be requested by contacting Dr. Joan McGowan at the address listed below. As follow-up to the report to the Senate Appropriations Committee and to be responsive to current congressional interest and support for osteoporosis research, a Request for Applications (RFA) is proposed to solicit applications in the particular areas of basic bone biology that are specifically and directly applicable to osteoporosis. RESEARCH GOALS AND SCOPE Some of the basic research areas that were identified as highly promising research opportunities are: (1) the effect of local and systemic growth regulators and osteoinductive factors on bone metabolism relevant to osteoporosis; (2) the development of animal and cell culture models for osteoporosis; (3) the role of mechanical/gravitational stress in maintaining bone mass and preventing bone loss; (4) studies of the mechanism of action on bone of factors with therapeutic potential, such as fluoride, estrogen and other hormones, bisphosphonates; (5) the roles of bone architecture and strength in osteoporotic fractures; and, (6) identification, characterization, and molecular mechanisms of action of receptors for hormones, growth factors, and cytokines active in bone cells and relevant to the etiology of osteoporosis. Applications addressing other topics directly and specifically pertinent to osteoporosis and osteoporosis-induced fractures are encouraged. MECHANISM OF SUPPORT The support mechanism for this RFA will be the the traditional, investigator-initiated research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Approximately $2,000,000 in total costs per year for three to five years will be committed by the NIAMS, specifically to fund applications that are submitted in response to this RFA. The NIDDK will provide additional funds to support approximately two projects. The funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed five (5) years. The earliest possible start date for the initial awards will be September 30, 1991. Although this program is provided for in the financial plans of the NIAMS and the NIDDK, award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Applications may receive secondary assignment, when appropriate, to the National Institute on Aging, which may fund projects in addition to those funded by NIAMS and NIDDK. Non-profit and for-profit institutions, and foreign as well as domestic institutions, are eligible to apply. This RFA is a one-time solicitation. Generally, future unsolicited competing renewal applications that result from this current RFA will compete as research project applications with all other investigator-initiated applications and be reviewed by a standing Division of Research Grants study section. However, should there be sufficient continuing program need, NIAMS and NIDDK may announce a request for renewal applications. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NIAMS and NIDDK program staff function. Applications that are judged non-responsive will be returned to the applicant but may be submitted as investigator-initiated application at the next receipt date. Questions concerning the relevance of proposed research to the RFA should be directed to program staff as described in INQUIRIES. In cases where the expected number of applications is large compared to the number of awards to be made, the NIH will conduct an administrative prereview (triage) to eliminate those that are clearly not competitive. The NIH will withdraw from further competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both responsive and competitive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate initial review group convened by the NIAMS Review Branch. The second level of review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council, the National Institute of Diabetes and Digestive and Kidney Diseases National Advisory Council and, in some cases, the National Advisory Council on Aging will make recommendations regarding funding. REVIEW CRITERIA Proposals responsive to this competitive solicitation will be reviewed in accordance with the following criteria: 1. Extent of relevance of the proposed research to the aims of the RFA. 2. Scientific merit of the proposed approach, including the adequacy and quality of the methodological approach and the research design. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 3. Expertise and qualifications of the Principal Investigator and proposed staff and/or collaborators to perform the proposed experiments. 4. Documentation of the adequacy of the facilities and resources. The review group will critically examine the proposed budget and recommend an appropriate budget for each approved application. METHOD OF APPLYING The research grant application form PHS 398 (revised 10/88) must be used in applying for these grants. These forms are available at most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland 20892. The RFA label available in the 10/88 revision of 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. In addition, the title of the RFA and the RFA number must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to the Division of Research Grants at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two (2) additional copies of the application must also be sent to: REFERRAL OFFICER Division of Extramural Activities National Institute of Arthritis and Musculoskeletal and Skin Diseases Room 5A-07, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 15, 1991. If an application is received after that date, it will be returned to the applicant. 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. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to: Dr. Joan A. McGowan Bone Biology and Bone Diseases Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases 5333 Westbard Avenue Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 496-7495 or Dr. Ronald Margolis Director, Endocrinology Research Program Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK/NIH 5333 Westbard Avenue Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7504 The program directors welcome the opportunity to clarify any issues or questions from potential applicants. LETTER OF INTENT Prospective applicants are asked to submit by April 1, 1991, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being 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 is extremely helpful in planning for the review of applications. It allows NIAMS staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent should be sent to Dr Joan McGowan at the address listed above. This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and No. 93.855 Diabetes, Endocrinology and Metabolism Research. Awards will be made under authorization of the Public Health Service Act, Title III, Section 301 (c) (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant 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. REQUEST FOR APPLICATIONS RFA NUMBER: AR-91-03 CLINICAL AND EPIDEMIOLOGY RESEARCH ON OSTEOPOROSIS P.T. 34; K.W. 0705050, 0785055, 0760020, 0760025, 0755030, 0745027 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: April 1, 1991 Application Receipt Date: May 15, 1991 INTRODUCTION Osteoporosis is a disease characterized by low bone mass, microarchitectural deterioration of bone tissue, and a consequent increase in fracture risk. Osteoporosis represents a major public health problem in the United States, exacting an enormous societal toll annually in morbidity and mortality. It affects more than 24 million Americans and is responsible for at least 1.3 million fractures each year. Moreover the frequency of osteoporosis and osteoporosis-related fractures is expected to increase with the expansion of the elderly population in the upcoming decades. Bone mass in the adult skeleton reflects the accumulation and maintenance of bone tissue during growth and maturation, and the rate and duration of bone loss thereafter. Factors that induce a low peak bone mass and those that underlie excessive postmenopausal and aging associated bone loss predispose an individual to osteoporosis. Although our knowledge is incomplete, genetic, endocrine and lifestyle factors are contributory. The development and testing of strategies for building and maintaining an adequate bone mass and preventing bone loss are essential. BACKGROUND A national scientific conference on RESEARCH ADVANCES IN