From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 25, pt.2, 28 June 1991 Message-ID: Date: 3 Jul 91 18:28:58 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 1219 $$XID RFA AA9102 AA-91-02 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: AA-91-02 P.T. 04; K.W. 0404003, 0745020, 0745027, 0755030, 0745070 ALCOHOL RESEARCH CENTER GRANTS National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: October 1, 1991 Application Receipt Date: December 16, 1991 I. INTRODUCTION The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The Center grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, diagnosis, treatment, control, prevention, and consequences of alcohol abuse and alcoholism. NIAAA currently supports 14 Centers and anticipates that the level of support for this program will not expand during this competition. Applications for new Centers will be evaluated with applications from currently funded Centers seeking renewal support beyond December 1, 1992. Grants are typically awarded for a five-year period. The application receipt date is December 16, 1991. It is estimated that approximately $13-14 million will be available in FY 1993 to fund approximately eight Centers. Continuation support in the future years is anticipated; however, the amount of support available will depend on appropriated funds. Under this announcement, NIAAA will accept applications for support of specialized Centers (P50) that include core as well as research components. II. PURPOSE OF THE PROGRAM The Alcohol Research Centers Grant program is designed to complement the research project grants program of the NIAAA by providing long-term (typically, for five years) support for interdisciplinary research programs with a distinct focus on a particular theme relating to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, social science, and other relevant disciplines to bring a full range of expertise, approaches, and advanced technologies to the study of problems related to alcohol abuse and alcoholism. Research to improve knowledge of other drug abuse and mental disorders that co-occur with alcohol abuse disorders is also encouraged. Center grants help to provide a stable environment for investigators to engage in alcohol research in a coordinated and integrated effort. A Center is expected to be a source of scientific excellence and, through sustained excellence, to become a significant regional or national research resource. In addition, the applicant institution is expected to afford opportunities for research training to persons from various disciplines and professions. A specialized Center is a comprehensive, broadly based, multidisciplinary, multi-investigator, long-term program of combined research and research support activity planned around a specific major research objective or research theme. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. III. ELIGIBILITY Any domestic, public (non-Federal) or private, non-profit or for-profit, institution may apply for a Center grant. However, the proposed Center must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program. An applicant institution must demonstrate the ability to attract high-quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to research. An application must also have a detailed five-year plan for a proposed research program. In addition, the applicant must assure that research training opportunities will be available. Women and minority investigators are encouraged to apply. IV. APPLICATION REQUIREMENTS All proposed research to be conducted within a Center must be clearly directed toward one or more of the following goals: prevalence, etiology, diagnosis, prediction, clinical course, management or treatment of alcohol abuse, alcoholism, or alcohol-related health problems; consequences of alcoholism or alcohol abuse; and factors that relate to prevention of alcohol abuse, alcoholism, or other problems associated with alcohol consumption. The Alcohol Research Center grant provides a mechanism for fostering interdisciplinary cooperation in a group of established investigators conducting high-quality alcohol research. Therefore, existence of a strong research capability is fundamental to the establishment of a new Center or the continuation of an existing Center. A Center should be an identifiable organizational unit within an institutional or organizational structure such as a university, medical center, or a consortium of affiliated cooperating institutions. A. Definitions 1. Administrative Core Component A Center must promote synergistic interaction of broad and diverse elements that require clearly specified lines of authority and accountability by appropriate institutional officials. The purpose of the administrative core component is to provide the organizational framework for the management, direction, and coordination of the Center. The administrative core component must be managed by the Center Director or Scientific Director and may include funds for scientific enrichment activities such as special lectures, visiting scientists, symposia, seminars, and workshops; and for education and research dissemination activities for the public. 2. Scientific Core Components Core components for this RFA are defined as shared research resources that enhance productivity or in other ways benefit a group of investigators working in alcohol-related research to accomplish the stated goals of the Center. A core component is a laboratory, facility, service, or resource that interacts synergistically with research projects of the Center. Research projects that use the core may be funded primarily from the Center grant award (Specialized Research Center), from other support mechanisms such as Research Project Grants, Program Projects, or a combination thereof. Core components must provide investigators with some technique, instrumentation, service, or resource in a way that will enhance research progress and contribute to effectiveness. Each core component is directed by an investigator with established expertise relative to the support or service to be provided, usually a faculty member or equivalent. Some examples of research support that core components typically provide are: (1) technology that lends itself to automation or large-batch preparation; (2) tissue and/or cell culture facilities; (3) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology; (4) animal care and preparation; (5) service and training; (6) patient coordination; and (7) information processing, data management, and statistical services. 3. Research Components Research components are individual scientifically meritorious research projects that are interrelated. As a group, research components contribute to the overall goals of the Center program to a greater extent than if each project were to be pursued separately. Each research component must be under the direction of a component director who may also be the Center Director. The component director is an established researcher of independent and scientifically recognized standing who is responsible for the scientific direction and conduct of an individual research component of a Center. 4. Pilot Project Component The purpose of pilot projects is to provide the Center with a flexible means to develop and explore new research activities or directions, and unique scientific opportunities that could evolve into independently funded research projects. These funds are not intended to supplement ongoing research projects. Pilot projects should be in a separate pilot project core component that incorporates all of the pilot studies of the proposed Center grant. B. General Requirements Details for preparing the application are provided in the "Special Instructions" listed below. Center grant applications must be logically organized into discrete components that comprise a proposed program of research. Each component is either a research component or a core component for which a separate detailed budget is included in the application. The application must include an administrative core and at least three research components, and may also include shared resource cores and/or a pilot project core component. A maximum and minimum number of components that will be accepted for Center grant applications has been established. The minimum acceptable combined number of research components and core components is four (three of which must be research components). The maximum combined number of research components and core components, including any pilot project core component, is ten for the total project period. The research plan for each core component and each research component is limited to 20 pages. Pages not used for one component may not be used to extend the page limit of other components/cores. These page limits do not apply to pilot projects. For pilot project requirements, see section entitled "Pilot Project Component." 1. Administrative Core Component The administrative core component will play a key role in the coordination and operation of the Center. This core must be described in sufficient detail to assure that all proposed components and related activities will function optimally. An important function of this core is the administration of the budget. Through this component, the Center Director provides substantive leadership and manages the administrative core component. This component may also include the costs of scientific enrichment, education, and information dissemination activities. The administrative core should also provide for integration of Center functions. 2. Scientific Core Components Each shared resource component must be clearly described in terms of the services/resources to be provided to investigators. The description must include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, time saving, and increased efficiency attributable to the existence of the cores must also be addressed. A core component may support Center grant research components and separately funded research project grants that are related to the Center's theme. Each separately funded research project associated with the Center and utilizing core facilities must have a two-page description that includes its research objectives and how the Center's core facility will impact upon it. The minimum number of research components/projects supported by a core component is two. Each core component director must have experience and scientific expertise relative to the purpose of each core. This person must be an established scientist. The description of the organization and mode of operation of the shared resource core must include discussion of quality control for the service or resource, and the procedures for evaluating and selecting projects eligible for use of the facility. Training in complex techniques and methods must be described if they are functions in proposed cores. Core components are intended to enhance opportunities for investigators at the Center to include new technologies that broaden their research initiatives. Research is an appropriate initiative of a core when it is directly related to improving the operation, function, quality, or utility of the core. Renewal applications must describe oncoing and completed core activities that have enhanced or facilitated research. Past performance and accomplishments of cores and the effect of services provided by cores on investigators' productivity must be described. 3. Research Components For each proposed research component, a clear description of the major goals, objectives, and its integration with the other components, as well as its relationship to the overall Center, must be provided to include: o The question(s) to be addressed and the hypotheses to be tested by the proposed research must be highly focused and fully explained. o A discussion of the design and procedures must describe the strategies proposed to accomplish the specific aims of the project and innovative aspects of the approach. o A description of the resources and working arrangements required to implement and conduct the proposed research must be fully elaborated. Particular attention should be devoted to a description of necessary resources, subjects, clinical populations, tissue resources, and others, that will be involved in proposed studies. All proposed research components need not be ongoing at any one time, but may be phased in at different time points during the life of the proposed Center grant. This aspect should receive careful attention in the application and individual component preparation. 4. Pilot Project Component Pilot projects must be adequately, though concisely, described. Although the specific number of pilot projects to be proposed is at the discretion of the applicant, requested funding for pilot studies may not exceed $200,000 or 20 percent (whichever is larger) of the direct cost budget proposed for any one year. All proposed pilot projects need not be ongoing at any one time but may be phased in at different points during the life of the proposed Center grant. It is also recognized that the relative priority or need for specific pilot projects may change over time. Although the Center's framework for management of pilot funds and the mechanism for operating the program are left to the discretion of the Center, the application must provide specific information to enable adequate scientific review. The application must include: o A description of each proposed pilot study including its rationale, objectives, approach, investigators, and significance for the Center. The research description of any individual pilot project may not exceed eight pages; the entire narrative for this Pilot Project Component may not exceed 50 pages regardless of the number of pilot projects proposed. o A full description of the management of the pilot project component, including a description of the process to be followed by the Center Director in selecting new pilot projects, should a need arise to replace any of the pilots contained in the application. o For competing renewal applications, describe the past experience of the Center in utilizing pilot funds to further the goals. The narrative must include an assessment of the overall benefits derived from the availability of pilot resources. See "Special Instructions" for information on pilot project description requirements. C. Renewal Applications A comprehensive progress report is required for competing continuation (renewal) applications. A statement must be included in the application regarding the progress made by the Center as a whole in its development as a national or regional research resource. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal. More specific details are provided in the "Special Instructions" listed below. D. Facilities and Environment Applicants must demonstrate the availability of adequate laboratory, clinical, and office facilities needed to carry out the objectives of the proposed Center program. Although not required, it is desirable for all Centers to have a commitment for sufficient contiguous space so that the Center has a high degree of cohesion and visibility. Reference facilities affording access to the relevant literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through Center funding. Relevant support services, including adequate data processing facilities, must also be readily accessible within or through the institution. Assurances of such support must be included with the application. E. Organization and Administration A Center must be an identifiable organizational unit with an administrative structure and clear lines of authority that will facilitate coordination among Center personnel to assure maximum accountability and efficiency in Center operations. An applicant must designate an institutional official to serve as Principal Investigator for the Center grant and as director of the Center. The institutional appointment of this person must provide sufficient authority to allocate space, personnel, and other resources essential to the Center. This individual must demonstrate ability to organize, administer, and direct the Center. The director of the Center will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center. Overall program management, coordination, communication, progress assessment, and quality control are typically responsibilities of the director and are facilitated through the administrative core. The administrative core must be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting must be detailed in the description of this core. The applicant may also designate a Scientific Director who will be responsible to the Center Director and provide direct supervision of the scientific and operational aspects of the research program. Such a person must be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the research program. The Scientific Director will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center. The Scientific Director also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. Key professional staff, such as directors of individual research components and core components of the Center, must have the necessary training/experience to assure that the objectives and goals of the proposed studies will be achieved. Such persons must be established investigators with proven track records. A Program Advisory Committee shall be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, must be composed of at least five members. Members should be persons of recognized scientific standing who are generally familiar with the Center's activities and represent a cross-section of disciplines that are relevant to the work of the proposed Center. It shall be the responsibility of this Committee to review and make recommendations to the Center Director on the conduct of all activities of the Center. F. Training While the primary function of each Center is the conduct of high-quality interdisciplinary research, an important component related to the Center and its research efforts is the training of research and clinical personnel. The applicant institution must therefore demonstrate or give reasonable assurances that it has: (a) the capacity to train predoctoral and/or postdoctoral students for careers in alcohol research; (b) the capacity to conduct programs of continuing education in the Center's designated research theme in the medical and health service fields. While the Center need not necessarily have formal training programs of its own, there must be specific provision for coordination between the Center and the training programs of the applicant institution and/or affiliated institutions. Center grant funds may not be used to pay stipends or other trainee costs; however, Center staff may participate in the development of training programs, and Center resources may be made available for use of trainees. V. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF ADAMHA POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for ADAMHA grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either women or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to clinical trials; and minorities include U.S. racial/ethnic minority populations (specifically, American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). ADAMHA recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. Applications should include a description of the composition of the proposed study population by gender and racial/ethnic group, and the rationale for the numbers and kinds of subjects selected to participate. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects, for each clinical research component. Applications should incorporate in the study design of each clinical research component the gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. The rationale may relate to the purpose of the research, the health of the subjects, or other compelling circumstances (e.g., if in the only study population available there is a disproportionate representation in terms of age distribution, risk factors, incidence/prevalence, etc., of one gender or minority/majority group). 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 gender and/or minority representation/justification are judged to be inadequate, reviewers will consider this as a deficiency in assigning the priority score to the application. All applications/proposals for clinical research submitted to ADAMHA are required to address these policies. ADAMHA funding components will not award grants that do not comply with these policies. VI. TERMS AND CONDITIONS OF SUPPORT Center grant funds may be requested for support of core components and individual research components associated with the Center program. Core resources may include, for example, salaries of personnel responsible for management of the Center, services and facilities to be shared by Center personnel, program enrichment activities such as special lectures, visiting scientists, symposia, seminars, and workshops, and costs related to dissemination of research information to the scientific community and lay public. Funds may be requested for costs associated with individual research components that are part of the Center program. Examples of such costs include: research staff salaries, supplies, travel, special consultation, research patient costs, publication costs, and the like. Funds also may be requested for the allowable indirect costs of the applicant organization. In addition, costs of advisory committees, steering committees, and consultants may be included in the administrative core. Consultants for specific research components must be included in the budgets for those components. If committees are included, specific plans as to how the committees will be selected and how they will function must be presented in the application. Alcohol Research Center grant funds may be used only for costs that are necessary to carry out the research and research support activities of the Center program, and must be in conformance with HHS cost principles (encompassed in 45 CFR Part 74), and the Public Health Service Grants Policy Statement, (Revised 10/1/90). This publication may be available from the institutional office of sponsored research. Funds provided under this program may not be used for the purchase of land; nor for the purchase, construction, preservation, or repair of any building. However, costs of alteration and renovation of existing facilities necessary to accomplish the objectives of the grant may be allowed subject to PHS grants policy limitations. Funds provided through Center grants may not be used for support of trainee stipends, fees, or other expenses directly relating to training activities. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and scientific progress. Applicants may request up to $1.7 million total cost (including direct and indirect costs combined) per year. The actual amount of support awarded will depend upon consideration of factors listed in Section XI, AWARD OF GRANTS. The Center grant is neither expected nor intended to cover all costs of running a successful Alcohol Research Center program. Research and training activities associated with the Center may receive additional funding from Federal sources as well as from State and local sources. NIAAA expects and encourages the institution and scientists attracted to such Centers to seek and compete actively for such funding. Research staff in funded Centers may submit applications for independent research project grants for support of research projects that do not overlap with their Center project. Requests for funds to expand the scope or number of research components within the Center grant must be discussed with NIAAA staff before an application is prepared. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. Centers will be required to submit detailed annual progress reports including substantive information about research results to date, status of ongoing research, research plans for the next year, and any modifications in long-term research plans. Also required are reporting of inventions, reports of expenditures, final reports, and other reports in accordance with PHS policy. VII. LETTER OF INTENT Applicants are requested to submit a brief letter of intent to NIAAA (address shown below). The letter of intent is to be submitted by October 1, 1991. The letter of intent should include a descriptive title, the name and address of the Principal Investigator, the names and addresses or any other key investigators, and any other participating institutions. VIII. APPLICATION PROCESS AND RECEIPT DATE Applicants must use the grant application form PHS 398 (rev. 10/88). The title and number of this RFA, Alcohol Research Center Grants, AA-91-02, must be typed in item number 2 on the face page of the PHS 398 application form. When using the PHS 398 application form to respond to an RFA, applicants must affix the RFA label available in the PHS 398 kit to the bottom of the face page. Failure to use this label could result in delayed processing of the application, such that it may not reach the review committee in time for review. Application kits containing the necessary forms and instructions may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: Centers Program National Institute on Alcohol Abuse and Alcoholism Division of Basic Research 5600 Fishers Lane, Room 16C-06 Rockville, MD 20857 Telephone: (301) 443-4703 The receipt date for applications is December 16, 1991. The signed original and four permanent legible copies of the application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies must be sent to: NIAAA Office of Scientific Affairs Parklawn Building, Room 16C-20 5600 Fishers Lane Rockville, MD 20857 Applications received after the December 16, 1991, receipt date will be returned to the applicant without review. IX. REVIEW OF APPLICATIONS Each Center application will be reviewed by a group of experts to evaluate the scientific and technical merit. Recommendations from this review will be presented to the National Advisory Council on Alcohol Abuse and Alcoholism that will make a final recommendation to the Director, NIAAA. Grant awards will be made with a start date of December 1, 1992, or later. X. REVIEW CRITERIA The initial review for scientific and technical merit of applications will emphasize two major aspects: (1) review of the Center as an integrated research effort focused on a central theme, including the administrative core; and (2) the review of each research component and all other core components. The review will also include an assessment of the academic and physical environment and special considerations, e.g., compliance with human subject and animal welfare requirements, and compliance with policies concerning inclusion of women and minorities in clinical research study populations. 1. The Center as an Integrated Effort o The significance of the overall research goals and development of a well-defined central research theme. o Multidisciplinary scope of the Center; its cohesiveness, coordination, and interrelation; and the synergistic potential among the Center components and core units. o The stature, experience, and administrative competence of the Center Director; and his or her commitment and ability to devote substantial time and effort to the Center. o The scientific ability of the Scientific Director and his or her professional experience and leadership. o The justification of the core components in terms of accomplishing the Center objectives, and their usefulness to the research components and/or independently supported investigators who utilize the core services or facilities. o The scientific stature of the directors of the research project components and/or the core components, the extent to which each of the Directors will contribute to overall Center goals, and their commitment to the Center. o Administrative arrangements and organizational structure of the administrative core to facilitate and monitor attainment of Center objectives and maintain quality control of ongoing projects. These factors include: a. plans for communication and cooperation among investigators involved in the Center; b. mechanisms for allocation of funds and core resources and selecting meritorious pilot projects; c. quality control, oversight; d. day-to-day management, long-term planning and periodic evaluation; e. contractual and consortium arrangements; f. procedures for replacement of key persons, if necessary; g. Appropriateness of the overall budget for the work proposed in the Center; and h. Potential of the Center to become or maintain itself as a regional and national resource, including capacity to provide quality research training, opportunities for independent research career development, and plans for research information dissemination and education activities. o In addition, applications for renewal support will be evaluated in terms of the degree to which the Center has achieved stated goals with special attention to: a. the scientific merit of completed research; b. recruitment of new scientists into alcohol research; c. development of a multidisciplinary research team; and d. coalescence of the Center staff into an effective team. 2. Individual Research Components and Core Components o The scientific and technical merit of each research component and each core component. o The significance of each research and core component and its relation to the central theme of the Center. o Evidence of quality control of proposed core component's services, resources, and facilities. o The qualifications, experience, and commitment of the component director responsible for the research component and/or core component, including his or her ability to devote adequate time and effort to the Center. o The appropriateness of the budget request for each of the proposed research project components and/or core components, administrative core, and any pilot project core component. 3. Resources and Environment In addition to the scientific components, e.g., research project and core components, the initial review group will also evaluate: o The academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects and materials, and the potential for interaction with scientists from other departments and other institutions. o The institutional strength, stability, commitment to research and support for the Center, including fiscal responsibility and management capability to assist the Center Director and staff in complying with HHS, PHS, and ADAMHA policies. o Opportunities for research training and education for persons from various disciplines and professions. 4. Other Considerations o When an application proposes research or research-related activity that involves potential risks to human subjects, animals, and/or the environment, the adequacy of the proposed means for protecting against such risks must be demonstrated for each component. o Specific statements addressing compliance with ADAMHA policies on inclusion of women and minorities in clinical research studies. XI. AWARD OF GRANTS Applications recommended for approval by the NIAAA National Advisory Council will be considered for funding on the basis of the overall merit of the application, as well as such considerations as program balance, relevance to the mission and goals of NIAAA, research program priorities, equitable geographic distribution, continuity of support, and availability of funds. Awards will be made for up to five year project periods with separate fiscal awards made annually. XII. RELATIONSHIP TO NIAAA In view of the special significance of this program, close coordination and communication between the NIAAA staff and staff of the Alcohol Research Centers is intended. The NIAAA program official will have responsibility for maintaining liaison with appropriate Center leadership, serve as resource consultant to the Center program, and keep NIAAA staff informed on progress and accomplishments of the Center. In addition, the program official with other NIAAA staff and consultants will, from time to time, make on-site visits for purposes of program coordination and exchange of information. XIII. INQUIRIES Before preparing an application, potential applicants are strongly encouraged to seek more specific information by telephoning Dr. Ernestine Vanderveen, Associate Director, Division of Basic Research, at 301-443-1273, or by writing to: Centers Program National Institute on Alcohol Abuse and Alcoholism Division of Basic Research 5600 Fishers Lane, Room 16C-06 Rockville, MD 20857 For fiscal and administrative matters, contact: Ed Ellis Grants Management Specialist Management Review and Assistance Section Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16-86 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4703 This program is described in the Catalog of Federal Domestic Assistance No. 93.891. The statutory authorities for awards under this RFA are Sections 301 and 511 of the Public Health Service Act (42 USC 241 and 290bb-1). Federal Regulations at 42 CFR Part 54a, Subpart E "Grants for National Alcohol Research Centers" apply to grants under this RFA. This program is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through HHS regulations at 45 CFR Part 100. SPECIAL INSTRUCTIONS FOR PREPARING AN ALCOHOL RESEARCH CENTER GRANT APPLICATION (Revised June 1991) Applicants for Alcohol Research Center grants are to make application on form PHS 398 (revised 10/88). The following are instructions to be used in addition to the instructions that accompany the application form. Send the signed original with the RFA label contained in the kit, affixed to the bottom of the face page, and four copies of the completed application to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Failure to use the RFA label and to follow instructions could result in delayed processing of the application, such that it may not reach the review committee in time for review. In addition, it is requested that two copies of the completed application be sent to: NIAAA - Office of Scientific Affairs Parklawn Building, Room 16C-20 5600 Fishers Lane Rockville, MD 20857 IMPORTANT: PAGE LIMITATIONS MUST BE STRICTLY OBSERVED. SPECIFIC INSTRUCTIONS: SECTION 1 (FACE PAGE) ITEM 1. Title of Project: The title should identify the central theme of alcohol research around which the Center program will be organized. ITEM 2. Response to Specific Program Announcement: Check the box marked "yes" and indicate that the application is being submitted in response to the Request for Applications, "AA-91-02, Alcohol Research Center Grants." ITEM 3a. Name of Principal Investigator: Designate an institutional official who will serve as Center Director (Principal Investigator) and will be responsible for planning and coordination of the Center program. ITEM 6. Dates of Entire Proposed Project Period: The total project period proposed must not exceed five years, starting no earlier than December 1, 1992. ITEM 7a. Direct Cost Requested for First 12-month Period. In determining direct costs, the applicant must keep in mind that the total request for each year, including direct and indirect costs, must not exceed $1.7 million per annum. ITEM 7b. Total Costs Requested for First 12-month Budget Period: This amount must not exceed $1.7 million. (FORM PAGE 2) Description: Give an overall description of the proposed Center's research program and the central theme around which its research is organized. (Do not exceed the space provided.) Key Personnel Engaged on Project: Provide information as described in the general instructions contained in the application kit in the following order: (a) Principal Investigator (Center Director), (b) Scientific Director (if different from Center Director), (c) Directors of core and/or research components, and (d) All other key professionals. (FORM PAGE 3) Number pages consecutively at the bottom right throughout the application, and type the name of the Principal Investigator (Center Director) at the top right of each printed page and each continuation page. TABLE OF CONTENTS SECTION 1 Page Numbers Face Page, Description, Key Personnel, 1-3 Table of Contents Detailed Budgets for Year 01-Direct Costs Only 4-__ Center as a Whole (number consecutively) Administrative Core Each Core Component Include Budgets for Contractual/Consortium Arrangements behind the relevant Core or Research Component Budget Each Research Component Detailed Budgets for Entire Project Period-Direct Costs Only Center as a Whole __ Administrative Core __ Core Components __ Research Components Chart Showing Percent Effort for all Key Personnel by Project and Year __ Biographical Sketches __ Center Director __ Scientific Director __ All other Key Personnel in Alphabetical Order __ Other Support __ Resources and Environment __ SECTION 2 - Research Plans I. Introductory Overview: (Not to exceed 10 pages) The Center as an Integrated Whole: A. Specific Aims __ B. Background and Significance __ C. Progress Report/Preliminary Studies __ D. Training Opportunities __ II. Administrative Core (Not to exceed 20 pages) A. Abstract and Key Personnel __ B. Center Organization and Operation __ C. Center Publications D. Education, Enrichment, and Dissemination Activities __ III. Each Additional Core and Research Component in Turn (Not to exceed 20 pages for sections A-D) A. Specific Aims __ B. Background and Significance __ C. Progress Report/Preliminary Studies __ D. Experimental Design and Methods __ E. Human Subjects __ F. Vertebrate Animals __ G. Consultants/Collaborators __ H. Consortium/Contractual Arrangements __ I. Literature Cited (do not exceed 4 pages) J. If relevant, 2-page description of independently funded projects using core component __ IV. Pilot Project Component (Not to exceed 50 pages) A. Management of pilot program B. Individual Pilot Project Research Descriptions (Not to exceed 8 pages per project) C. Progress Report, if applicable, for renewal applications SECTION 3. Appendices (Six collated sets) Clearly identify the component to which the various appendices relate. (FORM PAGE 4) Detailed Budget for First 12-month Budget Period - Direct Costs Only Individual budget pages must be submitted for (a) the overall Center budget, (b) each core component, and (c) each research component. The budget for the entire Center for the first project year will retain the imprinted number 4. All subsequent pages will be renumbered consecutively at the bottom right. At the top left of each budget page, indicate the nature of the content (e.g., Administrative Core, Research Component 1). Overall Summary of Center Budget: This is a budget summary total for the Center. For each budget category (e.g., Personnel, Consultant Costs, and Equipment), enter a single amount that is the total for that category of all core components and all research components for year 01. Specific budget details should not be itemized here but should be shown in the separate budget pages for each core and each research component. Administrative Core Activities: Funds may be requested for personnel responsible for overall direction and support for the Center (such as the Scientific Director and any administrative staff); and for equipment, supplies, and other items to be used by several investigators or available to all Center personnel. Support also may be requested for program enrichment activities (such as colloquia or visiting scientists) and for consultant costs relating to planning and evaluation of the Center program. Administrative support requirements vary widely and will depend upon the nature of the Center's research and the collective needs of the investigators for resources. Research and/or Core Components: Each individual research component and each core component, including pilot projects if any, must have its own separate budget request. The individual component director and staff must be identified under "Personnel," and all costs related to the activity to be conducted within the component must be included. Sufficient detail and justification must be given to allow an assessment of the budget request in light of the research or service/support being proposed within the component. (FORM PAGE 5) Budget for Entire Proposed Project Period - Direct Costs Only Form Page 5 (renumbered with the appropriate consecutive number), is to be used for presentations of budgets for the entire project period and for detailed budget justifications, beginning with a summary of the request for the Center as a whole, then separately for each Center component. At the top left of each budget page, indicate the nature of the content (e.g., administrative core, research component 1). Overall Summary of the Center Budget Administrative Core Activities Core Components and/or Research Components: Identify and arrange in same order as previous budget section. Some components may not require the full five-year period of support; therefore, funds should be requested only for the period of time necessary to complete the proposed research. In addition, if, for example, a component is to start in the second year of the project period and funds are requested for a three-year period, the columns for the "1st Budget Period" and the 5th additional year must be left blank. Be sure that the year 01 budget for that component is clearly labelled to indicate the start year. Budget increases in excess of inflationary or cost-of-living increases must be clearly identified and justified. Chart Showing Percent of Effort for all Key Personnel by Project and Year Follow the budget presentations with a chart that summarizes for each component the percent of effort to be devoted by each individual listed as key personnel. Present one such chart for each project year, and include a total effort column on each chart. Use continuation pages. (BIOGRAPHICAL SKETCHES) Self-explanatory (OTHER SUPPORT) Self-explanatory (RESOURCES AND ENVIRONMENT) Resources and environment pages may be included for each component if such a presentation will facilitate understanding of the availability of needed resources. SECTION 2 - RESEARCH PLANS I. INTRODUCTORY OVERVIEW - The Center as an Integrated Whole (Must not exceed 10 pages) A. Specific Aims: Provide an overview of the entire proposed Center describing the central theme, purpose, and objectives. Discuss the philosophy and general plans for the proposed grant period and how the Center will achieve its major objectives. The narrative must clearly articulate the reasons a Center approach is needed for this work. B. Background and Significance: Describe the history of the proposed Center, the unique contributions that will accrue, the potential contribution of each component and pilot project (if applicable), the significance of the overall research goals and research theme, and the importance and relevance of these to the goals and mission of the Centers Program. C. Progress Report/Preliminary Studies: Renewal applications must provide a summary overview of major research accomplishments and progress toward achievement of goals since the last competitive review. Detailed information must be included in relevant components. Preliminary findings to be utilized in proposing new studies may be highlighted but discussed in detail in relevant components. Applicants may include reprints of the most significant research representing proposed or ongoing studies as an appendix to augment or support this section. The maximum number of reprints that will be accepted for each research component is five. D. Training Opportunities: Provide a brief description of opportunities for research training for persons from various disciplines and professions. Each core component and research component must begin with a Form Page 2 that includes an abstract (including the years the component will function), and a listing of key personnel for that component. Each core component and research component must be presented individually. II. Administrative Core A. Abstract and Key Personnel (Form Page 2 renumbered consecutively) B. Center Organization and Operation The administrative core component must include discussion of such issues as the framework and organization (including an organizational chart); authority and role of Center Director; authority and role of Scientific Director; committee structure and function; quality control mechanisms; institutional support; decision-making processes and day-to-day management; services provided by the core and how they are administered. C. Center Publications Center publications may be listed in the administrative core. It would be preferable that Center publications relevant to a particular component be listed in the research plan of that component and that especially relevant papers be appendices of a particular component. D. Educational Enrichment and Dissemination Activities Describe any scientific enrichment activities, such as special lectures, visiting scientist symposia, seminars, and workshops, and any scientific education and research dissemination activities for the public. III. Core and Research Components Core Component Narratives: The narrative for each must include a discussion of contributions that would be made to the Center as a whole. For core components, the research components and other research to be served should be made clear. The narrative must include how the core will contribute to the overall goals of the Center and how existing research projects or proposed research components will benefit from utilizing the core. The description must clearly indicate the facilities, resources, services, and professional skills that the core will provide. Include information on: A. Specific aims and objectives B. Background and significance Administration and overall management of the core including: 1) The decision-making process for use of services by investigators supported by the Center and/or by independent investigators supported by NIAAA. 2) Plans for use of core by investigators who are not part of the Center and not supported by NIAAA. 3) Resources and environment. C. Progress report/preliminary studies 1) Provide information on past and/or current utilization for renewal applications including benefits accrued in terms of research productivity of core users, cost savings to the Center and/or individual investigators. 2) Justify the need for continuing core or expanding current capacity, if applicable. D. Experimental Design and Methods 1) Outline design and procedures of service, techniques, training, and others, to be provided. 2) Identify professional staff and support staff, qualifications, role. 3) Describe services/support to be provided and their bearing on research productivity and quality. 4) Identify independent research projects and/or Center-supported research components proposed for core usage. 5) Describe plans for quality control. E-I See PHS 398 for instructions J. If relevant, two-page description of independently funded research projects using the core component. Research Component Narratives: The narrative for each proposed research component must have a clear description of major objectives and goals, its integration with the other components, and its relationship to the overall Center. In addition, detailed information must be provided in the following areas. A. Specific aims and objectives B. Background and Significance C. Progress Report/Preliminary Studies 1) Preliminary studies and findings 2) Progress report if component is proposed in renewal or supplemental application. Report must cover current and past grant period. D. Experimental Design and Methods 1. Outline experimental design and procedures. 2. Provide timetable or sequence for proposed studies. 3. Identify hazardous procedures, situations, and materials; and describe precautions to be exercised. Additional information is also required for the following areas for both core and research components. E. Human Subjects F. Vertebrate animals G. Consultants/Collaborators H. Consortium/Contractual Arrangements I. Literature cited (do not exceed four pages) Continue with as many research components as are proposed in the Center application, not to exceed a total of ten core and research components combined. IV. Pilot Project Component (optional) (Not to exceed 50 pages) Plans for support and management of pilot projects must be described in sufficient detail to permit scientific and technical merit review. The description must include the objectives, a brief description of planned pilot studies, and plans for administration of pilot project funds. The mechanism to oversee use of funds for proposed pilot studies must be described in sufficient detail to assure systematic and objective scientific review of pilot fund requests. In addition to information on evaluation and selection of new pilot projects, the narrative must state how progress of funded pilot studies will be evaluated. A. Management of pilot program (see "Pilot Project Component" of RFA) B. Individual pilot project research descriptions must be concise and may not exceed eight pages. Information must include: 1. Proposed investigator(s) 2. Specific aims 3. Background and significance 4. Preliminary data or findings 5. Methods and procedures 6. Innovative approaches 7. Human and animal subject issues 8. Consortium/collaborative arrangements if applicable 9. Literature cited 10. Budget estimate C. Renewal applications requesting continuation of pilot project support must provide a progress report on how the pilot program has contributed to the Center's overall accomplishments and provide an assessment of the benefits derived from availability of pilot project resources. SECTION 3. Appendix (Six collated sets. No page numbering necessary for Appendix) Number of publications and manuscripts accepted for publication (not to exceed five per major research component and/or core component). Appendix materials must be clearly labeled in terms of the component(s) to which they relate. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 45, 29 November 1991 Message-ID: Date: 3 Dec 91 01:51:12 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 1039 $$XID NIHGUIDE 19911129 V20N45 P1O1 ************************************ No RFAs present NIH GUIDE - Vol. 20, No. 45 - November 29, 1991 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NOTICE OF SKIPPED GUIDE PUBLICATION $$INDEX N2 ********************************************************** NOTICE OF REGIONAL MEETINGS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** UNITED STATES RENAL DATA SYSTEM (RFP NIH-NIDDK-92-2) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R2 03/03/92 ************************************************* RESEARCH ON PHARMACOLOGIC TREATMENTS FOR ALCOHOLISM (RFA AA-92-01) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** RESEARCH ON HAIR TESTING FOR DRUGS OF ABUSE (PA-92-18) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** SMALL INSTRUMENTATION GRANTS PROGRAM (PA-92-19) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX P3 ********************************************************** CENTERS FOR RESEARCH ON MENTAL HEALTH SERVICES FOR CHILDREN AND ADOLESCENTS (PA-92-20) National Institute of Mental Health INDEX: MENTAL HEALTH ERRATUM $$INDEX E1 ********************************************************** NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION (AI-91-13) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX E2 ********************************************************** ORPHAN RECEPTORS IN ENDOCRINOLOGY (DK-92-03) National Institutes of Diabetes and Digestive and Kidney Disease INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NOTE: The NIH Guide for Grants and Contracts will not be published on December 6. The next issue will be December 13. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NOTICE OF REGIONAL MEETINGS P.T. 42; K.W. 1014006, 1014002 National Institutes of Health The National Institutes of Health (NIH) has been engaged in a strategic planning process aimed at developing the Agency's first corporate long- range Strategic Plan. The purpose of the NIH Strategic Plan is to: (1) identify areas of research that promise extraordinary dividends for the Nation's future health, (2) nurture the intellectual base of biomedical research and the conditions that lead to breakthroughs on the cutting edge of science, and (3) provide approaches for addressing broad administrative and science policy issues that affect the ability of the NIH to carry out its mandate. The Strategic Plan incorporates the ideas of all the organizational components of the NIH as well as the research components of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). The NIH will convene two regional meetings to provide a forum for the extramural community to comment on the draft Strategic Plan before it is finalized. The first meeting will take place on February 12, 1992, at Occidental College, Los Angeles, California, and will be co-hosted by Occidental College and the Charles R. Drew University of Medicine and Science. The second meeting will be held on February 25, at the University of Connecticut Health Center, Farmington, Connecticut. Each of the regional meetings will be of one day duration, beginning at 9 a.m. and ending at 3 p.m. The meetings will begin with the NIH Director presenting an overview of the NIH Strategic Plan. Immediately afterwards, representatives of concerned organizations and institutions will be invited to present testimony before a panel of senior NIH officials, to be chaired by the Director, NIH. Due to time constraints, it would be appreciated if only one representative from each organization would present testimony; oral presentations will be limited to five minutes. Written testimony may be any length and should include a brief description of the organization presenting. Testimony will be scheduled based upon when notification of intent to present testimony is received. If the number of organizations that want to present oral testimony exceeds the time available on the agenda, the individual written statements will serve as testimony presented. All testimony, whether oral or written, will form a part of the official record of the NIH Strategic Plan. If you or others from your organization who plan to attend one of these regional meetings have any special needs that require assistance, please inform the office listed below. If you have questions concerning either of the two regional meetings, please contact Ms. Mary Demory (301) 496-1454. If you will be attending one of the regional meetings or if your organization would like to testify before the NIH panel, please provide the name, title, institution, telephone number, and mailing address of the individual attending. Indicate which regional meeting and whether or not testimony will be presented. The requested information is to be sent by mail or facsimile no later than December 16, 1991 to: NIH Strategic Plan Regional Meetings c/o Dr. Jay Moskowitz NIH, Building 1, Room 103 9000 Rockville Pike Bethesda, MD 20892 FAX: (301) 402-1759 A copy of the Draft NIH Strategic Plan and additional information will be sent prior to the regional meetings to participants attending and/or testifying. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are sponsoring a series of workshops on the responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: WEST COAST WORKSHOP DATES: January 23 and 24, 1992 (REVISED DATES) WORKSHOP SITE: Los Angeles, CA SPONSORS: University of Southern California Los Angeles, CA 90089-4014 California State University - Los Angeles 5151 State University Drive Los Angeles, CA 90032-8202 REGISTRATION CONTACT: Ms. Lily Patterson Assistant to the Director Research and Sponsored Programs California State University - Los Angeles 5151 State University Drive Los Angeles, CA 90032-8202 Telephone: (213) 343-3820 TOPIC: Whose Research is it Anyway? A Workshop on the Protection of Human Subjects in Research SOUTH MIDWESTERN WORKSHOP DATES: February 20 and 21, 1992 WORKSHOP SITE: San Antonio, TX SPONSORS: University of Texas Health Science Center at San Antonio 7703 Floyd Curl Drive San Antonio, TX 78284-7972 St. Mary's University One Camino Santa Maria San Antonio, TX 78228-8572 REGISTRATION CONTACT: Ms. Angie Khan Institutional Coordinator of Research Review University of Texas Health Science Center at San Antonio 7703 Floyd Curl Drive (Room 402L) San Antonio, TX 78284-7972 Telephone: (512) 567-2351 TOPIC: Identifying and Assessing Risks in Human Subject Research For further information regarding these workshops and future NIH/FDA National Protection of Human Subjects Workshops, please contact: Ms. Darlene Marie Ross Executive Assistant for Education Division of Human Subject Protections Office for Protection from Research Risks National Institutes of Health 9000 Rockville Pike Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-NIDDK-92-2 ******************************************* UNITED STATES RENAL DATA SYSTEM RFP AVAILABLE: NIH-NIDDK-92-2 P.T. 34; K.W. 0755018, 0780030, 1010013, 0785055 National Institute of Diabetes and Digestive and Kidney Diseases The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Division of Kidney, Hematology and Urology (DKUH) has a requirement to continue the Coordinating Center (CC) for the United States Renal Data System (USRDS). The CC, in coordination with the NIDDK and the Health Care Financing Administration (HCFA), shall provide the medical, biostatistical, epidemiological, data management, and analytical expertise to maintain and update the database. Equally important functions of the CC will be the coordination, scientific management, development, and expansion of the database, data analysis, preparation, and release of subset(s) of the database to support investigator-initiated research, and publications of papers and reports of scientific findings based on USRDS data. This program will be undertaken through the joint efforts of the NIDDK/DKUH and the HCFA Bureau of Data Management and Strategy, Health Standards and Quality Bureau, and the ESRD Networks or equivalent system in close collaboration with the United States nephrology and renal transplant communities and the major specialty organizations. The Request for Proposals (RFP) NIH-NIDDK-92-2 will be released on or about November 29, 1991, with a closing date on or about March 31, 1992. To receive a copy of this RFP, supply this office with two self addressed mailing labels and cite the RFP number referenced above. Requests must be in writing and addressed to: Patrick M. Sullivan Contracting Officer, Contracts Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 602 Bethesda, MD 20892 This advertisement does not commit the Government to make an award. $$R1 END ************************************************************ $$R2 BEGIN AA-92-01 ************************************************* RESEARCH ON PHARMACOLOGIC TREATMENTS FOR ALCOHOLISM RFA AVAILABLE: AA-92-01 P.T. 34; K.W. 0404003, 0710100, 0740020 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: April 3, 1992 PURPOSE Development of new medications for the treatment of brain and behavior disorders is a priority of the Alcohol, Drug Abuse,and Mental Health Administration (ADAMHA). As part of this initiative, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking applications for grants in the area of clinical pharmacological treatments for alcoholism. The Request for Applications (RFA), available from the program administrators listed below, briefly discusses current knowledge on pharmacologic therapies, some specific research questions under each topic, broader issues that "cut across" pharmacotherapy in the treatment of alcoholism, key study design considerations, procedures for submission and review of grant applications, and terms and conditions for grant support. The RFA deals with a range of pharmacological agents at various stages of research development, ranging from preclinical research and development to Food and Drug Administration (FDA) approval. 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, Research on Pharmacologic Treatments for Alcoholism, is related to the priority area of alcohol abuse reduction. 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 Applications may be submitted by domestic and foreign, nonprofit and for-profit public and private organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISMS OF SUPPORT Research support may be requested through applications for an individual research grant (R01), small grant (R03), First Independent Research Support and Transition (FIRST) Award (R29), and exploratory/developmental grants (R21). Applicants who are interested in applying for a FIRST Award (R29), Exploratory/Developmental Grant (R21), or Small Grant (R03) may request additional information about these funding mechanisms from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, Rockville, MD 20852, telephone (301) 468-2600. AVAILABILITY OF FUNDS In FY 1992, it is anticipated that approximately $2,300,000 will be available to support approximately 10 to 20 new grants, depending on the mechanism of support, under this RFA. 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 plans of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. BACKGROUND AND AREAS OF RESEARCH Over the past decade, research activity on the pharmacological treatment of alcohol dependency has burgeoned (Litten and Allen, 1991). As a result, many types of pharmacological agents have been employed in the various situations encountered in clinical practice. The pharmacological agents for managing the clinical events can be divided into the following categories (Liskow and Goodwin, 1987): Anticraving agents Aversive agents Agents to treat acute alcohol withdrawal Agents to treat the protracted withdrawal syndrome Agents to diminish drinking by treating associated psychiatric pathology Agents to decrease drinking by treating associated drug abuse Agents to induce sobriety in intoxicated individuals (amethystic agents) Research is needed to resolve questions within each of these classes of pharmacological agents. Research is also needed to address general questions that transcend specific pharmacological classes. The following provides a background on each of the classes of pharmacological agents listed, describes general, cross-cutting research issues in the area of pharmacotherapy, and identifies some specific research questions. The discussion of any agent within this announcement is not to be considered a comprehensive appraisal of its effectiveness nor an endorsement of its suitability for clinical trial. GENERAL RESEARCH QUESTIONS IN PHARMACOTHERAPY Even though research efforts on alcoholism treatment have expanded over the past decade, a wide range of general research questions remain in developing effective alcoholism treatments that employ pharmacotherapeutic agents. These include: o What are the precise conditions that are amenable to pharmacological interventions? How can psychosocial and behavioral interventions be integrated with pharmacotherapy to enhance treatment outcome? What should be the short-and long-term goals of these interventions? o What psychological and biomedical variables are associated with responsiveness to alcoholism medications in general and specific agents or classes of agents? o Is the concept of matching specific treatments to different aspects of alcoholism (e.g., alcohol subtypes, comorbid psychopathology, and primary versus secondary alcoholism) more efficacious than a more generalized medicational approach to treatment? o Does collateral pharmacological treatment enhance or detract from participation in traditional alcoholism treatment and sobriety support groups? o What are the most effective research/statistical methodologies for conducting pharmacologic research on alcoholism treatment? o How can alcohol abuse phenomena be quantified to assess more precisely the impact of psychopharmacological agents? o How can treatment compliance be measured during pharmacotherapy? o What are the long-range effects of pharmacotherapy? STUDY DESIGN CONSIDERATIONS Well-designed studies need to be conducted to answer research questions such as those listed above. These studies must include the use of appropriate control groups (i.e., double blind studies) with adequate sample sizes and employment of proper statistical analyses. In addition, all treatment interventions must be specified. Although developmental projects may employ highly homogeneous samples in a single setting, it is desirable in later-stage research to include greater heterogeneity in samples and sites. Finally, efficacy studies need to measure compliance and adequately verify self-reports. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS For projects involving clinical research, ADAMHA requires applicants to give special attention to the inclusion of women and minorities in study populations. If women and minorities are not included in the study populations, a specific and compelling justification for this exclusion must be provided. Applications that do not include women and minorities and that are without such documentation will not be accepted for review. APPLICATION PROCESS Applicants must use the grant application form PHS 398 (rev. 10/88). The number and title of this RFA, "AA-92-01, Research on Pharmacologic Treatments for Alcoholism," must be typed in item 2 on the face page of the PHS 398 application form. When using the PHS 398 application form to respond to an RFA, applicants must staple the RFA label, printed in the application kit, to the bottom of the face page. Failure to use this label could result in delayed processing of the application, such that it may not reach the review committee in time for review. The signed original and five permanent legible copies of the completed application should be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892 ** In addition, one copy must be sent directly to: Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16C-20 Rockville, MD 20857 Telephone: (301) 443-4375 INQUIRIES Potential applicants are encouraged to request a copy of the RFA and may contact the individuals listed below for consultation in preparing an application under this RFA. Direct inquiries regarding to program issues to: Division of Clinical and Prevention Research Raye Z. Litten, Ph.D. Treatment Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 14C-20 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-0796 Division of Basic Research Walter Hunt, Ph.D. Chief, Neuroscience and Behavioral Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16C-03 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4223 Direct inquiries regarding fiscal matters to: Ms. Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16-86 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4703 REVIEW PROCESS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this RFA will be assigned to an Initial Review Group (IRG) convened by the NIAAA in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the National Advisory Council on Alcohol Abuse and Alcoholism, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for consideration by the Council will be considered for funding. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authority of Sections 301 and 510 of the Public Health Service Act, as amended (42 USC 241 and 290bb). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-92-18 ************************************************* RESEARCH ON HAIR TESTING FOR DRUGS OF ABUSE PA AVAILABLE: PA-92-18 P.T. 34; K.W. 1003008, 0404009, 0710100 National Institute on Drug Abuse PURPOSE The goals of this program for which a program announcement is now available from the contact named below, are to encourage systematic research on the use of hair testing to detect drugs of abuse in an accurate and reliable manner and to develop the necessary procedures and safeguards. The purpose is to provide the scientific basis to enable the routine use of such testing in workplace situations, epidemiological studies, studies of the behavioral effects and medical consequences of chronic drug use, maternal and fetal studies, and other applications. Specific areas of interest discussed are: pharmacological studies, analytical studies, and cost/benefit studies. RESEARCH OBJECTIVES The National Institute on Drug Abuse (NIDA) is interested in exploring the pharmacokinetics of drugs in hair and some of the factors that would influence variability in these processes. Studies are encouraged that will identify the mechanisms by which drugs of abuse are incorporated into hair; the relationship between the amount of drug used and the concentration of the drug or its metabolites in hair; the relationship of hair incorporation to urine elimination; the minimum dose required to produce a positive result; the time interval between drug use and appearance of drug in the hair shaft; the in situ stability ,chemical and positional, of drugs; the variability of drug incorporation and retention in hair according to race, age, sex, and other individual differences; the extent to which externally applied drugs (whether by sweat, glandular secretions or environmental exposure) are retained in hair; the effect of various washing and hair treatment procedures on the removal of externally applied drugs and internally incorporated/bound drugs. This program encourages research aimed at evaluating existing methods or the development of new methodologies for the detection of drugs of abuse in hair specimens. Validation of these analytical techniques by assessing their accuracy, precision, sensitivity, and specificity and identifying ways to establish appropriate cutoffs that define potentially false-positive or false-negative results for either screening or confirmation procedures is strongly encouraged through this initiative. Research endeavors aimed at the development of reference materials for hair testing are also of interest to NIDA. Studies are encouraged that deal with sample preparation including those that relate to the effectiveness of various washing procedures in removing externally and/or internally bound drug and the effectiveness of various sample preparation techniques. The biggest costs of hair analysis are labor intensive preparation, handling, and analysis techniques. Instrumentation is an additional factor. Cost/benefit studies that compare drug testing using hair specimens with those using body fluids, such as urine or blood, would be extremely useful. Benefits of hair testing, including its non-invasiveness and the historical information it may provide, must be weighed against potential costs. 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, Research on Hair Testing for Drugs of Abuse, 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 "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). MECHANISM OF SUPPORT Mechanisms of support included under this announcement are limited to Research Project Grants (R01). Annual awards will be made subject to continued availability of funds and progress achieved. ELIGIBILITY Applications may be submitted by public and private non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. 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. APPLICATION PROCEDURES Applicants must use the research grant application form PHS 398 (rev. 10/88). Support may be requested for a period of up to five years (renewable for subsequent periods). A competing supplemental application may be submitted during an approved period of support to expand the scope of protocol of a project during the approved period. A competing continuation (i.e., renewal) application may be submitted before the end of an approved period of support to continue a project. RECEIPT AND REVIEW SCHEDULE Advisory Receipt Dates Initial Council Earliest New/Renewal Review Review Start Date Jun 1/Jul 1* Oct/Nov Jan/Feb Apr Oct 1/Nov 1* Feb/Mar May/Jun Jul Feb 1/Mar 1* May/Jun Sep/Oct Dec * Competing continuation, supplemental, and revised applications are to be submitted by these dates. REVIEW PROCESS AND CRITERIA Applications received under this announcement will be assigned to an Initial Review Group (IRG) consisting primarily of non-Federal scientific and technical experts. Applications will receive a second-level review by the appropriate National Advisory Council. Criteria for scientific/technical merit review of applications will include the following: significance and originality from a scientific or technical standpoint of the goals of the proposed research; adequacy of the methodology proposed to carry out the research; feasibility of the proposed research; qualifications and research experience of the Principal Investigator and other key research personnel; and adequacy of provisions for the protection of human subjects and the welfare of animal subjects, as applicable. AWARDS Applications recommended for approval by the appropriate National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, Institute program needs and balance, and availability of funds. INQUIRIES Further information and consultation on this program announcement may be obtained from: Robert L. Stephenson II, M.P.H. Division of Applied Research National Institute on Drug Abuse Parklawn Building, Room 9A-53 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6780 A copy of the complete program announcement may be obtained from: Grants Management Branch, OPRM National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Questions on fiscal or grant management issues may also be directed to this office. AUTHORITY AND REGULATIONS This program is described in Catalog of Federal Domestic Assistance No. 93.279. Grants will be awarded under the authority of sections 301 and 515 of the Public Health Service Act, as amended (42 USC 241 and 290cc) and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-92-19 ************************************************* SMALL INSTRUMENTATION GRANTS PROGRAM PA: PA-92-19 P.T. 34; K.W. 0735000, 1002024, 0735015, 1014001 National Institutes of Health Application Receipt Date: February 12, 1992 BACKGROUND The appropriations for the National Institutes of Health (NIH) for Fiscal Year (FY) 1987 included, for the first time funds for grants to purchase small instruments costing between $5,000 and $60,000. This action was in response to several studies of the problem of obsolete biomedical research instrumentation that indicate that the state of biomedical research instrumentation had seriously eroded over the previous ten years and that this situation was retarding the progress of biomedical research. Approximately $5 million will be available from the NIH in FY 1992 for small instrumentation grants. ELIGIBILITY AND TERMS OF AWARD Each institution that received $21,608 or less in support under the Biomedical Research Support Grant (BRSG) Program in FY 1991 and currently has active NIH research grant support is eligible to apply. Only one application may be submitted from each eligible institution or organizational component. Each institution may establish its own procedures for identifying equipment requests to be included. The small instrumentation award will be restricted to the purchase of equipment costing between $5,000 and $60,000. Awards will be made on or before September 30, 1992. The amount of the award will be based upon a percentage of the institution's research grants base for FY 1991 or $5,000, whichever is greater. Specific funding decisions will depend on available funds and the appropriateness of the request to the active projects. Institutions will be notified of the maximum amount for which they may apply. METHOD OF APPLYING Letters of instructions to eligible institutions will be mailed on or about November 28, 1991. Completed applications must be received by February 12, 1992. Investigators interested in participating in their institution's application must contact the institution's BRSG Program Director. Institutional officials who expect to be involved in preparing an application are requested to review the letter of instructions prior to contacting the NIH. For additional information contact: Office of Research Training and Special Programs Office of Extramural Programs National Institutes of Health Building 31, Room 5B44 Bethesda, MD 20892 Telephone: (301) 496-1968 AUTHORITY AND REGULATIONS Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241. $$P2 END ************************************************************ $$P3 BEGIN PA-92-20 ************************************************* CENTERS FOR RESEARCH ON MENTAL HEALTH SERVICES FOR CHILDREN AND ADOLESCENTS PA AVAILABLE: PA-92-20 P.T. 04, AA; K.W. 0715095, 0730050, 0403001 National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) announces the availability of support for Centers on Research on Mental Health Services for Children and Adolescents to develop multidisciplinary research to improve the organization, financing, delivery, effectiveness, and outcomes of mental health services for children and adolescents. This announcement addresses one of the major goals set forth in The National Plan for Research on Child and Adolescent Mental Disorders. It also complements the NIMH program announcement, Implementation of the National Plan for Research on Child and Adolescent Mental Disorders, available from NIMH, Room 9-95, 5600 Fishers Lane, Rockville, MD 20857; telephone: (301) 443-4673. 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. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017- 001-00473-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20042-9325 (telephone: 202-783-3238). This announcement is responsive to the Healthy People 2000 Objectives in the areas of suicide attempts among adolescents (6.2), mental disorders among children and adolescents (6.3), and assessment by primary care providers of children's and adolescents' cognitive, emotional, and parent-child functioning with appropriate counseling, referral, and followup (6.4). ELIGIBILITY Applications may be submitted by any public and private, nonprofit and for-profit organizations such as universities, colleges hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS For projects involving clinical research, ADAMHA requires applicants to give special attention to the inclusion of women and minorities in study populations. If women and minorities are not included in the study populations, a specific and compelling justification for this exclusion must be provided. Applications that do not include women and minorities and that are without such documentation will not be accepted for review. Applicants should also be aware that the Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations for the protection of children. A copy of these regulations, 45 CFR 46, Protection of Human Subjects, is available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B59, Bethesda, MD 20892. METHOD OF APPLYING Applications will be received under the usual PHS receipt and review schedule. To be considered for fiscal year 1992 funding, applications must be complete and must be submitted by February 1, 1992. All research applicants must use the grant application form PHS 398 (rev. 10/88). Support may be requested for a period of up to five years. Annual awards will be made subject to continued availability of funds and progress achieved. A competing supplemental application may be submitted during an approved period of support to expand the scope or protocol of a project during the approved period. A competing continuation (i.e., renewal) application may be submitted before the end of an approved period of support to continue a project. Grant funds may be used for expenses clearly related and necessary to conduct research projects, including direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention intervention service program. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make significant contribution to theoretical concepts. REVIEW PROCEDURES Applications will be reviewed by an initial review group (IRG) primarily consisting of non-Federal scientific and technical experts. Applications will receive a second-level review by the appropriate Advisory Council based on policy considerations and scientific merit. Only applications recommended for approval by Council may be considered for funding. Preference will be given to projects consistent with the NIMH Public-Academic Liaison initiative (bringing together public sector service providers and academic researchers), projects involving high-risk populations (e.g., homeless children and adolescents, and those with severe mental disorders), and projects that include females and minorities in study groups. INQUIRIES Applicants are strongly encouraged to contact the office listed below. Copies of the full program announcement and additional information may be obtained by contacting: Thomas L. Lalley, M.A., Chief Kathryn M. Magruder, Ph.D., M.P.H., Assistant Chief Kimberly Hoagwood, Ph.D. Services Research Branch Division of Applied and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-372 Information on grants management issues can be obtained from: Steven J. Hudak Grants Management Section National Institute of Mental Health 5600 Fishers Lane, Room 7C-26 Rockville, MD 20857 Telephone: (301) 443-4596 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Under the authority of Section 301 of the Public Health Service Act (42 U.S.C. 241), as amended, NIMH will accept applications in response to this announcement. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or review by a Health Systems Agency. $$P3 END ************************************************************ ERRATUM $$E1 BEGIN R5 19911101 APPEND RFA AI-91-13 BOTH ************************ NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION RFA: AI-91-13 P.T. 34; K.W. 0715008, 0740020, 0755025 National Institute of Allergy and Infectious Diseases The National Cooperative Drug Discovery Groups for the Treatment of Human Immunodeficiency Virus Infection (NCDDG-HIV) Request for Applications (RFA) (NIH Guide for Grants and Contracts, Vol. 20, No. 41, November 1, 1991) has been amended. This amendment applies only to copies of the RFA that are obtained from the Division of AIDS, National Institute of Allergy and Infectious Diseases. The amendment is to clarify the purpose of the letter of intent (p.2), to state that an NIAID peer review group will determine the competitiveness of the application in triage (p. 22), to include acknowledgement of the recent approval of didanosine by the Food and Drug Administration (p. 2), and to modify the wording of the section on the Inclusion of Women and Minorities in Basic Research Studies (pp. 21-22). Copies of the modification may be obtained from: Ms. Besita Wyche Targeted Drug Discovery Section Developmental Therapeutics Branch, Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2C11 Bethesda, MD 20892 Telephone: (301) 496-8197 $$E1 END ************************************************************ $$E2 BEGIN R4 19911004 APPEND RFA DK-92-03 BOTH ************************ ORPHAN RECEPTORS IN ENDOCRINOLOGY RFA: DK-92-03 P.T. 34: K.W. 0785050, 0760075, 1002004, 1002008, 0710100, 1002061 National Institutes of Diabetes and Digestive and Kidney Disease Letter of Intent Receipt Date: December 15, 1991 Application Receipt Date: January 24, 1992 This Request for Applications was published in the NIH Guide for Grants and Contracts on October 4, 1991, Vol. 20, No. 37. The applications will be reviewed for scientific and technical merit by an Initial Review Group convened by the Division of Research Grants. The other review procedures remain unchanged. For further information, contact: Ronald N. Margolis, Ph.D. Director, Endocrinology Research Program Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 605 Bethesda, MD 20892 Telephone: (301) 496-7504 $$E2 END ************************************************************ **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, MD 20816 From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!ere.umontreal.ca!yang From: yang@ere.umontreal.ca (Yang Jing-Hua) Newsgroups: bionet.sci-resources Subject: sub Message-ID: <9111240727.AA01025@alize.ERE.UMontreal.CA> Date: 24 Nov 91 07:27:51 GMT Sender: daemon@genbank.bio.net Distribution: bionet Lines: 2 subscribe sci-res Jinghua YANG From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!BRUFV.BITNET!DBGX3283 From: DBGX3283@BRUFV.BITNET ("clovis a. neves") Newsgroups: bionet.sci-resources Subject: subscribe Message-ID: <9110152112.AA14300@genbank.bio.net> Date: 15 Oct 91 21:12:12 GMT Sender: daemon@genbank.bio.net Distribution: bionet Lines: 1 i would like subscribe-me in this list. thanks. clovis a. neves. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 16, 19 April 1991 Message-ID: Date: 17 Apr 91 20:26:08 GMT Sender: kristoff@genbank.bio.net Lines: 1279 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19910419 V20N16 P1O1 ************************************ X-comment: RFAs described: HG-91-02 NIH GUIDE - Vol. 20, No. 16, April 19, 1991 $$INDEX BEGIN ********************************************************** NOTICES $$INDEX N1 ************************************************************* THE NATIONAL CELL CULTURE CENTER National Center for Research Resources Index: RESEARCH RESOURCES $$INDEX N2 ************************************************************* NOTICE FOR APPLICANTS USING PHS FORM 416-1 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration Index: NATIONAL INSTITUTES OF HEALTH ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 07/15/91 **************************************************** NEW TECHNOLOGIES FOR DETECTING ALL GENES AND CODING REGIONS IN GENOMIC DNA (HG-91-02) National Center for Human Genome Research Index: HUMAN GENOME ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ************************************************************* SPECIALIZED MENTAL HEALTH CLINICAL RESEARCH CENTERS GENERAL MENTAL HEALTH CLINICAL RESEARCH CENTERS (PA-91-43) National Institute of Mental Health Index: MENTAL HEALTH $$INDEX P2 ************************************************************* RESEARCH GRANTS ON THE NEUROLOGICAL BASIS OF COGNITION (PA-91-44) National Institute of Neurological Disorders and Stroke Index: NEUROLOGICAL DISORDERS, STROKE ERRATA $$INDEX E1 ************************************************************* CLINICAL MENTAL HEALTH ACADEMIC AWARD (PA-91-38) National Institute of Mental Health Index: MENTAL HEALTH $$INDEX END ************************************************************ NOTICES $$N1 BEGIN ************************************************************* THE NATIONAL CELL CULTURE CENTER P.T. 34; K.W. 0780015, 0780000, 0760045 National Center for Research Resources The National Cell Culture Center is a resource facility that provides large scale mammalian cell culture services. The Center, available to researchers throughout the United States, has been established to alleviate the current shortage of facilities and expertise required to meet the cell culture needs of the biomedical research community. Specifically, the Cell Culture Center supports basic research and provides investigators with the following customized services: o Large quantity production of mammalian cells in suspension or monolayer cultures. Quantities range from 10 to 150 liters. o Large quantity production of monoclonal antibodies. Quantities range from 0.5 to 100 grams. o Large quantity production of non-hybridoma cell secreted proteins. Quantities vary depending on individual cell lines. An application form, obtained from the Cell Culture Center, should contain a description of the relevant research project. Following approval of the application by the Cell Culture Center's Scientific Advisory Board, the applicant's cell line is sent to the Center, and grown to the requested amount. Researchers are charged only for the consumable materials and a portion of the labor costs required for each project. Application forms and inquiries should be directed to: Mark Hirschel, Ph.D. Director National Cell Culture Center Endotronics, Inc. Minneapolis, MN 55433 Telephone: 1-800-325-1112 The Cell Culture Center is supported by a cooperative agreement award from the National Center for Research Resources, NIH. $$N1 END *************************************************************** $$N2 BEGIN ************************************************************* NOTICE FOR APPLICANTS USING PHS FORM 416-1 P.T. 34; K.W. 1014006 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration INSERT FLYER FOR APPLICANTS USING PHS FORM 416-1 REGARDING IMPLEMENTATION OF THE NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS The purpose of this notice is to provide special instructions to research grant and cooperative agreement applicants using Form PHS 416-1, regarding NIH and ADAMHA policies concerning the inclusion of women and minorities in clinical research study populations. These policies were published in the NIH Guide for Grants and Contracts on February 8, 1991, Vol. 20, No. 6. PRIORITY ANNOUNCEMENT SPECIAL INSTRUCTIONS TO APPLICANTS USING FORM PHS 416-1 REGARDING IMPLEMENTATION OF THE NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NOTE: THESE INSTRUCTIONS APPLY ONLY TO THE LIMITED NUMBER OF GRANT AND COOPERATIVE AGREEMENT APPLICANTS WHO PROPOSE CLINICAL RESEARCH STUDIES, WHICH INCLUDE 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. NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants, cooperative agreements and contracts 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. If women or minorities are not included or are inadequately represented in clinical research, particularly in proposed populations-based studies, a clear, compelling rationale should be provided. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH and ADAMHA recognize that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e, Native Americans (American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. Beginning immediately, all applications submitted to NIH/ADAMHA will be required to address this policy. INSTRUCTIONS TO APPLICANTS Applications must include a description of the composition of the proposed study population in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 416-1 in Part I (Applicant), Item 29.b. (1) - (3) of the Research Proposal AND summarized in 29.b. (5) Human Subjects/Vertebrate Animals, and in Part II (Sponsor), Item 36. Human Subjects. Applications must employ a study design with gender and/or minority representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the disease, disorder or condition being studied. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women with regard to the hypothesis under investigation, applicants should include an evaluation of gender and minority group differences in the proposed study. If adequate inclusion of women or minorities is impossible or inappropriate with respect to the purpose of the research, the health of the subjects, or other reasons, or if in the only study population available there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified in the application. 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 in the application. PEER REVIEW Scientific Review Administrators (formerly Executive Secretaries) of the Initial Review Groups (IRGs) will request written clarification from the applicant when the application does not describe and justify the gender or minority composition of the study population. If such information is not contained within the application, and is not provided upon request, the application will be deferred without IRG review until it is complete, or be returned to the applicant. In the case of responses to RFAs with single receipt dates, applications that are not brought into compliance will be returned without review, rather than deferred. Scientific Review Administrators of all scientific IRGs will instruct the IRG members that the assessment of scientific and technical merit of applications must include an evaluation of the proposed gender and minority composition of the study population and its appropriateness to the scientific objectives of the study and to this policy. If the representation of women and 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 the assigned score given to the application. When preparing the summary statement, the Scientific Review Administrator will summarize the findings and recommendations of the reviewers on this policy in a special section at the end of the Critique sub-headed: Women and Minority Subjects. Regardless of the priority score, percentile ranking or program relevance of the proposed research, the NIH and ADAMHA funding components will not fund/award grants that do not comply with this policy. APPLICANTS SHOULD CONTACT NIH/ADAMHA PROGRAM STAFF FOR ADDITIONAL GUIDANCE IN INTERPRETING THIS POLICY IN THE CONTEXT OF ANY SPECIFIC INSTITUTE, CENTER OR DIVISION RESEARCH PROGRAM OF NIH/ADAMHA. For further information or for questions concering this notice, contact: Dr. Samuel Joseloff Chief, Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 Bethesda, MD 20892 Telephone: (301) 496-7441 $$N2 END *************************************************************** NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN HG-91-02 FULL-TEXT ****************************************** NEW TECHNOLOGIES FOR DETECTING ALL GENES AND CODING REGIONS IN GENOMIC DNA RFA AVAILABLE: HG-91-02 P.T. 34; K.W. 1215018, 0755045, 1002008, 1002058 National Center For Human Genome Research Letter of Intent Receipt Date: June 17, 1991 Application Receipt Date: July 15, 1991 The National Center for Human Genome Research (NCHGR) invites applications for assistance awards to support the development of new technologies capable of (1) detecting all coding sequences and/or genes in genomic DNA or (2) preparing complementary DNA (cDNA) libraries that are representative of all expressed genes. BACKGROUND There are several approaches to detecting coding information in the genome: (1) identification of cDNAs representing expressed genes; (2) identification of sequences conserved across species; and (3) identification of sequences capable of being expressed, using techniques such as exon trapping. Problems in using these approaches for thorough screening of the genome include the low abundance of many mRNAs and the differential tissue or developmental expression of many genes. Given the magnitude of the effort necessary to identify all genes and/or coding sequences and to differentiate non-coding sequences from coding sequences, new or significantly improved strategies need to be developed to insure that all coding sequences located within a region of genomic DNA can be identified and characterized in an expeditious and cost-effective manner. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDIES NIH policies concerning research on human subjects apply to this program. For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded from this requirement. 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 must be addressed by applicants. RESEARCH SCOPE Projects responsive to this Request for Applications (RFA) should seek to develop new technologies or research strategies to identify genes and/or coding sequences in genomic DNA or to isolate cDNAs in a rapid, thorough and cost-effective manner. Applications in the following areas are encouraged: o Methods of identifying all the genes or complete coding regions directly from genomic DNA; o New methods of generating high quality, full- length cDNAs; o New methods of generating and ordering cDNA libraries that are representative of the complete coding information content of genomic DNA or of all coding regions expressed in various tissues. Emphasis will be on projects that are based on experimental rather than computational approaches. MECHANISM OF SUPPORT Support for this program will be through research grants (R01s). The total amount of support available for grants under this RFA is approximately $1.5 million for the first year of the project and is contingent upon the appropriation of funds for this purpose. Approximately six awards will be made and will be contingent upon the quality of the applications received. ELIGIBILITY Domestic universities, medical colleges, hospitals, and other public or private research institutions, including State and local government units, are eligible. Applications from minority investigators and women are encouraged. LETTER OF INTENT Potential applicants are asked to submit a letter of intent by June 17, 1991. This letter should include a descriptive title of the proposed research, name of the Principal Investigator and other key investigators and their institutions. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. Letters of intent should be sent to the program person listed at the end of this RFA. APPLICATION AND REVIEW PROCEDURES Applications in response to this announcement will be reviewed in accordance with the usual NIH peer review procedures. Applications will be screened first by NIH staff for responsiveness to this RFA. Those deemed non- responsive will be returned to applicants or referred to the Division of Research Grants for processing by the regular procedure. If a large number of responsive applications is received, they will undergo a preliminary peer review by the Genome Research Review Committee, NCHGR, to identify the most meritorious ones. Applications that are deemed non-competitive by this process will receive only a brief critique and will not be reviewed further. The remaining applications will be reviewed for scientific and technical merit by the Genome Research Review Group, NCHGR. The second level of review will be conducted by an appropriate national advisory council. Review criteria include the following: o Originality and innovativeness of the approach; o Overall scientific and technical merit of the research; o The potential of the proposed work to attain the research objectives outlined in this RFA; o Training, experience, research competence, and dedication of the investigator(s); o Adequacy of available facilities; o Provision for the protection of human subjects and the humane care of animals; and o Appropriateness of the requested budget for the work proposed. Applications must be submitted using the form PHS 398 (rev. 10/88). The RFA label available in the revised application kit MUST be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Application kits are available in the business or grants offices at most academic or research institutions and from the Division of Research Grants, National Institutes of Health. TIMETABLE: Receipt Date: July 15, 1991 IRG Review: November 1991 Council Review: February 1992 Earliest Funding Date: April 1992 It is essential that applicants type "New Technologies for Detecting Genes in Genomic DNA" and the RFA number, HG-91-02, on line 2 on the face page of the application form. The original and four copies of the application must be submitted to: Grant Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 5333 Westbard Avenue Bethesda, MD 20892** To expedite the review process, it is also important to submit two copies of the application directly to: Office of Scientific Review National Center for Human Genome Research National Institutes of Health Building 38A, Room 604 9000 Rockville Pike Bethesda, MD 20892 Funding decisions will be based on recommendations of the initial review group and the advisory council regarding scientific merit and program relevance, and on the availability of funds. Prospective applicants are encouraged to contact staff very early in the planning phase of the application. For more information regarding the program or a complete copy of the RFA, please contact: Bettie J. Graham, Ph.D. Chief, Research Grants Branch National Center for Human Genome Research National Institutes of Health Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 E-mail: B2G@NIHCU.BITNET; B2G@CU.NIH.GOV For information about PHS Grant Policy, applicants may contact: Ms. Alice Thomas Chief, Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 National Institutes of Health Bethesda, MD 20892 The program and grants management officials welcome the opportunity to clarify any issues or questions related to this RFA and encourage written or telephone inquiries. $$R1 END *************************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN ************************************************************* SPECIALIZED MENTAL HEALTH CLINICAL RESEARCH CENTERS GENERAL MENTAL HEALTH CLINICAL RESEARCH CENTERS PA: PA-91-43 P.T. 04; K.W. 0715095, 0715129 National Institute of Mental Health The National Institute of Mental Health seeks applications for the support of Specialized Mental Health Clinical Research Centers (SMH-CRC) and General Mental Health Clinical Research Centers (GMH- CRC). An SMH-CRC provides research resources that are to be used by a cooperating group of researchers as the foundation for a research program focused around a single major theme, typically a mental disorder or a group of closely related disorders. A GMH- CRC has no single thematic focus but provides the enabling research infrastructure to support a broad range of mental health clinical investigations; it may have multiple research foci that are not necessarily related in nature. Both types of centers provide infrastructure support, rather than support for specific research studies. 