From owner-sci-resources@net.bio.net Tue Dec 01 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: No NIH Guide on 4 December Message-ID: Date: 2 Dec 92 15:38:52 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 10 $$MAIL BEGIN *********************************************************** NOTE: The NIH Guide for Grants and Contracts will not be published on December 4. The next issue will be on December 11, 1992. Please inform your colleages who receive the paper copy of the NIH Guide for Grants and Contracts that there will not be an issue for the week of December 4. $$MAIL END************************************************************** From owner-sci-resources@net.bio.net Mon Dec 07 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 6 December 1992 Message-ID: Date: 8 Dec 92 00:05:00 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 59 ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: FY93 RESEARCH EQUIPMENT GRANT PROGRAM (REG) File size (bytes): 27941 STIS Filename: nsf90146 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Program Guideline Title: FY93 RESEARCH EQUIPMENT GRANT PROGRAM (REG) File size (bytes): 27941 STIS Filename: nsf90146 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf90146, the text of your message should be as follows: get nsf90146 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf90146, you would enter: ftp> get nsf90146 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet) or "pubs@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Wed Dec 09 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 44, pt. 5, 11 December 1992 Message-ID: Date: 10 Dec 92 00:49:09 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1352 $$XID RFA AR9301 AR-93-01 P1O1 ***************************************** JUVENILE RHEUMATIC DISEASES RESEARCH CENTER PLANNING GRANT NIH GUIDE, Volume 21, Number 44, December 11, 1992 RFA: AR-93-01 P.T. 34; K.W. 0715170, 0715010, 0710030 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 1, 1993 Application Receipt Date: April 20, 1993 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for a planning grant for a juvenile rheumatic diseases research center. The goal of the planning grant is to establish a Juvenile Rheumatic Diseases Research Center (JRDRC). The JRDRC planning grant will allow the applicant to develop key multidisciplinary research areas needed to establish a JRDRC. A JRDRC is envisioned to be a resource center for research in juvenile arthritis and musculoskeletal diseases. This center will be associated with a major medical complex or consortium and dedicated to furthering the research effort related to juvenile arthritis and musculoskeletal diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Juvenile Rheumatic Diseases Research Center Planning Grant, is related to the priority area of chronic disabling conditions. 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, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government that have an established program for pediatric rheumatology and a relevant research base. Foreign research organizations are ineligible. International collaborations in domestic applications will only be accepted if the resources are clearly shown to be unavailable in the United States. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) planning grant (P20). Responsibility for the planning, direction, and execution of the proposed program will be solely that of the applicant. The total project period for applications submitted in response to the present RFA should be three years. The anticipated award date is September 30, 1993. The direct costs requested cannot exceed $200,000 each year. The award will not be renewed, but may be converted to another funding mechanism. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for a JRDRC planning grant is $300,000. One award is anticipated. Funding will depend on receiving applications judged highly meritorious by peer review. RESEARCH OBJECTIVES Chronic rheumatic diseases represent an important entity among chronic conditions affecting children. Among the rheumatic diseases seen in juvenile populations are rheumatoid arthritis, chronic arthritis (systemic, polyarthritic, and pauciarticular), spondyloarthropathy, systemic lupus erythematosus, dermatomyositis, scleroderma and other vasculopathies and connective tissue disorders. Many childhood rheumatic diseases have orthopaedic aspects. A research agenda for the genetic, infectious, and immunologic aspects of juvenile rheumatic diseases will benefit from a multidisciplinary approach. Because the research issues for juvenile arthritis and musculoskeletal diseases are complex, the NIAMS seeks to use a planning grant to explore the potential for establishing a JRDRC through a planning grant. Applications for a JRDRC planning grant should propose a program of multidisciplinary research development as a resource for research in arthritis and musculoskeletal diseases in children and for research to develop effective education programs for children, their families, and the public. The goal of the planning grant will be to develop those areas needed at the applicant institution or consortium. The applicant should outline the areas that may be part of a future JRDRC and the research projects presented in the planning grant should relate to the development of key areas in that center. A major goal of a JRDRC is to promote bench to bedside application of research. Clinical projects are required. The planning grant will provide funds for an Administrative and Planning Core and for Pilot Studies to develop and expand the research base. An Administrative and Planning Core will manage the overall activities related to developing the JRDRC. There must be a Director (Principal Investigator of the planning grant), a discrete administrative structure, and an Advisory Committee. The Core may also include the administration of shared resources, such as data sets or community or clinical research facilities, or provide research design and data analysis/statistical service. The Director will be the key figure in the scientific administration and management of the planning grant. The Director must be an experienced researcher with demonstrated leadership appropriate to the coordination and development of a Center. Although the final administrative structure of a Center will be left to the discretion of the applicant institution, experience demonstrates that effective development of Center programs requires interaction among the Director, the Principal Investigators of the pilot studies, appropriate institutional administrative personnel, and the staff of the NIAMS. Like other interdisciplinary grant programs, the success of a Center is dependent upon the involvement of scientific and professional personnel representing a variety of disciplines who must be willing to relate to and collaborate with each other in order to facilitate the development of new knowledge. The Advisory Committee assists the Director in making the scientific and administrative decisions relating to a Center. With the Director, the Advisory Committee will have the responsibility of evaluating the pilot studies proposed in the initial application and to be developed during subsequent years. (This does not preclude the applicant institution from developing a separate external review process to evaluate the scientific merit of the individual pilot studies developed during subsequent years. The final evaluation of the pilot studies, however, will rest with the Advisory Committee and the Director). The Advisory Committee may perform other duties as deemed appropriate by the applicant institution. The Advisory Committee must be composed of scientists and administrators with expertise and experience relevant to the Center's scientific program. Members may be employees of the applicant institution or of other institutions. However, at least two members of this committee must be from outside the Director's supervision (i.e., either at the applicant institution or another institution). The program areas of a JRDRC are to be related to arthritis and musculoskeletal diseases in children and may include treatment strategies. In the planning grant, pilot studies are to be proposed to expand the research base at the applicant institution. The P20 funding mechanism is intended to furnish modest support that will allow the investigators the opportunity to develop preliminary data sufficient to provide the basis for applications for independent research through conventional granting mechanisms. Pilot studies are typically limited to a nonrenewable period of one to two years. Applications submitted in response to this RFA must propose a minimum of three pilot studies to be supported during at least the first year of the award. Subsequent preliminary research projects may be developed during the course of the award. The Advisory Committee will have final approval for future pilot studies after a local peer review of the proposals. Appropriate research areas may include, but are not limited to: o Basic and clinical research leading to understanding the cause(s), diagnoses, improved treatment, and ultimate prevention of arthritis and musculoskeletal diseases in children is a critical aspect of the JRDRC. Clinical studies may address such research areas as: providing critical data for the design of larger clinical trials, testing the feasibility of new pharmacologic interventions, and devising improved diagnostic strategies. Studies integrating physical therapy and/or orthopaedic research with functional outcome may be included, as may epidemiologic studies that offer new insights. o Research development and evaluation of new programs, techniques or methodologies for the education of health professionals, patients, families of patients, and the public are appropriate. Evaluation and validation of patient assessment tools for the pediatric population may be proposed. Psychosocial research leading to improved intervention strategies, counseling, and enhancing the coping skills of children and their families are appropriate. SPECIAL REQUIREMENTS Investigators will be asked to meet periodically with NIAMS staff in Bethesda to review progress and plans for future work. 