OSTEOPOROSIS, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute on Aging, was held in February 1990. Following the general meeting, the NIAMS convened a meeting of leaders in basic and clinical osteoporosis research to develop future research directions and opportunities. These research directions became part of a report that was requested last year by the Senate Appropriations Committee. The Report on HHS-wide Research, Education, and Health Promotion Activities in Osteoporosis also contained information on the status of current research in osteoporosis throughout the Department of Health and Human Services. A copy of this report may be requested by contacting Dr. Joan McGowan at the address listed below. As follow-up to the report to the Senate Appropriations Committee and to be responsive to current congressional interest and support for osteoporosis research, a Request for Applications (RFA) is proposed to solicit applications in the particular areas of clinical and epidemiologic research that are specifically and directly applicable to osteoporosis. RESEARCH GOALS This RFA is intended to foster and enhance research specifically directed to prevention and treatment strategies, as well as epidemiologic studies of osteoporosis. Some of these areas, identified as needing additional research, are listed below: o Studies on maximizing bone mass in early life o Biochemical markers of bone remodeling o Non-invasive measurement of bone density/mass and structure o Further studies of sex hormone use in osteoporosis o Role of exercise in prevention and treatment of osteoporosis o Development of hormone analogs with specific therapeutic application in osteoporosis o Therapeutic potential for growth factors o Incidence and etiology of osteoporosis in men and blacks o Etiology of juvenile and adult idiopathic osteoporosis o Additional research on risk factors o Research on prevention strategies Other clinical and epidemiologic research applications in the field of osteoporosis are encouraged. In order to be considered responsive to this RFA, applications must be specifically directed to osteoporosis. MECHANISM OF SUPPORT This RFA will use the traditional National Institutes of Health (NIH) research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Approximately $2,000,000 in total costs per year for three to five years will be committed by the NIAMS specifically to fund applications that are submitted in response to this RFA. The NIDDK will provide additional funds to support approximately two projects. The funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed five (5) years. The earliest possible start date for the initial awards will be September 30, 1991. Although this program is provided for in the financial plans of the NIAMS and the NIDDK, award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Applications may receive secondary assignment, when appropriate, to the National Institute on Aging, which may fund projects in addition to those funded by NIAMS and NIDDK. Non-profit and for-profit institutions, and foreign as well as domestic institutions, are eligible to apply. This RFA is a one-time solicitation. Generally, future unsolicited competing renewal applications that result from this RFA will compete as research project applications with all other investigator-initiated applications and be reviewed in a standing Division of Research Grants study section. However, should it be determined that there is a sufficient continuing program need, NIAMS and NIDDK may announce a request for renewal applications. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE Upon receipt, applications will be reviewed initially by the Division of Research Grants for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NIAMS and NIDDK program staff function. Applications that are judged non-responsive will be returned to the applicant but may be submitted as investigator-initiated applications at the next receipt date. Questions concerning the relevance of proposed research to the RFA should be directed to program staff as described in INQUIRIES. In cases where the expected number of applications is large compared to the number of awards to be made, the NIH will conduct an administrative prereview (triage) to eliminate those that are clearly not competitive. The NIH will withdraw from further competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both responsive and competitive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate initial review group convened by the NIAMS Review Branch. The second level of review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council, the National Institute of Diabetes and Digestive and Kidney Diseases National Advisory Council and, in some cases, the National Advisory Council on Aging will make recommendations regarding funding. REVIEW CRITERIA Proposals responsive to this competitive solicitation will be reviewed in accordance with the following criteria: 1. Extent of relevance of the proposed research to the aims of the RFA. 2. Scientific merit of the proposed approach, including the adequacy and quality of the methodological approach and the research design. Familiarity with the proposed techniques should be demonstrated, e.g., by the presentation of preliminary data. 3. Expertise and qualifications of the Principal Investigator and proposed staff and/or collaborators to perform the proposed experiments. 4. Documentation of the adequacy of the facilities and resources. The review group will examine critically the proposed budget and recommend an appropriate budget for each approved application. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAHMA policy is that applicants for NIH/ADAHMA 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 group 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, the 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, 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 form 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 the research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained in 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 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. METHOD OF APPLYING The grant application form PHS 398 (revised 10/88) must be used in applying for these grants. These forms are available at most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Rm. 449, 5333 Westbard Avenue, Bethesda, Maryland 20892. The RFA label available in the 10/88 revision of 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. In addition, the title of the RFA and the RFA number must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to the Division of Research Grants at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two (2) additional copies of the application must also be sent to: REFERRAL OFFICER Division of Extramural Activities National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 5A-07 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by May 15, 1991. If an application is received after that date, it will be returned to the applicant. 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. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to: Dr. Joan A. McGowan Bone Biology and Bone Diseases Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases 5333 Westbard Avenue Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 496-7495 or Dr. Ronald Margolis Director, Endocrinology Research Program Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK/NIH 5333 Westbard Avenue Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7504 The program directors welcome the opportunity to clarify any issues and answer questions from potential applicants. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1991, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being 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 is extremely helpful in planning for the review of applications. It allows NIAMS staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent should be sent to Dr Joan McGowan at the address listed above. This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research and No. 93.855 Diabetes, Endocrinology and Metabolism Research. Awards will be made under authorization of the Public Health Service Act, Title III, Section 301 (c) (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant 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.