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, "Specialized Mental Health Clinical Research Centers; General Mental Health Clinical Research Centers," is related to the priority area of mental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). This announcement supersedes the prior announcements for Mental Health Clinical Research Centers (MH-CRC) and Clinical Research Centers for the Study of the Psychopathology of the Elderly (CRC/PE) and will govern future competitive renewals for existing Centers, as well as applications for new Centers. These grants are available to any public or private, nonprofit institution, such as a university, college, hospital, or community agency, units of State and local government, authorized units of the Federal Government, and for-profit institutions and entities. Each of the Centers should involve a clinical facility with research laboratory capability and be affiliated with a major university or research center. No organization may have both an SMH-CRC and a GMH-CRC, and it may not have more than one GMH-CRC. Applications for NIMH grants are required to include both women and minorities in study populations for clinical research. Research projects that use Center resources should incorporate into their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. There are two categories of grant applications under each of these two different programs: applications for Developing Centers (P20) and applications for Mature Centers (P30). The intent is to encourage the broadened use of the clinical research center approach across a wide range of institutions at various stages of research capacity development. The funding cap for grants for Developing Centers is $300,000, plus negotiated institutional indirect costs. The funding cap for Mature Centers is $1,000,000, plus negotiated institutional indirect costs. All of the following characteristics must be apparent in each application: Each Center should provide an environment of scientific excellence that will assure the highest quality research and leadership in its particular area(s) of investigation. Each SMH-CRC and GMH-CRC must include a research apprentice or career development component that is an integral aspect of training programs in psychiatry, nursing, social work, clinical psychology, and/or graduate training programs in basic science departments in medical and graduate schools. Each Center must have a scientifically and administratively well-qualified Center Director with primary responsibility for administration. He or she is responsible for the overall coordination and development of the Center as a valuable integral resource for the parent institution and for the quality of the ongoing research. The Center must have an administrative structure that will assure maximum effectiveness and efficiency of operation and sound financial practices. The Center should have access to sufficient inpatient and/or outpatient facilities to ensure availability of patients for the specific clinical research programs. The Center accomplishes its research goals through the provision of core facilities and research laboratories that provide an infrastructure for the independently funded research associated with the Center. The provision of these facilities is designed to enhance the overall research effort. One of the most important roles of a Developing Center is that of a magnet to draw other high quality scientists, laboratories, and project grants into the Center. Application for a Developing Center should not be made if the resources for a full operating Center are present. Each Developing CRC should be capable of providing research experience for at least two research apprentices annually. Such apprenticeships shall be made available to junior faculty and postdoctoral staff, as well as senior residents. Criteria for Developing Centers include the quality and extent of institutional support available to facilitate the development of the Center; the likelihood that the Center will develop into a fully mature Center during the five years of support; the quality of the plans to recruit excellent, new research faculty; and the likelihood that the establishment of a Developing Center will facilitate the existing research activities. For a Mature Center, the research program must be focused on an organizing theme which should be a clearly defined mental disorder or related group of disorders or a specific mental health problem or issue of major scientific and/or public health importance. The following criteria apply specifically to MH-CRCs: the quality, appropriateness, and originality of the integrating theme, including its logic and linear development; the appropriateness and novelty of the research questions being asked; and the kind and degree of synergistic potential of the individually supported research projects. Applications will be accepted and reviewed according to the regular Center review schedule. Funding for Developmental Centers is for a five-year period only. Funding for Mature Centers can be for a maximum project period of five years, and additional project periods may be funded following competitive renewal. Actual amounts and years of support that may be approved and awarded will depend on the appropriate level of support necessary for the scientifically meritorious work proposed. Potential applicants may seek information and consultation from the Division of Clinical Research, NIMH, by contacting: Leonard Lash, Ph.D., Chief Parklawn Building, Room 10-99 Telephone: (301) 443-3264 For Aging Clinical Research Centers: Barry D. Lebowitz, Ph.D., Chief Parklawn Building, Room 7-103 Telephone: (301) 443-1185 For grants management information: Stephen J. Hudak Parklawn Building, Room 7C-26 Telephone: (301) 443-4456 The address for all of the above is: National Institute of Mental Health 5600 Fishers Lane Rockville, MD 20857 This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Under authority of Section 301 of the Public Health Service Act, as amended PL 78-410, 42 U.S.C. 241, the National Institute of Mental Health provides support for Clinical Research Centers. $$P1 END *************************************************************** $$P2 BEGIN ************************************************************* RESEARCH GRANTS ON THE NEUROLOGICAL BASIS OF COGNITION PA: PA-91-44 P.T. 34; K.W. 1002030, 0414005, 0705010 National Institute of Neurological Disorders and Stroke This program announcement, reissued by the Division of Fundamental Neurosciences of the National Institute of Neurological Disorders and Stroke (NINDS), is designed to encourage the submission of research grant applications dealing with the neurological basis of cognitive processes. I. BACKGROUND The 1990s have been designated as the Decade of the Brain. The 1980s saw a burgeoning of research into how the two hemispheres of the mammalian brain differ in anatomy and in their contributions to cognitive functions, and it can now be expected that sophisticated physiological investigations will provide a more thorough understanding of mechanisms that underlie asymmetrical brain functions. Recent studies have demonstrated a system of structures in the human brain supporting mechanisms of attention; different components of attention will likely be found to be associated with different neural systems. Sex differences also have been reported in brain functions underlying cognitive processes, but possible reasons for these differences are not yet well understood. Lately, research on cognitive processes has intensified because of advances in understanding the neurobiology of cognitive function. This announcement encourages continued research in this field and development of new investigative techniques. II. SCOPE The Division presently supports research on the nature of the neurological basis of cognition, some of which resulted from an announcement on the "Neurophysiology of Cognitive Processes" issued a decade ago. The present announcement supersedes the earlier one and is meant to expand this area of research. Examples of research areas: Investigations envisioned by this announcement could include the following: o Localization of function with brain scanning devices, using reliable methods of assessing such functions as imagery, closure, autobiographical memory, different facets of attention and problem solving. o Neurophysiological and noninvasive neuropsychological research on nonhuman primates engaged in language-relevant communication, including the use of numbers. If, as in the human being and certain birds, there is asymmetrical function, tracking the localization as it develops can provide further insight into the nature of the mechanisms. o Comprehensive analysis of gender differences on the effects of circumscribed static neurological lesions upon well-standardized cognitive measures, with attention to comparing patients with either anterior or posterior locations of lesions, subcortical or cortical locations, right or nonright handedness, etc. o Neurophysiological measures obtained from nonhuman primates engaged in repetitive event-related activities. Certain theories about brain function during event-related potentials might profitably be tested in primates or other nonlissencephalic animals. Noninvasive methods could be used with the more rare and endangered species. o Investigations of episodic and semantic memory which could lead to biologically based distinctions. III. MECHANISM OF SUPPORT The support mechanisms for grants in this area are individual research grants (RO1), program projects (PO1), and First Independent Research Support and Transition (FIRST) awards (R29). APPLICATION AND REVIEW PROCEDURES Applications are to be prepared on form PHS 398 (rev. 10/88) using the instructions included in the application kit available from the Office of Sponsored Research at most institutions, from the Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, or from the NINDS address given below. Additional application guidelines for NINDS PO1 applications should be obtained from NINDS (see below). Receipt dates for new research project grant and FIRST award applications are February 1, June 1, and October 1. To identify responses to this announcement, indicate "Research Grants on the Neurological Basis of Cognition, PA-91-44" under item 2 of page 1. A mailing label is provided in the application kit. Send the signed original and six exact copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applications for research project grants and FIRST awards will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Secondary review will be provided by an appropriate national advisory council. Applications judged to be within the purview of other Institutes of NIH will be assigned accordingly, e.g., applications dealing with cognition and aging would be sent to NIA. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC progam director or Principal Investigator may be included in the application. For further information, and for program project guidelines (P01s), potential applicants are encouraged to call or write to: Herbert C. Lansdell, Ph.D. Division of Fundamental Neurosciences National Institute of Neurological Disorders and Stroke Federal Building, Room 916 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-5745 For fiscal and administrative matters, contact: Patricia Driscoll Grants Management Specialist National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7500 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH 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 review will be deferred until the information is provided. (For RFAs, change to read: If the required information is not contained within the application, the application will be returned.) Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. ELIGIBILITY REQUIREMENTS Applications for research grants may be made by public or private for-profit or non-profit organizations, such as universities, colleges, hospitals or laboratories, units of State or local government, or authorized units of the Federal Government. Women and minority investigators, in particular, are encouraged to apply. This program is described in the Catalog of Federal Domestic Assistance No. 93.854, Biological Basic Research in the Neurosciences. Awards will be made under the authority of the Public Health Service Act, Section 301 (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 review by a Health Systems Agency. $$P2 END *************************************************************** ERRATA $$E1 BEGIN ************************************************************* CLINICAL MENTAL HEALTH ACADEMIC AWARD PA: PA-91-38 P.T. 34; K.W. 0715095, 0715129 National Institute of Mental Health The National Institute of Mental Health announces that incorrect information pertaining to funding was contained in the third paragraph of the Clinical Mental Health Academic Award announcement in the NIH Guide for Grants and Contracts, Vol. 20, No. 13, March 29, 1991. The funding information is as follows: NIMH will provide 75 percent of the base institutional salary, up to a maximum stipend of $75,000 plus fringe for each year of the award. An additional $25,000 may be requested each year for research and/or career development support. $$E1 END *************************************************************** **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 FULL TEXT OF RFAs FOR ONLINE ACCESS $$XID RFA HG9102 HG-91-02 P1O1 ***************************************** NEW TECHNOLOGIES FOR DETECTING ALL GENES AND CODING REGIONS IN GENOMIC DNA RFA: HG-91-02 P.T. 34; K.W. 1215018, 0755045, 1002008, 1002058 National Center For Human Genome Research Letter of Intent Receipt Date: June 17, 1991 Application Receipt Date: July 15, 1991 The National Center for Human Genome Research (NCHGR) invites applications for assistance awards to support the development of new technologies capable of (1) detecting all coding sequences and/or genes in genomic DNA or (2) preparing complementary DNA (cDNA) libraries that are representative of all expressed genes. The NCHGR sponsors basic and applied research concerned with the development and application of new technologies for the characterization and analysis of the human genome and the genomes of selected model organisms. The activities encompassed by the NCHGR program include genetic and physical mapping, DNA sequencing, informatics related to mapping and sequencing, and technology development which will facilitate all of these efforts. The NCHGR, in conjunction with the Department of Energy, recently formulated a five-year plan that identifies areas where further research, including new technology development, is needed if the characterization of the human and other genomes is to proceed to the degree envisioned by the scientific community. A copy of the five-year plan is available from: Human Genome Management Information System; Oak Ridge National Laboratory, Oak Ridge, TN 37831-6050; telephone number (615) 576-6669. BACKGROUND One of the long-range objectives of the Human Genome Program is the sequencing of the 3 billion base pairs of human DNA and the genomes of select model organisms. A challenge attendant upon acquisition of a large amount of DNA sequence is the identification of all coding sequences or genes within it. To date only a small fraction of the estimated 50,000 to 100,000 human structural genes has been identified. While over 5,000 diseases that are genetic in origin have been identified, only a small number of genes associated with such diseases have been mapped and fewer have been sequenced. The GenBank nucleic acid sequence database lists approximately 2,800 expressed protein-coding sequences which are of human origin. Most of these data have been accumulated through the efforts of individual investigators whose primary interest was in a particular gene and its biology. There are several approaches to detecting coding information in the genome: (1) identification of cDNAs representing expressed genes; (2) identification of sequences conserved across species; and (3) identification of sequences capable of being expressed, using techniques such as exon trapping. Problems in using these approaches for thorough screening of the genome include the low abundance of many mRNAs and the differential tissue or developmental expression of many genes. Given the magnitude of the effort necessary to identify all genes and/or coding sequences and to differentiate non-coding sequences from coding sequences, new or significantly improved strategies need to be developed to insure that all coding sequences located within a region of genomic DNA can be identified and characterized in an expeditious and cost-effective manner. The purpose of this Request for Applications (RFA) is to solicit applications for investigator-initiated research projects in two areas: (1) the development of new methods of identifying coding sequences or genes. As a guideline, contigs on the order of two million base pairs are currently being produced in the course of physical mapping projects and new technologies for megabase sequencing are being developed. Thus, two megabases of DNA appears to be a reasonable target size in which to test the ability of any new technology to identify all coding sequences. (2) The development of more general and efficient methods of preparing, isolating and characterizing libraries of intact cDNAs. Current methods are limited, labor-intensive and inefficient. These two areas represent a major challenge in completely analyzing complex genomes. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDIES NIH policies concerning research on human subjects apply to this program. For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded from this requirement. 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 must be addressed by applicants. RESEARCH SCOPE Projects responsive to this RFA should seek to develop new technologies or research strategies to identify genes and/or coding sequences in genomic DNA or to isolate cDNAs in a rapid, thorough and cost-effective manner. Applications in the following areas are encouraged: o Methods of identifying all the genes or complete coding regions directly from genomic DNA; o New methods of generating high quality, full-length cDNAs; o New methods of generating and ordering cDNA libraries that are representative of the complete coding information content of genomic DNA or of all coding regions expressed in various tissues. Emphasis will be on projects that are based on experimental rather than computational approaches. Computational-based applications that focus on new technologies and approaches to identifying all genes or coding sequences among several million contiguous nucleotides of genomic sequence data should be submitted under the regular program announcement, "Mapping, DNA Sequencing, and Technology Development in Support of the Human Genome Program," which was published July 27, 1990, in the NIH Guide to Grants and Contracts, Vol. 19, No. 28. Proposals that use standard or currently available techniques for the isolation of candidate cDNAs associated with a specific function or phenotype will not be considered responsive. MECHANISM OF SUPPORT Support for this program will be through traditional research grants (R01s). The total amount of support available for grants under this RFA is approximately $1.5 million for the first year of the project and is contingent upon the appropriation of funds for this purpose. There is no set limit on the size of each award. Rather, each investigator should propose a budget adequate to accomplish the work proposed. Approximately six awards will be made and will be contingent upon the quality of the applications received. ELIGIBILITY Domestic universities, medical colleges, hospitals, and other public or private research institutions, including State and local government units, are eligible. Applications from minority investigators and women are encouraged. LETTER OF INTENT Because of the specialized interest of this NCHGR program, and the potential for overlap with other NIH programs, it is strongly recommended that potential applicants contact NCHGR staff to discuss research objectives. Potential applicants are also asked to submit a letter of intent by June 17, 1991. This letter should include a descriptive title of the proposed research, name of the Principal Investigator and other key investigators and their institutions. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. Letters of intent should be sent to: Bettie J. Graham, Ph.D. Chief, Research Grants Branch National Center for Human Genome Research National Institutes of Health Building 38A, Room 610 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7531 E-MAIL: B2G@NIHCU.BITNET; B2G@CU.NIH.GOV APPLICATION AND REVIEW PROCEDURES Applications in response to this announcement will be reviewed in accordance with the usual NIH peer review procedures. Simultaneous submission of identical applications to different NIH solicitations is not allowed, nor can essentially identical applications be reviewed by different initial review committees. Therefore, if the application submitted in response to this RFA is identical to or substantially the same as one already submitted to the NIH, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Similarly, an application which is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of a previously reviewed application which has undergone substantial revision; however, such application must address, in the Introduction, the previous critique. Applications will first be screened for responsiveness to this RFA by NIH staff. Those deemed non-responsive will be returned to applicants or referred to the Division of Research Grants for processing by the regular procedure. If a large number of responsive applications is received, they will undergo a preliminary peer review by the Genome Research Review Committee, NCHGR, to identify the most meritorious ones. Applications that are deemed non-competitive by this process will receive only a brief critique and will not be reviewed further. The remaining applications will be reviewed for scientific and technical merit by the Genome Research Review Group, NCHGR. The second level of review will be conducted by an appropriate national advisory council. Review criteria include the following: o Originality and innovativeness of the approach; o Overall scientific and technical merit of the research; o The potential of the proposed work to attain the research objectives outlined in this RFA; o Training, experience, research competence, and dedication of the investigator(s); o Adequacy of available facilities; o Provision for the protection of human subjects and the humane care of animals; and o Appropriateness of the requested budget for the work proposed. Applications must be submitted using the form PHS 398 (rev. 10/88). The RFA label available in the revised application kit MUST be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Application kits are available in the business or grants office at most academic or research institutions and from the Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applications will be accepted in accordance with the following schedule: TIMETABLE Receipt Date: July 15, 1991 IRG Review: November 1991 Council Review: February 1992 Earliest Funding Date: April 1992 It is essential that applicants type "New Technologies for Detecting Genes in Genomic DNA" and the RFA number, HG-91-02, on line 2 on the face page of the application form. The original and four copies of the application should be submitted to: Grant Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite the review process, it is also important to submit two copies of the application directly to: Office of Scientific Review National Center for Human Genome Research National Institutes of Health Building 38A, Room 604 9000 Rockville Pike Bethesda, MD 20892 It is important to send these two copies to the NCHGR at the same time as the original and four copies are sent to the Division of Research Grants; otherwise the NCHGR cannot guarantee that the application will be reviewed in competition for the RFA. Funding decisions will be based on recommendations of the initial review group and the advisory council regarding scientific merit and program relevance, and on the availability of funds. Prospective applicants are encouraged to contact staff very early in the planning phase of the application. For more information regarding the program, please contact: Bettie J. Graham, Ph.D. Chief, Research Grants Branch National Center for Human Genome Research Building 38A, Room 610 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7531 E-mail: B2G@NIHCU.BITNET; B2G@CU.NIH.GOV For information about PHS Grant Policy, applicants may contact: Ms. Alice Thomas Chief, Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 402-0733 The program and grants management officials welcome the opportunity to clarify any issues or questions related to this RFA and encourage written or telephone inquiries. This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Sections 301 (Public Law 78-410, as amended 42 U.S.C. 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 requirement of Executive Order 12372 or to Health Systems Agency review. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 25, pt. 1, 28 June 1991 Message-ID: Date: 3 Jul 91 18:21:35 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 929 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19910628 V20N25 P1O1 ************************************ X-comment: RFAs described: AI-91-10, AA-91-04, AA-91-02 NIH GUIDE - Vol. 20, No. 25, June 28, 1991 $$INDEX BEGIN ********************************************************** NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ************************************************************* PERSPECTIVE STUDY OF PERSISTENT OR RECURRENT ARTHROPATHY AND OTHER POTENTIAL ADVERSE EVENTS FOLLOWING RUBELLA VACCINATION OF ADULT WOMEN (RFP) Centers for Disease Control Index: CENTERS FOR DISEASE CONTROL $$INDEX R2 ************************************************************* PEDIATRIC AND PERINATAL HIV CLINICAL TRIALS CENTERS (Sources Sought) National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 09/13/91 **************************************************** EXPANSION OF THE PEDIATRIC AIDS CLINICAL TRIAL UNITS (RFA AI-91-10) National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 11/15/91 **************************************************** RESEARCH ON THE PREVENTION OF ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES (RFA AA-91-04) National Institute on Alcohol Abuse and Alcoholism Office for Substance Abuse Prevention Index: ALCOHOL ABUSE, ALCOHOLISM, SUBSTANCE ABUSE PREVENTION $$INDEX R5 12/16/91 **************************************************** ALCOHOL RESEARCH CENTER GRANTS (RFA AA-91-02) National Institute on Alcohol Abuse and Alcoholism Index: ALCOHOL ABUSE, ALCOHOLISM ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ************************************************************* RESEARCH ON MANAGED MENTAL HEALTH CARE (PA-91-71) National Institute of Mental Health Index: MENTAL HEALTH $$INDEX P2 ************************************************************* MOVEMENT DISORDERS (PA-91-72) National Institute of Neurological Disorders and Stroke Index: NEUROLOGICAL DISORDERS, STROKE $$INDEX END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN 200-91-0931(P) ********************************************** PERSPECTIVE STUDY OF PERSISTENT OR RECURRENT ARTHROPATHY AND OTHER POTENTIAL ADVERSE EVENTS FOLLOWING RUBELLA VACCINATION OF ADULT WOMEN RFP AVAILABLE: 200-91-0931(P) P.T. 34, II; K.W. 0715006, 0740075 Centers for Disease Control The Centers for Disease Control contemplates award of a 48-month research contract to study persistent or recurrent arthropathy and other potential adverse events following rubella vaccination of adult women. The purpose of the contract is to compare the rate and severity of these events following rubella vaccination of seronegative and seropositive adult women to the rate in seropositive adult women not receiving rubella vaccine. Written requests for copies of the solicitation will be honored if received within 45 days of the Request for Proposals (RFP) issue date, which will be on or about June 24, 1991. The date specified for the receipt of the offers will be approximately 90 days after the RFP issue date. Requests for the RFP must cite RFP No. 200-91-0931(P). Telephone requests will not be accepted. All responsible sources may submit a proposal that shall be considered by the Agency. Requests for the RFP and questions about this announcement should be directed to: Mark Federer Centers for Disease Control Procurement and Grants Office Program Acquisitions Branch 255 East Paces Ferry Road, N.E. Room 314 Atlanta, GA 30305 $$R1 END *************************************************************** $$R2 BEGIN NA-01-01***************************************************** PEDIATRIC AND PERINATAL HIV CLINICAL TRIALS CENTERS SOURCES SOUGHT FOR SUBCONTRACTING OPPORTUNITES P.T. 34; K.W. 0715008, 0745027, 0785170, 0755015, 0403020 National Institute of Child Health and Human Development Under Contract #NO1-HD-7-2925 with Westat, Inc., the National Institute of Child Health and Human Development sponsors a network of clinical centers that participate in clinical trials of therapies to prevent pediatric HIV infection or treat pediatric HIV disease. Clinical centers serve as subcontractors to Westat. NICHD and Westat intend to award additional subcontracts to expand patient access to trials. Preference will be given to clinical centers that can conduct both perinatal and pediatric protocols, have no other source of NIH funding for HIV-related clinical trials, and are located in areas where patients do not have reasonable access to existing clinical trials centers. Interested parties must submit three copies of a statement of capabilities, including a description of clinics for HIV-infected women and children, an estimated number of available patients, a description of staff qualifications, and a description of HIV-related research experience, to: Mr. Stephen Durako Vice President Westat, Inc. 1650 Research Boulevard Rockville, MD 20850 One additional copy of the response must also be sent to: Dorothy McKelvin OGC, CMB National Institute of Child Health and Human Development 9000 Rockville Pike EPN, Room 515 Rockville, MD 20892 The response must be received by 5:00 p.m. on July 15, 1991. $$R2 END *************************************************************** $$R3 BEGIN AI-91-10 FULL-TEXT ****************************************** EXPANSION OF THE PEDIATRIC AIDS CLINICAL TRIAL UNITS RFA AVAILABLE: AI-91-10 P.T. 34; K.W. 0715008, 0785170, 0755015 National Institute of Allergy and Infectious Diseases Application Receipt Date: September 13, 1991 PURPOSE The purpose of this Request for Applications (RFA) is to provide support for the expansion of the pediatric AIDS clinical trials program through the establishment of new pediatric clinical trial units. Pediatric components of adult AIDS Clinical Trial Units (ACTUs) that are currently enrolling patients, subunits of pediatric ACTUs currently enrolling patients, and new applicants are invited to apply. Upon funding, each new unit will be a free-standing pediatric unit; thus, the Principal Investigator is expected to be a pediatrician. This RFA specifically addresses and outlines requirements for ancillary services including outreach for pediatric and adolescent populations. While the inclusion of adolescents is encouraged, the main thrust of the RFA is on infants and children. We expect that applications will include obstetricians and their services as a part of the research team. Applications considered responsive to this RFA must demonstrate a capability to conduct pediatric clinical trials and provide the necessary ancillary services and outreach for HIV-infected infants, children, adolescents, and their families. The RFA focuses on these ancillary services because of the critical link between provision of such services and the ability to recruit and maintain pediatric patients in clinical trials. Because of the increasing incidence of maternal-fetal transmission, applicants are required to describe the capability to conduct perinatal transmission studies or plans to develop such capability. Need for increased attention to studies of primary HIV infection, opportunistic infections, neurologic complications of HIV infection and enrollment of HIV-infected adolescents into clinical trials must be addressed. Strong emphasis will be placed on the enrollment of study participants from populations currently underrepresented in clinical trials (e.g., infants and children of minority women and substance abusers and disenfranchised youth). 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, Expansion of the Pediatric AIDS Clinical Trial Units, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). Clinical Core Funding will provide the resources required to maintain an infrastructure sufficient to maintain an agreed-upon minimum number of new patients onto protocols each year. A portion of the total AIDS Clinical Trial Group (ACTG) pediatric budget may be set aside and designated as Incentive Funding. These funds will be awarded either as administrative supplements after review by the Treatment Research Program and Division of Extramural Activities staff or as competing supplements. Awards will be made consistent with National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) policies and will support various activities including, but not limited to, the following: (1) augmenting awards to pediatric ACTUs able to accrue a greater than expected number of patients into high-priority protocols; (2) availability in mid-period of priority protocols established by the ACTG and the NIAID that require funding not included in the Clinical Core Funding budget; and (3) providing limited support to institutions whose investigators contribute a substantial amount of uncompensated time and effort to ACTG committees or other program activities. RESEARCH OBJECTIVES The aim of this initiative is to broaden the cooperative network of institutions and investigators with the capability to provide an effective and efficient system to evaluate the safety and efficacy of therapeutic interventions against HIV infection, AIDS, and its associated conditions in children and adolescents. Emphasis will be placed on the provision of ancillary services, the inclusion of obstetrical and perinatal research, and the inclusion of women and minorities. This goal will be accomplished through the accrual of pediatric patients into trials, analysis of the results of these trials, and publication of their findings. Throughout this process, the participation of awardee clinical investigators from individual clinical trial units, with substantive involvement of the NIAID under the cooperative agreement mechanism, is key in the overall ACTG efforts. MECHANISM OF SUPPORT Awards under this RFA will be made as cooperative agreements. Assistance provided through the cooperative agreement differs from the traditional research grant in that the Government component (NIAID) anticipates substantial programmatic involvement during performance of the award. It should be understood, however, that applicants must define their objectives in accord with individual interests and approaches to conducting the research. It is anticipated that approximately six to ten new pediatric ACTUs will be funded to supplement the current pediatric clinical trials group. Ongoing pediatric subunits or components of adult ACTUs that are successful in competing for these awards will cease to exist as such. The approximate total amount of this RFA will be $7.6 million. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit and availability of funds. Awards will be made for a 12-month budget period within a total project period of five years. Continuation awards for new budget periods within an approved project period will be made on the basis of satisfactory performance and availability of funds. The anticipated award date will be February 14, 1992. It is anticipated that the NIAID will continue this program after the initial project period through a competitive renewal of the cooperative agreements, however, continuation is contingent upon available funds and NIAID priorities. SPECIAL INSTRUCTIONS FOR THE 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 or adequately represented in the study population for clinical studies, a specific justification for this exclusion or inadequate representation must be provided. Applications without such documentation will not be accepted for review. APPLICATION AND REVIEW PROCEDURES The research grant application form PHS 398 (rev. 10/88) must be used in applying. Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. Failure to address all minimum requirements in the Specific Instructions, Section 2 of the RFA will result in the application being considered nonresponsive. If the application is not responsive to the RFA, NIH staff will return it to the applicant. 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 NIAID. Those applications may be subjected to triage by a Special Review Committee to determine their scientific merit relative to other applications received in response to this RFA. The NIH will administratively withdraw from competition those applications judged to be noncompetitive and notify the applicants and institutional business official. The second level review will be provided by the National Advisory Allergy and Infectious Diseases Council. INQUIRIES Copies of the complete RFA describing the research goals and scope, the cooperative agreement mechanism, the review criteria, and other application requirements may be obtained from: Tina Johnson, M.A. National Institute for Allergy and Infectious Diseases 6003 Executive Boulevard, Room 201W Rockville, MD 20892 Telephone: (301) 496-8214 Written or telephone inquiries of a budgetary nature should be addressed to: Ms. Jane Unsworth National Institute of Allergy and Infectious Diseases Westwood Building, Room 706 Bethesda, MD 20892 Telephone: (301) 496-7075 $$R3 END *************************************************************** $$R4 BEGIN AA-91-04 FULL-TEXT ****************************************** RESEARCH ON THE PREVENTION OF ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES RFA AVAILABLE: AA-91-04 P.T. 34, FF; K.W. 0404003, 0745027, 0404000 National Institute on Alcohol Abuse and Alcoholism Office for Substance Abuse Prevention Application Receipt Date: November 15, 1991 PURPOSE The primary purpose of this Request for Applications (RFA) is to encourage and facilitate alcohol abuse prevention research focused on Black Americans, Hispanic Americans, American Indians, Alaskan Natives, and Asian/Pacific Americans. The research envisioned will develop and test prevention strategies that are effective for these minority populations that are at elevated risks for specific types of alcohol problems and have diverse and distinctive sociocultural characteristics that must be considered in the development and implementation of prevention activities. The 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, "Research on the Prevention of Alcohol-Related Problems among Ethnic Minorities," 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). RESEARCH OBJECTIVES This RFA calls for diverse prevention and pre-intervention studies directed specifically to ethnic minority populations. Prevention research investigates ways of reducing the adverse personal and social consequences of alcohol abuse guided by the public health model that views alcohol-related problems as arising through a complex of individual, interpersonal, and social factors. The research may focus on entire communities, specific environments or high-risk groups, or individual behavior. Studies of the effectiveness of environmental prevention strategies in minority settings may include national, state, or community-wide policies designed to control alcohol availability and reduce demand for such products including; (1) strengthening and/or enforcing alcohol beverage control laws regulating the hours of operation and the location and number of outlets for sales of alcoholic beverages; (2) enhancing enforcement of minimum drinking age laws; (3) implementing server training programs; and (4) raising taxes on alcoholic beverages. Research strategies oriented to changing individual behavior, particularly that of youth, adolescents, and pregnant women, include further scrutiny of those programs that have been successfully tested in the general community but need adaptation to ethnic minorities and evaluation of their efficacy. Also needed is the systematic testing of prevention programs that appear to have been successfully implemented within ethnic communities but tested on only a limited scale and/or not systematically evaluated. Applicants also may propose pre-intervention studies of sociocultural factors that may contribute to the occurrence or reduction of alcohol-related problems among ethnic minorities. Sociocultural factors related to the use of alcohol in ethnic minority communities of particular interest include: socialization processes and the role of the family; peer group influences on alcohol-related behavior; acculturation and the change process in response to immigration and migration; the effects of gender roles on alcohol consumption patterns; the effects of mass media messages; and the contributions of community institutions to alcohol use and abuse. METHODOLOGICAL ISSUES Research in the areas discussed above may be cast within any of the standard research traditions. If applicants do not have the full range of methodological and technical skills requisite to the design and analysis of the proposed research, they are strongly urged to consult with statisticians or other relevant specialists. Studies involving interventions must include comprehensive evaluation components that are conceptually and procedurally integrated with the overall research program. The three areas of evaluation (formative, procedural, and outcome) provide information relevant to the interpretation of the research findings. Of central importance in the planning and execution of these studies is careful attention and sensitivity to the unique aspects of the culture of the group(s) under study. MECHANISMS OF SUPPORT Applicants may submit research project grants (R01s) requesting up to four years of support. Applications in response to this RFA will compete for $800,000 in new grant money that is expected to be made available for this purpose in fiscal year 1992. It is anticipated that three to five projects will be supported. REVIEW PROCEDURES Applications submitted in response to this RFA will be assigned to an Initial Review Group (IRG) in accordance with established Public Health Service Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review applications for scientific and technical merit. Applications will receive a second level review by the National Advisory Council on Alcohol Abuse and Alcoholism and the Advisory Committee on Substance Abuse Prevention, where reviews may be based on policy considerations as well as scientific merit considerations. Only applications recommended for approval by these advisory bodies may be considered for funding. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN IN CLINICAL RESEARCH STUDIES For projects involving clinical research, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) requires applicants to give special attention to the inclusion of women in study populations. If women are not included in the study population for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. APPLICATION PROCEDURES Applicants must use the grant application form PHS 398 (revised 10/88). Application kits containing the necessary forms and instructions may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities and from: National Clearinghouse for Alcohol and Drug Information Post Office Box 2345 Rockville, Maryland 20852 Telephone: (301) 468-2600 INQUIRIES For the complete RFA and pre-application consultation, contact: Elsie Taylor or Susan E. Martin Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 For fiscal and administrative matters, contact: Elsie Fleming Chief, Management Review and Assistance Section Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16-86 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4703 $$R4 END *************************************************************** $$R5 BEGIN AA-91-02 FULL-TEXT ****************************************** ALCOHOL RESEARCH CENTER GRANTS RFA AVAILABLE: AA-91-02 P.T. 04; K.W. 0404003, 0745020, 0745027, 0755030, 0745070 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: December 16, 1991 PURPOSE AND OBJECTIVES The National Institute on Alcohol Abuse and Alcoholism (NIAAA) provides grant support for Alcohol Research Centers to conduct interdisciplinary research on alcoholism and alcohol abuse. The Center grants program is interrelated with and complementary to all other research support mechanisms and scientific activities that comprise the NIAAA programs of research on the nature, causes, diagnosis, treatment, control, prevention, and consequences of alcohol abuse and alcoholism. The Alcohol Research Centers Grant program provides long-term (typically, for five years) support for interdisciplinary research programs with a distinct focus on a particular theme relating to alcoholism, alcohol abuse, and other alcohol-related problems. The program is intended to encourage outstanding scientists from biomedical, behavioral, social science, and other relevant disciplines to bring a full range of expertise, approaches, and advanced technologies to the study of problems related to alcohol abuse and alcoholism. Research to improve knowledge of other drug abuse and mental disorders that co-occur with alcohol abuse disorders is also encouraged. A Center is expected to be a source of scientific excellence and, through sustained excellence, to become a significant regional or national research resource. In addition, the applicant institution is expected to afford opportunities for research training to persons from various disciplines and professions. MECHANISM OF SUPPORT A Specialized Center Grant (P50) is a comprehensive, broad-based multidisciplinary, multi-investigator, long-term program of combined research and research support activity planned around a specific major research objective or research theme. In addition to providing support for shared resources, this type of Center supports a full range of basic, developmental, clinical, and/or applied research components; allows for growth and development through pilot projects; and is intended to provide state-of-the-art leadership in the alcohol field. It is estimated that approximately $13-14 million will be available in FY 1993 to fund approximately eight Centers. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, ADAMHA requires applicants to give special attention to the inclusion of women and minorities in study populations. If women and 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. APPLICATION SUBMISSION Applicants must use the grant application form PHS 398 (rev. 10/88). The title and number of this Request for Applications, "Alcohol Research Center Grants, AA-91-02" must be typed in item number 2 on the face page of the PHS 398 application form. REVIEW PROCEDURES Each Center application will be reviewed by a group of experts to evaluate the scientific and technical merit of the proposal. Recommendations from this review will be presented to the National Advisory Council on Alcohol Abuse and Alcoholism that will make a final recommendation to the Director, NIAAA. INQUIRIES For a copy of the RFA and preapplication consultation contact: Dr. Ernestine Vanderveen Associate Director Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16C-06 Rockville, MD 20857 Telephone: (301) 443-1273 For fiscal and administrative matters, contact: Ed Ellis Grants Management Specialist Management Review and Assistance Section Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16-86 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4703 $$R5 END *************************************************************** ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-91-71 **************************************************** RESEARCH ON MANAGED MENTAL HEALTH CARE PA: PA-91-71 P.T. 34; K.W. 0715095, 0715129, 0730000, 0755018 National Institute of Mental Health The National Institute of Mental Health (NIMH) expects to develop and expand scientific knowledge on the wide range of managed care programs. Researchers are encouraged to develop rigorous research designs for exploring the effect of managed mental health care. Such designs include natural experiments or quasi-experimental designs with comparison groups. Secondary data analysis of existing data sets may be adequate for some studies, as may other designs. Study populations should include subjects with primary mental disorders and/or those with co-occurring disorders such as alcohol or drug abuse. 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. The PHS urges applicants to submit work plans that address specific objectives of "Healthy People 2000." Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20042-9325 (telephone 202-783-3238). Applications may be submitted by any public or private, nonprofit or for-profit organization, including units of State or local governments. Women and minority investigators are encouraged to apply. Research support may be requested through applications for a research grant (RO1), small grant (R03), and First Independent Research and Transition (FIRST) award (R29). Applications must be prepared on the current version of the form PHS 398 (revised 10/88). All applications must clearly indicate the relevance of the proposed work to the stated purpose of this announcement. Applications for this grant are encouraged to include both women and minorities in study populations, unless scientific evidence or other justification for not including them is provided. Applications should include in their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities is not feasible or appropriate, the reasons must be explained and justified. Applicants should also be aware that the Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations for the protection of children. A copy of these regulations, 45 CFR 46, Protection of Human Subjects, is available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B39, Bethesda, Maryland 20892. Applications will be reviewed according to the usual PHS receipt and review schedule. Applications will be reviewed for scientific merit by an initial review group (IRG) composed primarily of non-Federal scientific experts. Final review is by the appropriate National Advisory Council. Only applications recommended for approval by the Council may be considered for funding. Review criteria include evidence of familiarity with relevant research literature; adequacy of the theoretical and conceptual framework of the proposed research and appropriateness of research methods; scientific quality of the project design and methodology; demonstrated research capability, experience, and commitment of the proposed research staff; demonstrated access to research subjects or data bases to conduct the research; adequacy of facilities, general environment, and core resources for the development and implementation of the proposed research; evidence of cooperation and commitment for persons and organizations whose support is essential for the conduct of the research; adequacy of the plan to protect research subjects; appropriateness of the budget requested; generalizability of the results; and applicability to minority populations and women. Award criteria include IRG and Council recommendations, program needs and priorities, and availability of funds. For a copy of the full announcement or for further information on research issues, applicants may contact: Paul Widem, Chief, or Agnes Rupp, Ph.D. Mental Health Economics Research Program Services Research Branch Division of Applied and Services Research National Institute of Mental Health Room 18C-14, 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4233 Further information on grants management issues may be obtained from: Stephen J. Hudak Grants Management Branch National Institute of Mental Health Room 7C-26, 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4456 Under authority of Section 301 of the Public Health Service Act as amended, PL 78-410, 42 U.S.C., 241 and the Catalog of Federal Domestic Assistance 93.242. $$P1 END *************************************************************** $$P2 BEGIN PA-91-72 **************************************************** MOVEMENT DISORDERS PA: PA-91-72 P.T. 34; K.W. 0715060, 0785035, 0785210, 0710100 National Institute of Neurological Disorders and Stroke PURPOSE An existing National Institute of Neurological Disorders and Stroke (NINDS) Program Announcement, published June 6, 1980, is being reissued to notify the scientific community of continuing NINDS interest in movement disorders with particular emphasis on dystonia, tremor, Parkinson's disease, and other basal ganglia degenerative disorders. The emphasis on dystonia is in response to the 1991 House and Senate Appropriations Reports. The NINDS invites grant applications to support neurological research leading to a better understanding of the etiology and pathogenesis of a variety of movement disorders, with the intent of improving the early diagnosis and the treatment of these nervous system dysfunctions and ultimately facilitating their prevention. BACKGROUND INFORMATION Neurological disorders of movement include dystonia, Parkinson's and Huntington's diseases, other basal ganglia degenerations (such as Progressive Supranuclear Palsy and Striatonigral Degeneration), and other diseases of varied causation characterized by tics, tremors, chorea, athetosis, and ballism. Most of these neurological disorders are progressive and may be associated with dementia, ataxia, and other neurological abnormalities, in addition to abnormal motor activity. In some cases, the symptoms reflect abnormal function of specific brain nuclei or classes of neurons; in others the abnormality is unknown. In no case is the pathophysiological process adequately understood. Dystonic movements can result from a number of causes. Typical torsion spasms are twisting in nature and usually repetitive in occurrence. The symptom severity and natural history are variable, making treatment evaluation measures and prevalence estimates difficult. Essential tremor is among the most common of all neurological disorders. It is generally benign in course but may, at times, become a significant cause of disability. The individual cost of medical care in these neurological disorders and the societal costs from lost or diminished function can be considerable. RESEARCH GOALS AND SCOPE Multidisciplinary and collaborative studies are encouraged. Experimental studies may focus on anatomical, pathological, biochemical, physiological, or pharmacological aspects of any of these diseases. There is particular need for work in the following: (1) more precise definition of the anatomical and/or physiological lesion; (2) identification of characteristic abnormalities in non-neural tissues, such as blood, skin, or muscle, that are more amenable to biopsy or tissue culture; (3) development of animal models, experimental or genetic, that mimic significant aspects of a movement disorder; (4) molecular genetics; and (5) advanced neuroimaging research. Existing therapies for the movement disorders are, in general, unsatisfactory. Many drugs currently used are either ineffective over long periods of time or associated with undesirable side effects. For this reason, experimental therapeutic studies on animal models of movement disorders and studies of appropriate in vivo systems are encouraged. MECHANISMS OF SUPPORT Applicants may apply for the research project grant (RO1), research program project (PO1), research center grant (P50), and First Independent Research Support and Transition Award (R29). Prospective applicants are encouraged to communicate with the Institute staff listed at the end of the announcement regarding the appropriate funding mechanism. Both basic science and clinical investigations are encouraged to address relevant research issues. APPLICATION AND REVIEW PROCEDURES Applications must be prepared on form PHS 398 (revised 10/88) according to instructions contained in the application kit. Application kits are available from most institutional business offices and may be obtained from the Division of Research Grants at the address given below: Office of Grants Inquiries National Institutes of Health Division of Research Grants Westwood Building, Room 449 5333 Westbard Avenue Bethesda, MD 20892 Check "yes" in item two on the face sheet of the application and type "Movement Disorders, PA-91-72." Applicants for the P01 or P50 should use the application format as described in the NINDS pamphlet, "Application Guidelines: Program Project and Clinical Research Center Grants" (revised 10/89), that may be obtained from the contacts listed under INQUIRIES. Applications will be judged on scientific merit and program relevance in accordance with NIH policy and procedures involving peer review. An initial review will be made by an appropriate study section of the Division of Research Grants for research grants and FIRST awards, and by an appropriate institute committee for program projects and centers. A second level of review will be made by an appropriate national advisory council. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the research plan and summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of incuding 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. Deadlines for the receipt of applications are February 1, June 1, and October 1. The original and six copies of the application must be sent directly to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** INQUIRIES For further information regarding this announcement, potential applicants should write or call: Philip H. Sheridan, M.D., Chief Developmental Neurology Branch Division of Developmental, Convulsive, and Neuromuscular Disorders NINDS Federal Building, Room 8C10 Bethesda, MD 20892 Telephone: (301) 496-6701 or Eugene J. Oliver, Ph.D. Division of Demyelinating, Atrophic, and Dementing Disorders NINDS Federal Building, Room 806 Bethesda, MD 20892 Telephone: (301) 496-1431 The program to which the intended grants relate is described in the Catalog of Federal Domestic Assistance, entry number 93.853 - Clinical Research Related Neurological Disorders, and 93.854 - Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END *************************************************************** **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 FULL TEXT OF RFAs FOR ONLINE ACCESS From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!UNCVX1.BITNET!WORIAX From: WORIAX@UNCVX1.BITNET Newsgroups: bionet.sci-resources Subject: bovine cDNA library wanted Message-ID: <9111251859.AA01187@genbank.bio.net> Date: 25 Nov 91 17:57:00 GMT Sender: daemon@genbank.bio.net Distribution: bionet Lines: 5 We are attempting to clone several mitochondrial proteins from bovine liver. We are low on money and are trying to obtain a bovine cDNA library from mitochondrial rich tissue without having to buy one. Does anyone have a bovine cDNA library they could send us? Thank you. Velinda Woriax, UNC-CH, Chemistry. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!ere.umontreal.ca!yang From: yang@ere.umontreal.ca (Yang Jing-Hua) Newsgroups: bionet.sci-resources Subject: sub Message-ID: <9111240727.AA01022@alize.ERE.UMontreal.CA> Date: 24 Nov 91 07:27:35 GMT Sender: daemon@genbank.bio.net Distribution: bionet Lines: 2 subscribe sci-rs Jinghua YANG From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 18, pt. 2, 3 May 1991 Message-ID: Date: 1 May 91 01:36:46 GMT Sender: kristoff@genbank.bio.net Lines: 1844 $$XID RFA MH9113 MH-91-13 P1O1 ***************************************** STATE SERVICE SYSTEMS IMPROVEMENT THROUGH CONSUMER AND FAMILY SUPPORT ACTIVITIES RFA: MH-91-13 P.T. 34; K.W. 0730050, 0715095, 0715129, 0403004 National Institute of Mental Health Application Receipt Date: June 24, 1991 PURPOSE Since its inception, the Community Support Program (CSP) of the National Institute of Mental Health (NIMH) has supported a variety of initiatives to enhance the involvement of consumers and family members in the public mental health system and to increase the number of consumer self-help and family support groups. These efforts have been reinforced by recent statutory requirements for consumer and family roles in planning community-based services, for example through the Advisory Councils mandated under P.L. 99-660, The State Comprehensive Mental Health Services Plan Act of 1987. To support the developing role of consumers and family members in service delivery and systems planning, NIMH is inviting applications under this Request for Applications (RFA) for three-year grants to demonstrate and evaluate service system improvement strategies that integrate consumers and family members into the planning and provision of mental health and support services at State and local levels. 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, "State Service Systems Improvement Through Consumer and Family Support Activities," is related to the priority area of mental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). NIMH intends that the activities supported in this effort be relevant to the State's comprehensive mental health service plan submitted to NIMH for review in accordance with the requirements of Title V of P.L. 99- 660 and its subsequent amendments, and to the required involvement of consumers and family members on the Advisory Councils. POPULATION OF CONCERN The population of concern for CSP grants includes individuals 18 years and over with a severe and persistent mental disorders that seriously impair functioning in primary aspects of daily living, such as interpersonal relations, living arrangements, and employment. Applicants should pay attention to the unique needs and special concerns of racial and ethnic minorities and women. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. ELIGIBILITY Only mental health authorities in States and Territories that do not currently have a CSP State Service System Improvement Demonstration Grant or are in the final year of a CSP State Service System Improvement Demonstration Grant for general community support development activities are eligible to apply for these grants. Each State and Territory may submit only one application. PROGRAM GOALS NIMH encourages the demonstration and evaluation of strategies that are directed toward the following programmatic goals: o Integrating primary consumers and family members into State and local service delivery, systems planning, decision-making, and research activities in order to develop mental health and support services that are considered responsive to consumer and family needs and preferences; o Improving linkages between consumer self-help and family support groups and the formal community support, treatment, and rehabilitation service systems; o Increasing the effectiveness of consumers and family members in identifying and fostering needed system, program, and service improvements; o Fostering participation of minority individuals in consumer self-help and family support groups; o Increasing opportunities for consumer employment within the formal service system. PROJECT ACTIVITIES The following are examples of supportable project activities: o Demonstrating and evaluating approaches to support the establishment or ongoing maintenance of consumer self-help and family support activities (e.g., providing start-up funding or ongoing funding, staffing, office space, supplies, travel). o Assessing the effectiveness of providing training and educational opportunities for consumers and family members (areas for assistance could include leadership training; educating families on mental illness; informing families and consumers on the organization and delivery of mental health services in the applicant's State or Territory; providing information on state-of-the-art service approaches; disseminating information on starting, operating, and evaluating self-help groups; providing support to attend key conferences and meetings; and training families and consumers on how to use data and research outcomes to improve mental health service systems). o Assessing effective approaches for recruiting and training consumers and family members to participate on State and local mental health planning councils, planning committees, governing boards, and task forces. etc. o Developing and evaluating a program to hire and train consumers for employment at the State level or in local programs in various positions such as peer support counselors, case management aides, research assistants, data technicians, computer programmers, and word processors. o Evaluating the impact of using consumers at in- service training sessions for mental health program staff in order to educate them on the consumer perspective of having a mental disorder and the consumer experience in the mental health system. o Conducting statewide surveys to determine consumer and family needs and preferences with respect to mental health and supportive services. NIMH funds may not be used for lobbying activities to influence Federal legislation. APPLICATION PROCEDURES All applicants must use form PHS-5161 (revised 3/89). The title of the announcement, "CSP State Systems Improvement, RFA MH-91-13," must be typed in Item 10 on the face page of the application. The descriptive title of the application should be entered in Item 11 but should not exceed 56 typewritten spaces. Applications must be complete and contain all information needed for initial and Advisory Council review. No subsequent addenda will be accepted unless specifically requested by the Science Review Administrator of the review committee. No site visits will be made. Application kits are available from: Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-15 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4414 The original and two (2) permanent, legible copies of the completed application must be received (not postmarked) by the close of business June 24, 1991. Applications must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To facilitate the timely review of your application, it is also requested that one additional copy of the application be sent directly to: Ms. Edna M. Hardy-Hill Division of Extramural Activities National Institute of Mental Health 5600 Fishers Lane, Room 9C-15 Rockville, MD 20857 The mailing envelope (including that provided by an express carrier) for this additional copy must be clearly marked, "RFA MH-91-13, CSP Demonstrations, SSIP." APPLICATION REQUIREMENTS The application must be written in a manner that is self-explanatory to objective, outside reviewers who may not be familiar with prior related activities of the applicant. The application must be as brief as possible. The narrative is limited to 20 single-spaced pages and must contain the necessary information for reviewers to understand the project. Appendices may be attached but must not be used to merely extend the narrative; extensive appendices are discouraged. It is important that the relationship between the proposed project and ongoing State and/or local activities be clearly explained. It is also important that the activities that are specific to the proposed project be clearly identified. To ensure that sufficient information is included for technical merit review, please follow the instructions for Program Narrative on page 16 of form PHS-5161. In addition, include the following: o Project abstract, which must not exceed one-half of a single-spaced, typewritten page o Summary description of the proposed project and discussion of the rationale for the project, including factors such as gaps in consumer and family involvement; relationship to the State's comprehensive mental health services P.L. 99-660 plan and Advisory Council, review of the literature and other relevant knowledge that provides justification for the proposed project; and previous activities and accomplishments that the proposed project builds upon o Discussion of involvement of primary consumers and family members in planning the project o Management plan that identifies the organizational location for the project, describes how the project will be managed, and explains the roles and responsibilities of consumers and family members in managing the project o Evidence of support from all organizations and entities to be involved in the project o If the State proposes to fund single or multiple projects through a Request for Proposals (RFP) process, inclusion of the rationale for selecting this approach, copy of the RFP, list of eligible applicants, and description of the advertisement and review process o Evaluation plan that describes who will conduct the evaluation of the project (should be an objective, outside evaluator), how State evaluation staff will be involved, and how the project will be evaluated o In addition to the budget information requested in form PHS-5161, for the funds to be requested in this application, a detailed justification for each line item of the budget for each year of the project o Identification of all key staff and consultants who will have major roles in implementing or evaluating the project, including position descriptions and resumes CLIENT SAFEGUARDS If the project will be collecting identifiable information about individual clients or project staff for project evaluation purposes, assurances for protecting client and staff confidentiality and anonymity must be included. TERMS AND CONDITIONS OF SUPPORT Period of Support Support may be requested for a period of up to 3 years. Annual awards will be made, subject to continued availability of funds and progress achieved. In Fiscal Year 1991, it is estimated that approximately $1 million will be available to support approximately 10 projects. The expected average amount of an award, for direct costs, is estimated to be $100,000 per year. However, the amount of funding available will depend on appropriated funds and program priorities at the time of award. Allowable Costs Applicants must include the following agreement in their applications: "(Applicant) agrees that not more than 10 percent of any resultant grant award will be expended for administrative purposes." Grants are intended to assist in meeting the costs of planning, developing, and implementing activities to support attainment of the project objectives. Applicants are expected to determine the costs of the project for the proposed project period. Grant funds are to be additive, not substitutive; they are not to be used to replace existing resources. Grant funds may be used for expenses clearly related and necessary to carry out the proposed project, including both direct and indirect costs that are specifically identified with the proposed project. Grant funds may be used to obtain consultation (e.g., from primary consumers, family members, community organizers, evaluators, and trainers) related to project activities. States are expected to provide in-kind support for the staffing necessary to implement the activities under the approved project. States may, however, request grant support for salaries, wages, and fringe benefits for non-State agency staff involved in project-related activities who are consumers or family members. Other items of expenditures, for which applicants may request grant support include: o Travel and training directly related to carrying out activities under the approved project (each grantee will be asked to participate, along with a consumer and a family leader, in one annual technical assistance/problem-solving meeting to be held in the Washington, D.C. area and to send a minimum of five consumers to the NIMH-supported National Alternatives Conferences); o Supplies, communications, and rental of space directly related to approved project activities; o Contracts to consumer or family organizations or programs and to consultants (preferably consumers or family members) as necessary for performance of activities under the approved project; o Other such items necessary to support project activities, as approved by NIMH. REVIEW PROCEDURES Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the National Mental Health Advisory Council whose review may be based on policy considerations as well as technical merit. Only applications recommended for approval by the Council may be considered for funding. Applicants must comply with the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100. Through this process, States, in consultation with local governments, are provided the opportunity to review and comment on applications for Federal financial assistance. Applicants should contact the State's single point of contact (SPOC) as early as possible to determine the applicable procedure. A current listing of SPOCs will be enclosed with the application kit. SPOC comments should be forwarded to Neal Brown, Chief, Community Support Section, System Development and Community Support Branch, Division of Applied and Services Research, National Institute of Mental Health, Parklawn Building, Room 11C-22, 5600 Fishers Lane, Rockville, Maryland 20857, by August 1, 1991. NIMH does not guarantee to accommodate or explain comments from the SPOC after August 1, 1991. REVIEW CRITERIA Each grant application is evaluated on its own merits. The following are the review criteria that will be used: o Quality and clarity of the description of the proposed project, rationale, relationship to the State comprehensive mental health P.L. 99-660 services plan, relationship to previous activities and accomplishments, and potential benefits; o Evidence that the project was planned by and has the endorsement of the major consumer and family support organizations in the State; o Relevance of the project to the goals of the announcement; o Quality, feasibility, and thoroughness of the project plan; o Quality of the evaluation plan; o Capability and experience of the project director, consultants, and other key staff proposed for the project; o Quality of the management plan; o Potential of the project to empower consumers and family members o Attention to racial, ethnic, and minority population issues and concerns; o Appropriateness of budget estimates for the proposed project activities. RECEIPT AND REVIEW SCHEDULE Receipt of Council Earliest Applications Initial Review Review Start Date June 24, 1991 July 1991 Sept. 1991 Sept. 1991 Applications received after the above receipt date will be returned to the applicant without review. AWARD CRITERIA In the decision to fund approved applications, the following criteria will be considered: o Quality of the proposed project as determined by the review process; o Consistency of the proposed initiative with the State's mental health service plan submitted to NIMH in October 1989, in accordance with the requirements of Title V of Public Law 99-660; o Geographical location in order to include States from all sectors of the Nation to the extent possible; o Availability of funds. FOR FURTHER INFORMATION Neal Brown, Chief Community Support Section System Development and Community Support Branch Division of Applied and Services Research National Institute of Mental Health Parklawn Building, Room 11C-22 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3653 Inquiries pertaining to grants management should be directed to: Steven Hudak Chief, Grants Management Section Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-23 Rockville, MD 20857 Telephone: (301) 443-4456 The Catalog of Federal Domestic Assistance Number is 93.125. Grants must be administered in accordance with the PHS Grants Policy Statement (revised October 1, 1990). Federal regulations, 45 CFR Part 92, are applicable to these awards, and under the authority of Section 520 of the Public Health Service Act, as amended by P.L. 101-93. $$XID RFA CA9109 CA-91-09 P1O1 ***************************************** REQUEST FOR APPLICATIONS COOPERATIVE NETWORK FOR EVALUATION OF PROGNOSTIC MARKERS OF URINARY BLADDER CANCER RFA: CA-91-09 P.T. 34; K.W. 0715035, 0785220, 0765033 National Cancer Institute Letter of Intent Receipt Date: May 31, 1991 Application Receipt Date: July 31, 1991 I. Purpose The Cancer Diagnosis Branch of the Division of Cancer Biology, Diagnosis and Centers at the National Cancer Institute (NCI) invites applications for cooperative agreements from institutions capable of, and interested in, participating in the "Cooperative Network for Evaluation of Prognostic Markers of Urinary Bladder Cancer." The goal of the network is to test biochemical, immunologic, genetic, and other quantifiable markers of urinary bladder cancer. The network will perform collaborative studies requiring expertise in urology, pathology, and/or basic cancer biology to evaluate appropriate quantifiable markers of urinary bladder cancer and to define relevant clinical applications. This network will continue and expand the collaborative studies of bladder cancer markers currently supported by the Marker Network for Bladder Cancer. Awards will be made as cooperative agreements that create an assistance relationship with substantial NCI programmatic involvement with the recipients during the performance of the project, as outlined in this request for applications (RFA). The cooperative agreement mechanism is used when the NCI wishes to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. The NCI anticipates making four to six awards for project periods of up to four years. A total of $950,000 is expected to be set aside for funding these activities in the initial year. Although this project is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated in fiscal year 1992. 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, "Cooperative Network for Evaluation of Prognostic Markers of Urinary Bladder Cancer," is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). II. Background Information Advances in immunology, molecular biology, and genetics have opened new possibilities for developing markers to detect cancer and its recurrence, invasion, and metastasis. This is expected to lead to new and more effective approaches to improve diagnostic accuracy, make prognostic and therapeutic decisions, more effectively monitor response to therapy, detect cancer at earlier stages, and identify high-risk populations. Different cell markers appear to correlate with particular biological behaviors of urinary bladder tumors. Separate markers may be useful for predicting recurrence, progression, or metastasis in early stage disease (Ta, T1) or for detecting carcinoma in situ. Markers for prediction of treatment response may prove useful in selecting the most appropriate treatment. DNA ploidy studies of exfoliated tumor cells have demonstrated some utility in predicting tumor behavior. The addition of other quantitative markers that can be evaluated by flow cytometric or other techniques will expand the range of diagnostic measurements and may add to the accuracy and range of diagnostic information available to the clinician. A variety of immunological, biochemical, and genetic markers are currently being evaluated by the "Marker Network for Bladder Cancer." While these activities are expected to continue, activities of the proposed network need not be confined to markers currently under study. Investigators are encouraged to propose interesting markers and appropriate studies for their evaluation. III. Research Goals and Scope The objective of this RFA is to invite applications for cooperative agreements to support a network of laboratories to cooperatively evaluate promising diagnostic and prognostic markers of urinary bladder cancer. The existing network has already demonstrated the feasibility of an inter-institutional network for collaborative clinical studies of urinary bladder cancer markers. Studies of new methods for cell marker identification and analysis, including: evaluation of additional genetic, biochemical, and immunological markers of urinary bladder cancer; evaluation of the most appropriate techniques for quantitatively assaying these markers; and development of tumor classification systems useful in patient management, are needed. Awardees will share clinical material and develop a plan to optimize research opportunities offered by the strengths of the participating institutions and the patient populations available to the network. The cooperative approach will expand the available patient resources, improve evaluation of potentially useful markers and allow comparison of their utility in different clinical and laboratory settings. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders or conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population- based studies, a clear, compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2 A-D of the Research Plan AND summarized in Section 2E Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of the 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 prevention strategies), diagnosis or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning 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 populations 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. IV. Mechanism of Support Support of this program will be through the cooperative agreement, an assistance mechanism in which substantial NIH programmatic involvement with the recipients during performance of the planned activity is anticipated as outlined in this RFA. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90- 50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete as research project applications with all other investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review, according to the procedures described in Section VII. NCI anticipates making four to six awards for project periods of up to four years and anticipates that a total of $950,000 will be set aside for the initial year's funding. Funding in response to this RFA is dependent on the receipt of a sufficient number of applications of high scientific merit. The earliest feasible start date for the initial awards will be April 1, 1992. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated for fiscal year 1992. The purpose of the proposed awards is to stimulate cooperative efforts to identify and evaluate diagnostic and prognostic markers of urinary bladder cancer. The cooperative agreement funding mechanism was selected because of substantial NCI programmatic involvement required to coordinate activities among several laboratories working toward a common goal. V. Terms of Cooperation The cooperative agreements will require cooperation between an NCI representative and the Principal Investigators of the individual projects in order to assure smooth interactions among the cooperating institutions. The NCI representative will assist in coordinating the activities of the research groups and in facilitating exchange of information. Awardees will retain custody and primary rights to their data developed under these awards, subject to government, e.g., NCI, NIH, or PHS, rights of access consistent with current DHHS, PHS, and NIH policies. A. Responsibilities of the NCI Representative The NCI representative will coordinate and facilitate the programs supported by these cooperative agreements, will attend and participate in all meetings as a member of the Coordinating Committee, and will serve as a liaison between the Coordinating Committee and participating research groups. The NCI representative will assist the Coordinating Committee in developing operating policies, quality control procedures, and consistent policies for dealing with recurring situations that require coordinated action. To assure consistency and quality, the NCI representative must concur in operating policies and clinical protocols prior to their implementation. The NCI representative may review the operations of individual laboratories for compliance with protocols and other operating policies developed by the Coordinating Committee. The NCI representative may recommend withholding of support, suspension, or termination of an award for lack of progress or failure to adhere to policies established by the Coordinating Committee. B. Responsibilities of Awardees Awardees are responsible for developing individual research projects to facilitate the activities of the network and to participate in the development of clinical protocols for network studies. All studies conducted under this RFA by members of the network must be approved by the Coordinating Committee. Responsibility for specific aspects of collaborative network studies, e.g., statistical design and analysis, will be determined by the Committee at the time each study is planned. Two members of each research group are required to attend meetings of the Committee (as detailed below), to help formulate the Committee's policies (which will be submitted to the NCI representative for approval), and to implement those policies. Awardees are required to have access to appropriate tumor tissue and normal tissue. They are required to submit progress reports at each meeting of the Coordinating Committee. C. Coordinating Committee The NCI representative and the participating research groups will be responsible for forming a Coordinating Committee as defined below. Operating policies will be developed by the Coordinating Committee and submitted to the NCI representative for concurrence prior to implementation. The NCI representative will facilitate the review of operating policies and clinical research protocols. Results of the review will be discussed with the Coordinating Committee and an arbitration system, as detailed below, will be available to resolve disagreements between the NCI representative and the other members of the Coordinating Committee. The Coordinating Committee will review the plans proposed in the applications by the individual research groups to ensure that they are compatible with the overall goals of the RFA. Members of the Coordinating Committee will be responsible for redefining research objectives and defining strategies for network studies to optimize progress and efficient use of patient and tissue resources. The Coordinating Committee will also be responsible for coordinating activities such as plans for statistical design and analyses, developing forms, distributing reagents and biological samples, data collection and data analysis, monitoring the progress of the network, and maintaining quality assurance. The Coordinating Committee will consist of the NCI representative and two members from each cooperating institution, one of whom is the Principal Investigator. The NCI representative will be appointed by the Chief of the Cancer Diagnosis Branch, Division of Cancer Biology, Diagnosis and Centers. The Coordinating Committee will be responsible for electing a Chairperson (who may not be the NCI representative). The Chairperson of the Coordinating Committee will be responsible for coordinating the Committee activities, preparing meeting agendas, and scheduling and chairing meetings. The NCI representative will attend and participate in all meetings of the Coordinating Committee and should be informed of major inter-group interactions. The Coordinating Committee will prepare an annual progress report that will include individual reports from each participating research group; each group is responsible for timely preparation of its report. The Coordinating Committee will meet initially to map strategies and set up operating procedures. The Coordinating Committee will meet at least twice a year thereafter. Meetings may be held at any of the participating institutions or at another convenient location. These meetings are aimed at coordinating the activities of the participating laboratories, establishing new policies and priorities, and reviewing progress. The NCI representative will participate in the discussions at these meetings. Travel funds for Coordinating Committee meetings are to be set aside as a budget line item in each project budget. D. Arbitration Procedure An arbitration panel of external consultants will be created as needed to resolve any irreconcilable differences of opinion related to scientific/programmatic matters between the NCI representative and the Coordinating Committee with respect to implementation of a proposed operating policy. The panel will include one member selected by the Coordinating Committee, one member selected by the NCI, and a third member chosen by the other two members of the arbitration panel. The NCI arbitration process for the cooperative agreement in no way affects the rights of awardees to appeal selected post award administrative decisions in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. VI. Eligibility Requirements Applicant organizations must be located in the United States, Canada, or Mexico. Non-profit and for-profit organizations and institutions, and government agencies are eligible to apply. VII. Special Instructions for Preparation of Cooperative Agreement Applications The grant application form PHS 398 (revised 10/88, reprinted 9/89) must be used for the cooperative agreement application. The general instructions, e.g., for format and budget issues, included in the application packet must be followed. Specific issues related to cooperative agreements must be addressed as follows: It is critical that each applicant include specific plans for responding to the Terms of Cooperation discussed in Section V above. Plans must describe how the applicant will comply with the involvement of the NCI representative, as well as how all the responsibilities of awardees will be fulfilled. Individual proposals for both network studies and individual studies must be included in order to provide the Coordinating Committee with a basis for planning network activites. For competing renewal applications, a complete description of past collaborative efforts must be included in the progress report. VIII. Review Procedures and Criteria A. Review Procedures Upon receipt, applications will be initially reviewed by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications that are judged to be non-responsive will be returned to the applicant, but may be submitted as investigator-initiated research grant applications at the next receipt date. In cases where the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those that clearly are not competitive for award. The NCI will remove from further competition those applications judged to be noncompetitive and notify the applicant Principal Investigator and institutional official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. B. Review Criteria Factors considered to be important for review include: demonstrated expertise in urology, pathology, and/or basic cancer biology applied to the diagnosis and treatment of urinary bladder cancer; expertise and an active research program in cell marker studies; availability of an appropriate population of patients for study; good interaction among collaborating researchers; demonstration of adequate facilities; and willingness to interact within the terms of a cooperative agreement as outlined in this document. Reviewers will be asked to review the grant applications by considering the following criteria: 1) Scientific merit, feasibility, and relevance of the proposed project to the overall goals and objectives of the RFA; 2) Demonstration of availability of, and access to, appropriate patients (including representative numbers of women and minorities or sufficient justification for their exclusion), archival tissue, and appropriate clinical data; 3) Proposed collaborations among urologists, pathologists, basic cancer biologists, and other key personnel; 4) Qualifications, experience, and proposed responsibilities of the Principal Investigators and of key support personnel; 5) Facilities and resources, and their availability for this project; 6) Plans for effective interaction and coordination among cooperating projects and with the NCI, including a proposed timetable; and 7) Plans to protect the rights of human subjects. The review group will recommend an appropriate budget and period of support for each approved application. IX. Method of Applying The most recent revision of the research grant application form PHS 398 (revised 10/88, reprinted 9/89) must be used in applying for cooperative agreements. These forms are available at most institutional business offices and from: Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 5333 Westbard Avenue Bethesda, MD 20892-4500 and from the NCI Program Director named below. The RFA label available in the application form PHS 398 (revised 10/88, reprinted 9/89) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the checklist, and four signed exact photocopies, in one package to the Division of Research Grants at the address below. Photocopies must be clear and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** At the time of submission send two additional copies of the application to: Referral Officer Division of Extramural Activities, DEA, NCI Room 838, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892-9912 Applications must be received by July 31, 1991. If an application is received after this date, it will be returned. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. X. Letter of Intent Prospective applicants are asked to submit by May 31, 1991, a letter of intent that includes a descriptive title of the proposed project, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of the applications to be reviewed. The letter of intent is to be sent to: Roger L. Aamodt, Ph.D. Program Director for Pathology and Cytology Cancer Diagnosis Branch, DCBDC, NCI Executive Plaza South, Room 638 6120 Executive Boulevard Rockville, MD 20892-9904 Telephone: (301) 496-7147 FAX: (301) 496-8656 XI. Inquiries Written and telephone inquiries concerning the objectives and scope of this RFA, about the activities of the currently funded marker network, or inquiries about whether specific proposed research would be responsive, are encouraged and should be directed to Dr. Roger L. Aamodt at the above address. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA CA9110 CA-91-10 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-10 COOPERATIVE NETWORK FOR MOLECULAR GENETIC AND CYTOGENETIC STUDIES OF PROSTATE CANCER P.T. 34; K.W. 0715035, 1002058, 1002004, 0413001 National Cancer Institute Letter of Intent Receipt Date: June 10, 1991 Application Receipt Date: September 6, 1991 Introduction The Cancer Diagnosis Branch of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invites applications for cooperative agreements from institutions capable of and interested in participating in a cooperative network for studies of molecular genetics and cytogenetics of prostate cancer. The goals of this Request for Applications (RFA) are: 1) to promote collaborations and interactions between basic scientists and clinicians in order to advance prostate cancer research; 2) to identify genetic alterations that may distinguish the behavior of clinically silent prostate cancer from that of clinically evident cancer; 3) to determine whether there is a molecular genetic basis for differences in prostate cancer incidence between Blacks and Whites; 4) to explore the biological basis for the striking increase in prostate cancer incidence with age. Groups participating in the network will attempt to assess biological differences in prostate cancer using molecular genetic and cytogenetic approaches with the long-term goal of developing a more informative classification system. Cooperative studies will facilitate the application of molecular techniques to prostate cancer research through the efficient use of prostate cancer and normal prostate tissue. Awards will be made as cooperative agreements that create an assistance relationship with substantial involvement of NCI staff during the performance of the project, as outlined in this RFA. The cooperative agreement mechanism is used when the NCI wishes to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. The NCI anticipates making three to five awards for project periods of up to four years. A total of $1,000,000 is expected to be set aside for funding these activities in the initial year. Although this project is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated in fiscal year 1992. 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, "Cooperative Network for Molecular Genetic and Cytogenetic Studies of Prostate Cancer", is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). A Background Information Prostate cancer is the most common cancer diagnosed in men and the second leading cause of cancer deaths in American men. In 1990, there were an estimated 106,000 cases that represents more than 10 percent of the expected new cases of cancer in the population (Silverberg, 1990). Thirty thousand deaths from prostate cancer were expected in 1990. The rate of prostate cancer is low before age 50, but rises sharply with age thereafter. The incidence of prostate cancer has increased from 62.4 cases per 100,000 in White males in 1973 to 73.9 in 1977 and 99.2 in 1987 (Ries et al., 1990, p. II-16). The age-specific incidence is 50 percent higher among Black males (ibid. p. I- 11). Nearly a third of males 50 years or older who have died of causes other than prostate cancer and have undergone autopsies have been shown to have microscopic foci of cancer within their prostates. Only about 1 percent of these potential patients are diagnosed each year as having prostate cancer. These foci of cancer, which seem to progress slowly or not at all in the majority of men, have been called "latent" or "histological" cancers. The major dilemma is that these cancers cannot be readily distinguished from those that will progress rapidly to clinically evident tumors. A means to differentiate those that will remain "latent" from those that will progress to "clinically evident" is required in order to treat patients most effectively. It has been shown with other tumors that genetic characteristics of the tumor can provide information about its behavior. Elegant studies of colorectal carcinoma have shown that specific gene deletions and alterations accumulate as tumors progress, and that these alterations may be useful in assessing prognosis (Vogelstein et al., 1988; Fearon and Vogelstein, 1990). Amplification of the N-MYC oncogene has been shown to be associated with poor prognosis in children with neuroblastoma (Seeger et al., 1985). Amplification and over-expression of the HER-2/neu oncogene appear to be associated with poor prognosis in breast cancer patients (Slamon et al., 1987, 1989) and also in ovarian cancer (Slamon et al., 1989). Molecular genetic studies of prostate cancer have been limited. One recent study of prostate tumors showed loss of heterozygosity on a number of different chromosomal arms; the highest frequency of loss of heterozygosity was on chromosome arms 10q and 16q (Carter et al., 1990). In-depth studies of molecular genetic alterations in prostate cancer are needed in order to determine whether such changes are useful in predicting the behavior of these tumors. A recent review of cytogenetic studies carried out in prostate cancer has shown that only a small percentage of the tumors revealed clonal abnormalities (Brothman et al., 1990). A correlation between the presence of karyotypic abnormalities and the Gleason grade of the tumor has been suggested. Additional cytogenetic studies are needed since these types of studies often point to important chromosomal regions for molecular exploration. References Brothman AR, Peehl DM, Patel AM, and 1 other. Frequency and Pattern of Karyotypic Abnormalities in Human Prostate Cancer. Cancer Res 50:3795-3803, 1990. Carter BS, Ewing CM, Ward SW, and 5 others. Allelic Loss of Chromosomes 16q and 10q in Human Prostate Cancer. Proc Natl Acad Sci US 87:8751-8755, 1990. Fearon ER and Vogelstein B. A Genetic Model for Colorectal Tumorigenesis. Cell 61:759-767, 1990. Ries LAG, Hankey BF, and Edwards BK (Eds.). Cancer Statistics Review 1973-87. U.S. Dept Health Human Services NIH Publication no. 90-2789, 1990. Seeger RC, Brodeur GM, Sather H, and 4 others. Association of Multiple Copies of the N-myc Oncogene with Rapid Progression of Neuroblastomas. N Engl J Med 313:1111-1116, 1985. Silverberg ES, Boring CC, Squires TS. Cancer Statistics 1990. CA 40:9-26, 1990. Slamon DJ, Clark GM, Wong SG, and 3 others. Human Breast Cancer: Correlation of Relapse and Survival with Amplification of the HER-2/neu Oncogene. Science 235:177-181, 1987. Slamon DJ, Godolphin W, Jones LA, and 8 others. Studies of the HER-2/neu Proto-oncogene in Human Breast and Ovarian Cancer. Science 244:707-712, 1989. Vogelstein B, Fearon ER, Hamilton SR, and 7 others. Genetic Alterations during Colorectal Tumor Development. New Engl J Med 319:525-532, 1988. B Research Goals and Scope The objective of this RFA is to invite applications for cooperative agreements to establish a network of laboratories to study the molecular genetic characteristics of prostate cancer and to relate the results to clinical parameters of the tumors. Collaborations among researchers with expertise in molecular genetics or cytogenetics and urologists or other clinical researchers engaged in studies of prostate cancer are encouraged. A number of important questions need to be addressed, including the following: Why are some prostate cancers aggressive, progressing rapidly, and metastasizing while others appear indolent? Are there genetic alterations that can explain why incidence and mortality rates vary so greatly among ethnic groups? Can genetic markers be developed to predict tumor behavior or response to treatment? Are there different genetic alterations in tumors from younger versus older men? Applicants are encouraged to address these and/or other questions that will advance our understanding of the behavior of prostate tumors. The cooperative approach outlined in this RFA is designed to optimize use of patient resources, tissues, and reagents. Comparisons of various markers and methods of detection or measurement in different laboratory settings will be possible. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. While inclusion of women is not relevant to this RFA, special emphasis should be placed on the need for inclusion of minorities in studies of diseases, such as prostate cancer that disproportionately affect them. This policy is intended to apply to persons of all ages. If 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 racial/ethnic group, together with a rationale for its choice. In addition, racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of the 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 prevention strategies), diagnosis or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning 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 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, since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign populations 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 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. C Mechanism of Support - Cooperative Agreement Support of this program will be through the Cooperative Agreement, an assistance mechanism in which substantial NCI programmatic involvement with the recipients is anticipated during performance of the planned activity, as outlined in this RFA. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in the RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH)) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future unsolicited competing continuation applications will compete as research project applications with all other investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competing continuation cooperative agreement applications for review according to the procedures described in Section F. NCI anticipates making three to five awards for project periods of up to four years and anticipates that a total of $1,000,000 will be set aside for the initial year's funding. Funding in response to this RFA is dependent on the receipt of a sufficient number of applications of high scientific merit. The earliest feasible start date for the initial awards will be July 1, 1991. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated for fiscal year 1992. The purpose of the proposed awards is to stimulate cooperative efforts to assess biological differences in prostate cancer and to identify and evaluate genetic markers for prognosis in prostate cancer. The cooperative agreement funding mechanism was selected because of substantial NCI programmatic involvement required to coordinate activities among several laboratories working toward a common goal. D Terms of Cooperation The cooperative agreements will require cooperation between an NCI representative and the Principal Investigators of the individual projects in order to ensure smooth interactions among the cooperating institutions. The NCI representative will assist in coordinating the activities of the research groups, and in facilitating exchange of information. Awardees will retain custody and primary rights to their data developed under these awards, subject to government, e.g., NCI, NIH or PHS, rights of access, consistent with current DHHS, PHS, and NIH policies. 1. Organization and Role of the Coordinating Committee The NCI representative and the participating research groups will be responsible for forming a Coordinating Committee as defined below. Operating policies will be developed by the Coordinating Committee and submitted to the NCI representative for concurrence prior to implementation. The NCI representative will facilitate the review of operating policies and clinical research protocols. Results of the review will be discussed with the Coordinating Committee and an arbitration system, as detailed below, will be available to resolve disagreements between the NCI representative and the other members of the Coordinating Committee. The Coordinating Committee will review plans for network studies and the operating procedures proposed by the individual research groups to ensure that they are compatible with the overall goals of the RFA. Members of the Coordinating Committee will be responsible for redefining research objectives and defining strategies for Network studies to optimize progress and efficient use of patient and tissue resources. The Coordinating Committee will also be responsible for coordinating activities such as plans for statistical design and analyses, developing forms, distributing reagents and biological samples, data collection and data analysis, monitoring the progress of the network, and maintaining quality assurance. The Coordinating Committee will consist of the NCI representative and two members from each cooperating institution, a basic scientist and a clinician (one of the two will be the Principal Investigator). The NCI representative will be appointed by the Chief of the Cancer Diagnosis Branch, DCBDC, NCI. The Coordinating Committee will be responsible for electing a chairperson (who may not be the NCI representative). This can be a rotating position. The Chairperson of the Coordinating Committee will be responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. The NCI representative will attend and participate in all meetings of the Coordinating Committee and must be informed of major inter-group interactions. The Coordinating Committee will prepare an annual progress report that will include individual reports from each participating research group; each group is responsible for timely preparation of its report. The Coordinating Committee will meet initially to plan basic operating procedures and integration of the participating programs, and will meet at least twice a year thereafter. Meetings may be held at any of the participating institutions or at another convenient location. These meetings are aimed at planning research activities, coordinating the tissue utilization, establishing priorities, and reviewing progress. The NCI representative will participate in the discussions at these meetings. Travel funds for Coordinating Committee meetings are to be set aside as a budget line item in each project budget. 2. Role of NCI Representative The NCI representative will coordinate and facilitate the programs supported by these cooperative agreements, will attend and participate in all meetings of the Coordinating Committee, and will provide liaison between the Coordinating Committee and participating research groups. The NCI representative will assist the Coordinating Committee in developing operating policies, quality control procedures, and consistent policies for dealing with recurring situations that require coordinated action. To ensure consistency and quality, NCI must concur in operating policies and proposed Network studies prior to their implementation. The NCI representative may review the operations of individual laboratories for compliance with protocols, quality control standards, and other operating policies developed by the Coordinating Committee. The NCI representative may recommend withholding of support, suspension, or termination of an award for lack of progress or failure to adhere to policies established by the Coordinating Committee. 3. Responsibilities of Awardees Awardees are responsible for proposing research projects to advance the goals of the network and for participating in the development and conduct of Network studies. All studies approved by the Coordinating Committee will be conducted by members of the network, and responsibilities for specific aspects (e.g., statistical design and analysis) will be determined by the committee for each study at the time it is developed. Two members of each research group are required to attend meetings of the Committee (as detailed in Section D. 1.), to help formulate the Committee's policies (which will be submitted to the NCI representative for approval), to implement those policies, and to participate in analysis of the data submitted by the various research groups. Awardees are required to have access to appropriate tumor tissue and normal tissue and to have the appropriate clinical and molecular biology and/or cytogenetic expertise. They are required to submit progress reports at each meeting of the Coordinating Committee. Awardees are required to publish worthwhile research results in appropriate peer-reviewed journals in a timely fashion. 4. Arbitration Procedures An arbitration panel of external consultants will be created as needed to resolve any irreconcilable differences of opinion related to scientific/programmatic matters between the NCI representative and the other members of the Coordinating Committee with respect to implementation of a proposed operating policy. The panel will include one member selected by the Coordinating Committee, one member selected by the NCI, and a third member chosen by the other two members of the arbitration panel. The NCI arbitration process for the cooperative agreement in no way affects the rights of awardees to appeal selected post award administrative decisions in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. E Eligibility Requirements Applicant organizations must be located in the United States, Canada, or Mexico. Non-profit and for-profit organizations and institutions, and government agencies are eligible to apply. F Special Instructions for Preparation of Cooperative Agreement Applications The grant application form PHS 398 (revised 10/88, reprinted 9/89) must be used for the cooperative agreement application. The general instructions, e.g., for format and budget issues, included in the application packet must be followed. Specific issues related to cooperative agreements must be addressed as follows: It is critical that each applicant include specific plans for responding to the Terms of Cooperation discussed in Section D above. Applicants must describe how they will comply with the involvement of the NCI representative and how they will fulfill their responsibilities in the cooperative agreement. Individual proposals for both Network studies and individual studies must be included in order to provide the Coordinating Committee with a basis for planning network activities. G Review Procedures and Criteria 1 Review Procedures Upon receipt, applications will be reviewed initially by the DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications judged to be nonresponsive to this RFA will be returned, but may be submitted as investigator-initiated research grant applications at the next grant application receipt date. In cases where the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those that are clearly not competitive for award. The NCI will remove from further competition those applications judged to be noncompetitive and will notify the applicant Principal Investigator and institutional official. Those applications judged to be both responsive and competitive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the Institute and the priorities of the National Cancer Program. 2 Review Criteria Factors considered to be important for review include a demonstrated expertise in the biology or diagnosis of prostate cancer; expertise in cytogenetics or molecular genetics; an active research program relating applications of molecular genetics or cytogenetics to human cancer; interactions between basic scientists and clinicians; availability of prostate cancer patients for study; demonstration of adequate facilities; and willingness to interact within the terms of a cooperative agreement as outlined in this document. Reviewers will be asked to review the applications by considering the following criteria: o Scientific merit and feasibility of the proposed project. o Proposed collaborations between basic scientists (e.g., molecular geneticists and/or cytogeneticists) and clinicians (e.g., urologists and pathologists). o Qualifications, experience, and proposed responsibilities of the Principal Investigator and key support personnel. o Demonstration of availability of and access to appropriate patients and to archival or fresh/frozen human prostate tumor tissue with associated pathological data. The patient population must include appropriate numbers of Blacks and other minorities or provide sufficient justification of their exclusion. o The proposed techniques and methodologies to be used to achieve the stated goals; demonstrated expertise in both the appropriate basic and clinical sciences. o Scientific plans and timetable for implementing the proposed research program. o Facilities and resources, and their availability for this project. o Plans for effective interaction and coordination among cooperating projects and with the NCI. o Plans to protect the rights of human subjects. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each application. H Application Complete applications are due no later than September 6, 1991, and must address all requirements in the RFA. Applications received after this date will be returned. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The research grant application form PHS 398 (revised 10/88, reprinted 9/89) must be used in applying for these grants. These forms are available at most institutional business offices and from: Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 5333 Westbard Avenue Bethesda, MD 20892-4500 and from the NCI Program Director named below. The RFA label available in the application form PHS 398 (revised 10/88, reprinted 9/89) must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2 of the face page of the application form. Submit a signed typewritten original of the application, including the checklist, and four signed exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892-4500** The photocopies must be clear and single sided. In addition, two copies must be sent to: Referral Officer Division of Extramural Activities, NCI Westwood Building, Room 848 5333 Westbard Avenue Bethesda, MD 20892-9912 I Letter of intent Prospective applicants are asked to submit by June 10, 1991, a letter of intent that includes a descriptive title of the proposed project, the name and address of the Principal Investigator, the names of other key personnel, any collaborating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of the applications to be reviewed. The letter of intent is to be sent to: Roger L. Aamodt, Ph.D. Program Director for Pathology/Cytology Cancer Diagnosis Branch, DCBDC, NCI Executive Plaza South, Room 638 6120 Executive Boulevard Rockville, MD 20892-9904 Telephone: (301) 496-7147 FAX: (301) 496-8656 J Inquiries Written and telephone inquiries concerning the objectives and scope of the RFA, or inquiries about whether or not specific proposed research would be responsive, are encouraged and should be directed to Dr. Roger L. Aamodt at the above address. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. For fiscal and administrative matters, contact: Robert E. Hawkins Grants Management Specialist Grants Administration Branch National Cancer Institute EPS, Room 216 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. 13 This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 35, pt. 2, 20 September 1991 Message-ID: Date: 19 Sep 91 22:07:33 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 1004 $$XID NIHGUIDE 19910920 V20N35 P2O2 ************************************ The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate national advisory council whose review may be based on policy considerations as well as scientific merit. REVIEW CRITERIA Criteria for scientific/technical merit review of applications will include the following: o The overall significance and scientific and technical merit of the proposed research. o The appropriateness and adequacy of the experimental design, including the adequacy of the methodology proposed for collection and analysis of data, including research schematics, detailed analytic plans, and proposed instrumentation. o The adequacy of the qualifications (including level of education and training) and relevant research experience of the Principal Investigator and key research personnel. o The availability of adequate facilities, general environment for the conduct of proposed research, other resources, and collaborative arrangements necessary for the research. o The appropriateness of budget estimates for the proposed research activities. o Where applicable, the adequacy of procedures to protect or minimize possible adverse effects on human, animals, or the environment. o Conformance of the application to the policy on inclusion of women and minorities in study populations. AWARD CRITERIA Applications recommended for consideration by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, NIAAA program needs and balance, and availability of funds. TERMS AND CONDITIONS OF SUPPORT Grant funds may be used for expenses clearly related and necessary to conduct research projects, including both direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention intervention service program. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. INQUIRIES Potential applicants are encouraged to seek preapplication consultation and may contact the individuals listed below for consultation in preparing an application under this announcement. Direct inquiries relating to program issues to: Treatment and Treatment Assessment: Joanne Fertig, Ph.D. Treatment Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Parklawn Bldg., Room 14C-20 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-0796 Basic Etiology: Sam Zakhari, Ph.D. or Walter Hunt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Parklawn Bldg., Room 16C-05 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4223 Direct inquiries regarding fiscal matters to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16-86 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4703 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. Awards are made under the authority of Sections 301 and 510 of the Public Health Service Act, as amended (42 USC 241 and 290bb). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************* $$P5 BEGIN PA-91-99 ************************************************** STUDIES ON OBESITY PA: PA-91-99 P.T. 34; K.W. 0715145, 0710095, 0765020 National Institute of Diabetes and Digestive and Kidney Diseases National Heart, Lung, and Blood Institute National Institute of Child Health and Human Development National Cancer Institute National Institute on Aging National Center for Nursing Research National Institute of Neurological Disorders and Stroke National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Deafness and Other Communication Disorders National Institute of Mental Health BACKGROUND INFORMATION Research on the biomedical and behavioral aspects of obesity is an important component of the NIH nutrition research program. Obesity is widely prevalent in the United States, affecting both children and adults. Data on body mass index from the second National Health and Nutrition Examination Survey (1976-80) indicated that 24 percent of men and 27 percent of women were overweight (body mass index equal to or greater than 27.8 for men and 27.3 for women). The prevalence of obesity in adults has not declined in the past three decades; some data suggest that its prevalence in children has increased over this time. Obesity is particularly prevalent in minority populations, especially among minority women. Obesity is multifactorial in origin, reflecting inherited, environmental, cultural, and socioeconomic conditions. Obesity is associated with elevated serum cholesterol levels, elevated blood pressure, and noninsulin-dependent diabetes, and is an independent risk factor for coronary heart disease. It also increases the risk for gallbladder disease and some types of cancer and has been implicated in the development of osteoarthritis of the weight-bearing joints. Obesity acquired during childhood or adolescence often persists into adulthood and increases the risk for some chronic diseases later in life. The great prevalence of obesity and its physical and mental health consequences make its prevention and treatment a public health priority. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000", a PHS-led national activity for setting priorities. This program announcement is related to the priority areas of nutrition, physical activity and fitness, heart disease and stroke, cancer, diabetes, and chronic disabling conditions. Potential applicants may obtain free of charge a copy of "Healthy People 2000" (Full Report: No. 017-001- 474-0, 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). RESEARCH GOALS AND SCOPE The emphasis of this program announcement is the support of research on the biomedical and behavioral aspects of exogenous obesity. The goals of this research, which includes basic, clinical, and population research, are to establish a clear understanding of the etiology, prevention, and treatment of this multifaceted condition. For example, the determinants of obesity during the early stages of the life cycle need to be identified in order to prevent the onset of obesity early in life and to identify individuals at high risk of becoming obese later in life. Preventive therapies, as well as successful treatment regimens, need to be designed. In order to accomplish these goals, further research is needed on the behavioral and developmental aspects of obesity in terms of its natural history and determinants in infancy, childhood, and adolescence; on the molecular, metabolic, genetic, and neurological aspects of obesity; on the successful treatment of obesity; and on the effects of obesity on health and longevity. A major question with respect to the health implications of obesity is determining the relative roles of body composition, body fat, and the regional distribution of body fat in the morbidity and mortality attributed to obesity. There is also the need to learn more about adipose tissue morphology as a determinant of the pattern of fat distribution and the impaired health and shortened life span associated with the obese state. Finally, more information is needed to support health-based standards of desirable weight for various age, sex, and ethnic groups. Examples of research areas in obesity of particular interest include, but are not limited to, the following: Molecular, Metabolic, and Genetic Factors o Mechanisms by which obesity contributes to the development of diseases such as diabetes, coronary heart disease, hypertension, and cancer, as well as possible differences in such mechanisms among different ethnic groups. o The contribution of genetic and metabolic factors to obesity, including the molecular and genetic basis of energy metabolism and the nature of genetic aberrations in human obesity. o Interactions of genetic and environmental factors, as well as dietary, behavioral, and social factors, in the etiology of obesity and their effects on the ability to lose weight successfully. o The contribution of muscle metabolism to energy balance. o Methods for measuring body fat distribution and determining its effects on disease. o Hypometabolism and factors that influence energy expenditure. o Influence of gestational diabetes on subsequent weight gain of offspring. o Role of nutrient composition of the diet in energy balance. Neurological and Endocrine Factors o The neurophysiology of ingestive behavior, including an understanding of the mechanisms of anorexia. o Central nervous system/hypothalamic/autonomic nervous system (including sympathetic nervous system) control of energy intake and expenditure, including the neuroanatomical organizations and pathways that control food intake and the behavioral, hormonal, and metabolic mechanisms by which such pathways influence satiety mechanisms and body weight. o Role of the brain in mediating acquisition, extinction, and aversion of associations to gustatory, olfactory, and trigeminal stimulation. o Neuroanatomical pathways connecting the gastrointestinal system to the hypothalamus, and the effect of changes in the gastrointestinal system on the electrophysical activity in the hypothalamus. o Functional and structural alterations in the brain resulting from changes in food intake in animals, as well as gustatory, olfactory, and trigeminal stimulation. o Neurological mechanisms of taste, smell, and common chemical reception in a variety of animal models. Behavioral and Developmental Factors o Behavioral interventions to prevent and treat obesity at all ages and in various population groups, including minority populations. o Behavioral change strategies for weight loss and to prevent relapse after weight loss. o Application of the techniques of behavioral neuroscience to the prevention and treatment of obesity. o Mechanism of action of reinforcers of food intake and physical activity. o Sensory-specific studies of habituation phenomena. o Genetic/environmental/behavioral interactions. Treatment of Obesity Due to the serious health implications of obesity, research must continue to find successful measures to treat obesity and to prevent its recurrence. Various treatments that need to be examined include the use of hypocaloric regimens, the effects of exercise alone or in combination with caloric restriction on metabolism and subsequent weight loss, and behavioral therapies. Such treatments need to be examined across the various stages of the life cycle and in different risk groups. Treatment outcomes, including regression of risk factors and effects on other medical disorders, need to be examined, including: o Treatment models and efficacy in various age groups and in minority populations. o Influence of duration of obesity on adverse health effects and response to intervention. o Effects of weight cycling on cardiovascular risk factors, fat patterning, and other physiological measures. o The effect of mild exercise on appetite and the role of exercise in weight control. o Mechanism of action and efficacy of pharmacologic agents in energy balance and weight control. Prevention of Obesity o Research emphasis on preventing obesity in children, adolescents, and adults and encouraging healthy active lifestyle at all ages. o Interventions to reduce sedentary behavior. o Evaluation of prevention strategies targeted at specific racial, ethnic, and socioeconomic high-risk groups. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS National Institutes of Health (NIH) policy is that applicants for NIH clinical research grants will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities in studies of diseases that 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 and compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group, together with a rationale for its choice. In addition, gender and racial or 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 on grant application form PHS 398 in Sections 2A-D of the Research Plan AND summarized in Section 2E (Human Subjects). Applicants are urged to carefully assess 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 or 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 or 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, applicants 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 specifically address 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 a priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. MECHANISM OF SUPPORT The mechanism of support for this program will be the grant-in-aid (RO1 and R29). The regulations (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part 74) and policies that govern the research grant programs of the Public Health Service will prevail. The award of grants pursuant to this request for grant applications is contingent upon ultimate receipt of appropriated funds for this purpose. The NIH requires applicants for grants to give added attention (where feasible and appropriate) to the inclusion of minority groups and/or women in the study populations for research. For proposed population-based studies that do not include women and/or minorities, a clear rationale for not including either or both must be provided. METHOD AND CRITERIA OF REVIEW Assignment of Application: Applications will be received by the Division of Research Grants (DRG), NIH, referred to an appropriate study section for scientific review, and assigned to individual Institutes for funding consideration. These decisions will be governed by customary programmatic considerations as specified in the DRG Referral Guidelines. Review Procedures: Applications in response to this announcement will be reviewed in competition with other applications received in the same review cycle, and in accord with the customary NIH peer review procedures. The initial review for scientific and technical merit will be by a review group composed mostly of non-Federal scientific consultants (study section). Following study section review, the application will be evaluated by the appropriate Institute Advisory Council or Board with respect to the adequacy of the technical merit review and the program relevance of the research proposed. The review criteria customarily employed by the NIH PHS for research grant applications will prevail. Deadlines: Applications will be accepted in accordance with the usual receipt dates for new applications: October 1, February 1, and June 1. METHOD OF APPLYING Applications should be submitted on form PHS 398 (rev. 10/88) that is available in the business or grants and contracts office at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, NIH, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. In line 2 on the face page of the application, the phrase, "Studies on Obesity" must be inserted. For further information, investigators are encouraged to contact one or more of the following individuals: Van S. Hubbard, M.D., Ph.D. Director, Obesity, Eating Disorders and Energy Regulation Program National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Westwood Building, Room 3A18B Bethesda, MD 20892 Telephone: (301) 496-7823 Eva Obarzanek, Ph.D., M.P.H., R.D. Prevention and Demonstration Research Branch Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute Federal Building, Room 604 Bethesda, MD 20892 Telephone: (301) 496-2465 Gilman Grave, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Plaza North, Room 637A 6130 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-5593 Carolyn K. Clifford, Ph.D. Acting Chief, Diet and Cancer Branch National Cancer Institute Executive Plaza North, Room 212 6130 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-8573 Ann W. Sorenson, Ph.D. Director, Nutrition Program Biology of Aging Program National Institute on Aging Building 31, Room 5C21 Bethesda, MD 20892 Telephone: (301) 496-6402 June Lunney, Ph.D., R.N. Nurse Scientist Administrator National Center for Nursing Research Building 31, Room 5B03 Bethesda, MD 20892 Telephone: (301) 496-0523 Kenneth Surrey, Ph.D. Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 802 Bethesda, MD 20892 Telephone: (301) 496-1431 Joan A. McGowan, Ph.D. Bone Biology and Bone Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 496-7496 Jack Pearl, Ph.D. Health Scientist Administrator National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400B-12 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-5061 Susan J. Blumenthal, M.D., M.P.A. Chief, Behavioral Medicine Program National Institute of Mental Health Parklawn Building, Room 11C06 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4337 Contacts for fiscal and administrative inquiries: Paulette S. Badman Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639C Bethesda, MD 20892 Telephone: (301) 496-7467 Marie Willett Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A11C Bethesda, MD 20892 Telephone: (301) 496-7536 E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 501 6130 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-1303 Eileen Natoli Team Leader, Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-7800 ext. 56 Carol Combs Biology of Aging Program National Institute on Aging Building 31, Room 5C15 Bethesda, MD 20892 Telephone: (301) 496-4996 Sally A. Nichols Grants Management Officer Office of Administrative Management National Center for Nursing Research Building 31, Room 5B06 Bethesda, MD 20892 Telephone: (301) 496-0237 Patricia Driscoll Grants Management Branch Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 Carol Clearfield Grants Management Specialist National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (301) 496-7495 Sharon Hunt Grants Management Officer Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-0909 Bruce L. Ringler Chief, Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3056 This program announcement replaces a previous one published in the NIH Guide for Grants and Contracts, Vol. 13, No. 4, March 30, 1984. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.848, 93.847, 93.837, 93.865, 93.393, 93.866, 93.854, 93.173, and 93.242. Awards are made under the authorization of the Public Health Service Act, Section 301 (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 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P5 END ************************************************************* $$XID RFA NS9201 NS-92-01 P1O1 ***************************************** FEASIBILITY GRANTS FOR BRAIN-TUMOR RESEARCH CENTERS RFA: NS-92-01 P.T. 34; K.W. 0705010, 0715035, 1002030, 071085, 0785120, 0745020 National Institute of Neurological Disorders and Stroke Letter of Intent Receipt Date: November 15, 1991 Application Receipt Date: January 15, 1992 PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) invites applications for feasibility (exploratory) grants for the development of brain-tumor research centers. The major purpose of this Request for Applications (RFA) is to develop additional research capabilities that will lead to improved diagnosis and management of patients with brain tumors and to foster an environment that would enhance the research skills of investigators in specialized methods relevant to the study of brain tumors. BACKGROUND In response to House Joint Resolution 174, which declared the 1990s the "Decade of the Brain," the NINDS developed the Implementation Plan for the Decade of the Brain that identifies the most compelling neurological disease areas and research issues in which the opportunity exists to make practical advances during the next several years. Among these highest priority issues is the recommendation that new ways of management of primary brain tumors be developed through an understanding of the highly specialized biology of brain tumors. This recommendation is based on the recognition that tumors of the brain are a devastating occurrence and that the expanding tumor mass interferes in several ways with the most delicate organ in the body. In addition, brain tumor is the second most common malignancy of childhood. In a second incidence peak at the age of 55, brain tumors cause the death of over 35,000 patients a year, a third of whom succumb to primary tumors of the brain. In The Labor-HHS Appropriations Act for Fiscal Year 1992, the Congress responded to knowledge that the incidence of brain tumors continues to increase and that this disease process is especially tragic because many of the victims are children and young adults. The Congress, therefore, urged the NINDS to establish several additional brain-tumor research centers with research training capabilities, and provided funds for feasibility grants to develop future capacities in this important area. RESEARCH GOALS AND SCOPE The overall purpose of this RFA is to award feasibility grants that will lead, ultimately, to several additional centers with investigators capable of generating complex research initiatives, developing essential pilot data, and answering important research questions about a variety of types of brain tumors, processes associated with malignant tumors, the management of spreading brain tumors, and other confounding effects of brain tumors. Areas of research appropriate to this RFA include, but are not limited to: o fundamental biological research on brain tumors, including such areas as tumor development, promoters and inhibitors of brain tumor growth, the specific genetic codes that regulate brain-cell growth to maturity, the sites at which these messengers act, the genetic markers that define the premalignant through the highly invasive stages of a tumor, the chromosomal abnormalities that neurogenetically link several tumor disorders (such as neurofibromatosis, bilateral acoustic neurons, meningiomas, and astrocytomas), the function of the basement membrane and the extracellular matrix of brain cells, the hormonal modulation of brain tumors, and factors that regulate tumor angiogenesis; o development of diagnostic and therapeutic monoclonal antibodies with a high degree of specificity and sensitivity toward brain tumors, including the basic developmental and clinical research required for these activities; o preclinical testing of pharmacological agents directed towards specific molecular characteristics of brain tumor cells; o development of new therapeutic approaches; and o refinement of existing forms of therapy for the treatment of brain tumors, such as systems for directly introducing vectors into tumors that can down-regulate their metabolic activity. Since applicants for the feasibility grant are at an early stage of developing the scope of a research program that would eventually qualify for center support, applications must be based on the goal of creating a clinical research center that would, at the end of the feasibility grant, conform to the "Application Guidelines: Program Project and Clinical Research Center Grants" (revised October 1989) that is available from the NINDS staff contact listed below. Therefore, the format for these feasibility grant applications must address at least the following essential components of the future center: o the feasibility of developing a research program centered around a unifying theme relevant to brain-tumor research and treatment; o a component devoted to fundamental brain-tumor research; o a component devoted to clinical research on brain tumors, including plans for research that may lead to the development of new therapeutic interventions, the refinement of existing forms of therapy, and the preclinical testing of these forms of therapy; and o an administrative core devoted to the integration and coordination of activities within the research center and among the several research centers selected for funding. Recognizing that the goal of this program is to develop the capabilities of the awardee investigators and institutions, applicants must emphasize the existing and the potential strengths of the applicant organization as related to the development of a clinical research center. Appropriate areas may include, but are not limited to: development of additional research capabilities for basic, applied, and clinical research; potential arrangements for improved capabilities for preclinical testing of new or refined methods of treatment of brain tumors; plans for collaborations that would strengthen existing research interests; identification of personnel that would be considered essential for the future of the center and possibilities for their successful recruitment; development of plans for acquiring or providing special research and clinical skills; and possible collaborations that would ensure the availability of patients for clinical studies. DISCIPLINES AND EXPERTISE The Center Director or Principal Investigator must be active in a discipline related to the study and/or treatment of brain tumors, such as neuro-oncology, neurosurgery, neurology, neurobiology, tumor-cell biology, immunology, neurophysiology, neuroanatomy, neuroradiology, radiation oncology, or neuropharmacology, and have demonstrated the potential for developing and directing a research program. Interrelated biomedical research projects included in the interdisciplinary research centers must be conducted by scientists who represent a variety of disciplines within basic, applied, and clinical science and who are willing and able to relate to each other so that new scientific leads may be readily developed and effectively utilized by others. For purposes of planning, it is important to recognize that the content of the individual components of a research center is critical; the research center program must be organized around a central research theme and must encompass a sufficient number of scientifically meritorious research activities (from a minimum of three to a maximum of five or more) to permit an effective collaborative effort among the participating investigators. SPECIAL INSTRUCTIONS REGARDING WOMEN AND MINORITIES IN CLINICAL RESEARCH Special instructions to applicants regarding implementation of NIH policies concerning inclusion of women and minorities in clinical research study populations: NIH and ADAMHA policy is that applicants for NIH or ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale for non-conformance to the policy should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial or ethnic minority populations (American Indians or Alaskan Natives, Asian or Pacific Islanders, Blacks, and 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 or ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If 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 being asked, it will be considered a weakness or deficiency in the study design and will be reflected in the assignment of 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 or do not have an approved, compelling rationale for non-compliance. ELIGIBILITY To be eligible for competition under this RFA, applicants must document the existence of, or potential for, ongoing basic, applied, and clinical research related to brain tumors; research resources in the encompassing fields of neuro-oncology and the neurological sciences; clinical facilities that demonstrate the ability to adequately receive and track patients who have brain tumors; cooperation among investigators within the represented disciplines so that scientific leads may be effectively implemented; and a plan for the further development of individual investigators, fellows, or clinicians in specialized techniques or procedures relevant to research on brain tumors. MECHANISM OF SUPPORT The support mechanism for this program will be the exploratory (feasibility) grant (P20). Applicants are requested to furnish their own estimates of the time required to achieve the objectives of the proposed developmental program. Feasibility grants will be awarded for up to three years (not renewable). The NINDS expects to make up to four awards for exploratory grants, depending upon availability of funds. No exploratory grant (P20) may exceed annual direct costs of $250,000 for each of three years. The current policies and requirements that govern the research grant programs of the NIH will prevail. NOTE: Although this RFA specifically invites applications for feasibility grants only, there may be applicants who are beyond the feasibility stage and who would be more appropriately judged as eligible for center status. Applications for clinical research centers are also welcome, but they must be submitted for any of the three annual receipt dates (February 1, June 1, and October 1). Such applications must conform to the application format as described in the NINDS pamphlet, "Application Guidelines: Program Project and Clinical Research Center Grants" (revised October 1989), which may be obtained from the individual to whom inquiries and letters of intent are directed (address below). REVIEW PROCEDURES AND CRITERIA Review Method. Upon receipt, applications will be reviewed by NINDS staff to determine responsiveness to this RFA. Applications judged unresponsive will be returned to the applicant. NOTE: APPLICATIONS THAT DO NOT CONFORM TO THE INSTRUCTIONS CONTAINED IN THE PHS 398 (rev.9/88, reprinted 10/89) APPLICATION KIT WILL BE JUDGED NON-RESPONSIVE AND WILL BE RETURNED TO THE APPLICANT. All applications that are complete and responsive to this RFA may be subjected to a triage by an NINDS peer review group to determine relative scientific merit among the applications. The NINDS will administratively withdraw those applications judged to be noncompetitive for award and will notify the applicant Principal Investigator and institutional business official. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by an initial review group convened by the Division of Extramural Activities, NINDS. A second level of review will be by the National Advisory Neurological Disorders and Stroke Council in May 1992. Review Criteria. The factors to be considered in the evaluation of the merit of each application will focus on the potential for the applicant institution to develop into a full clinical research center; potential access to appropriate patient populations; presence of facilities for basic, applied, or clinical research, with the potential to develop other areas; plans for future development in innovative areas of research and recruitment of needed personnel; planned collaborations to strengthen existing facilities; plans for further development of existing research personnel and exchange of ideas and techniques; and feasibility of the planned research within the time and budget requested. METHOD OF APPLYING Letter of Intent. The NINDS urges applicants to submit a letter of intent that includes the name and address of the Principal Investigator, the names and addresses of co-investigators who will be responsible for the planning of research projects and required components within the center, a descriptive title of each anticipated areas of research, if possible, and each required component for which support will be requested, and the identification of any collaborating institutions, if known at the time. A letter of intent is not binding, is not entered into the review of a subsequent application, and is not a precondition for an award. The information provided will be used by the NINDS staff in planning for the review of applications, to estimate the potential workload, and to avoid possible conflict of interest. The letters are requested by November 15, 1991, and are to be sent to Dr. George N. Eaves at the Division of Stroke and Trauma, NINDS (complete address below). Format of Applications. All applicants will submit applications on form PHS 398, the application form for the traditional research project grant. This form is available in an applicant institution's office of sponsored research or business office and from Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, Telephone: (301) 496-7441. Applicants must use the application format as described in the NINDS pamphlet, "Application Guidelines: Program Project and Clinical Research Center Grants" (revised October 1989), that may be obtained from the individual to whom inquiries and letters of intent are directed. To identify the application as a response to this RFA, check "yes" on item 2 of page 1 of the application and enter the title "NINDS: FEASIBILITY GRANTS FOR BRAIN-TUMOR RESEARCH CENTERS" and the RFA number NS-92-01. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Application Procedure. Send or deliver the completed application and four signed, exact photocopies to: Division of Research Grants Westwood Building, Room 240 National Institutes of Health Bethesda, MD 20892 In addition, send two exact photocopies to Dr. George N. Eaves at the address below. This RFA is a one-time solicitation with an APPLICATION DEADLINE OF January 15, 1992. An application not received by close of business on this date will be ineligible for consideration. The review for scientific and technical merit of applications judged responsive to the RFA will take place during Spring 1992. THERE WILL BE NO SITE VISITS. Review by the National Advisory Neurological Disorders and Stroke Council will be in May 1992. Awards will be made on or before September 30, 1992. INQUIRIES Inquiries regarding this announcement may be directed to: Dr. George N. Eaves Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 For fiscal and administrative matters, contact: Mr. King P. Bond, Jr. Grants Management Specialist National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9203 AUTHORITY AND REGULATIONS The program to which the intended grants relate is described in the Catalog of Federal Domestic Assistance, No. 93.853, Clinical Research Related Neurological Disorders and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, 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 Health Systems Agency review. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 18, pt. 1, 3 May 1991 Message-ID: Date: 1 May 91 01:32:30 GMT Sender: kristoff@genbank.bio.net Lines: 1028 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. There are quite a few lengthy RFAs in this issue so this will be sent out over the course of severla days to prevent mail overload on some systems. -D.K. ---------------------------------------------------------------------- NIH GUIDE - Vol. 20, No. 18, May 3, 1991 $$INDEX BEGIN ********************************************************** NOTICES $$INDEX N1 ************************************************************* REVIEW PROCEDURES FOR PROGRAM PROJECT GRANT APPLICATIONS National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ************************************************************* EVALUATION OF NIH IMPLEMENTATION OF SECTION 491 OF THE PUBLIC HEALTH SERVICE ACT, MANDATING A PROGRAM OF PROTECTION FOR RESEARCH SUBJECTS (RFP) National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH $$INDEX R2 ************************************************************* PROSTATE, LUNG, COLORECTAL, AND OVARIAN CANCER SCREENING TRIAL - SCREENING CENTERS (RFP) National Cancer Institute Index: CANCER $$INDEX R3 08/06/91 **************************************************** ADULT AIDS CLINICAL TRIALS UNITS (RFA AI-91-07) National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 09/06/91 **************************************************** COOPERATIVE NETWORK FOR MOLECULAR GENETIC AND CYTOGENETIC STUDIES OF PROSTATE CANCER (RFA CA-91-10) National Cancer Institute Index: CANCER $$INDEX R5 06/24/91 **************************************************** STATE SERVICE SYSTEMS IMPROVEMENT THROUGH CONSUMER AND FAMILY SUPPORT ACTIVITIES (RFA MH-91-13) National Institute of Mental Health Index: MENTAL HEALTH $$INDEX R6 07/31/91 **************************************************** COOPERATIVE NETWORK FOR EVALUATION OF PROGNOSTIC MARKERS OF URINARY BLADDER CANCER (RFA CA-91-09) National Cancer Institute Index: CANCER $$INDEX R7 06/21/91 **************************************************** ADAMHA SMALL INSTRUMENTATION PROGRAM (RFA AA-91-03) Alcohol, Drug Abuse, and Mental Health Administration Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH $$INDEX END ************************************************************ NOTICES $$N1 BEGIN ************************************************************* REVIEW PROCEDURES FOR PROGRAM PROJECT GRANT APPLICATIONS P.T. 34; K.W. 1014006 National Institute of Child Health and Human Development Effective for the June 1, 1991 receipt date, program project (P01) applications assigned to the National Institute of Child Health and Human Development (NICHD) will no longer be routinely site-visited. These applications will be considered by the relevant Initial Review Group (IRG) without interaction with the applicant. The IRG will have the option of deferring an application for a site visit, although this will be the exception rather than standard practice. As a result of this change, NICHD P01 applicants must ensure that the description of the proposed research for each component project/core facility is thorough and complete (not to exceed 20 pages), permitting direct evaluation by the reviewers. Unless otherwise indicated, NICHD Center Core (P30) Grant and Specialized Center (P50) Grant applications will continue to receive site visits as a part of the review process. Programatic questions about this announcement should be directed to: Laurance S. Johnston, Ph.D. Acting Director, Division of Scientific Review NICHD/NIH Executive Plaza North, Room 520 Bethesda, MD 20892 Telephone: (301) 496-1696 Grants management questions should be directed to: Donald Clark Chief, Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 501 Bethesda, MD 20892 Telephone: (301) 496-5001 $$N1 END *************************************************************** NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-OD-91-12 ************************************************ EVALUATION OF NIH IMPLEMENTATION OF SECTION 491 OF THE PUBLIC HEALTH SERVICE ACT, MANDATING A PROGRAM OF PROTECTION FOR RESEARCH SUBJECTS RFP AVAILABLE: NIH-OD-91-12 P.T. 34; K.W. 0783005 National Institutes of Health The Office of Extramural Programs, Office of Extramural Research, Office of the Director, National Institutes of Health, has a requirement to evaluate the national program of protection for research subjects at institutions engaged in research funded by the Department of Health and Human Services pursuant to Section 491 of the PHS Act. This evaluation will examine the extent to which the program is meeting this objective while continuing to facilitate needed research to improve the nation's health. Preliminary considerations suggest four broad categories of measurement: outcome measures focusing on adequacy of consent procedures, risk assessment and subject selection; output measures, including workload and caseload measures from institutional records; process measures exploring variations in institutional procedures and deployment of the program in new settings and in use of innovative interventions; and resource measures of personnel, time, effort and costs. The contractor must have the professional capabilities and facilities to evaluate government programs of national scope and comparable complexity with major implications for Federal health sciences policy, government- university relations, and the broad public. The results of the study will be the basis for recommendations to ensure responsiveness to rapidly changing research opportunities while maintaining appropriate safeguards for individuals involved as subjects of research. It is expected that the contract will have a two- (2) year period of performance. Any responsible offeror may submit a proposal that will be considered by the Government. The issuance date of the RFP will be on or about May 31, 1991, and proposals will be due by the close of business 50 days after issuance. Requests for the RFP must be directed to: Valerie Pickett Research Contracts Branch Division of Contracts and Grants Office of the Director National Institutes of Health Building 31, Room 1B44 9000 Rockville Pike Bethesda, MD 20892 $$R1 END *************************************************************** $$R2 BEGIN NCI-CN-15342-04 ********************************************* PROSTATE, LUNG, COLORECTAL, AND OVARIAN CANCER SCREENING TRIAL - SCREENING CENTERS RFP AVAILABLE: NCI-CN-15342-04 P.T. 34; K.W. 0715035, 0745020, 0755015 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control, Early Detection Branch, is interested in soliciting proposals from organizations for Screening Centers for the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. Up to fifteen (15) screening Centers will be established, each recruiting no less than 5,000 subjects and 5,000 controls to the trial. A total of 148,000 men and women will be recruited to the trial in approximately equal numbers. Female subjects will be screened for colorectal, lung, and ovarian cancers. Male subjects will be screened for colorectal, lung, and prostate cancer. Screening will be annually for four years for prostate, lung, and ovarian cancers and only in years one and three for colorectal cancer. Subjects and controls will be followed for at least ten years. A Coordinating and Data Management Center will develop and maintain systems and procedures for biomedical data management, study coordination, statistical analysis, and report writing. The NCI has selected the cancer sites and screening modalities. Screening Centers, in cooperation with the NCI, will develop screening logistics and diagnostic protocols. A pre-proposal conference will be held and the date will be specified in the Request for Proposals (RFP). Requests for this RFP must be in writing and reference RFP No. NCI-CN-15342-04. The RFP will be available approximately April 25, 1991 and will be due approximately June 10, 1991. Copies of the RFP may be obtained by sending a written request to: Mr. Christopher B. Myers, Contract Specialist National Institutes of Health National Cancer Institute Research Contracts Branch, PCCS Executive Plaza South, Room 635 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-8603 $$R2 END *************************************************************** $$R3 BEGIN AI-91-07 FULL-TEXT ****************************************** ADULT AIDS CLINICAL TRIALS UNITS RFA AVAILABLE: AI-91-07 P.T. 34; K.W. 0715008, 0755015 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: June 5, 1991 Preapplication Meetings: June 3, 4 and 5, 1991 Application Receipt Date: August 6, 1991 BACKGROUND The National Institute of Allergy and Infectious Diseases (NIAID) announces the availability of a Request for Applications (RFA) for AIDS Clinical Trials Units (ACTUs). The purpose of this RFA is to recompete the adult component of the AIDS Clinical Trial Group (ACTG) by soliciting applications from existing ACTUs and from new applicants. This initiative will utilize the cooperative agreement. The adult component of the ACTG is a network of 32 domestic biomedical research institutions that, in aggregate, has the capabilities to develop new therapeutic interventions from initial clinical trials in human subjects to their final approval by the Food and Drug Administration. The research objectives of the ACTG are to evaluate the safety and efficacy of therapeutic interventions for the treatment of Human Immunodeficiency Virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), and associated opportunistic conditions. 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, Recompetition of the Adult AIDS Clinical Trials Units, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). OBJECTIVES It is the intent of the recompetition to maintain a cooperative network of adult ACTUs that has the capability to conduct all phases of therapeutic clinical evaluation to identify new therapies and to facilitate the transfer of interventions from the research setting to routine patient care. Emphasis will be placed on the inclusion of women, minorities and substance abusers in the clinical studies so that the patients participating in the clinical trials network reflect the demographic features of the national HIV epidemic. This network will be composed of investigators from a variety of disciplines with demonstrated expertise and experience in conducting clinical trials especially among HIV infected patients. The research objectives will be accomplished through the development of protocols, accrual of patients to ACTG protocols, submission, analysis and publication of data, and by participation of the ACTU investigators in ACTG committees. The research agenda and priorities will be established by the ACTG Executive Committee whose members include the Associate Director of the Treatment Research Program, DAIDS. Scientific areas of highest priority include antiretroviral therapy and treatment of opportunistic infections associated with HIV infection. Studies of HIV-associated malignancies and neurological complications will also be emphasized. The ACTG committees (Scientific, Resource, and Executive) are composed of investigators from the ACTUs, a NIAID staff representative, and representatives from patient advocacy groups. In order to achieve these objectives, supplementary resources will continue to be provided to the ACTU Principal Investigators by the NIAID through other funding mechanisms and include: (1) a Statistical and Data Analysis Center that assists in protocol design and functions as a central data management center, (2) an Operations Office that provides technical and logistical support for the development and implementation of protocols, (3) Clinical Site Monitoring to ensure the quality of data and conformance with regulatory requirements, and (4) a Clinical Research Products Repository that provides for the receipt, inventory, and distribution of investigational drugs. The RFA contains information related to both required and optional components. All applicants must apply for the ACTU clinical core funding to be eligible to apply for optional components. The clinical core funding will provide the resources required to maintain an infrastructure sufficient to accrue an agreed upon minimum annual number of new patients on to protocols. The clinical core funds also will support laboratory costs for protocol mandated immunophenotyping. Applicants for the ACTU clinical core funding will be eligible to apply for optional components that include: (1) pediatric clinical trials [limited to adult ACTUs that have an existing pediatric component], (2) virology core laboratory support for protocol mandated testing, (3) pharmacology core laboratory support for protocol mandated testing, (4) developmental research in virology [limited to applicants who apply for and are awarded funds for (2)], (5) developmental research in pharmacology [limited to applicants who apply for and are awarded funds for (3)], (6) developmental research in immunology, and (7) developmental research in other areas of microbiology. An applicant must receive an award for the ACTU clinical core to be eligible for funding of the optional components. However, funding priorities for the optional components will be established independent of the priorities for the ACTU clinical core awards. Funding priorities for the ACTU clinical core will not be affected by the presence or absence of optional components. SPECIAL INSTRUCTIONS FOR THE INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES The following is a brief statement of the NIH and ADAMHA policy regarding the inclusion of women and minorities in study populations. The inclusion of women and minorities should be addressed in applications submitted in response to this RFA. 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 or adequately represented in the study populations for clinical studies, a specific justification must be provided. Application without such documentation will not be accepted for review. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (UO1). The cooperative agreement funding instrument differs from the traditional research grant in that the Government awarding component (NIAID) anticipates substantial programmatic involvement during the performance. The nature of NIAID staff assistance is described in the RFA. However, applicants must define their own objectives in accord with individual interests and approaches to conducting the research. The NIAID anticipates that $48,000,000 will be available for the initial year of funding applications in response to this RFA and that approximately 20-25 applications will be funded. The award of grants pursuant to this RFA is contingent on the continuing availability of funds for this purpose and on the receipt of a sufficient number of applications of high scientific merit. APPLICATION SUBMISSION Eligibility: Any domestic university, medical college, hospital, or other clinical research institution is eligible. Under the terms of this RFA, new applicants and established adult ACTUs are invited to apply. Only domestic organizations are eligible to apply and the application may not include an international component. Letter of Intent: Prospective applicants are asked to submit, by June 5, 1991, a letter of intent that includes a descriptive title and description of the proposed research not to exceed three pages. The letter of intent is requested to provide an indication of the number and scope of applications to be received and to promote early interaction between NIAID staff and the applicant. The letter of intent does not commit the sender to submit an application, nor is it a requirement for submission of an application. Submission: The research grant application form PHS 398 (rev. 10/88, reprinted 9/89) must be used in applying. These forms are available at most institutional business offices and from the Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892. To identify responses to this announcement under Item 2 on page 1 of the grant application, check 'yes' and include the title and number of the RFA. The RFA label in the form PHS 398 must be affixed to the bottom of face page of the original signed application. Failure to do so could result in delayed processing of the application so that it may not reach the review committee in time for review. Incomplete and nonresponsive applications will be returned to the applicant without review. REVIEW PROCEDURES Comprehensive evaluation of the applications will be conducted by a Special Review Committee (SRC) consisting primarily of non-Federal scientific experts. The adult component (Part A) and pediatric component (Part B, if present) will be evaluated and scored based on the scientific merit at one SRC session. Optional components will be forwarded to a second SRC for evaluation. The priority score assigned to the application will be based on the score received for Part A. The merit of Part B and Part C components will be used by NIAID to guide funding decisions with respect to these components. APPLICATION PROCEDURES Submit by August 6, 1991, a signed, typewritten original of the application, and 6 exact, single-sided photocopies (including Appendix) in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Submit 17 exact, single-sided photocopies of the application in one package directly to: Dr. Allen Stoolmiller AIDS Review Section NIAID/DEA/PPRB Westwood Building, Room 3A-07 5333 Westbard Avenue Bethesda, MD 20892 INQUIRES The RFA is available from and Letters of Intent are to be sent to: F.H. Batzold, Ph.D. Division of AIDS National Institute of Allery and Infectious Diseases 6003 Executive Boulevard, Room 208P Rockville, MD 20892 Telephone: (301) 496-8214 For budget questions, contact: Ms. Mary Kirker Chief, AIDS Grants Management Section Grants Management Branch/NIAID Westwood Building, Room 706 Bethesda, MD 20892 Telephone: (301) 496-7075 $$R3 END *************************************************************** $$R4 BEGIN CA-91-10 FULL-TEXT ****************************************** COOPERATIVE NETWORK FOR MOLECULAR GENETIC AND CYTOGENETIC STUDIES OF PROSTATE CANCER RFA AVAILABLE: CA-91-10 P.T. 34; K.W. 0715035, 1002058, 1002004, 0413001 National Cancer Institute Letter of Intent Receipt Date: June 10, 1991 Application Receipt Date: September 6, 1991 The Cancer Diagnosis Branch of the Division of Cancer Biology, Diagnosis and Centers (DCBDC) at the National Cancer Institute (NCI) invites applications for cooperative agreements from institutions capable of and interested in participating in a cooperative network for studies of molecular genetics and cytogenetics of prostate cancer. The goals of this Request for Applications (RFA) are: 1) to promote collaborations and interactions between basic scientists and clinicians in order to advance prostate cancer research; 2) to identify genetic alterations that may distinguish the behavior of clinically silent prostate cancer from that of clinically evident cancer; 3) to determine whether there is a molecular genetic basis for differences in prostate cancer incidence between Blacks and Whites; 4) to explore the biological basis for the striking increase in prostate cancer incidence with age. Groups participating in the network will attempt to assess biological differences in prostate cancer using molecular genetic and cytogenetic approaches with the long-term goal of developing a more informative classification system. Cooperative studies will facilitate the application of molecular techniques to prostate cancer research through the efficient use of prostate cancer and normal prostate tissue. Awards will be made as cooperative agreements that create an assistance relationship with substantial involvement of NCI staff during the performance of the project, as outlined in the RFA. This mechanism is used when the NCI wishes to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. Applicants will be responsible for the planning, direction, and execution of the proposed project. It is essential that there be good liaison between basic scientists and clinicians. Each group responding to this RFA must describe existing and proposed collaboration/cooperation between basic scientist(s) and clinician(s). The NCI anticipates making three to five awards for project periods of up to four years. A total of $1,000,000 is expected to be set aside for the initial year's funding. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated for fiscal year 1992. 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, "Cooperative Network for Molecular Genetic and Cytogenetic Studies of Prostate Cancer" is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. While inclusion of women is not relevant to this RFA, special emphasis should be placed on the need for inclusion of minorities, particularly blacks, who are disproportionately affected, in studies of prostate cancer. If minorities are not included or are inadequately represented in the study populations for clinical studies, a specific justification for this exclusion or inadequate representation must be provided. Applications without such documentation will not be accepted for review. This RFA is a one-time solicitation with a specified deadline of September 6, 1991 for receipt of applications. A copy of the complete RFA describing the research goals and scope, the cooperative agreement mechanism, the review criteria, and other application requirements is available from: Roger L. Aamodt, Ph.D. Program Director for Pathology/Cytology Cancer Diagnosis Branch, DCBDC, NCI Room 638, Executive Plaza South 6120 Executive Boulevard Rockville, MD 20892-9904 Telelephone: (301) 496-7147 FAX: (301) 496-8656 Inquiries concerning this RFA are encouraged and should be directed to Dr. Aamodt at the above address and telephone number. For fiscal and administrative matters, contact: Robert E. Hawkins Grants Management Specialist Grants Administration Branch National Cancer Institute EPS, Room 216 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. 13 This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END *************************************************************** $$R5 BEGIN MH-91-13 FULL-TEXT ****************************************** STATE SERVICE SYSTEMS IMPROVEMENT THROUGH CONSUMER AND FAMILY SUPPORT ACTIVITIES RFA AVAILABLE: MH-91-13 P.T. 34; K.W. 0730050, 0715095, 0715129, 0403004 National Institute of Mental Health Application Receipt Date: June 24, 1991 PURPOSE The Community Support Program (CSP) of the National Institute of Mental Health (NIMH) is inviting applications under this Request for Applications (RFA) to demonstrate and evaluate service system improvement strategies that integrate consumers and family members into the planning and provision of mental health and support services at State and local levels. 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, "State Service Systems Improvement Through Consumer and Family Support Activities," is related to the priority area of mental health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). Applications are encouraged that demonstrate and evaluate strategies that are directed toward the following programmatic goals: o Integrating primary consumers and family members into State and local service delivery, systems planning, decision-making, and research activities in order to develop mental health and support services that are considered responsive to consumer and family needs and preferences; o Improving linkages between consumer self-help and family support groups and the formal community support, treatment, and rehabilitation service systems; o Increasing the effectiveness of consumers and family members in identifying and fostering needed system, program, and service improvements; o Fostering participation of minority individuals in consumer self-help and family support groups as an element of the service delivery planning and decision making; o Increasing opportunities for consumer employment within the formal service system. POPULATION OF CONCERN The population of concern for CSP grants includes individuals 18 years and over with a severe and persistent mental disorders that seriously impair functioning in primary aspects of daily living, such as interpersonal relations, living arrangements, and employment. Applicants should pay attention to the unique needs and special concerns of racial and ethnic minorities and women. 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. ELIGIBILITY Only mental health authorities in States and Territories that do not currently have a CSP State Service System Improvement Demonstration Grant or are in the final year of a CSP State Service System Improvement Demonstration Grant for general community support development activities are eligible to apply for these grants. Each State and Territory may submit only one application. APPLICATION PROCEDURES All applicants must use form PHS-5161 (revised 3/89). Application kits are available from: Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-15 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4414 TERMS AND CONDITIONS OF SUPPORT Period of Support Support may be requested for a period of up to three years. Annual awards will be made subject to continued availability of funds and progress achieved. In Fiscal Year 1991, it is estimated that approximately $1 million will be available to support approximately 10 projects. The expected average amount of an award, for direct costs, is estimated to be $100,000 per year. However, the amount of funding available will depend on appropriated funds and program priorities at the time of award. Allowable Costs Applicants must include the following agreement in their applications: "(Applicant) agrees that not more than 10 percent of any resultant grant award will be expended for administrative purposes." Grants are intended to assist in meeting the costs of planning, developing, and implementing activities to support attainment of the project objectives. Grant funds are to be additive, not substitutive; they are not to be used to replace existing resources. Grant funds may be used for expenses clearly related and necessary to carry out the proposed project, including both direct and indirect costs that are specifically identified with the proposed project. INQUIRIES Applicants are encouraged to contact Institute staff before applying for an award: Neal Brown, Chief Community Support Section System Development and Community Support Branch Division of Applied and Services Research National Institute of Mental Health Parklawn Building, Room 11C-22 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3653 Inquiries pertaining to grants management should be directed to: Steven Hudak Chief, Grants Management Section Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-23 Rockville, MD 20857 Telephone: (301) 443-4456 $$R5 END *************************************************************** $$R6 BEGIN CA-91-09 FULL-TEXT ****************************************** COOPERATIVE NETWORK FOR EVALUATION OF PROGNOSTIC MARKERS OF URINARY BLADDER CANCER RFA AVAILABLE: CA-91-09 P.T. 34; K.W. 0715035, 0785220, 0765033 National Cancer Institute Letter of Intent Receipt Date: May 31, 1991 Application Receipt Date: July 31, 1991 The Cancer Diagnosis Branch of the Division of Cancer Biology, Diagnosis and Centers at the National Cancer Institute invites applications for cooperative agreements from institutions capable of and interested in participating in the "Cooperative Network for Evaluation of Prognostic Markers of Urinary Bladder Cancer." The objective of this Request for Applications (RFA) is to invite applications for cooperative agreements to support a network of laboratories to cooperatively evaluate promising diagnostic and prognostic markers of urinary bladder cancer. The network will perform collaborative studies requiring expertise in urology, pathology, and/or basic cancer biology to evaluate appropriate quantifiable markers of urinary bladder cancer and to define relevant clinical applications. This network will continue and expand the collaborative studies of urinary bladder cancer markers currently supported by the "Marker Network for Bladder Cancer." Awards will be made as cooperative agreements that create an assistance relationship with substantial NCI programmatic involvement with the recipients during the performance of the project, as outlined in this RFA. The cooperative agreement mechanism is used when the NCI wishes to stimulate investigator interest and proposes to assist in an important and opportune area of research. Applicants will be responsible for the planning, direction, and execution of the proposed project. The NCI anticipates making four to six awards for project periods of up to four years. A total of $950,000 is expected to be set aside for funding these activities in the initial year. Although this project is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent on the availability of funds appropriated in fiscal year 1992. 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, "Cooperative Network for Evaluation of Prognostic Markers of Urinary Bladder Cancer," is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). 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 or are inadequately represented in the study populations for clinical studies, a specific justification for this exclusion or inadequate representation must be provided. Applications without such documentation will not be accepted for review. This RFA is a one-time solicitation with a specified deadline of July 31, 1991 for receipt of applications. A copy of the complete RFA describing the research goals and scope, the cooperative agreement mechanism, the review criteria, and other application requirements is available from: Roger L. Aamodt Ph.D. Program Director for Pathology and Cytology Cancer Diagnosis Branch, DCBDC, NCI Executive Plaza South, Room 638 6120 Executive Boulevard Rockville, MD 20892-9904 Telephone: (301) 496-7147 FAX: (301) 496-8656 Inquiries concerning this RFA or the activities of the currently funded marker network are encouraged and should be directed to Dr. Roger L. Aamodt at the above address or telephone or FAX number. For fiscal and administrative matters, contact: Robert E. Hawkins Grants Management Specialist Grants Administration Branch National Cancer Institute EPS, Room 216 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. 13 This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended: 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END *************************************************************** $$R7 BEGIN AA-91-03 **************************************************** ADAMHA SMALL INSTRUMENTATION PROGRAM RFA: AA-91-03 P.T. 34; K.W. 0735000 Alcohol, Drug Abuse, and Mental Health Administration Letter of Intent Receipt Date: May 20, 1991 Application Receipt Date, June 21, 1991 The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) is announcing the third year of the ADAMHA Small Instrumentation Program (ASIP). This program was reauthorized by Congress for FY 1991 in Section 501(m) of the Public Health Service Act, as added to by P.L. 100-690, in response to findings that much of the research instrumentation in the Nation's principal universities is either obsolete or poorly maintained. These findings, documented in several reports, identified the need for upgrading equipment currently in use. The most significant need was for relatively low-cost pieces of equipment. To address this problem, ADAMHA established the Small Instrumentation Program in FY 1989. Awards are made under authority of Titles III and of the PHS Act as amended. Funds will be provided to research-intensive institutions currently receiving ADAMHA research support. The ASIP is not intended to replace requests for equipment in applications for individual research projects. Rather, it is intended to help fund items of equipment that are difficult to justify within the context of an individual research project but that will upgrade the institution's research infrastructure. The ADAMHA program has a similar purpose to the National Institutes of Health Small Instrumentation Program but will operate separately and under slightly different guidelines because of differences in the infrastructure support mechanisms available to the two agencies. The ADAMHA program will be funded in FY 1991 at $2,402,000. The program provides awards ranging from $20,000 to $60,000 to eligible institutions. Eligible institutions are those that had five or more active ADAMHA research grants awarded in FY 1990. The awards must be from the following types of research mechanisms: R01, R03, R29, and R37. The amount for which an institution may apply was calculated by a formula based on the $2,402,000 available for the program this year and on the number of ADAMHA-sponsored awards in the eligible mechanisms at an institution. Each eligible institution may submit ONLY ONE application that incorporates all appropriate equipment requests from that institution. Thus, it is essential that institutional officials publicize the availability of ASIP funds so that ADAMHA-supported investigators in need of small research instruments are provided the opportunity to indicate their needs for such equipment to the appropriate institutional official. The equipment requested must be available for use by more than one project either currently or in the future. The primary user(s) of the equipment must be one or more Principal Investigators of active ADAMHA-supported research grants, and the specific projects must be cited in the application. No indirect costs will be provided and there will be no future year funding commitment. The requested funds may be for full or partial support of one or more pieces of equipment In no case, however, can the total purchase price of a requested piece of equipment be less than $5,000 or more than $100,000 regardless of the source(s) of funding. If the total dollar amount of proposed eguipment purchases exceeds the amount for which the institution is eligible, a statement must be submitted indicating the institution will provide the difference. Support from this program cannot be used to purchase items exceeding $100,000 in cost even if costs are shared. The equipment purchased must be the same as that specified in the ASlP application. Applications must be received by June 21, 1991, and letters of intent should be received by May 20, 1991. Detailed application procedures have been sent to eligible institutions. Applications will be peer reviewed by a single ADAMHA-wide committee. The review criteria are: Degree of adherence to the terms of the letter of eligibility and adequacy of the justification provided for the equipment requested. The reviewers will determine whether the application is recommended for approval; no priority scores will be voted. Applications will be assigned to individual ADAMHA Institutes for consideration by their National Advisory Councils and for funding. The Institutes expect to make the awards in September. Ouestions concerning this program may be directed to any of the following persons: Dr. Charles Sharp Division of Preclinical Research National Institute on Drug Abuse Room 10A-31 Telephone: (301) 443-6300 Mr. James Moynihan Division of Basic Brain and Behavioral Sciences National lnstitute of Mental Health Room 11-95 Telephone: (301) 443-3107 Dr. Leslie Isaki Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Room 16C-05 Telephone: (301) 443-4223 Grants Management Contact: Elsie M. Fleming Chief, Management Review and Assistance Section National Institute on Alcohol Abuse and Alcoholism Room 16-86 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4703 $$R7 END *************************************************************** **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 FULL TEXT OF RFAs FOR ONLINE ACCESS From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 24, 21 June 1991 Message-ID: Date: 20 Jun 91 04:09:09 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 1072 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19910621 V20N24 P1O1 ************************************ X-comment: RFAs described: DK-91-14 NIH GUIDE - Vol. 20, No. 24, June 21, 1991 $$INDEX BEGIN NOTICES $$INDEX N1 NOTICE OF MEETING: THE SYSTEM FOR THE ELECTRONIC TRANSMITTAL OF FINANCIAL STATUS REPORTS National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 10/16/91 DIGESTIVE DISEASES CORE CENTERS (RFA DK-91-14) National Institute of Diabetes and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 SMALL GRANTS FOR THE DEVELOPMENT OF NONMAMMALIAN MODELS (PA-91-68) National Center for Research Resources Index: RESEARCH RESOURCES $$INDEX P2 RESEARCH PROGRAM PROJECTS FOR THE STUDY OF HUMAN NEUROCHRONOBIOLOGY (PA-91-69) National Institute of Neurological Disorders and Stroke National Institute on Aging National Institute of Mental Health Index: NEUROLOGICAL DISORDERS, STROKE, AGING, MENTAL HEALTH $$INDEX P3 ETIOPATHOGENESIS AND TREATMENT OF PSORIASIS (PA-91-70) National Institute of Arthritis and Musculoskeletal and Skin Diseases Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES $$INDEX END NOTICES $$N1 BEGIN NOTICE OF MEETING: THE SYSTEM FOR THE ELECTRONIC TRANSMITTAL OF FINANCIAL STATUS REPORTS P.T. 42; K.W. 1014006 National Institutes of Health The National Institutes of Health is sponsoring a two-day workshop, August 22-23, 1991, to be held in Bethesda, Maryland, on "The System for the Electronic Transmittal of Financial Status Reports". The workshop will include a hands-on computer demonstration as well as discussions on indirect costs and The Federal Cash Transactions Report (PMS-272). There is no fee for this workshop. However, the number of participants has been limited to 75. Participants will be accepted on a first-come, first-served basis. To request a registration form or for more information, please contact Priscilla Irick or Arlene Griesmer on (301) 496-5287 between the hours of 8:00 a.m. and 3:30 p.m. Registration forms must be received in this office no later than July 31, 1991. $$N1 END NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN DK-91-14 DIGESTIVE DISEASES CORE CENTERS RFA AVAILABLE: DK-91-14 P.T. 04; K.W. 0715085, 0710030, 0785035 National Institute of Diabetes and Digestive and Kidney Diseases Application Receipt date: October 16, 1991 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Digestive Diseases Core Center grants. NIDDK anticipates the award of one competitive Digestive Diseases Core Center grant in Fiscal Year 1992. The objective of the Core Center is to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will enhance and extend the effectiveness of research being conducted in the field of digestive diseases. The research activities of the Center must include projects that are relevant to the underlying causes(s), mechanism(s), diagnosis, early detection, prevention, control, and treatment of digestive diseases and related physiological, pathophysiological, congenital, or metabolic disorders resulting from such diseases. The focus of the research program in the Center can be a disease such as pancreatitis, functional bowel diseases, chronic hepatitis; an organ such as liver, esophagus, large bowel; a process such as absorption, secretion, motility; or an appropriate combination thereof that may also include areas of relevant technology. Institutions that have the necessary foundation of multidisciplinary digestive diseases-related research are encouraged to apply for a Digestive Diseases Core Center grant. Each applicant must show that at least 50 percent of the fiscal support for the ongoing research projects in the areas relevant to digestive diseases are from the NIDDK and that the remainder of the research projects to be included in the Center research base are relevant to the goals of the research Core Center. Foreign institutions are not eligible to apply. The NIDDK expects to award one Digestive Diseases Core Center grant in Fiscal Year 1992 on a competitive basis. The receipt of one competitive continuation application is anticipated, and it will be in competition for an award together with other applications received in response to this announcement. The requested budget may not exceed $700,000 direct costs per year. Any application exceeding this amount will be returned to the applicant. INQUIRIES For the complete Request for Applications, Core Center Grant Guidelines, and consultation, please contact: Tommie Sue Tralka Director, Digestive Diseases Centers Program Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 496-9717 Business Information Nancy Dixon Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 This program is described in the Catalog of Federal Domestic Assistance No. 93.848, Digestive Diseases and Nutrition. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 and Section 431 (b) (Public Law 78-410, as amended: 42 USC 241 and 42 USC 285c-5) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R1 END ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-91-68 SMALL GRANTS FOR THE DEVELOPMENT OF NONMAMMALIAN MODELS PA: PA-91-68 P.T. 34; K.W. 0755020, 0780020, 1004005 National Center for Research Resources Application Receipt Dates: October 1, February 1, June 1 PURPOSE The Biological Models and Materials Research (BMMR) Program supports the development of nonmammalian models for biomedical research through the award of research and resource grants and contracts. To enhance this program, the BMMR Program announces the initiation of a small grant award program for support of pilot studies in this area. Models that are considered appropriate for the purposes of this announcement are: lower organisms such as poikilothermic vertebrates, invertebrates, and microorganisms; in vitro systems such as cell and tissue culture from nonmammalian sources and established mammalian cell lines; and nonbiological systems, such as mathematical and computer simulations. DESCRIPTION OF THE AWARD This is a one-year, nonrenewable award for a pilot project/feasibility study of an innovative idea aimed at developing the aforementioned nonmammalian models that would provide a basis for more extended research. ELIGIBILITY This program is open to both non-profit and for-profit institutions, and is designed to support new and established researchers for work in nonmammalian pilot/feasibility research projects in the biomedical research area. APPLICATION AND REVIEW PROCEDURE Applications must be submitted on form PHS 398 (rev. 10/88), available at most institutional business offices and from the Division of Research Grants (DRG), National Institutes of Health (NIH). Because the format for preparing the small grant application is different from that used for research grants, additional instructions are needed. These instructions are available from the Director, BMMR Program as indicated below. Application receipt and review dates: NATIONAL ADVISORY INITIAL REVIEW RESEARCH RESOURCES RECEIPT DATE GROUP MEETINGS COUNCIL MEETINGS October 1 February/March June February 1 May/June September June 1 October/November February REVIEW CRITERIA AND PROCEDURES Applications will be evaluated with respect to the following criteria: o Significance and scientific merit of the proposed project as it relates to nonmammalian model development; o Innovativeness and risk as a pilot project; o Probability that the study will provide a basis for more extended research; o Adequacy of the background training and experience of the investigators; o Adequacy of the facilities; o Appropriateness of the budget; o Appropriateness and adequacy of experimental methods, including data to be collected, procedures of data analysis, and potential problems that may be encountered in the study and how they will be addressed. Applications will be received by the NIH, DRG. Applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this announcement. NIH will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be competitive will be further evaluated for scientific/technical merit by initial review groups that will be convened by the Office of Review, NCRR. The second level of review will be conducted by the appropriate national advisory council or board. TERMS OF THE AWARD The award will be for one year and will provide a maximum of $35,000 (direct costs) for personnel, supplies, small equipment, and travel required for conduct of the project. In most cases, the award can be extended on request for an additional year without additional funds. The award may not be used to supplement projects currently supported by Federal or non-Federal funds or to provide interim support for projects under review by the Public Health Service. Support for student employees who are performing work on a dissertation is discouraged because of the short term of this award. STAFF CONTACT Louise E. Ramm, Ph.D. Director, Biological Models and Materials Research Program National Center for Research Resources National Institutes of Health 5333 Westbard Avenue, Room 8A07 Bethesda, MD 20892 Telephone: (301) 402-0630 The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) also provides small grant support for research on nonmammalian models. For information about ADAMHA small grant program eligibility and characteristics, contact: Niles Bernick, Ph.D. Associate Director for Referral and Review Office of Extramural Programs Alcohol, Drug Abuse, and Mental Health Administration 5600 Fishers Lane, Room 13-103 Rockville, MD 20857 Telephone: (301) 443-5184 GRANTS MANAGEMENT CONTACT Ms. Diana L. Jaeger Supervisory Grants Management Specialist Office of Grants and Contract Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 496-9840 This program is described in the Catalog of Federal Domestic Assistance, No. 93.198, Biological Models and Materials Resources. Awards will be made 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 Health Systems Agency review. SUPPLEMENTARY INSTRUCTIONS: FOR THE BIOLOGICAL MODELS AND MATERIALS RESEARCH PROGRAM SMALL GRANTS PROGRAM FORM PHS 398 (rev. 10/88) Applications must be submitted on the standard PHS research grant application form (PHS 398, rev. 10/88), following the instructions supplied with those forms EXCEPT for the following: 1. Face page of application Item 2: Response to specific Program Announcement: Yes. Write in: Small Grants for Development of Nonmammalian Models, PA-91-68. Item 8: Not applicable; mark NA. 2. Application page 4: Detailed Budget for the 12-Month budget period. Funds should be limited to the following categories: personnel (including technicians), consultants, rental or service fees, supplies, travel, and small equipment items. The total direct costs request may not exceed $35,000. 3. Application page 5: Budget Estimates for All Years. Not applicable; do not complete this section. Justification: All requests must be strongly and SPECIFICALLY justified for the one-year project period. 4. Biographic sketch: Not to exceed one page per individual. Include this information for all professional personnel associated with this project as collaborators, consultants, and others. Include an appropriate letter from each collaborator or consultant confirming his/her role in the project. 5. Introduction: Not to exceed one-half page (including a brief statement on preliminary work, if any). 6. Research Plan: Specific aims, background and significance, and experimental design and methods; not to exceed four pages. These sections of the research plan are described in the PHS 398 grant application kit instructions, and must be followed while keeping within the four-page limitation. Citations in this section are limited to one additional page entitled: Literature Cited. Application must be readily legible. In an effort to include as much information as possible within the page limitations, some applicants have compressed the spaces between letters and words and reduced the type size to such a degree that the application is not readily legible. Such applications will also be returned without review. Follow the type size instructions on page 12 of the PHS 398 form. 7. Appendix: Not applicable. Do not submit. 