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. Details of the interaction of the planning center staff and pilot study members with the GCRC staff and research personnel may be provided in a statement describing the collaborative linkages being developed. A letter of agreement from the GCRC Program Director must be included with the application. STUDY POPULATIONS 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 and cooperative agreements are 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 must 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 must 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 must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, 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 should be provided. For the purpose of this policy, clinical research is defined as 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 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1993 a letter of intent that includes a descriptive title of the proposed research projects, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Julia B. Freeman Centers Program, Extramural Programs National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 402-3348 FAX: (301) 480-7881 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441; and from the NIAMS program administrator listed under INQUIRIES. Special guidelines have been developed for the JRDRC planning grant. These guidelines must be used in writing and assembling the application. The guidelines may be obtained by contacting the Centers Program Director listed under INQUIRIES. The RFA label available in the application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Dr. Tommy L. Broadwater Chief, Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Applications must be received by April 20, 1993. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NIAMS. Incomplete applications will be returned to the applicant without further consideration. Applications may be triaged by an NIAMS peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIAMS. The second level of review will be provided by the National Arthritis and Musculoskeletal and Skin Diseases Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Director (Principal Investigator) and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; and o appropriateness of the proposed budget and duration in relation to the proposed research. Additional scientific/technical merit criteria specific to the objectives of a JRDRC program include: o qualifications, experience and commitment of the Director (Principal Investigator) and his/her ability to devote time and effort to provide effective leadership; o scientific and administrative structure, including internal and external procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; o adequacy of plans for interaction among investigators, and the integration of the various projects; o potential for developing a JRDRC from the resources and projects described; and o commitment to developing a JRDRC as a national resource. AWARD CRITERIA The anticipated date of award is September 30, 1993. The primary factors determining the award will be the priority score and the availability of funds. Since the NIAMS is interested in funding only the best research, individual research projects of lesser quality may not be funded, even if approved, under the "umbrella" of the planning grant (P20) mechanism. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Julia B. Freeman Centers Program, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 402-3348 FAX: (301) 480-7881 Direct inquiries regarding fiscal matters to: Mara H. DeKemper Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732 Bethesda, MD 20892 Telephone: (301) 496-0552 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, 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 intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA HL9312 HL-93-12 P1O1 ***************************************** EXPRESSION OF TUBERCULOSIS IN THE LUNG NIH GUIDE, Volume 21, Number 44, December 11, 1992 RFA: HL-93-12L P.T. 34; K.W. 0715165, 0715125, 1002004, 0710070, 1002027, 1002019 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 15, 1993 Application Receipt Date: April 13, 1993 PURPOSE The National Heart, Lung and Blood Institute (NHLBI) invites grant applications for support of research on the expression of tuberculosis (TB) in the lung. The primary objectives of this grant program are to encourage research on elucidating the factors involved in disease expression following infection by Mycobacterium tuberculosis (Mtb) and to determine the mechanisms by which such factors exert their influence on the lung. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Expression of Tuberculosis in the Lung, is related to the priority areas of HIV infection, and immunization and infectious diseases. 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, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Among the disciplines and expertise that may be appropriate for this research program are cell biology, immunology, infectious diseases, microbiology, molecular biology, molecular immunology, pathology, genetics, and pulmonary medicine. Applications may be submitted by for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and transition (FIRST) (R29) award. Applications from minority individuals and women are encouraged. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. Awards under this announcement to foreign institutions will be made only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. MECHANISMS OF SUPPORT The support mechanisms for this program will be the individual research grant (R01) and the FIRST award (R29). While multidisciplinary approaches are encouraged, it is not the intent of this announcement to solicit applications for large studies encompassing a variety of individual subprojects, i.e., program projects. If collaborative arrangements through subcontracts with other institutions are planned, consult the program staff listed below. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request travel funds for a one-day meeting each year, most likely to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Applicants (who will plan and execute their own research programs) are expected to furnish their own estimates of time required to achieve the objectives of the proposed research project. Up to five years of support may be requested for R01s; five years are required for FIRST awards. Requested budgets for FIRST awards may not exceed those specified in the FIRST award guidelines. At the end of the initial award period, renewal applications may be submitted for peer review and competition for support through the regular grant program of the NIH. It is anticipated that support for this program will begin in September 1993. Administrative adjustments in project period and/or amount may be required at the time of the award. Since a variety of approaches would represent valid responses to this announcement, it is anticipated that there will be a range of costs among individual grants awarded. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Although approximately $1,500,000 for this program is included in the financial plans for fiscal year 1993, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that six to eight new grants will be awarded under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background The Centers for Disease Control estimates that since 1984 nearly 39,000 excess cases of TB have accumulated in the United States. This recent change in the TB morbidity trend appears attributable, in large part, to TB occurring in persons infected with the Human Immunodeficiency Virus (HIV), although increasing homelessness and immigration from regions of the world where TB is endemic are also contributing factors. Currently a number of general approaches are being actively pursued in basic research related to TB. Efforts are ongoing to define mycobacterial antigens involved in T-lymphocyte-dependent protective immunity. Gamma-delta-T-cells appear to be important in the immunologic response to Mtb and are under vigorous investigation. Research is being pursued in studies of the immunology of TB in the context of mammalian heat shock proteins; to date four such proteins have been identified. The lung is the portal of entry for Mtb and local defenses in the lung, including the mucociliary clearance mechanisms and bronchus-associated lymphoid tissue (BALT), are involved in processes that limit spread of infection within the lung as well as to extrapulmonary sites. However, most current research on TB delves into the systemic immune response to mycobacteria and basic mycobacteriology. By contrast, there is little research on specific pulmonary defenses or on TB as a disease of the lungs. Almost nothing is known about the basic mechanisms of protective immunity against Mtb in the lung and the local factors that contribute to lung injury, damage, or fibrosis. Furthermore, little is known about the breakdown of the lung defenses that allow the rapid progression and unusual, extrapulmonary patterns of primary and reactivation TB that are now being observed in HIV-infected patients who have depressed immune function. Little or no effort has been directed at the molecular and cellular mechanisms of TB, disease expression in the lung or the events that relate to host defenses in the human lung. Beyond descriptive clinical information on the pathology of TB, almost no new information has been obtained on the basic mechanisms of protective immunity and the immune factors that contribute to the natural history of Mtb infection. A number of factors are thought to influence susceptibility, resistance, and severity of disease when the lung responds to infection with Mtb. Data from clinical studies suggest a role for innate factors which might include such things as age, gender, ethnicity, and acquired conditions such as associated disease states. Aside from identifying such factors, there has been no recent progress on obtaining information about the mechanisms by which they exert their influence on susceptibility/resistance or severity of TB disease. Objectives and Scope The overall objective of this initiative is to encourage research directed at gaining a better understanding of disease expression in the lung following infection with Mtb. Applications are invited for innovative multidisciplinary approaches to identify the factors involved in disease expression, to determine their relationship to other factors of disease, and to better understand how such factors exert their influence on pathogenesis. Several topics relevant to the objectives of this RFA are described below in order to provide a perspective of the scope of the research that would meet the goals of the program. Studies in humans are encouraged where possible. Investigators are also encouraged to consider other approaches that meet the goals of this program in addition to those cited below. More information is clearly needed to clarify the specific and non-specific host defenses against Mtb in the lung, the local anatomic and immunologic factors that influence the natural history of pulmonary infection, with particular emphasis on the molecular basis for the generation of immunopathology. Acquired resistance to TB following primary infection is known to directly involve the immune system