8. Submission of the completed application forms: Mail or deliver the complete and signed typewritten original application and four copies, to the Division of Research Grants, as specified in the general instructions. Two additional copies must be sent to: Biological Models and Materials Research Program (SMALL GRANTS) National Center for Research Resources, NIH 5333 Westbard Avenue, Room 8A07 Bethesda, MD 20892 Applications not following the above instructions will be returned to the applicant. If you have any questions, contact Dr. Ramm at the address above. $$P1 END $$P2 BEGIN PA-91-69 RESEARCH PROGRAM PROJECTS FOR THE STUDY OF HUMAN NEUROCHRONOBIOLOGY PA: PA-91-69 P.T. 34; K.W. 1002030, 0705055 National Institute of Neurological Disorders and Stroke National Institute on Aging National Institute of Mental Health The Division of Convulsive, Developmental, and Neuromuscular Disorders, National Institute of Neurological Disorders and Stroke (NINDS), the Neuroscience and Neurophysiology of Aging Program, National Institute on Aging (NIA), and the Behavioral Medicine Program, National Institute of Mental Health (NIMH), encourage the submission of research grant and program project grant applications for the basic and clinical study of neurochronobiology. BACKGROUND The central nervous system supports basic life regulatory functions and is largely responsible for the maintenance and regulation of circadian rhythms such as the sleep-wake cycle and the periodic secretion of neuropeptides and many hormones. These brain-controlled biological rhythms directly determine much human behavior. Although there are many "zeitgebers," the major one for control of central nervous system circadian rhythms appears to be the light-dark cycle. A large body of knowledge concerning neurological circadian rhythms exists. There are, however, major gaps in present knowledge that modern research techniques could address. The precise molecular mechanism(s) by which the suprachiasmatic nucleus modulates circadian rhythms remains unknown. The neurobiological consequences of phasic secretion, in contrast to a constant level, of critical hormones, such as melatonin, somatostatin, or cortisol, are also unknown. Although there is evidence to indicate that the sensitivity of neuroreceptors to a variety of ligands is circadian, the relevance of this phenomenon to understanding fluctuating responses to neuroactive drugs or to developing optimum daily dosing schedules for chronic diseases has not been studied. There is evidence that the developing fetus responds to circadian changes in secretion of maternal hormones and possibly also to the normal daily light-dark cycle. The normal maturation and myelination of the neural substrates for sleep-wake cycling in the developing brain is purported to underlie the dramatic electroencephalographic (EEG) changes so well documented in sleep and wakefulness in the pre- and post-term infant. Disturbances of this maturation or abnormal development in those brain areas responsible for sleep and breathing have been implicated in a number of clinical entities. However, little is known about these neural substrates, and what constitutes normal and abnormal maturation and/or development of them. There are obviously major changes in the zeitgebers at birth, e.g., the newborn nursery environment obscures circadian light-dark cycles in the first few days of life. For neonates in pediatric intensive care units, the loss of light-dark time cues persists even longer. The temporary or permanent effect of such changes in zeitgebers on the developing nervous system is unknown. At the other end of the life span, there are age-related changes in circadian rhythmicity that may be associated with degenerative changes in the neural substrates of this cycling. Little is known about how these phenomena may be causally related to the sleep disturbances so prevalent in the elderly. The demands of modern society require individuals to function when the endogenous circadian rhythms of the central nervous system are desynchronized with the light-dark cycle. Examples include rotating shift work, long distance jet airplane travel, and space travel. Other circumstances in which normal light-dark periodicities are distorted occur in controlled artificial environments such as those aboard naval vessels and in hospital intensive care units. There is abundant anecdotal evidence concerning the effect of changing light-dark cycles on physiological parameters. There is also some evidence that frequent uncompensated changes in circadian phase may alter cognitive function, mood, and behavior. However, systematic study of the effect of temporary or long-term changes in light-dark cycles and/or work-leisure cycles is lacking. Such studies could lead to the development of more rational strategies to facilitate resetting of the human biological clock either to a new phase or a new period. This information could be of significant economic and social value. RESEARCH GOALS The goal of this announcement is to stimulate research in both basic and clinical neuroscientific aspects of circadian rhythms. Examples of areas of potential research include, but are not limited to: Study of normal and pathological human neurochronobiological rhythms across the life span; environmental or pharmacological modification of phase and/or period of circadian rhythms; adaptation to changes in the work-sleep cycles (i.e., rotating shift work); circadian variations in the effect of drugs upon the nervous system; effects of non-diurnal variations in light level (i.e., controlled artificial environments such as intensive care units) on the nervous system; effects of maturation of the developing brain and changes in the aging brain on sleep-wake cycling and brain-controlled biological rhythms and vital functions. Multidisciplinary approaches are encouraged. APPLICATION PROCEDURES AND FORMAT OF APPLICATIONS Applicants must submit applications on form PHS 398 (rev. 10/88). This form is available in the office of sponsored research or business office of the applicant institution 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. Program project applicants must use the application format as described in the NINDS pamphlet, "Application Guidelines: Program Project and Clinical Research Center Grants" (revised October 1989), which may be obtained from the NINDS individual listed below. To identify the application as a response to this program announcement check "yes" on item 2 of page 1 of the application and enter the title "Research Program Projects for the Study of Human Neurochronobiology, PA-91-69." 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 and compelling rationale for non-conformance to the policy should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in section 2, e, human subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e. American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purposes 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 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. Assignment of applications to specific Institutes will be on the basis of existing referral guidelines. Applications will be judged on scientific merit and program relevance in accordance with NIH policy and procedures involving peer review. An initial review will be made by an appropriate review group. A second level of review will be conducted by the appropriate National Advisory Council. Deadlines for the receipt of applications are February 1, June 1, and October 1. The original and six copies of the application must be mailed or delivered to the following address: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** For further information, applicants may contact: Charlotte B. McCutchen, M.D. NIH, NINDS, DCDND, EB Federal Building, Room 114 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1917 If the focus is upon issues of neurochronobiology during late life and the aging nervous system, applicants should also contact: Andrew A. Monjan, Ph.D., M.P.H. NIH, NIA, NNA Building 31, Room 5C35 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-9350 If the emphasis is upon the mental health aspects of neurochronobiology, applicants should contact: Susan Blumenthal, M.D. Chief, Behavioral Medicine Program Division of Basic Brain and Behavioral Sciences National Institute of Mental Health 5600 Fishers Lane, Room 11-C-06 Rockville, MD 20857 Telephone: (301) 443-4337 For fiscal and administrative matters, contact: Angeline L. Wilson Grants Management Specialist National Institute of Neurological Diseases and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 This program is described in the Catalog of Federal Domestic Assistance No 93.853, Clinical Basis Research, NINDS. Awards will be made under the authority of the Public Health Service Act, Title IV, 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 Health Systems Agency review or Executive Order 12372. $$P2 END $$P3 BEGIN PA-91-70 ETIOPATHOGENESIS AND TREATMENT OF PSORIASIS PA: PA-91-70 P.T. 34; K.W. 0715185, 0755030, 0765033, 0745070 National Institute of Arthritis and Musculoskeletal and Skin Diseases I. PURPOSE The Skin Diseases Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases supports research on the structure, function, and diseases of the skin. This program announcement is to encourage submission of research grant applications in the area of etiopathogenesis and treatment of psoriasis. II. BACKGROUND Psoriasis is a common skin disease affecting several million Americans. It may be disfiguring and even disabling. Treatments exist and are reasonably satisfactory for mild cases; but an understanding of the underlying etiopathogenesis of the disease is lacking and, thus, treatments for the more severe forms of the disease are empiric, often less than completely satisfactory in terms of efficacy, and may have significant, even life-threatening, side effects. Psoriasis is characterized by a hyperproliferation of epidermis. Much of the prior treatment and research have been directed at this aspect of the disease. However, the recognition that psoriasis responds to Cyclosporin A, an immune suppressive agent that does not affect proliferation to any significant degree, and that psoriasis may develop or become more severe with HIV infection and then may respond to treatment of the immune deficit caused by HIV infection, has resulted in new lines of research focusing on immune mechanisms in the development of psoriasis. In addition, advances in molecular biology and the development of new knowledge in relation to cytokines and other intermediary proteins that may tie together immunologic effects with hyperproliferative effects have prepared the way for new advances in understanding and treating psoriasis. Psoriasis often runs in families. This genetic aspect has, in the past, not been studied to any great degree, but, with recent advances in molecular genetics and the development of techniques for linkage analysis, an approach to this aspect of the etiopathogenesis of psoriasis would seem appropriate. Toward this end, the National Psoriasis Foundation has announced the availability of a contract to support the development of a tissue bank for well-established, informative families to act as a source of material to aid in the molecular genetic investigations of psoriasis. This tissue bank will be available in July 1992. (For further information, contact Gail M. Zimmerman, Executive Director, National Psoriasis Foundation, 6443 S.W. Beaverton Highway, Suite 210, Portland, OR 97221, (503) 297-1545). Much of the current state of knowledge in regard to psoriasis research was summarized at a psoriasis workshop held in September 1989 and published as a supplement to the Journal of Investigative Dermatology in November 1990. A psoriasis workshop emphasizing the molecular genetic aspects of the disease is planned for September 1991. It is expected that these workshops, in combination with the availability of the tissue bank, will encourage the preparation and submission of grant applications investigating the etiopathogenesis and treatment of psoriasis. RESEARCH GOALS AND SCOPE The goals of this program announcement is to stimulate research in various areas related to the etiopathogenesis and treatment of psoriasis. Some research objectives appropriate for inclusion in applications responding to this announcement are: o Studies of the molecular mechanisms involved in the hyperproliferative state of psoriasis. o Investigations of immune interactions with and control of the hyperproliferation of psoriasis. o Molecular genetic investigations of the hereditary basis of psoriasis. o Development of new therapeutic approaches to psoriasis based upon new information regarding etiopathogenesis and the characteristics of the disease state. MECHANISMS OF SUPPORT Funding mechanisms to support these investigations include research grants (RO1), Clinical Investigator Awards (KO8), First Independent Research and Transition (FIRST) Awards (R29), and Individual National Research Service Awards (F32). SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION AND REVIEW PROCEDURES Applications in response to this announcement will be reviewed in accordance with the usual Public Health Service peer review procedures for research grants. Review criteria include: significance and originality of the research goals and approaches; feasibility of the research and adequacy of the experimental design; training, research competence, and dedication of the investigator(s); adequacy of available facilities; and provision for the humane care of animals. Decisions will be based on initial review group and National Advisory Council recommendations. Applications must be submitted on form PHS 398 (rev. 10/88), or the appropriate fellowship application form (PHS 416-1), available in the business or grants office at most academic or research institutions and from the Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applications will be accepted in accordance with the submission dates for new applications on a continuing basis: The phrase, "ETIOPATHOGENESIS AND TREATMENT OF PSORIASISi, PA-91-70" must be typed on line 2 of the face page of the application. The original and six copies must be sent or delivered to: Grant Application Receipt Office Division of Research Grants Westwood Building, Room 240 National Institutes of Health Bethesda, MD 20892-4500** For further information, investigators are encouraged to contact the following individuals: Alan N. Moshell, M.D. Skin Diseases Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 496-7326 For fiscal and administrative matters, contact: Diane M. Watson Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 407-A Bethesda, MD 20892 Telephone: (301) 496-7495 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 authorization of the Public Health Service Act, Title III, Section 301 (c) (public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 FULL TEXT OF RFAs FOR ONLINE ACCESS $$XID RFA DK9114 DK-91-14 P1O1 ***************************************** DIGESTIVE DISEASES CORE CENTERS RFA: DK-91-14 P.T. 04; K.W. 0715085, 0710030, 0785035 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: August 15, 1991 Application Receipt Date: October 16, 1991 PURPOSE The National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) invites applications for Digestive Diseases Core Center grants. NIDDK anticipates the award of one competitive Digestive Diseases Core Center Grant in Fiscal Year 1992. BACKGROUND The NIDDK-supported Digestive Diseases Core Centers are part of an integrated program of digestive disease related research support provided by NIDDK. These Centers have provided a focus for increasing collaboration and improving the cost effectiveness of supported research among groups of successful investigators at institutions with an established comprehensive digestive diseases research base. At least 50 percent of this research base must be supported by NIDDK. OBJECTIVE AND SCOPE The objective of the Core Centers is to bring together investigators from relevant disciplines to enhance and extend the effectiveness of research related to digestive diseases and their complications. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of digestive diseases research. An existing program of excellence in biomedical research in the area of digestive diseases disorders is required. This research must be in the form of NIH-funded research projects, program projects, or other peer-reviewed research that is in existence at the time of submission of a Center grant application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. The Core Centers must have a central focus of research investigation. The central focus must be a digestive disease or group of diseases; at least half of the research must focus on this area. Examples of a central focus of research investigation include (but are not restricted to) inflammatory bowel disease, peptic ulcer disease, pancreatic disease, liver disease, and pediatric gastrointestinal disease. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application. Digestive Diseases Core Centers are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in digestive diseases centers to accomplish the stated goals of the Center. Two other types of activities may also be supported with Center funding: a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators and at investigators established in other research disciplines with expertise that may be applied to digestive disease research. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. ELIGIBILITY Nonprofit institutions within the United States may apply for Digestive Diseases Core Center grants. Applicant institutions must have an adequate base of established programs of high quality in laboratory and/or clinical digestive diseases-related research. The quality of the programs must be evident from the fact that they have been awarded support through peer-reviewed competition, such as in the form of NIDDK research grants, cooperative agreements, and contracts. MECHANISM OF SUPPORT The NIDDK expects to award one Digestive Diseases Core Center Grant in the Fiscal Year 1992 on a competitive basis. The receipt of one competitive continuation application is anticipated. This application will compete for the award along with other applications received in response to this Requests for Applications (RFA). The anticipated award will be for five years and is contingent upon the availability of appropriated funds. The requested budget may not exceed $700,000 direct costs per year. Any application exceeding this amount will be returned to the applicant. The current Center is supported at approximately $700,000 total cost per year. The general description and guidelines for the digestive disease centers and consultation may be obtained from: Technical Information Tommie S. Tralka Director, Digestive Diseases Centers Program National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 Bethesda, MD 20892 Telephone: (301) 496-9717 Business Information Nancy Dixon Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 REVIEW PROCEDURES Applications for the Core Center grant will be evaluated by the NIH grant peer review process. Applications will be reviewed initially by an ad hoc review group convened by the NIDDK and subsequently by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Applications are unlikely to be reviewed by a site visit team; therefore, the written application must be complete to facilitate review without a site visit. Extensive additional materials submitted subsequent to the stated receipt date will not be accepted. METHOD OF APPLYING Letter of Intent: Potential applicants are requested to submit a letter of intent by August 15, 1991. The letter of intent is non-binding, is not a necessary requirement for submission of an application, and is not a precondition for an award. Letters of intent are requested for review planning purposes. The NIDDK will not respond to such letters. The letter of intent should include the name(s) of the Principal Investigator and principal collaborators, descriptive titles of the core facilities and pilot/feasibility projects, and the institution(s) involved. Letters of intent are to be sent to: Dr. Robert Hammond Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. Applications must be submitted using PHS 398 (rev. 10/88). Check the "YES" box in line 2 of the application face page and insert "DIGESTIVE DISEASES CORE CENTERS, RFA DK-91-14." THE RFA LABEL CONTAINED IN THE APPLICATION KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COPY OF THE APPLICATION. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING AND REVIEW OF THE APPLICATION. Submit a signed, typewritten original of the application, including the checklist and four signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: August 15, 1991 Application Receipt Date: October 16, 1991 Initial Review Date: Feb./Mar. 1992 National Digestive Diseases Advisory Council Review Date: May/June 1992 Anticipated Award Date: September 1992 IMPORTANT: At the time of submission, two additional copies of the application must be sent under separate cover to: Dr. Robert Hammond Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 Applications must be received by October 16, 1991. If an application is received after that date, it will be returned. This program is described in the Catalog of Federal Domestic Assistance No. 93,848, Digestive Diseases and Nutrition. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 and Section 431 (b) (Public Law 78-410, as amended: 42 USC 241 and 42 USC 285c-5) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 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 Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 32, pt. 2, 23 August 1991 Message-ID: Date: 22 Aug 91 01:48:05 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 1107 $$XID RFA CA9123 CA-91-23 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: CA-91-23 CANCER CENTER OUTREACH EDUCATION PROGRAMS P.T. 34; K.W. 0715035, 0403004 National Cancer Institute Letter of Intent Receipt Date: November 1, 1991 Application Receipt Date: December 6, 1991 I. INTRODUCTION The purpose of this Request for Applications (RFA) is to invite grant applications for the support of community outreach education programs from recipients of National Cancer Institute (NCI) Center Core Grants (P30). It is anticipated that these education programs will result in increased community efforts related to cancer prevention, to expansion of programs for screening, to earlier detection of cancer, and to the systematic application of the best available methods for the treatment and care of cancer patients. The underserved, elderly, and minority populations must receive high priority in carrying out these objectives. 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, Cancer Center Outreach Education Programs, is related to the priority area of health promotion: educational and community-based programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). II. BACKGROUND INFORMATION A number of reports have indicated that if state-of-the-art approaches to the prevention, detection, diagnosis, treatment, and care of cancer patients used at major cancer centers were widely implemented at the local community level, there would be a significant reduction in cancer incidence, morbidity, and mortality. A key step in the dissemination of this knowledge is the establishment of educational programs that will transmit state-of-the-art cancer information to community health professionals who are primarily responsible for providing the majority of cancer care. These educational programs must also include community leaders (e.g., those affiliated with civic, religious, and occupational organizations) who are concerned about improving the prevention, detection, diagnosis, and treatment of cancer. These individuals can access and influence the behavior of large segments of the population. The NCI-designated Cancer Centers are a logical location for these outreach education programs since an essential programmatic element of the Cancer Centers is their role as a focal point for clinical and research training and for continuing education programs designed for local and regional health care professionals. III. GOALS AND SCOPE The purpose of this RFA is to provide funding, on a competitive basis, for the development and implementation of cancer education outreach programs by Cancer Centers that have been awarded a P30 grant by the National Cancer Institute. These education programs must provide state-of-the-art knowledge related to the prevention, screening, detection, diagnosis, and treatment of cancer to local and regional health care professionals, community leaders, and staff of relevant community organizations. Topics must be selected on the basis of their relevance to the day-to-day activities and problems of the community health care professionals and to the welfare of cancer patients and their families. These outreach programs are intended to be of particular benefit to underserved communities and to groups with disproportionate cancer incidence and death rates (e.g., minorities, people over age 65). High priority local and regional needs for specific types of cancer education programs must be addressed by the proposed programs and described in the application. The type of programs, their subject content and duration will depend upon local priorities, the availability of appropriate resources, and the nature of the target professional and lay populations to be addressed. IV. MECHANISM OF SUPPORT Support of this program will be through the National Cancer Institute Cancer Education Grant mechanism (R25). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. These awards will provide support for the administrative and didactic costs associated with the continuing education sessions. The type of training sessions to be offered may include seminars, workshops, short courses, and other appropriate formats that the applicant organization might propose. Arrangements must be made to provide continuing medical education (CME) credit for these courses when appropriate. This RFA is a one-time solicitation. Future competitive continuation applications will compete with all investigator-initiated applications. Should the NCI, however, determine that there is a sufficient continuing program need, a request for competitive continuation and/or new applications will be announced. $l.0 million in total costs per year for three years will be committed to fund applications submitted in response to this RFA. Awards will be limited to a maximum of $100,000 in direct costs plus eight percent indirect costs, and only one award will be made to a given Cancer Center. It is anticipated that ten to 15 awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed three years. The earliest feasible start date for the initial awards will be July 1, 1992. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. V. SPECIAL REQUIREMENTS The application must describe examples of specific topics and approaches that might be included in the cancer education programs if an award were to be made. Emphasis must be given to outreach education topics that would have the greatest impact on reducing cancer incidence and mortality and on improving the quality of life for cancer patients in general. An area of special interest to NCI, for example, would be educational programs designed to improve the quality of mammography and the accuracy of its interpretation. Other high priority topics include: improved procedures for prevention, detection, diagnosis, and treatment of cancer among elderly, ethnic, minority, low socioeconomic, and other underserved populations that have an elevated incidence of cancer. The application must include a detailed budget describing and justifying each category of costs requested, and it must indicate the nature and extent of any institutional contribution to the activities supported by a grant awarded as a result of this RFA. VI. ELIGIBILITY REQUIREMENTS Only organizations that have a currently active Cancer Center Support Grant (P30) are eligible to apply for this grant since its primary purpose is to encourage Cancer Centers to expand their role in technology transfer by providing state-of-the-art information about cancer prevention, detection, diagnosis, and treatment to community professionals and relevant community organizations. VII. REVIEW PROCEDURES AND CRITERIA A. REVIEW PROCEDURES Upon receipt, each application will be initially reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Subsequently, applications will be evaluated by NCI scientific administration staff to determine how well each application meets the goals and objectives of the program as described in this RFA. Applications judged non-responsive will be returned to the applicant. Program staff named in the INQUIRIES section below will be happy to address questions concerning the relevance of any proposed educational or training activities to this RFA. If the number of applications submitted is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate applications that are clearly not competitive. The NCI will withdraw from competition those applications judged to be noncompetitive and will notify the applicant and institutional business official of this action. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board will consider the special needs of the Institute and the priorities of the National Cancer Program. B. REVIEW CRITERIA o The quality of the overall proposed approach to outreach education programs and the likelihood that the proposed approach will significantly improve the prevention, screening, detection, diagnosis, or treatment of cancer in the community. o The quality of topics and the content of specific examples of outreach education programs described in the application. o The extent to which specific and appropriate target groups for the proposed outreach programs are identified and accessed. o The extent to which the proposed programs would augment the ongoing outreach education efforts and/or would initiate new efforts. o The administrative and scientific qualifications, availability, commitment, and relevant experience of the Principal Investigator and key staff proposed for the outreach education programs. o The availability of appropriate resources and facilities for the proposed activities. o Plans for short-term evaluation of the outcome of the proposed cancer education programs in terms of changes in professional and lay knowledge, practice, attitudes, and behavior. o Adequacy of the proposed means for protecting human subjects and vertebrate animals against hazardous or unethical research procedures. C. BUDGET The review group will critically examine the proposed budget and recommend an appropriate budget for each approved application not to exceed $100,000 in direct costs plus eight percent indirect costs for each year of up to three years of grant support. VIII. METHOD OF APPLYING The most recent revision (10/88) of the research grant application form PHS 398 must be used in applying for these grants. These forms are available at most institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441. The RFA label provided in the 10/88 revision of application form _HS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2 of the face page of the application form to ensure proper processing of the application. Submit a signed, typewritten original of the application, including the Checklist, and four signed, exact photocopies, in one package to the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two additional copies of the application to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Room 838, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by December 6, 1991. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. IX. LETTER OF INTENT Prospective applicants are asked to submit, by November 1, 1991, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to the NCI Program Director: Dr. Robert Adams Cancer Training Branch Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 232 Bethesda, MD 20892 Telephone: (301) 496-8580 FAX: (301) 402-0181 X. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not the specific proposed research would be responsive are encouraged and should be directed to Dr. Robert Adams or Dr. John Schneider at (301) 496-8580. The Program Directors welcome the opportunity to clarify any issues or questions from potential applicants. For information regarding budgetary/administrative issues related to this RFA, contact: Mr. Robert Hawkins Team Leader, Grants Administration Branch National Cancer Institute National Institutes of Health Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext 13 This program is described in the Catalog of Federal Domestic Assistance Number 93.398, Cancer Research Manpower. Awards are made under the 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 Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA HG9105 HG-91-05 P1O1 ***************************************** REQUEST FOR APPLICATIONS RFA: HG-91-05 MAPPING THE DROSOPHILA GENOME P.T. 34; K.W. 1002058, 0755045, 0760015 National Center For Human Genome Research Letter of Intent Receipt Date: October 18, 1991 Application Receipt Date: November 15, 1991 The National Center for Human Genome Research (NCHGR) invites applications for assistance awards to support research projects to develop high-resolution physical maps of the Drosophila melanogaster genome and feasibility studies for large-scale DNA sequencing projects using biologically interesting regions of the Drosophila genome for such pilot projects. The NCHGR sponsors basic and applied research concerned with the development and application of new technologies for the characterization and analysis of the human genome and the genomes of selected model organisms. The activities encompassed by the NCHGR program include genetic and physical mapping, DNA sequencing, informatics related to mapping and sequencing, and technology development that will facilitate all of these efforts. The NCHGR, in conjunction with the Department of Energy, recently formulated a five-year plan that identifies areas in which further research, including technology development, is needed if the characterization of the human and other genomes is to be accomplished within the established 15 year time frame. The five-year plan is available from: Human Genome Management Information System; Oak Ridge National Laboratory, Oak Ridge, TN 37831-6050; telephone (615) 576-6669. BACKGROUND A major long-term goal of the Human Genome Program is to identify all the genes encoded in the three billion pairs of human DNA. Because a large amount of molecular and genetic information is already available for the study of model organisms and there is evidence of cross-species similarities at the DNA level, the study of the genomes of model organisms will assist in understanding the human genome. The Human Genome Program has identified five organisms as major emphases for genomic study to serve as guides in the study of the human genome. These are E. coli, S. cerevisiae, C. elegans, D. melanogaster, and the laboratory mouse. The physical map of the E. coli genome is complete, and the physical maps of the genomes of S. cerevisiae and C. elegans are essentially so. Moreover, significant large-scale DNA sequencing projects have begun on the DNAs of these three organisms in laboratories in the United States, Europe, and Japan. D. melanogaster is the next organism of increased complexity among the list of organisms to be studied comprehensively in the Human Genome Program. There are several structural features about the D. melanogaster genome that make its study particularly important to that of the human genome--both have large amounts of non-protein coding DNA, introns, transposable elements, heterochromatin, centromeres, and complex gene structures (i.e., clustered, overlapping, and nested genes). Thus, knowledge gained from the study of the D. melanogaster genome will aid significantly in elucidating the structure and function of the human genome. The NCHGR wishes to stimulate research on the D. melanogaster genome because interest in studying it has lagged behind that in other model organisms. Moreover, because large-scale mapping and sequencing technologies for studying complex genomes are improving rapidly, the application of these techniques to the D. melanogaster genome is appropriate and timely. The goal of this Request for Applications (RFA) is to encourage molecular biologists to consider developing mapping and/or sequencing programs on the D. melanogaster genome. RESEARCH SCOPE Research projects responsive to this RFA to support characterization of the D. melanogaster genome must focus on the following areas: o Development of high-resolution physical maps: The objective of these projects will be to achieve map continuity across the genome and to develop a resource that will serve as a basis for DNA sequencing and detailed functional studies; o Feasibility studies for large-scale DNA sequencing, using regions of high biological interest for the pilot studies: Applications will be accepted for feasibility studies under the conditions described in the NCHGR RFA on large-scale sequencing (RFA HG-90-03, NIH Guide for Grants and Contracts, Vol. 19, No. 32, S this announcement are available from NCHGR program staff listed at the end of this RFA. A reasonable definition of a "large-scale sequencing project" is one that attempts to determine on the order of three megabase pairs of (largely) contiguous sequence in three years. Projects responsive to this section of the RFA must test hypotheses and new research strategies designed to yield new information on the feasibility of determining large amounts of DNA sequence rapidly and in a cost-effective manner; o New technologies to detect all the coding regions or expressed genes in genomic DNA: applications will be accepted for the types of studies described in the NCHGR RFA on this subject (RFA HG-91-02, NIH Guide for Grants and Contracts, Vol. 20, No. 15, section of the RFA must use biological approaches to develop new technologies or research strategies to identify genes and/or coding sequences in genomic DNA or to isolate cDNAs in a rapid, thorough, and cost-effective manner, i.e., (1) methods of identifying all the genes or complete coding regions directly from genomic DNA; (2) new methods of generating high quality, full-length cDNAs; and (3) new methods of generating and ordering cDNA libraries that are representative of the complete coding information content of genomic DNA. Applications submitted in response to this RFA must approach the characterization of the Drosophila genome from a global perspective, i.e., from the point of view of the whole genome rather than one or a few genes, must use the most appropriate, state-of-the-art technology, and must be cost- and labor-efficient. Moreover, the resources and technology developed must be easily transferrable among laboratories. Projects must focus on the development of new resources, rather than on the maintenance of existing resources. For the purposes of this announcement, computation-based applications will not be accepted under this RFA. Such projects must be submitted under the regular announcements. The program announcement, "Mapping, DNA Sequencing and Technology Development in Support of the Human Genome Program," was published in the NIH Guide for Grants and Contracts, Vol. 14, No. 28, July 27, 1990. However, applications in response to this RFA must address data management issues consistent with the objectives of the project proposed in the application. MECHANISM OF SUPPORT Support for this program will be through individual research grants (R01s), pilot projects/feasibility studies (R21), program project grants (P01s), developmental grants (P20s), and center grants (P30s and P50s). Applicants may request support for three to five years. The total amount of support available for grants under this RFA will be $2.5 million (direct and indirect costs) for the first year of the project and is contingent upon appropriation of funds for this purpose. It is anticipated that three to five awards will be made representing a mix of research topics and grant mechanisms. This number may be increased if a large number of highly meritorious applications are received and if funds are available. The number of awards made will be contingent upon the quality of applications received and the availability of funds. Applications for Small Business Innovative Research support are also encouraged under this initiative. Such applications must be submitted through the SBIR application process. ELIGIBILITY Domestic universities, medical colleges, hospitals, and other public, private, and for-profit and non-profit research institutions, including state and local government units, are eligible. Applications from minority investigators and women are encouraged. LETTER OF INTENT Because of the specialized interest of this NCHGR program, and the potential for overlap with other NIH programs, it is strongly recommended that potential applicants contact NCHGR staff to discuss research objectives. Potential applicants are also asked to submit a letter of intent by October 18, 1991. This letter is to include a descriptive title of the proposed research, names of the Principal Investigator and other key investigators, and their institutions. The letter of intent is requested in order to provide an indication of the number and scope of applications to be reviewed and does not commit the sender to submit an application, nor is it a requirement for submission of an application. Letters of intent are to be sent to: Bettie J. Graham, Ph.D. Chief, Research Grants Branch National Center for Human Genome Research National Institutes of Health Building 38A, Room 610 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-7531 E-MAIL: B2G@NIHCU.BITNET; B2G@CU.NIH.GOV APPLICATION AND REVIEW PROCEDURES Applications in response to this announcement will be reviewed in accordance with the customary NIH peer review procedures. Simultaneous submission of identical applications to different NIH solicitations is not allowed, nor can essentially identical applications be reviewed by different initial review groups. Therefore, if the application submitted in response to this RFA is identical to or substantially the same as one already submitted to the NIH, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Similarly, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of a previously reviewed application that has undergone substantial revision; however, such an application must address, in the Introduction, the previous critique. Applications will first be screened for responsiveness to this RFA by NIH staff. Those deemed non-responsive will be returned to applicants. If a large number of responsive applications is received, they will undergo a preliminary peer review by the Genome Research Review Committee (GRRC), NCHGR. Applications that are deemed non-competitive by this process will receive only a brief critique, will not be reviewed further, and will be returned to the applicant. The remaining applications will be reviewed for scientific and technical merit by the Genome Research Review Group, NCHGR. Review criteria will include the following: o Originality and innovativeness of the approach; o Feasibility of the research and adequacy of the experimental design; o Overall scientific and technical merit of the research; o The potential of the proposed work to attain the research objectives outlined in this RFA; o Training, experience, and research competence of the investigator(s); o Adequacy of available facilities; o Provision for the protection of human subjects and the humane care of animals; and o Appropriateness of the requested budget for the work proposed. o The adequacy of plans for data management and data sharing will also be evaluated. AWARD CRITERIA The second level of review will be conducted by the National Advisory Council for Human Genome Research. Applications will compete for funds set aside for this purpose. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Value of the research for achieving the goals of the Human Genome Program; o Adequacy of any plans proposed for managing data and sharing data and resources in a timely manner; o Balance among research goals with respect to the NCHGR grant portfolio; o Availability of funds. Applications must be submitted using the form PHS 398 (rev. 10/88). The RFA label available in the revised application kit MUST be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Application kits are available in the business or grants office at most academic or research institutions and from the Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, in accordance with the following schedule: TIMETABLE: Letter of Intent (optional): October 18, 1991 Receipt Date: November 15, 1991 IRG Review: March 1992 Council Review: May 1992 Earliest Funding Date: July 1, 1992 It is essential that applicants type "Mapping the Drosophila Genome" and the RFA number, HG-91-05, on line 2 on the face page of the application form. The original and four copies of the application must be submitted to: Grant Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite the review process, it is also important to submit two copies of the application directly to: Office of Scientific Review National Center for Human Genome Research National Institutes of Health Building 38A, Room 604 9000 Rockville Pike Bethesda, MD 20892 It is important to send these two copies to the NCHGR at the same time as the original and four copies are sent to the Division of Research Grants. Otherwise the NCHGR cannot guarantee that the application will be reviewed in competition for the RFA. Prospective applicants are encouraged to contact staff very early in the planning phase of the application. For more information regarding specific research areas or mechanisms, please contact: Physical Mapping Grant Applications (R01, R21, P01): Bettie J. Graham, Ph.D. Chief, Research Grants Branch National Center for Human Genome Research Building 38A, Room 610 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7531 E-mail: B2G@NIHCU.BITNET; B2G@CU.NIH.GOV Sequencing and Technology Development Grant Applications (R01, R43, R44): Robert L. Strausberg, Ph.D. Program Director, Technology Development Program National Center for Human Genome Research Building 38A, Room 610 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7531 E-mail: CXR@NIHCU.BITNET; CXR@CU.NIH.GOV Center Grant Applications (P20, P30, P50): Jane L. Peterson, Ph.D. Chief, Research Centers Branch National Center for Human Genome Research Building 38A, Room 610 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 496-7531 E-mail: JP2@NIHCU.BITNET; JP2@CU.NIH.GOV For information about PHS Grants Policy, applicants may contact: Ms. Alice Thomas Chief, Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 National Institutes of Health Bethesda, MD 20892 Telephone: (301) 402-0733 The program and grants management officials welcome the opportunity to clarify any issues or questions related to this RFA and encourage written and telephone inquiries. This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Sections 301 (Public Law 78-410, as amended 42 U.S.C. 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 requirement of Executive Order 12372 or to Health Systems Agency review. $$XID RFA AG9112 AG-91-12 P1O1 ***************************************** REQUEST FOR APPLICATIONS LEADERSHIP AND EXCELLENCE IN ALZHEIMER'S DISEASE RFA: AG-91-12 P.T. 34; K.W. 0715180 National Institute on Aging Application Receipt Date: January 15, 1992 PURPOSE The U.S. Congress, through section 445B of the Public Health Service Act as amended (42 U.S.C. 285e-3) authorized the National Institute on Aging (NIA) to make one or more awards to senior researchers who have made distinguished achievements in Alzheimer's disease (AD) and related dementias. The overall goal of this solicitation is to provide awards to senior investigators with strong histories of outstanding research accomplishments and commitments to the study of dementias in the aged. These awards are designed to free awardees from further commitment of the time usually consumed by application preparation and administrative and/or clinical duties, thus allowing them to devote more time to research and to the development of outstanding junior investigators. Awardees would be expected to use some of the funds provided to support and develop exceptionally promising junior researchers who are working on AD or related dementias. The objectives of this program are to help strengthen the capabilities of established senior investigators who have distinguished records in biomedical research on AD by providing up to seven years of support to allow the recipients the time to devote to research and the development of outstanding but less established biomedical investigators who are interested in working on AD and related dementias. ELIGIBILITY REQUIREMENTS Although the award will be made to the applicant institution in the name of the senior investigator, it may not be transferred to another investigator. Eligibility is restricted to U.S. institutions. Only one application per institution will be accepted. Applications will not be accepted from institutions that have received a Leadership and Excellence in Alzheimer's Disease (LEAD) award. Applications may be submitted by domestic for-profit or nonprofit organizations, whether public or private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This Request for Applications (RFA) will use the National Institutes of Health g in-aid mechanism (R35). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as stated in this RFA, awards will be administered under PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. FUNDS AVAILABLE No more than $1,000,000 total cost per year for seven years will be committed to specifically fund each award made in response to this RFA. Up to three awards may be granted. 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 plans of the NIA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest start date will be July 1, 1992. RESEARCH OBJECTIVES The senior scientist is to be the focal point of this award. That individual is to provide leadership on research in AD and related dementias of aging. Relevant activities are provision of encouragement and assistance to other faculty members so that they may integrate issues of aging and AD other related dementias into their research and teaching, organization and conduct of research, development of courses on these issues, recruitment and development of junior investigators, and integration of AD-related activities among and within the various units of his or her institution. This individual must have the active and continuing support of the principal executive officials of the institution, and the institution must be strongly committed to the objectives of this program. Prospective awardees must demonstrate a strong commitment to and history of research on AD and related dementias of the aged. It is hoped that this award will stimulate the recipient institution(s) to develop substantial continued support such as endowed chair(s) for AD and related dementias of aging when this award is terminated. SPECIAL REQUIREMENTS Applications must include the following three components: o Salary support for the applicant. The primary intention of this component is to provide continued and stable salary support for the duration of the award thus permitting the awardee time to devote to the goals of this award while being relieved of other competing responsibilities. Up to 80 percent, consistent with the time and effort, of the awardee's salary and related fringe benefits will be provided. Adjustments will be made with other PHS-supported grants for overlapping salary commitments; funds released from those grants may not be used for any other purpose without the specific approval of the funding agencies. It is required that the Principal Investigator commit at least 70 percent of his/her time and effort to research efforts on AD and related dementias associated with aging. No more that 20 percent of the total costs of the award may be used for salary support for the senior investigator. o Salary support for at least one, but not more than three, junior researchers who demonstrate exceptional promise to conduct research in the area of aging and AD and related dementias. The primary intention of this component is to provide continued and stable salary support for the duration of the award to outstanding and promising junior investigators who would have the opportunity to develop as researchers under the close tutelage of the senior awardee. At the initiation of the award, the junior investigator shall not have an academic rank exceeding that of Assistant Professor, or its equivalent, with regular faculty tenure-track appointment. It is expected that these junior investigators will develop their own research programs on aging and AD and related dementias by applying for independent support by the customary grant mechanisms. Adjustments will be made with other PHS-supported grants for overlapping salary commitments; funds released from these grants may not be used for other purposes without the specific approval of the funding agencies. Support, consistent with time and effort, may be provided for the duration of the award for up to 80 percent of salary and related fringe benefits. No more that 30 percent of the award may be used for salary support of the junior investigator(s). o Research Support. The primary intention of this component is to support the research program(s) to the senior investigator in the following ways: A. Expansion of the scope of currently funded research into new lines of inquiry through novel techniques or approaches and by the addition of personnel. Applicants must provide sufficiently detailed research protocols and budgets, following the guidelines in the PHS 398, to permit evaluation of the research plan by the Initial Review Group (IRG). B. Support or expansion of the research of the junior investigator(s) for up to three years. Applicants must provide sufficiently detailed research protocols and budget, following the format for traditional (R01) research grants. C. Support of innovative or opportunistic research on aging and AD and related dementias as pilot studies of no more than two years duration. Pilot projects must be budgeted for all years and specific pilot projects must be proposed for the first two years of this award as well as the mechanism for selection of future projects which must have final approval by the NIA. The pilot studies need not be conducted by the senior applicant. STUDY POPULATIONS: SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants 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 or 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 to the applicant without review. 