such that the ability of activated macrophages to ingest and kill virulent Mtb organisms is influenced by the function and number of T-helper lymphocytes. This is of particular interest in the context of HIV infection where T-helper cells are known to be adversely affected, and where the pathogenesis of TB in HIV-infected patients has been observed to differ from the classic granulomatous processes seen in HIV-negative individuals. Research directed at obtaining more detail about the mechanisms of TB pathogenesis and the factors affecting susceptibility/resistance and severity in the presence of HIV infection are of particular interest in response to this initiative. Another area that deserves further study concerns the genetically determined and acquired local and systemic factors that affect immunity and disease expression in the lung. Studies in inbred mice have revealed a genetic locus that modulates the innate resistance to mycobacterial infection. There appears to be a human homolog to this non-Major Histocompatibility locus. Various studies have suggested an association between HLA-type and pulmonary TB. Epidemiology and clinical/pathologic studies have indicated that certain racial groups such as African Americans develop more extensive lung damage from pulmonary TB. Basic research that addresses these aspects of TB could be considered in responding to this initiative. Little is known about the mechanisms of reactivation of TB in the lung. The development of animal models that simulate reactivation disease would permit exploration of areas of research on reactivation that are not easily addressed in human studies. Studies in humans that provide insights into the basic mechanisms of this aspect of disease expression would also be a desirable approach. Local factors in the lung such as underlying bronchiectasis or silicosis are known to influence fibrosis and other sequelae of TB. In cases where extensive fibrosis occurs, the mechanisms involved remain unexplored. In most cases of TB extensive fibrosis is not seen, yet when bronchiectasis is present fibrosis is a common occurrence. Studies elucidating the relationship between TB complicated by bronchiectasis and/or silicosis, and fibrosis is another example of research that would meet the goals of this program. SPECIAL REQUIREMENTS Applications that propose descriptive studies in humans only and do not contain studies directed at uncovering mechanisms of disease or supporting hypotheses related to mechanisms of disease expression will not be acceptable. This program will not support studies directed at development of animal models alone. Models must be applied to the study of disease mechanisms associated with expression of TB in the lung and whenever possible, the testing of hypothesis in the animal model should carry over to human studies. Applications that focus on molecular biology and molecular immunology of disease expression are of particular interest. STUDY POPULATIONS 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 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 Sections 1-4 of the Research Plan AND summarized in Section 5, 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 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 not subject to these policies. 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 in 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. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 15, 1993, a letter of intent that includesa descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of any other participating institutions or investigators, and the number and title of the RFA in response to which the application may be submitted. A letter of intent is not binding, will not enter into the review of any application subsequently submitted, and is not a requirement for application. Such letters are requested for the purpose of obtaining an indication of the number of applications to be received. The NHLBI will not provide a response to a letter of intent. The letter is to be received no later than February 15, 1993 and sent to: Chief, Centers and Special Projects Review Section Review Branch, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 Bethesda, MD 20892 Telephone: (301) 496-7351 FAX: (301) 402-1660 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-496-7441; and from the NIH program administrator named below. Use the conventional format for research project grant applications and ensure the points identified in the section Review Procedures and Criteria are fulfilled. To identify the application as a response to this RFA, check "yes" on item 2a of page 1 of the application and enter the title, Expression of Tuberculosis in the Lung, HL-93-12L. The RFA label available in the application kit must be affixed to the bottom of the face page of the original completed application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Send or deliver the completed application and three signed and completed photocopies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Centers and Special Projects Review Section at the address listed under letter of intent. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants (DRG). Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by April 13, 1993. If an application is received after this date, it will be returned to the applicant without review. The DRG will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to the objectives of this RFA by the NHLBI. Incomplete applications will be returned withoug further consideration. If an application is judged unresponsive, the applicant will be contacted and given an opportunity to withdraw the application or to have it considered for the regular, investigator-initiated grant program of the NIH. Applications judged to be responsive will be reviewed for scientific and technical merit by an initial review group, convened by the Division of Extramural Affairs, NHLBI, solely to review these applications. This initial review will include a preliminary evaluation to determine scientific merit relative to the other applications received in response to this RFA (triage); the NIH will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures. Review Criteria. The factors to be considered in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research project grant applications including the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; and the appropriateness of the requested budget to the work proposed. AWARD CRITERIA The anticipated date of award is September 30, 1993. In addition to the scientific merit of the applications, awards will be based on responsiveness to the RFA and the availability of resources. INQUIRIES Direct inquiries regarding programmatic issues to: Hannah H. Peavy, M.D. Interstitial Lung Diseases Branch Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A09 Bethesda, MD 20892 Telephone: (301) 496-7034 FAX: (301) 496-9886 Direct inquiries regarding review matters to: Chief, Centers and Special Projects Review Section Review Branch, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 Bethesda, MD 20892 Telephone: (301) 496-7351 FAX: (301) 402-1660 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 496-4970 FAX: (301) 402-1200 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.838. Grants will be awarded under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, 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 to review by a Health Systems Agency. $$XID RFA DK9310 DK-93-10 P1O1 ***************************************** HUMAN GENES FOR NON-INSULIN DEPENDENT DIABETES MELLITUS NIH GUIDE, Volume 21, Number 44, December 11, 1992 RFA: DK-93-10 P.T. 34; K.W. 0715075, 0755035, 0755040, 0760015 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 18, 1993 Application Receipt Date: March 17, 1993 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the American Diabetes Association (ADA) invite investigator-initiated research grant applications to identify specific genes responsible for non-insulin dependent diabetes mellitus (NIDDM) in humans. It is anticipated that this identification will require an interdisciplinary approach to develop and utilize strategies that will elucidate genes responsible for NIDDM using appropriate family pedigrees. Applications will be submitted to the National Institutes of Health (NIH) and will be reviewed by NIH according to the usual NIH peer review procedures. Applications judged meritorious and designated for funding will be supported partially by the NIDDK and partially by the ADA through the issuance of coordinated but separate awards by the two funding organizations. In order to facilitate the coordination of the NIDDK and the ADA, applicants are requested to provide the NIDDK authorization to allow the NIDDK to provide a copy of their letter of intent, application, NIH-prepared summary statement of the initial review, and yearly progress reports (if the application is funded) to the ADA. Applicants wishing to be considered for funding only by the NIDDK should so indicate in their letter of authorization. Under these latter circumstances, no information pertaining to their application will be shared with the ADA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Human Genes for Non-Insulin Dependent Diabetes Mellitus, is related to the priority area of diabetes and chronic disabling conditions. 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, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications for research grants may be made by public and private, foreign and domestic, for-profit and non-profit organizations, such as universities, colleges, hospitals and laboratories, units or State and local governments, and authorized units of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the present RFA may not exceed five years. The anticipated award date is September 30, 1993. For the purpose of cost-containment, requested direct costs must not exceed $160,000 per year for any single application. Applications exceeding this limit will not be reviewed as part of this RFA. The average award made by the NIDDK is expected to be approximately $200,000 in total costs. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Highly meritorious applications in response to this solicitation will be partially funded by the NIDDK and partially funded by the ADA if permission is given by the applicant. The NIDDK will commit up to $2 million for first-year expenses and additional funds for approved expenses in subsequent years for up to five years to fund applications submitted in response to this RFA. The ADA anticipates support of up to 20 percent of recommended direct costs for each funded application per year. The NIDDK and the ADA plan to make approximately 10 to 12 awards in FY 1993 contingent on the receipt of highly meritorious applications in response to this solicitation. With respect to post-award administration, the current policies and requirements that govern the research grant programs of the NIH will prevail for awards made by the NIDDK. Applicants should note that funds from the ADA will be subject to the indirect cost policy and post-award administration policies of the ADA. The award of grants pursuant to this RFA is contingent on the availability of funds for this purpose. RESEARCH OBJECTIVES Background The term "diabetes" encompasses a number of different diseases, and hence, a number of different genes may be involved. Because of the potential for complex interplay between several genes, novel approaches may be necessary to ascertain the genes involved in the etiology of diabetes. The NIDDK recognizes this area as a high priority for research and has taken steps to stimulate research in genetics and molecular biology. In addition, the National Diabetes Advisory Board, in its "Long-Range Plan to Combat Diabetes, 1987," made several recommendations to the NIDDK directed at increasing progress in this area, including an increased emphasis on interdisciplinary research collaboration. In 1990, the NIDDK convened a scientific workshop to address opportunities in the search for the diabetes genes. The participants analyzed the current state of knowledge and endorsed a multifaceted and concerted effort to discover the genetic basis of diabetes and its complications. The NIDDK is coordinating efforts with the ADA to expeditiously and efficiently achieve the goal of both organizations: identify genes responsible for NIDDM. Toward this end, the ADA has recently embarked on the development of family pedigrees and the acquisition of genetic resources to aid in the elucidation of human genes responsible for NIDDM. The last decade has witnessed an expansion in knowledge and scientific methods allowing the isolation of genes responsible for a few but growing number of severe human diseases, such as Duchenne muscular dystrophy and Huntington's disease. Most recently, a five-year effort has culminated in the cloning and sequencing of the gene responsible for cystic fibrosis. This achievement has had a dramatic effect on research into the cause and cure for cystic fibrosis. Similar scientific approaches are being directed toward the search for the diabetes genes. NIDDM affects approximately 13 million Americans. It is the predominant form of the disease and severely impacts upon U.S. minority populations. This clustering of prevalence among ethnic/racial groups along with twin and family studies and animal models points to the genetic nature of this disease. Several genetic markers have been described as being associated with a rare form of NIDDM called Maturity Onset Diabetes of the Young (MODY) that shows autosomal dominant inheritance. One of these genetic markers is the gene for glucokinase, a key enzyme of glucose homeostasis found in the insulin-secreting beta cell of the pancreas and in the liver. This is the first evidence that a gene involved in glucose metabolism could be implicated in the pathogenesis of NIDDM. A variety of other genes may be related to the long-term complications suffered by those with all forms of diabetes. It will be worthwhile to apply a wide array of molecular biological techniques to explore genes related to insulin secretion, insulin action and key metabolic processes that regulate the body's metabolism. It is important to identify specific genetic markers/elements that are relevant to diabetes and its complications. These markers can take the form of genetic-susceptibility markers identifying the presence of specific genetic loci that predispose an individual to the disease and/or genetic mutations in key metabolic elements involved in the pathogenesis of NIDDM. Scope Through this solicitation, the NIDDK and the ADA intend to stimulate investigator-initiated research designed to develop and utilize new molecular genetic strategies to provide a better understanding of the major genes involved in NIDDM in humans. To achieve this objective, appropriate family pedigrees may need to be collected as a prerequisite for the identification or for the verification of specific gene involvement. Since a large number of families may need to be recruited, accumulation of these families must be included within the framework of the proposed research plan. Utilization of existing sources of genetic material is encouraged. For example, the ADA is developing a repository of data, DNA, and cell lines of family pedigrees with NIDDM. This repository will be completed by the spring of 1995 but data and cell samples will likely become available much sooner. It is anticipated that these results will elucidate mechanisms involved in disease onset, thus enabling the development of specific intervention therapies and the identification of individuals at risk for the development of NIDDM. Relevant research topics listed below are examples and should not be construed as required or limiting. Responsive applications to this solicitation include: o development of gene mapping strategies for the specific identification and localization of genes for NIDDM o utilization of subtractive hybridization techniques to identify pathophysiologic processes in NIDDM o employment of highly informative polymorphic markers such as variable number repeat polymorphisms or microsatellite markers to evaluate relevant family pedigrees. Applications must propose the testing of an hypothesis rather than the establishment of, for example, a genetic resource. SPECIAL REQUIREMENTS Upon initiation of this program, the NIDDK and the ADA will sponsor periodic meetings to encourage exchange of information among investigators, to foster collaborative efforts between program grantees, and to identify resources that would enhance the productivity of grantees. For this purpose, requests for travel funds for a one day meeting each year, probably to be held in the Washington, DC metropolitan area, must be included in the budget section of the application. It is anticipated that the first meeting will be held soon after the award of grants in order to discuss and establish the nature and extent of possible collaboration among the group of investigators. Applicants should also include a statement in their applications indicating their willingness to participate in such meetings. Letter of Authorization Each applicant must submit a brief statement to the NIDDK indicating whether or not they wish their application to be considered for coordinated funding by the ADA. Although applicants may request that their applications be considered only by the NIDDK and not by the ADA, it is necessary that the record indicate the applicant's consideration of this opportunity. For each applicant who wishes to have the ADA consider their application for coordinated funding, all materials relating to the application will be promptly forwarded to that organization by the NIDDK, and the summary statement for the application will be shared with the ADA at the time of their availability. The NIDDK will provide no information to the ADA, nor any other non-governmental agency, related to applications from any applicant who requests that the ADA not consider their application. Letters of authorization should be prepared by the Principal Investigator and co-signed by the official signing for the applicant organization. This must be submitted as a cover letter accompanying the application. Whether or not an applicant wishes to be considered for coordinated funding by the ADA will not effect the funding decisions of the NIDDK. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES NIH policy is that applicants for NIH clinical research grants and cooperative agreements are 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 must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, 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 should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventative strategies), diagnosis, or treatment or 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 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. LETTER OF INTENT Potential applicants are strongly encouraged to submit a letter of intent by February 18, 1993. The letter of intent is to include: (1) names of the Principal Investigator/program director and principal collaborators, (2) descriptive title of the potential application, (3) identification of the organization(s) involved, and (4) the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 5333 Westbard Avenue Bethesda, MD 20892 APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), that is available from an applicant institution's office of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Use the conventional format for research project grant applications. To identify the application as a response to this RFA check "yes" on item 2a of page one of the application and enter the title "Human Genes for NIDDM" and the RFA number DK-93-10. The RFA label included in the PHS 398 application package must be affixed to the face page to assist in the processing of the application. Failure to use this label could result in the delayed processing of the application such that it may not reach the review committee in time for review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center of Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director should be included in the application material. Applications must be received by March 17, 1993. If an application is received after that date, it will be returned to the applicant without review. The original, including the Checklist, and three signed photocopies of the application must be submitted in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent under separate cover to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 5333 Westbard Avenue Bethesda, MD 20892 The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness and by NIDDK staff for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIDDK staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NIDDK peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. The second level of review will be provided by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Applications in response to this RFA will be reviewed using the usual NIH peer review procedures. The factors to be considered in the evaluation of scientific merit of each application will be those used in the review of traditional research project grant applications, including the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed; and the adherence, whenever appropriate, to NIH guidelines concerning clinical research involving minorities and women. AWARD CRITERIA The anticipated date of award is September 30, 1993. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Scientific interrelationships among the proposed projects. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Joan T. Harmon, Ph.D. Executive Director, Diabetes Research Program Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 496-7731 Direct inquiries regarding fiscal matters to: Betty E. Bailey Grants Management Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 496-7467 Schedule: Letter of Intent: February 18, 1993 Application Receipt Date: March 17, 1993 Initial Review: June/July 1993 NIDDK Advisory Council Review: September 1993 Anticipated Award Date: September 30, 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, Diabetes, Endocrinology and Metabolism Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Wed Dec 09 22:00:00 1992 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 21, no. 44, pt. 2, 11 December 1992 Message-ID: Date: 10 Dec 92 00:41:45 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1500 $$XID NIHGUIDE 19921211 V21N44 P2O4 ************************************ returned to the applicant without further consideration. If the application is not responsive to the RFA, NHLBI staff will contact the applicant to determine whether to return the application or submit it for review in competition with unsolicited applications at the next review cycle. Applications judged to be responsive will be reviewed for scientific and technical merit by an initial review group, convened by the Division of Extramural Affairs, NHLBI, solely to review these applications. Review criteria for this RFA are generally the same as those for unsolicited research grant applications. INQUIRIES Written and telephone inquiries regarding this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and requests for the RFA to: Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 6A09 Bethesda, MD 20892 Telephone: (301) 496-7034 FAX: (301) 496-0886 Direct inquiries regarding review matters to: Chief, Centers and Special Projects Review Section Review Branch, Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 553 Bethesda, MD 20892 Telephone: (301) 496-7351 FAX: (301) 402-1660 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 496-4970 FAX: (301) 402-1200 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.838. Grants will be awarded under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, 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 to review by a Health Systems Agency. $$R7 END ************************************************************ $$R8 BEGIN AR-93-01 FULL-TEXT *************************************** JUVENILE RHEUMATIC DISEASES RESEARCH CENTER PLANNING GRANT NIH GUIDE, Volume 21, Number 44, December 11, 1992 RFA AVAILABLE: AR-93-01 P.T. 34; K.W. 0715170, 0715010, 0710030 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 1, 1993 Application Receipt Date: April 20, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA AND GUIDELINES FROM THE CONTACT NAME IN INQUIRIES, BELOW. PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for a planning grant for a juvenile arthritis and musculoskeletal diseases center. The goal of the planning grant is to explore the potential for establishing a Juvenile Rheumatic Diseases Research Center (JRDRC). The JRDRC planning grant will support development of key multidisciplinary research areas needed to establish a JRDRC. A JRDRC is envisioned to be a resource center for research in juvenile arthritis and musculoskeletal diseases. This center will be associated with a major medical complex or consortium and will work in furthering the research effort related to juvenile arthritis and musculoskeletal diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Juvenile Rheumatic Diseases Research Center Planning Grant, is related to the priority area of chronic disabling conditions. 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, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. An established clinical and research program in areas pertaining to juvenile arthritis and musculoskeletal diseases should be present. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) planning grant (P20). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA should be three years. The anticipated award date is September 30, 1993. The direct costs requested cannot exceed $200,000 each year. The award will not be renewed, but may be converted to another funding mechanism. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the JRDRC planning grant is $300,000. One award is anticipated. Funding will depend on receiving applications judged highly meritorious by peer review. RESEARCH OBJECTIVES Chronic rheumatic diseases represent an important entity among chronic conditions affecting children. Among the rheumatic diseases seen in juvenile populations are rheumatoid arthritis, chronic arthritis (systemic, polyarthritic, and pauciarticular), spondyloarthropathy, systemic lupus erythematosus, dermatomyositis, scleroderma and other vasculopathies and connective tissues disorders. Many childhood rheumatic diseases have orthopaedic aspects. A research agenda for the genetic, infectious, and immunologic aspects of juvenile rheumatic diseases will benefit from a multidisciplinary approach. Because the research issues are complex for juvenile arthritis and musculoskeletal diseases, the NIAMS seeks to explore the potential for establishing a JRDRC through a planning grant. The planning grant for a JRDRC will provide funds for an administrative and planning core and for pilot studies to develop and expand the research base. Appropriate research areas include basic, clinical, and epidemiologic research as well as educational and psychosocial research. SPECIAL REQUIREMENTS Investigators will be asked to meet periodically with NIAMS staff in Bethesda to review progress and plans for future work. The planning center will work with the NIAMS to hold a workshop to review the research agenda for juvenile arthritis. Applicants should include in the budget plans, appropriate travel costs for these meetings. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1993, a letter of intent that includes a descriptive title of the proposed research projects, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Julia B. Freeman at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Special guidelines have been developed for the JRDRC planning grant. These guidelines must be used in writing and assembling the application. The guidelines may be obtained by contacting the Centers Program Director listed under INQUIRIES. Applications must be received by April 20, 1993. The RFA label available in the application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by Division of Research Grants (DRG) and responsiveness by the NIAMS. Incomplete applications will be returned to the applicant without further consideration. Applications may be triaged by an NIAMS peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. Additional scientific/technical merit criteria specific to the objectives of the JRDRC program include: o qualifications, experience and commitment of the Director (Principal Investigator) and his/her ability to devote time and effort to provide effective leadership; o scientific and administrative structure, including internal and external procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review; o adequacy of plans for interaction among investigators, and the integration of the various projects and core units; and o potential for developing a JRDRC from the resources and projects described. AWARD CRITERIA The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Julia B. Freeman Centers Program, Extramural Programs National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 402-3348 FAX: (301) 480-7881 Direct inquiries regarding fiscal matters to: Mara H. DeKemper Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 732 Bethesda, MD 20892 Telephone: (301) 496-0552 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, 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 intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R8 END ************************************************************ $$R9 BEGIN AR-93-03 FULL-TEXT *************************************** SKIN DISEASES RESEARCH CORE CENTERS NIH GUIDE, Volume 21, Number 44, December 11, 1992 RFA AVAILABLE: AR-93-03 P.T. 04; K.W. 0715185, 1003002, 0710070, 0710030 National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: May 10, 1993 Application Receipt Date: June 18, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for research core centers in skin diseases. The Skin Diseases Research Centers (SDRCs) will provide the resources for a number of established, currently funded investigators, often from different disciplines, to adopt a multidisciplinary approach to common research problems in skin diseases and to ensure greater productivity than from each of the separate projects. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Skin Diseases Research Core Centers, is related to the priority area of chronic disabling conditions. 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, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. A strong clinical and research program in skin diseases should be present. Foreign organizations are not eligible. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) core research center grant (P30). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this RFA should be five years. The direct costs requested cannot exceed $400,000 each year. The anticipated award date is March 1, 1994. FUNDS AVAILABLE The NIAMS intends to fund two SDRCs in FY 1994, subject to the availability of resources and receipt of sufficiently meritorious applications. The estimated funds (total costs) available for the first year of support is $1.0 million. RESEARCH OBJECTIVES Research in skin diseases is at a stage where broad advances can be effectively fostered by research core centers. Examples of these areas include, but are not limited to: o stratum corneum: biochemistry, structure, function o epidermis: differentiation, keratinization, cellular constituents o dermal-epidermal junction: structure, functions, diseases o skin as an immunological organ o autoimmune skin diseases o dermis: structural components, diseases The choice of research problem upon which the SDRC would focus is made by the principal and collaborating currently funded investigators. The SDRC (P30) is a mechanism for integrating, coordinating, and fostering the interdisciplinary cooperation of a group of established investigators conducting programs of active, high-quality research that relate to a common theme. The SDRC provides support for: 1. Core resources and facilities to be used by investigators of individually supported research projects in order to enhance and coordinate their activities. This support may include personnel, equipment, supplies, services, and facilities. 2. Limited funds for pilot and feasibility studies. 3. Program enrichment activities. SPECIAL REQUIREMENTS Specific guidelines have been developed for the SDRC application and program. These guidelines may be obtained from the contact person listed under INQUIRIES. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by May 10, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows the NIAMS staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Dr. Julia B. Freeman Centers Program, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 402-3348 FAX: (301) 480-7881 APPLICATION PROCEDURES Special guidelines have been developed for the SDRC program in NIAMS. These guidelines must be used in assembling the application. These guidelines may be obtained by contacting the Centers Program Director listed above. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Applications must be received by June 18, 1993. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by NIAMS. Incomplete applications will be returned to the applicant without further consideration. Applications may be triaged by an NIAMS peer review group on the basis of relative competitiveness. The NIAMS will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. This review will be for scientific/technical merit by an appropriate peer review group convened by the NIAMS. The second level of review will be provided by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. AWARD CRITERIA The primary factors determining the award will be the priority score and the availability of funds. Since the NIAMS is interested in funding only the best research, individual research projects of lesser quality may not be funded, even if approved, under the "umbrella" of the SDRC mechanism. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Dr. Julia B. Freeman Centers Program, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 402-3348 FAX: (301) 480-7881 Direct inquiries regarding fiscal matters to: Mary L. Graham Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 722A Bethesda, MD 20892 Telephone: (301) 402-3361 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, 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 intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R9 END ************************************************************ $$R10 BEGIN HL-93-07 FULL-TEXT ************************************** MONOENERGETIC X-RAY SYSTEMS FOR CARDIOVASCULAR IMAGING NIH GUIDE, Volume 21, Number 44, December 11, 1992 RFA AVAILABLE: HL-93-07-H P.T. 34; K.W. 0706030, 0705015 National Heart, Lung, and Blood Institute (NHLBI) Letter of Intent Receipt Date: July 5, 1993 Application Receipt Date: October 13, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE This solicitation will support grants for research and development of monoenergetic (10-20 eV) x-ray sources that can be hospital based and are clinically applicable for imaging cardiovascular structures. It is desirable that the proposed imaging system be tuneable with spectral concentration in a narrow band and at an intensity appropriate for specific cardiovascular imaging applications. A principal objective is to achieve improved image quality at lower radiation dose as compared with conventional x-ray imaging systems. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Monoenergetic X-ray Systems for Cardiovascular Imaging is related to the priority area of cardiovascular imaging. 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. 017-002-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Federal agencies must ensure that their own authorizing legislation will allow them to respond to this solicitation and to receive a PHS grant. Applications from minorities and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FUNDS AVAILABLE Approximately $1.5 million in total costs will be provided for the first year of support for the entire program. It is anticipated that three to four new grants will be awarded under this program. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the National Heart, Lung, and Blood Institute (NHLBI), awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Administrative adjustments in project period and/or amount of support may be required at the time of the award. RESEARCH OBJECTIVES The proposed RFA seeks to support grant applications to study, develop, and evaluate minimally invasive x-ray systems using monoenergetic radiation to achieve improved resolution and image quality. Complete systems would need to be described, including both source and detector. Grant applications should propose a specific application, such as coronary artery imaging without intraarterial injection of contrast material, and include quantitative objectives for resolution, patient dose, and image quality. Grant applications should also emphasize close collaboration among physicists, biophysicists, radiologists, cardiologists, and bioengineers with both a theoretical basis and an experimental plan for the proposed system. Grant applications may propose research in imaging systems for cardiovascular application utilizing monoenergetic or nearly monoenergetic x-ray sources and detector systems, including, but not limited to, the following technologies: o Transition x-ray sources o Channeling radiation sources o Cerenkov radiation sources o Smith-Purcell radiation sources o Parametric conversion systems o Coherent superlattice radiation systems o Free electron Laser systems Each application must provide evidence that the proposed system is feasible as a hospital based facility, with size and cost estimates based upon calculations and experimental data. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by July 5, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Centers and Special Projects Section Review Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 553A Bethesda, MD 20892 Telephone: (301) 496-7351 FAX: (301) 402-1660 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Send or deliver a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Centers and Special Projects Section, at the address listed under LETTERS OF INTENT. Applications must be received by October 13, 1993. REVIEW CONSIDERATIONS Those applications that are complete and responsive will be evaluated for scientific/technical merit by an appropriate peer review group convened by the NHLBI. The second level of review will be provided by the National Heart, Lung, and Blood Advisory Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. Although multidisciplinary approaches are encouraged, it is not the intent of this announcement to solicit applications for large studies that encompass a variety of independent projects, i.e., program projects. AWARD CRITERIA The most important criterion in selecting awardees will be the scientific merit. However, factors such as program balance and available funds may enter into selection from among competing applications. The anticipated date of award is April 1, 1994 INQUIRIES Inquiries regarding programmatic issues and requests for the RFA document be directed to: Dr. Alan Berson or Dr. Rosalie Dunn Devices and Technology Branch Division of Heart and Vascular Diseases National Heart, Lung and Blood Institute Federal Building, Room 312 Bethesda, MD 20892 Telephone: (301) 496-1586 Direct inquiries regarding fiscal and administrative matters to: Mr. William Darby Grants Operations Branch Division of Extramural Affairs National Heart, Lung and Blood Institute Westwood Building, Room 4A11 Bethesda, MD 20892 Telephone: (301) 496-7536 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, Heart and Vascular Diseases. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. $$R10 END *********************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-27 ************************************************* PSYCHOTHERAPY, BEHAVIOR THERAPY, AND COUNSELING IN DRUG DEPENDENCE TREATMENT NIH GUIDE, Volume 21, Number 44, December 11, 1992 PA NUMBER: PA-93-27 P.T. 34; K.W. 0745060, 0404009, 0414014 National Institute on Drug Abuse PURPOSE The purpose of this Program Announcement (PA) is to encourage the study of psychotherapy, behavior therapy, drug abuse counseling, and other psychosocial interventions in the treatment of drug abuse and dependence. Studies involving the use of controlled clinical trials or other scientifically established research methods are encouraged. A secondary aim is to encourage the development of instruments to measure the process and outcome of psychotherapy/counseling of drug addicts and instruments that may be useful in determining therapist and patient characteristics predictive of treatment outcome. This announcement is intended to encourage the investigation of the treatment of individuals who are dependent upon cocaine, opiates, and other types of drugs (including polydrug abusers). This announcement is not intended to support therapy development research. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This PA, Psychotherapy, Behavior Therapy, and Counseling in Drug Dependence Treatment, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT Support mechanisms include: research projects (R01), small grants (R03), and FIRST awards (R29). Most investigator-initiated research is supported by regular research grants. Research grants are awarded to institutions on behalf of Principal Investigators who have designed and will direct a specific project or set of projects. Except for small grants (R03) and FIRST awards (R29), investigator(s) may apply for a renewal (competing continuation) of the project by submitting an application for further support, including a report of progress and including specific plans for future work. For details on a particular support mechanism or program, contact the program staff listed under INQUIRIES. RESEARCH OBJECTIVES Background Some form of psychotherapy, behavior therapy, or drug abuse counseling occurs in virtually every type of drug abuse/dependence treatment. Even where effective pharmacological treatments exist, such as the use of methadone for opiate dependence, they are usually administered with appropriate psychosocial/behavioral interventions (Grabowski et al., 1984). Numerous behavioral interventions have been studied in attempts to improve the efficacy of drug abuse treatment. Contingency management has been shown to have some efficacy in medically withdrawing patients from methadone (Higgins et al., 1986) for some methadone-maintained individuals, but not all (Stitzer et al., 1986; Iguchi et al., 1988; Stitzer et al., 1992). Where the methadone dose has been decreased as a consequence to drug positive urine specimens, treatment dropout has been exacerbated (Stitzer et al., 1986; Iguchi et al., 1988). While it has been suggested that the use of "negative incentives" increases dropout rate, the extent to which the observed increases in dropout rate are due to methadone dose reduction per se has not been established. Operant behavioral interventions appear to be most effective when integrated into a complete treatment package, as in the Community Reinforcement Approach (Hunt & Azrin, 1973; Azrin, 1976). This approach, originally developed for alcoholics, has been modified for cocaine abusers and has shown promise (Higgins et al., 1991). Behavioral interventions based upon principles of classical conditioning, such as cue exposure, are also believed to have promise. When used as an adjunct to a comprehensive outpatient cocaine treatment program, patients given repeated cue exposure (to induce "extinction" to cocaine-related cues) evidenced better retention in treatment and fewer cocaine-positive urine specimens than patients not receiving the cue exposure (Childress, et al., 1992). Individual cognitive-behavioral and psychodynamic as well as family approaches have all been demonstrated to have some efficacy (Stanton et al., 1982; Woody et al., 1983, 1987; Rounsaville et al., 1983; Carroll et al., 1991), but none has been demonstrated consistently to be more effective than another. This is congruent with findings in the psychotherapy research field at large; that is, it has not been consistently demonstrated that one type of psychotherapy is more effective than another (Luborsky et al., 1975; Smith & Glass 1977; Lambert et al., 1986; Stiles et al., 1986). For particular subgroups of patients, however, there is reason to believe that particular types of therapies may be more useful than others. For example, there is some evidence that a structured, behavioral therapy may be more effective for substance abusers with sociopathic characteristics than an interactionally focused therapy (Kadden et al., 1989). In subgroups of patients with antisocial personality disorder who have an additional diagnosis of depression, cognitive-behavioral and supportive-expressive psychotherapy appears to be of some benefit. However, antisocial personality disorder alone appears to be a negative indicator for response to psychotherapy (Woody et al., 1985). There is also some evidence that the addition of psychotherapy to drug abuse counseling may be necessary for other subgroups of addicts. For example, in a methadone-maintenance program, drug abuse counseling is a sufficient complement to the treatment of opiate addicts with low levels of psychiatric severity. Providing psychotherapy to low psychiatric severity methadone-maintained opiate addicts who are already receiving drug abuse counseling does not appear to yield any further benefit (Woody et al., 1984). However, in methadone-maintained opiate addicts with high levels of psychiatric severity, psychotherapy in addition to drug abuse counseling is significantly more effective than drug counseling alone (Woody et al., 1984). Inherent in doing research on psychosocial treatments for drug dependence are substantial methodological difficulties. Attrition is a problem in any form of behavioral treatment research, but especially so in drug dependence treatment. While there are numerous statistical procedures for dealing with the problem of attrition (Howard et al., 1990), none can replace lost data. It is, therefore, important to be aware of the ramifications of utilizing the array of available statistical techniques that are sometimes used to partially "correct" for lost data. Defining and including control groups as opposed to comparison groups (Borkovec, 1990) also presents a dilemma in comparative psychosocial treatment research. While there is no "perfect" design in such research, there are more or less perfect designs depending upon the research question we are asking. Other methodological and statistical issues, such as those dealing with therapist/counselor variance (Crits-Christoph et al., 1990) and choosing appropriate outcome measures (Lambert, 1990) are also important considerations and have been discussed at length elsewhere (Onken and Blaine, 1990). Additional research is needed to answer a number of questions in this field such as: 1. Are certain strategies of drug abuse counseling/psychotherapy more effective than others in helping individuals achieve treatment goals? 2. In what way are various immediate treatment goals related to long-term outcome goals? 3. What is the relative efficacy of drug abuse counseling versus psychotherapy, and when and with whom is drug abuse counseling sufficient? 4. What populations of drug addicts (e.g., the dually diagnosed, racial and ethnic minorities, women, adolescents, etc.) require what types of counseling or psychotherapy? 5. How is the process of psychotherapy or counseling related to outcome in drug dependence treatment? 6. What are the characteristics of successful therapists, patients, and therapist/patient pairs? Specific Areas of Interest: 1. Development of Psychotherapy/Counseling Instruments and Research Methods. Psychotherapy research, particularly with drug addicts, is in an early stage of development. The development and the refinement of instruments and methods that measure the theoretical constructs in the fields of psychotherapy and counseling are needed. Without instruments that measure these constructs in a valid and reliable manner, the controlled, scientific study of psychotherapy and counseling is impossible. Investigators are encouraged to develop new instruments and refine existing instruments from the mental health field that can be used in controlled psychotherapy/counseling research studies with drug addicts. The development of valid and reliable instruments that measure various aspects of the process and strategies of psychotherapy/counseling, the immediate goals and outcome of these treatments, therapist characteristics predictive of treatment outcome, and patient characteristics predictive of outcome are encouraged. 2. Comparative Psychosocial Treatment Research with Drug Addicts. Controlled clinical trials that examine the relative efficacy of psychotherapy, behavior therapy, counseling, pharmacotherapy, and the many combinations of these forms of treatment with various populations of drug addicts are encouraged. The goal of such comparative treatment research is not to determine which treatments "win," but, rather to determine which treatments are most efficacious with which populations, and under what conditions. Studies that investigate the relative efficacy of individual, group, or family psychotherapy, behavior therapy, and drug abuse counseling in patients with various co-morbid Axis I and Axis II disorders are particularly encouraged. Investigations that compare the efficacy of one form or combination of psychotherapy, behavior therapy, or counseling to another in other subpopulations of drug addicts (e.g., racial and ethnic minorities, pregnant women, and individuals who abuse cocaine intravenously) are also encouraged. Where effective pharmacotherapies are available, research projects that attempt to maximize the efficacy of that pharmacotherapy through integration with psychosocial treatment are encouraged. Applicants proposing comparative psychosocial treatment research studies are encouraged to examine the interactions of relevant therapist/patient characteristics with therapy type and to assess the relative contribution of therapist, patient, and type of therapy to treatment outcome. For these studies, it is imperative that investigators accurately measure and control for the psychiatric diagnosis and problem severity level of the patients. It is also necessary that clear definitions of treatment outcome variables be specified, and that valid and reliable measures of outcome be used. It is recommended that therapists/counselors providing the treatment be systematically trained, that manuals be used to guide the treatments, that valid and reliable therapist competence and adherence scales be used, and that the treatment process be measured accurately. For all efficacy studies, it is recommended that adequate followup assessments be planned. It is also important that these studies use procedures and methods that can be replicated. It is strongly suggested that pilot data showing that a counseling or psychotherapy strategy is promising be provided when proposing comparative research involving this treatment. These pilot data should indicate that the utilization of the therapy approach shows promise in its ability to produce a decrease in drug use, dropout rate, or psychiatric symptoms. 3. Research on Therapist and Patient Variables in Psychotherapy and Counseling. Researchers have highlighted the importance of individual differences among therapists and counselors independent of the form of treatment. Some studies have shown that certain therapists/counselors are more successful than others, and that this success is more related to the treatment provider than to the type of treatment provided (e.g., McLellan et al., 1988). Studies are sought that assess therapist and/or counselor characteristics and relate these characteristics to effective treatment. Studies that examine the interaction of therapist/counselor and patient variables as related to outcome are also encouraged. Additionally, studies that link the characteristics of patients with successful psychotherapeutic, behavioral, or drug abuse counseling treatment are desired. Measurements of therapist and patient characteristics should be obtained using psychometrically sound instruments. These studies should control for the type of treatment offered and should use objective, empirical measures of the treatment process that occurs. 4. Short-Term vs. Long-Term Goals of Drug Abuse Counseling/Psychotherapy/Behavior Therapy. The treatment process may be viewed as having two distinctive but interrelated sets of goals. One set involves long-term objectives to be achieved as a result of involvement in the treatment program. These goals include reduction in illicit drug use, reduction in illegal activities, improvement in social adjustment, etc. The other set of goals involves specific objectives to be achieved within the treatment program that, it is assumed, will allow clients to attain the long-term treatment goals. These immediate goals include assisting the client in recognizing the harm caused by drug dependence, developing personal strategies for reducing or avoiding stress, recognizing irrational ideas or beliefs, developing realistic strategies for interpreting life events, etc. Research is needed to determine how immediate treatment goals are related to long-term treatment goals (i.e., how success in achieving goals within treatment is related to success in achieving goals that result from treatment). For example, investigators may wish to establish different measures of immediate treatment goals, evaluate clients on success in achieving those goals, and then relate success in attaining immediate treatment goals to outcome measures of drug use or social adjustment. Research is also needed to identify, operationally define, and compare the efficacy of different strategies for attaining immediate treatment goals. For example, investigators may wish to establish different measures of immediate treatment goals, evaluate clients on success in achieving those goals, and then relate success in attaining immediate treatment goals to outcome measures of drug use or social adjustment. Also, investigators may wish to establish two distinctive procedures for achieving stress management (or employment) by clients and then compare the efficacy of the two procedures in terms of stress management. Controlled clinical trials or other rigorous research methods should be used. 5. Component Analysis Research. Knowing the effective components of treatment can greatly aid in improving the quality of treatment. Theoretically based research that attempts to determine the effective components or combination of components in drug dependence psychotherapies, behavior therapies, or counseling strategies is encouraged. Where there is more than one way to answer a proposed research question, investigators are urged to state their theoretical, ethical, and practical reasons for choosing one research design over another (see Borkovec, 1990). Investigators should address the issues of selection bias and attrition (Howard et al., 1990), and any other pertinent methodological issues (see Onken and Blaine, 1990). If a subject is identified as being at risk for HIV acquisition and/or transmission, HIV testing and counseling should be offered to the subject in accordance with current guidelines. Furthermore, in high-risk populations, investigators are encouraged to assess the effect of the new therapy on the acquisition/ transmission of associated infectious disease, including HIV. STUDY POPULATION 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 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 Sections 1-4 of the Research Plan AND summarized in Section 5, 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 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an initial review group in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Small grant applications (R03) do not receive a second-level review. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute/Center/Division. The following will be considered in making funding decisions: o Scientific and technical merit of the proposed project as determined by peer review o Availability of funds o Institute program needs and balance INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Dr. Lisa Onken Treatment Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Mrs. Shirley Denney, Chief Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301 and administered under PHS grants policies and Federal Regulations at Title 42 CFR Part 52, Grants for Research Projects, Title 45 CFR part 74 and 92, Administration of Grants, and 45 CFR Part 46, Protection of Human Subjects. Title 42 CFR Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records, may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Awards must be administered in accordance with the PHS Grants Policy Statement, (rev. 10/90), which is available from institutional offices of sponsored research. REFERENCES Azrin, N., "Improvements in the community reinforcement approach to alcoholism," Behavior Research and Therapy, 14: 339-348, 1976. Borkovec, T.D., "Control groups and comparison groups in psychotherapy outcome research," In Onken, L. Simon and Blaine, J.D. (Eds.) Psychotherapy and counseling in the treatment of drug abuse, NIDA Research Monograph #104, Department of Health and Human Services Publication Number (ADM)90-1722, 1990. Carroll, K., Rounsaville, B., and Gawin, F., "A comparative trial of psychotherapies for ambulatory cocaine abusers: Relapse Prevention and Interpersonal Psychotherapy," American Journal of Drug and Alcohol Abuse, 17: 229-247, 1991. Childress, A.R., Ehrman, R., McLellan, A.T., and O'Brien, C.P., "Cue reactivity assessment and a cue exposure intervention in cocaine dependence," American Journal of Psychiatry, under review. Crits-Christoph, P., Beebe, K., and Connolly, M.B. "Therapists effects in the treatment of drug dependence: Implications for conducting comparative treatment studies," In Onken, L. Simon and Blaine, J.D. (Eds.) Psychotherapy and counseling in the treatment of drug abuse, NIDA Research Monograph #104, Department of Health and Human Services Publication Number (ADM)90-1722, 1990. Grabowski, J., Stitzer, M.L., and Henningfeld, J.E., "Therapeutic applications of behavioral techniques: An overview,". In Behavioral Intervention Techniques in Drug Abuse Treatment, Grabowski, J., Stitzer, M.L., and Henningfeld, J.E.(Eds.) NIDA Research Monograph #46, Department of Health and Human Services Publication Number (ADM)86-1282, 1984. Higgins, S.T., Stitzer, M.L., Bigelow, G.E. and Liebson, I.A., "Contingent methadone delivery: Effects on illicit opiate use," Drug and Alcohol Dependence; 17: 311-322, 1986. Higgins, S.T., Delaney, D.D., Budney, A.J., Bickel, W.K., Hughes, J.R., Foerg, F., and Fenwick. J.W., "A behavioral approach to achieving initial cocaine abstinence," American Journal of Psychiatry, 148,9: 1218-1224, 1991. Howard, K.I., Cox, M., and Saunders, S.M., "Attrition in substance abuse comparative treatment research: The illusion of randomization," In Onken, L. Simon and Blaine, J.D. (Eds.) Psychotherapy and counseling in the treatment of drug abuse, NIDA Research Monograph #104, Department of Health and Human Services Publication Number (ADM)90-1722, 1990. Hunt, G.M., and Azrin, N., A community reinforcement approach to alcoholism. Behavior Research and Therapy, 11: 91-104, 1973. Iguchi, M.Y., Stitzer, M.L., Bigelow, G.E., and Liebson, I.A., "Contingency management in methadone maintenance: Effects of reinforcing and aversive consequences on illicit polydrug use," Drug and Alcohol Dependence; 22: 1-7, 1988. Kadden, R.M., Cooney, N.L., Getter, H., and Litt, M.D., "Matching alcoholics to coping skills or interactional therapies: Posttreatment results," Journal of Consulting and Clinical Psychology, 57: 698-704, 1989. Lambert, M.J., Shapiro, D.A., and Bergin, A.E., "The effectiveness of psychotherapy," In Garfield, S.L. and Bergin, A.E. (Eds.) Handbook of Psychotherapy and Behavior Change. New York: Wiley, 157-211, 1986. Lambert, M.J., "Conceptualizing and selecting measures of treatment outcome: Implications for drug abuse outcome studies," In Onken, L. Simon and Blaine, J.D. (Eds.) Psychotherapy and counseling in the treatment of drug abuse, NIDA Research Monograph #104, Department of Health and Human Services Publication Number (ADM)90-1722, 1990. Luborsky, L., Singer, B., and Luborsky, L., "Comparative studies of psychotherapies: Is it true that "everyone has won and all must have prizes?" Archives of General Psychiatry 32: 995-1007, 1975. McLellan, A.T., Woody, G.E., Luborsky, L, and Goehl, L., "Is the counselor an 'active ingredient' in substance abuse rehabilitation? An examination of treatment success among four counselors," The Journal of Nervous and Mental Disease, 176: 423-430, 1988. Onken, L. Simon and Blaine, J.D. (Eds.) Psychotherapy and counseling in the treatment of drug abuse, NIDA Research Monograph #104, Department of Health and Human Services Publication Number (ADM)90-1722, 1990. Rounsaville, B.J., Glazer, W., Wilbur, C.H., Weissman, M.M., and Kleber, H.D., "Short-term interpersonal psychotherapy in methadone maintained opiate addicts," Archives of General Psychiatry 40: 629-636, 1983. Smith, M.L. and Glass, G.V., "Meta-analysis of psychotherapy outcome studies," American Psychologist 32: 752-760, 1977. Stanton, M.D., and Todd, T.C. and Associates, The Family Therapy of Drug Abuse and Addiction. New York: The Guilford Press, 1982. Stiles, W.B., Shapiro, D.A., and Elliott, R., "Are all psychotherapies equivalent?" American Psychologist 41: 165-180, 1986. Stitzer, M.L., Bickel, W.K., Bigelow, G.E., and Liebson, I.A., "Effect of methadone dose contingencies on urinalysis results of polydrug-abusing methadone-maintenance patients," Drug and Alcohol Dependence; 18: 341-348, 1986. Stitzer, M.L., Iguchi, M.Y., and Felch, L.J., "Contingent take-home incentive: Effects on drug use of methadone maintenance patients," Journal of Consulting and Clinical Psychology, In press. Woody, G.E., Luborsky, L., McLellan, A.T., O'Brien, C.P., Beck, A.T., Blaine, J., Herman, I., and Hole, A., "Psychotherapy for opiate addicts- Does it help?" Archives of General Psychiatry 40: 639-645, 1983. Woody, G.E., McLellan, A.T., Luborsky, L., and O'Brien, C.P., Blaine, J., Fox, S., Herman, I., and Beck, A.T., "Severity of psychiatric symptoms as a predictor of benefits from psychotherapy: The Veterans Administration-Penn Study," American Journal Of Psychiatry 141: 1172-1177, 1984. Woody, G.E., McLellan, A.T., Luborsky, L., and O'Brien, C.P., "Sociopathy and psychotherapy outcome," Archives of General Psychiatry 42: 1081-1086, 1985. Woody, G.E., McLellan, A.T., Luborsky, L., and O'Brien, C.P., "Psychotherapy and counseling for methadone-maintained opiate addicts: Results of research studies," In Psychotherapy and Counseling in Drug Abuse Treatment, Onken, L. Simon and Blaine, J.D., NIDA Research Monograph #104, Department of Health and Human Services Publication Number (ADM)90-1722, 1990. $$P1 END ************************************************************ $$P2 BEGIN PA-93-28 ************************************************* RESEARCH TO IMPROVE DRUG ABUSE TREATMENT ENTRY, RETENTION, COMPLIANCE, AND EFFECTIVENESS NIH GUIDE, Volume 21, Number 44, December 11, 1992 PA NUMBER: PA-93-28 P.T. 34; K.W. 0404009, 0415001, 0404000 National Institute on Drug Abuse PURPOSE The purpose of this announcement is to encourage research to investigate entry, retention, and compliance in drug abuse treatment, and research on strategies to improve entry and retention in treatment, and to bring about compliance with program expectations and effectiveness of drug abuse treatment. An important focus of these studies will be on the various environmental and intrapersonal factors that promote drug abuse treatment entry, retention, compliance, and effectiveness. Research may be conducted in conjunction with clinical trials, evaluation studies, or through separate epidemiological and ethnographic studies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Program Announcement (PA), Research to Improve Drug Abuse Treatment Entry, Retention, Compliance, and Effectiveness, is primarily related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, non-profit and for-profit organizations