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. REVIEW PROCEDURES Applications must be submitted to the NIH Division of Research Grants and will be assigned to the NIA. Applications will be assigned to a special review committee for review. Because a site visit is not a prerequisite, each application must be thorough and complete enough to stand on its own. The second level review will be by the National Advisory Council on Aging. REVIEW CONSIDERATIONS Applications will be reviewed by NIA staff to determine administrative and programmatic responsiveness to this RFA; those judged to be nonresponsive will be returned to the applicant without review. Those applications that are complete and responsive may be subjected to a preliminary review by a subcommittee of the review group to determine those applications deemed to be competitive. Those applications judged to be noncompetitive for award will be withdrawn from further competition. Those applications judged to be competitive will be further reviewed for scientific and technical merit by a special review committee convened by the Scientific Review Office, NIA. Following review by an initial review group, the application will be considered by the National Advisory Council on Aging. The following factors will be considered in the evaluation of each application: o Scientific merit of the research. o Background, productivity, and commitment of the applicant investigator in the area of aging and AD and related dementias. o Likelihood that the award will foster expansion and break new ground in AD research. Exploration of innovative ideas is encouraged over a simple continuation of previous lines of inquiry. o Likelihood of continued productivity and innovation. o Ability to foster development of junior faculty and researchers. o Plan of research development of the junior investigator(s). o Commitment of the institution to strengthening its research and other activities in AD and other dementias of aging. o Scope and nature of activities to enhance research in these areas. Applicants must document their individual and institutional commitments to research on aging and the dementias of aging. They must develop a plan linking this award to currently held research grants. APPLICATION PROCEDURES Applications must be complete when submitted. Additional information will not be accepted after the receipt date. Applicants are urged to secure the necessary institutional approvals for the use of human subjects and vertebrate animals, as appropriate, prior to submitting their applications. Applications without the required certifications will be returned without review. The applicant investigator must submit an expanded curriculum vitae with the application in place of the standard biographical sketch. This may be up to 15 pages in length and must include positions held, experience in the development of junior investigators, record of extramural funding, summation of significant findings, and major publications. Applicants must identify at least one outstanding and promising junior investigator, provide complete curriculum vitae, and present a plan for the individual(s) research development. "To be appointed" investigators will not be accepted. Supporting letters from other members of the scientific community, as well as institutional commitments, will assist in the evaluation by the IRG. Replacement of promising junior investigators after the initial award has been made will require submission of such information by the Principal Investigator to the NIA. Material will be reviewed and evaluated by NIA staff. Approval of support of such candidates will require concurrence by the National Advisory Council on Aging. Relevant institutional official(s), e.g., Department Chair, Dean, President, must submit letters of support detailing institution's plans. The application must be submitted on the 10/88 revision of form PHS 398, the application for the traditional research-project grant. To identify these applications as being in response to the RFA, check "yes" on item 2 of page 1 of the application and enter the title, "Leadership and Excellence in Alzheimer's Disease" and the RFA number AG-91-12. The RFA label available in the 10/88 revision of application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Applications must be received by January 15, 1992 for earliest starting date of July 1, 1992 . If received late, the application will be returned without review. Up to three awards may be granted based upon availability of funds and the number of meritorious applications. CONDITIONS OF THE AWARD A. Awards will not be renewed. B. Funds may be carried over from one budget period to the next. C. Awards may be extended for up to one additional year without additional funds at the end of the award, without prior approval of awarding agency. D. The award recognizes the distinguished accomplishments of the senior researcher in biomedical research in areas related to aging and AD and related dementias. Although the award will be made to the applicant institution in the name of the senior investigator, it may not be transferred to another investigator. E. Allowable total costs (direct plus indirect) are not to exceed $1,000,000 per year. F. Eligibility is restricted to U.S. institutions. G. Only one application per institution will be accepted. H. Applications will not be accepted from institutions that have received a LEAD award. I. Except as stated in this RFA, awards will be administered under the PHS Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. INQUIRIES Applicants are encouraged to obtain supplemental information, to discuss their plans, and to direct any programmatic inquiries to: Carl Banner, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging National Institutes of Health Building 31, Room 5C35 Bethesda, MD 20892 Telephone: (301) 496-9350 Direct inquiries regarding fiscal matters to: Joseph Ellis Grants Management Officer Office of Extramural Affairs National Institute on Aging National Institutes of Health Building 31, Room 5C07 Bethesda, MD 20892 Telephone: (301) 496-1472 Application kits may be secured from institutional offices of grants and contracts and from: Office of Grants Inquiries Division of Research Grants National Institutes of Health Westwood Building, Room 449 5333 Westbard Avenue Bethesda, MD 20892 Mail the complete application and four copies to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** To expedite review, two exact copies must be sent to: Dr. Michael Oxman Scientific Review Office National Institute on Aging National Institutes of Health Building 31, Room 5C12 Bethesda, MD 20892 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. 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. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816 From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!snorkelwacker.mit.edu!hsdndev!cmcl2!mcclb0.med.nyu.edu!smith From: smith@mcclb0.med.nyu.edu Newsgroups: bionet.general,bionet.software,bionet.sci-resources Subject: A NIH-Guide Reading Program for VAX/VMS Message-ID: <1991Jun13.081135.7009@mcclb0.med.nyu.edu> Date: 13 Jun 91 12:11:35 GMT Organization: NYU Medical Center, New York, NY, USA Lines: 55 Xref: bionet bionet.general:1194 bionet.software:992 bionet.sci-resources:225 Announcing V1.0 of the NIH-Guide Reading Program ================================================ We have developed an NIH-Guide reading program for VAX/VMS. Its purpose is to provide a user-friendly tool to browse the NIH-Guide for Grants and Contracts, as distributed electronically via BITNET. It is designed to allow the NIH-Guide database to be updated automatically as new Guide information is distributed, allowing administrative overhead for database management to be significantly reduced. The program consists of two main components: The Guide-Reading program itself, and the Guide-Formatting program. The Guide-Reading program is the component used to browse the Guide. This program reads the guide database and presents the Guide items for inspection. The program is driven by single key-strokes using programmed keys on the VT100 or VT200-style keyboard. The user can print items of interest on a convenient printer. The Guide-Formatting program is meant to be run in a batch queue. This program takes the incoming mail to the NIH Guide 'user' and processes it to update the NIH-Guide information database. The updating of the Guide is therefore achieved automatically, without user intervention. The software is available free of charge from our MAILSERVer. To get it, send mail to MAILSERV@MCCLB0.MED.NYU.EDU with the following lines in the body of the message: SEND NIH-GUIDE.1 SEND NIH-GUIDE.2 SEND NIH-GUIDE.3 SEND NIH-GUIDE.4 The distribution will be mailed to you. Follow the instructions at the begining of the first mailed message: the distribution is in a VMS_SHARE archive. You should note that the program makes heavy use of VMS system services, and is not suitable for a port to UNIX, as yet: A SHAR archive will be available for anonymous/FTP for those interested in getting started, however! If you would like to test the package before installing it, AND you have access to TELNET, please contact us and we will tell you how to log in to our VAX to run the program. The development of these programs owes much to the help of people who called or mailed comments on what they saw during the testing phase of development: particular thanks to Foteos Macrides for many detailed reports which were key to resolving significant problems. Contacts: smith@mcclb0.med.nyu.edu SMITH@NYUMED.BITNET gottesman@mcclb0.med.nyu.edu GOTTESMAN@NYUMED.BITNET +---------------------------------------------------------------------------+ |Ross Smith, Cell Biology, NYU Medical Center, 550 First Ave., NYC, 10016| |E-Mail: SMITH@NYUMED.BITNET (BITNET), SMITH@MCCLB0.MED.NYU.EDU (Internet)| +---------------------------------------------------------------------------+ From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 10, pt. 3, 8 March 1991 Message-ID: Date: 9 Mar 91 03:03:16 GMT Sender: kristoff@genbank.bio.net Lines: 1116 $$XID RFA MH9105 MH-91-05 P1O1 ***************************************** SHORT-TERM GRANTS FOR TRAINING MEDICAL STUDENTS IN THE DIAGNOSIS AND TREATMENT OF DEPRESSIVE DISORDERS RFA: MH-91-05 P.T. 34; K.W. 0720005, 0715072, 0745020, 0745060, 0745070 National Institute of Mental Health Letter of Intent Receipt Date: May 1, 1991 Application Receipt Date: May 22, 1991 (Catalog of Federal Domestic Assistance 93.244) Under the authority of Section 303 of the Public Health Service Act, U.S.C. 242a; 42 CFR, Part 64, the National Institute of Mental Health will accept applications for short-term grants to provide training to medical students in the diagnosis and treatment of depressive disorders under the single receipt date of May 22, 1991. Darrel A. Regier, M.D., M.P.H. Director Division of Clinical Research Alan I. Leshner, Ph.D. Acting Director National Institute of Mental Health INTRODUCTION Serious depressive disorders are a major public health problem in the United States. Because of the existence of effective psychological and pharmacological treatments, which are often used in combination, most people with depressive disorders can be successfully treated. Evidence suggests, however, that clinical depression is all too frequently poorly recognized and underdiagnosed, with resulting undertreatment. Although more than half of all clinically depressed patients are initially seen in the general medical system, their symptoms are frequently not diagnosed as a depressive syndrome and, thus, they are not likely to receive the proper treatment. The National Institute of Mental Health (NIMH) has developed the Depression Awareness, Recognition, and Treatment (D/ART) program to provide the most up-to- date research knowledge to the general public, primary care providers, and mental health specialists. This grant program is responsive to the need for addressing the special issues relating to the diagnosis and treatment of clinical depression in a medical setting as well as to the need for training greater numbers of primary care physicians at early stages of their professional development. PURPOSE As part of the D/ART program, NIMH seeks applications from medical schools to develop and implement training of pre-doctoral medical students in the diagnosis and treatment of clinical depression according to a basic curriculum presented in this request for application. Support is available for the detailed development of this curriculum, its implementation, and evaluation of its educational effectiveness and impact. The goal of the training is to prepare medical students to deal with depressive disorders (including major depression and bipolar disorder) as these disorders appear in medical settings. It is not designed to provide specialty training for psychiatric residents. ELIGIBILITY Applications may be submitted by accredited schools of medicine and osteopathy. There is special interest in applications submitted by departments of family medicine, internal medicine, obstetrics and gynecology, and other nonpsychiatric specialties. APPLICATIONS CHARACTERISTICS The applicant should provide: o a description of the applying entity, its relevant personnel, and its training resources o a conceptualization of the training program, including its goals and objectives o a detailed description of the proposed training program, including the curriculum which must include, but need not be limited to the following elements: 1) Epidemiology and Overview of Depression, including issues of prevalence and incidence, drawing data from the NIMH Epidemiological Catchment Area Study; risk factors; disability of clinical depression relative to chronic medical illness; etiology; and accessibility to medical treatment of clinical depression 2) Diagnosis and Assessment, including the major categories of depression in DSM-III R (or subsequent revisions); overview of major screening instruments for depression; impact of patient and physician attitudes on diagnosis (and treatment); and determining severity of depression 3) Depression within a Medical Setting, including disability from depression; depression presenting with somatic symptoms, depression comorbid with alcohol and substance abuse, depression secondary to medical disorder; medication-induced depression; the primary physician's role in diagnosis and treatment of clinical depression; issues of relapse, recurrence and chronicity; referral and relationships with other practitioners; and dealing with suicidality 4) Biological Treatments of Depression, including pharmacologic treatments, their indications for use, relative efficacy and side effects, and use in combination; ECT, light therapy, sleep deprivation 5) Psychosocial Aspects of Depression, including the psychosocial context in which clinical depression occurs; the impact on the family; the role and effectiveness of short-term psychotherapies (specifically cognitive and interpersonal therapy); the relative effectiveness of psychosocial therapies; and the use of pharmacological and psychosocial treatments in combination 6) Special Issues, including depression in the elderly, adolescents, the chronically ill, and other groups of concern. The applicant should also provide: o for each component of the curriculum, a description of the content to be addressed, the teaching materials to be used, the proposed faculty, the time frames to be allotted to each training module, and the teaching methods to be used o a detailed description of how the curriculum will be implemented o the proposed number and level of students to be trained TERMS AND CONDITIONS OF SUPPORT The mechanism of support for these awards will be the Continuing Education Grants (T15). Period of Support The period of support is 1 year. Average Size of Award It is expected that up to 10 awards will be made, each award not to exceed $15,000 total (direct and indirect) costs per award. Funds made available under this grant may not be used to supplement existing training or other support for such training. Direct Costs Grants described in this announcement are awarded directly to eligible applicants. Direct cost items are allowable for teaching costs associated with this program. They include personnel, consultants, materials, supplies, reproduction and printing costs, rental equipment, minor equipment items, and other items which are directly related to the proposed training program and are otherwise unavailable from the institution. Funds are not available for tuition or other subsidies of medical students. Funds may be used only for those expenses which are directly related and necessary to carry out the project and must be expended in conformance with DHHS cost principles, the Public Health Service Grants Policy Statement,* and conditions set forth in this document. Regulations at 42 CFR Part 242 A are applicable to this awards. * Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (rev. 10/1/90) APPLICATIONS PROCEDURES It is suggested that those who apply send a brief letter of their intention to Harold Goldstein, Ph.D., Director of Training, D/ART. Dr. Goldstein is also available for consultation on program development. A letter of intent is not binding, nor a necessary requirement of applications but is useful in planning the review of applications. This letter should be received by May 1, 1991 at the address below. Preparation of the application may proceed simultaneously. For questions of eligibility, fiscal and administrative matters and for assistance in developing applications, prospective applicants should consult: Harold Goldstein, Ph.D. Director of Training Prevention Research Branch Division of Clinical Research National Institute of Mental Health Parklawn Building, Room 14C-02 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4140 Applicants should use the grant application kit (PHS 398, revised 10/88) available from the Prevention Research Branch, Rm 14C-02, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, (301) 443-4140. To identify this application as a response to an RFA, check 'yes' on item 2 page one of the PHS 398 form. Also enter in item 2 the number and shortened title of this RFA (MH-91-05, Short-Term Grants for Training Medical Students in the Diagnosis and Treatment of Depressive Disorders). THE RFA LABEL FOUND ON THE PHS KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COMPLETED APPLICATION FORM. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF YOUR APPLICATION SUCH THAT IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW. Applications must be complete and contain all information needed for initial and Advisory Council review. No addenda will be accepted later unless specifically requested by the Executive Secretary of the review committee. No site visits will be made. The applicant should include a project abstract which should not exceed two single-spaced typewritten pages. The narrative section of the application should not exceed 20 pages; appendices may not be used inappropriately to expand the narrative section. Applications exceeding this limitation will be returned. The original and five copies of the application must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** One additional copy of the application must be submitted directly to: NIMH Division of Extramural Activities Parklawn Building, Room 9C-15 5600 Fishers Lane Rockville, MD 20857 Attention: Mrs. Edna Hardy-Hill REVIEW Review Procedures A dual review system is used to insure knowledgeable, objective review of the quality of applications. Initial peer review for scientific, educational, and/or technical merit is by groups of non-Federal experts called Initial Review Groups. Final review is by the National Advisory Mental Health Council. Applications submitted in response to this announcement are not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through DHHS regulations at 45 CFR Part 100. Review Criteria Each grant application is evaluated on its own merits and will be reviewed according to the following criteria: o experience in education on mental disorder issues o compliance with the requested application characteristics o appropriateness and feasibility of the content, methods and organization of the project to specified project goals and objectives o quality of the proposed program evaluation o quality of the resources of the applying organization o qualifications of the program director and other staff o number and range of students to be trained, especially the minorities and women RECEIPT AND REVIEW SCHEDULE National Advisory Receipt of Initial Mental Health Earliest Application Review Council Review Start Date May 22, 1991 July 1991 September 1991 September 1991 Applications submitted after the receipt date will be returned to the applicant without review. AWARD CRITERIA The responsibility for award decisions on applications recommended for approval by the National Advisory Mental Health Council lies solely with authorized NIMH program staff. The basic criteria to be used in making award decisions will be the quality of the proposed project as determined during the review process and the availability of funds. $$XID RFA MH9104 MH-91-04 P1O1 ***************************************** SHORT-TERM CLINICAL TRAINING GRANTS IN DIAGNOSIS AND TREATMENT OF DEPRESSIVE DISORDERS RFA: MH-91-04 P.T. 34; K.W. 0720005, 0715072, 0745020, 0745060, 0745070 National Institute of Mental Health Letter of Intent Receipt Date: May 1, 1991 Application Receipt Date: May 22, 1991 (Catalog of Federal Domestic Assistance 93.244) Under the authority of Section 303, of the Public Health Service Act, U.S.C. 242a; 42 CFR, Part 64, the National Institute of Mental Health will accept applications for short term clinical training grants in diagnosis and treatment of clinical depression under the single receipt date of May 22, 1991. Darrel A. Regier, M.D., M.P.H. Director Division of Clinical Research Alan I. Leshner, Ph.D. Acting Director National Institute of Mental Health BACKGROUND Serious depressive disorders are a major public health problem in the United States. Because of the existence of effective psychological and pharmacological treatments, which are often most effective when used in combination, most people with depressive disorders can be successfully treated. Evidence suggests, however, that depression is poorly recognized, undertreated, or incorrectly treated in the health and mental health system. The National Institute of Mental Health (NIMH) developed the Depression Awareness, Recognition and Treatment (D/ART) program to provide the most up-to- date research information on depressive disorders to the general public, primary care providers, and mental health specialists. PURPOSE As part of the D/ART program, NIMH seeks applications for programs of short-term (not to exceed 5-days duration) continuing education. Each program will be carried out at multiple locations (minimum of six different sites per year) and will provide continuing education for primary care providers and mental health professionals. Support is available for the development, implementation, and evaluation of training programs that are designed to foster the more effective recognition, diagnosis, and treatment of major depressive disorders, including manic depression and clinical depression. This initiative is intended to provide for the development of effective training that is directly tied to major recent research findings and clinical knowledge and which incorporates both didactic and experiential modes of teaching; it is not, however, designed to test training models. The focus is on training providers to more effectively diagnose and treat clinical depression in adults and adolescents; childhood depression does not fall within the scope of this announcement. The training is intended to give primary care providers and mental health professionals with a didactic and experiential program that will increase their capacity to recognize, diagnose, and treat clinical depression effectively, in a manner appropriate to their discipline. Training must include recent major research findings on psychosocial and pharmacological aspects of treatment. Priority in funding will be given to approved applications from geographic areas, particularly rural, which have not yet been served by D/ART grants. ELIGIBILITY Applications may be submitted by: o a department of psychiatry in, or associated with, a school of medicine, or a free- standing mental health institution with an approved psychiatric residency program o a university-based department of psychology offering doctoral training in clinical psychology, or a school of professional psychology with appropriate accreditation for doctoral training in clinical psychology o a college or university school of nursing which offers a graduate program in psychiatric nursing o a school of social work with a graduate program All applicants must have experience and demonstrated capacity in the provision of continuing education tied to research on depressive disorders and must use multidisciplinary teams of trainers. AREAS OF INTEREST NIMH particularly encourages applications for programs which contain the following: o a focus in part of the curriculum on such special populations as the aged, adolescents, women, and minorities which include, but are not limited to, Blacks, Hispanics, American Indians, Alaskan Natives, and Native Hawaiians. o A coherent plan for training staff of Employee Assistance Programs (EAP). o a coherent plan to address issues of co- morbidity and depression. APPLICATION CHARACTERISTICS The applicant must provide: o a description of the applying entity, its relevant personnel, its training resources, and its prior experience in the provision of continuing education in the area of clinical depression o the rationale underlying the conceptualization of the training program,including specific assumptions, goals, and objectives o a concise review and critical assessment of the most up-to-date research in clinical depression and a discussion of how the research will be incorporated into the training program o the concepts of depressive disorders on which the training program is to be based o a detailed description of the proposed training program, including proposed curriculum, which contains the following elements: 1) a balanced approach to psychosocial and biological aspects of depression 2) didactic components, i.e., lectures and formal presentations which include research and clinical knowledge to be developed to provide students with the context for better diagnoses and treatment of depressive disorders 3) selection and development of the experiential components in which the students will be directly involved 4) explanation of how the integration of the didactic and experiential components will provide students with the attitudes and competencies to provide effective services 5) a plan for materials development as appropriate 6) for each area of training, the content to be addressed, the teaching materials to be used, the proposed faculty, the time frames to be allotted to each training module, and the teaching methods to be employed o a description of the proposed participants, their manner of recruitment and selection, and the relevance of the training to their specific needs o a description of the number of training programs to be offered, the sites at which the training is to be presented, the rationale for site selection, and the total number of proposed students to be trained o a comprehensive and detailed plan for an evaluation to establish the program's effectiveness and generalizability, including before and after measures as well as a plan for a followup of students who have completed training and an assessment of the value of curricular content and training experiences o a focus on improving the skills and knowledge of health care professionals in the pharmacological and psychological treatments for depressive disorders o a comprehensive scope, addressing issues of diagnosis, treatment, case management, development of coordinated treatment plans, and relationships with other health care professionals o a focus particularly on the early diagnosis and treatment of outpatients with depressive disorders o a broad base in their approach to continuing education, including experiential, interactive, and didactic teaching methods o innovative plans on how to recruit mental health and health professionals as students TERMS AND CONDITIONS OF SUPPORT The mechanism of support for these awards will be the Continuing Education Grants (T15). Period of Support The period of support is up to 3 years (with a maximum of $125,000 per year), though no firm commitment can be made beyond the first year. Therefore, activities in the first year must be significant with a minimum of six programs provided at six different sites in each grant year. Average Size of Award It is expected that up to four awards may be made, each award generally not to exceed $125,000 total (direct and indirect) costs per award in fiscal year 1991. Funds made available under this grant may not be used to replace currently existing training or other support for such training. Direct Costs Grants described in this announcement are awarded directly to eligible applicants. Funds may be used only for those expenses which are directly related and necessary to carry out the project and must be expended in conformance with DHHS cost principles, the Public Health Service Grants Policy Statement,* and conditions set forth in this document. Regulations at 42 CFR Part 242a are applicable to these awards. *Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000 (rev. 10/1/90). All budget items must be fully justified at the level requested. Grantees are expected to be familiar with and comply with applicable cost policies. Teaching Costs Direct cost items are allowable for teaching costs associated with these programs. They include personnel, consultants, materials, supplies, travel, reproduction and printing costs, rental equipment, minor equipment items, and other items which are directly related to the proposed training program and are otherwise unavailable from the institution. Trainee Expenses Trainee expenses are not allowable for support. Participants may not be charged for training. APPLICATION PROCEDURES Harold Goldstein, Ph.D., Director of Training, D/ART Program is available for consultation on program development and may be reached at the address below. It is further suggested that those who apply send a brief letter of their intention to Dr. Goldstein. The letter of intent is not binding, nor is it a requirement for applications. (This letter should be received by May 1, 1991.) Preparation of application may proceed simultaneously. Questions regarding eligibility, application development, and fiscal and administrative matters should be directed to: Harold Goldstein, Ph.D. Director of Training D/ART Program Prevention Research Branch Division of Clinical Research NIMH Parklawn Building, Room 14C-02 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4140 Applicants must use the grant application kit (PHS 398, revised 10/88). Application kits are available from the Prevention Research Branch, Room 14C-02, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, (301) 443-4140. To identify this application as a response to an RFA, check 'yes' on item 2 page one of the PHS 398 form. Also enter in item 2 the number and modified title of this RFA (MH-91-04, Short-Term Clinical Training Grants on Depressive Disorders). THE RFA LABEL FOUND IN THE PHS 398 KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COMPLETED APPLICATION FORM. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF YOUR APPLICATION SUCH THAT IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW. Applications must be complete and contain all information needed for initial and Advisory Council review. No addenda will be accepted unless specifically requested by the Executive Secretary of the review committee. No site visits will be made. The applicant should include a project abstract that should not exceed two single-spaced typewritten pages. The narrative section of the application should not exceed 20 pages; appendices may not be used inappropriately to expand the narrative section. Applications exceeding this limitation will be returned. Applicants submitting revised proposals of earlier applications should follow the instructions in the application kit regarding such revisions. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The original and five copies of the application must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Because of the short time available for initial and Council review, one (1) additional copy of the application should also be sent directly to: NIMH Division of Extramural Activities Parklawn Building, Room 9C-15 5600 Fishers Lane Rockville, MD 20857 Attention: Mrs. Edna Hardy-Hill REVIEW Review Procedures A dual review system is used to insure knowledgeable, objective review of the quality of applications. Initial peer review for scientific, educational, and/or technical merit is by groups of non-Federal experts called Initial Review Groups. Final review is by the National Advisory Mental Health Council. Review Criteria Applications submitted in response to this announcement are not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through DHHS regulations at 45 CFR Part 100. Each grant application is evaluated on its own merits. The following criteria will be used: o relationship of the goals of the proposed project to the purposes of this announcement o appropriateness and feasibility of the content, methods, and organization of the project to specified project goals and objectives o quality of the training program plan and its linkages to major research findings and clinical knowledge o balance in the curriculum between psychosocial and pharmacological treatments o multidisciplinary team of trainers o multi-model training using a variety of educational techniques including didactic and experiential training methods o effectiveness of the plans for recruiting trainees outreach to geographic locations throughout the training area o previous experience in the provision of continuing education programs. o quality of the resources of the applying organization o qualifications of the program director and other staff o adequacy of the evaluation plan o adequacy of the budget projections and other resources for carrying out the project activities RECEIPT AND REVIEW SCHEDULE National Advisory Receipt of Initial Mental Health Earliest Application Review Council Review Start Date May 22, 1991 July 1991 September 1991 September 1991 Applications submitted after this date will be returned to the applicant. AWARD CRITERIA The responsibility for award decisions on applications recommended for approval by the National Advisory Mental Health Council lies solely with authorized NIMH program staff. The basic criteria to be used in making award decisions will be the quality of the proposed project as determined during the review process and the availability of funds. $$XID RFA HD9110 HD-91-10 P1O1 ***************************************** REQUEST FOR RESEARCH APPLICATIONS RFA: HD-91-10 EFFECT OF SPECIFIC COMPONENTS OF HUMAN MILK ON THE NURSLING P.T. 34; K.W. 0750015, 0775015, 1003008, 0760020, 0760025 National Institute of Child Health and Human Development Application Receipt Date: July 24, 1991 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, Effect of Specific Components of Human Milk on the Nursling, is related to the priority areas of Nutrition and Maternal and Infant Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-783-3238). The Endocrinology, Nutrition, and Growth Branch of the Center for Research for Mothers and Children of the National Institute of Child Health and Human Development (NICHD) invites research grant applications on the effects of specific components of human milk on the nursing infant with respect to nutrition, physiological maturation of specific tissues or organ systems, and susceptibility to infection and malignancies, endocrinopathies, and degenerative disorders. Of particular interest are studies designed to determine the mechanisms of these effects. BACKGROUND Over the last twenty years we have become aware that human milk is a complex mixture which contains many substances besides those which meet the classical nutritional requirements of newborn infants. Many of these substances are not present in cow milk or infant formula or are present there only in much lower concentrations. They include enzymes, hormones, growth factors, antibodies, specific proteins of other classes, non-protein nitrogenous substances, and oligosaccharides. Some of these substances which are of large molecular size can nevertheless be absorbed intact from the immature gastrointestinal tract. Many of them have powerful biological actions in other in vivo and in vitro contexts, but for only a few have we learned the physiological import of their presence in milk. Whether the others have significant developmental effects on the nursing infant or are only incidental passengers of the milk secretion process is unknown. It seems likely that hormones present in human milk at levels several-fold greater than those in plasma, like somatostatin or growth hormone, or five-fold greater, like oxytocin, or 20-90 times greater, like calcitonin, have some effect on the nursing infant, but even those hormones with low milk/plasma ratios may have functional significance in milk. In rats, prolactin ingested by the pups in milk is necessary for the development of normal pituitary control over prolactin secretion in later life. Whether any of the other hormones of milk, which include insulin, TRH, TSH, corticosteroids, estrogen, progesterone, EGF, NGF, IGF 1 and 2, TGFs, erythropoietin, bombesin, neurotensin, VIP, and prostaglandins, have any physiological significance to the infant remains to be determined. There are a number of other compounds which are present in much higher concentrations in human milk than in formula. These include small molecules like lactoferrin, an iron chelator with putative antibacterial or other immunologic properties, enzymes like bile salt-stimulated lipase, lysozyme, and amylase, purine and pyrimidine nucleotides, and secretory IgA. There are also leukocytes, leukocyte migration factors, and probably polysaccharides or glycoproteins which mimic intestinal receptors for pathogenic organisms, binding to those organisms and serving as a defense against infection. There are unknown materials which facilitate the absorption of iron and other elements and factor(s) which stimulate the establishment of normal intestinal flora. Many infants have been raised successfully on non-human milks. Nevertheless, it is important to learn whether various components of human milk affect development and maturation, not only for the basic science information to be gained, but also for the potential benefit to infants who do not receive beikost at an early age, as well as those who must be maintained on parenteral nutrition, those who are suckled in unsanitary environments, and those who are of low birth-weight. Even for normal infants in favorable surroundings there may be long-term benefits from specific components of human milk, as suggested by case-control studies of juvenile diabetes and childhood lymphoma. It is difficult to do this kind of research in human infants, and sometimes non-rigorous inferences must be drawn from research on animal models. Until recently taurine, which is the second most common amino acid in human milk, was not present in any commercial infant formula. However, because of evidence that taurine deficiency produces abnormal electroretinographic responses in infant animals, and because a study in low-birth-weight human infants suggested that they developed mature auditory evoked responses more rapidly when given taurine, this substance is now routinely added to all infant formulas. As a result, ethical considerations now forbid the intentional induction of taurine deprivation in human babies, and studies of taurine function in the newborn demand model systems. Similarly, there is a delay in the maturation of rod cells in the retina when premature infants are fed formulas which differ from human milk by containing relatively low levels of omega-3 fatty acids. Because of this and because of convincing animal studies on the effect of such fatty acids on maturation of the visual system, the addition of linolenic acid to formula intended for low-birth-weight infants is now mandated in Canada. Although it is commonly stated that human milk is the optimal food for newborn humans, it might be possible to develop artificial formulae which enhance infant development and health even more than does human milk, especially in situations where the infant is stressed, ill, handicapped with congenital defects or inborn errors of metabolism, or developmentally delayed. The development of such formulas will depend on knowledge of how specific components of human milk affect the nursling. RESEARCH GOALS Most full-term infants thrive on artificial formulas which lack high concentrations of the human milk-specific components. Their development apparently proceeds satisfactorily without any specific stimulation that these substances may provide. On the other hand, the maturation of low-birth-weight infants proceeds less smoothly, and is complicated by conditions such as the respiratory distress syndrome, bronchopulmonary dysplasia, and necrotizing enterocolitis which seem to result from maturational deficiencies. An understanding of how human milk components influence intestinal maturation, lung function, intellectual development, specific or nonspecific immunity, or other variables in the neonatal period could lead to specific therapeutic uses of these components in undersized, developmentally delayed, or ill infants. Studies of human milk components could also provide important, broadly applicable information about their biological functions in general. This RFA is issued to encourage investigators to undertake clinical studies of the role of specific components of human milk in normal development and disease resistance, and to develop animal or organ/tissue models when studies in humans are impractical or unethical. Nonclinical model studies must focus on the effects of components of human milk. Studies of these topics are expected to increase our understanding of the physiologic role and pharmacologic potential of human milk components, and to lead to improved formulas for artificially fed infants. This is an underinvestigated area of research on maternal-infant interactions, with potentially important clinical applications. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. MECHANISM OF SUPPORT Applications in response to this RFA will be funded through the traditional individual research award (RO1) program of the NIH. This announcement is for a single competition with the application receipt deadline of July 24, 1991. The earliest possible start date for these grants is March 1, 1992. It is anticipated that four (4) grants will be awarded under this program, contingent upon receipt of a sufficient number of meritorious applications and the availability of funds. $600,000 has been set aside for fund these awards. REVIEW PROCEDURES AND CRITERIA Applications will be reviewed by NICHD staff for responsiveness to the RFA. Applications judged to be nonresponsive will be returned. The applicant may resubmit the application and have it assigned for review in the same manner as unsolicited grant applications. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. NIH will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be competitive will be further evaluated for scientific/technical merit by a group review convened solely for this purpose by the Scientific Review Program, NICHD. Criteria for the initial review will include the significance and originality of research goals and approaches; the feasibility of research and adequacy of the experimental design; the research experience and competence of the investigator(s) to conduct the proposed work; the adequacy of investigator effort devoted to the project; and the appropriateness of the project duration and cost relative to the work proposed. Following review by the Initial Review Group, applications will be evaluated by the Institute's Advisory Council for program relevance and policy issues before awards for meritorious proposals are made. APPLICATION PROCEDURE Applications must be submitted on form PHS 398 (rev. 10/88), available in business or grants offices at most academic research institutions or from the Division of Research Grants, NIH. The phrase RFA HD-91-10 EFFECT OF SPECIFIC COMPONENTS OF HUMAN MILK ON THE NURSLING must appear in item 2 of the face page. The RFA label available in the 10/88 version of form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of an application, so that it may not reach the initial review group in time for review. The original and four (4) copies are to be sent no later than July 24, 1991, to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition to the copies sent to the Division of Research Grants, two (2) copies of the application should be sent to: Laurance Johnston, Ph.D. Scientific Review Program National Institute of Child Health and Human Development Executive Plaza North, Room 520A Rockville, MD 20852 Any inquiries about this RFA should be directed to: Ephraim Y. Levin, M.D. Medical Officer, Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Plaza North, Room 637 Rockville, MD 20852 Telephone: (30l) 496-5593 For fiscal and administrative matters, contact: Mr. E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 501 Rockville, MD 20852 Telephone: (301) 496-1303 This program is described in the catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards will be made under the authority of the Public Health Service Act, Section 301 (42 USC241), and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to review by a Health Systems Agency. From owner-sci-resources@net.bio.net Sun Sep 27 23:00:00 1992 Path: bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 20, no. 32, pt. 1, 23 August 1991 Message-ID: Date: 22 Aug 91 01:45:21 GMT Sender: kristoff@genbank.bio.net Distribution: bionet Lines: 1720 NOTE: The NIH Guide may be split into more than one mail message to avoid truncation during e-mail distribution. The first message always begins with the RFP/RFA summary sections followed by the appended texts of the full RFP/RFAs. ---------------------------------------------------------------------- $$XID NIHGUIDE 19910823 V20N32 P1O2 ************************************ X-comment: RFAs described: CA-91-23, CA-91-26, AG-91-12, HL-91-09-L, HG-91-05 NIH GUIDE - Vol. 20, No. 32, August 23, 1991 $$INDEX BEGIN ********************************************************** NOTICES $$INDEX N1 ************************************************************* NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN IN STUDY POPULATIONS National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration Index: NATIONAL INSTITUTES OF HEALTH ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION $$INDEX N2 ************************************************************* ADAMHA/NIH POLICY CONCERNING INCLUSION OF MINORITIES IN STUDY POPULATIONS Alcohol, Drug Abuse, and Mental Health Administration National Institutes of Health Index: ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ************************************************************* REMINDER: REQUIREMENT FOR PROGRAMS ON THE RESPONSIBLE CONDUCT OF RESEARCH IN NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING PROGRAMS National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration Index: NATIONAL INSTITUTES OF HEALTH ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION $$INDEX N4 ************************************************************* NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS National Institutes of Health Food and Drug Administration Index: NATIONAL INSTITUTES OF HEALTH FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ************************************************************* DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS FOR CLINICAL STUDIES (RFP) National Cancer Institute Index: CANCER $$INDEX R2 ************************************************************* DEVELOPMENT AND IMPLEMENTATION OF A PLAN TO ASSESS THE NEURODEVELOPMENT OF INFANTS AND CHILDREN EXPOSED TO DRUGS IN UTERO (RFP) National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 ************************************************************* FAMILY AND GENETIC STUDIES OF CARDIOVASCULAR DISEASE - COORDINATING CENTER (RFP) National Heart, Lung, and Blood Institute Index: HEART, LUNG, BLOOD $$INDEX R4 ************************************************************* GROUP B STREPTOCOCCAL VACCINE DEVELOPMENT (Sources Sought) National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 ************************************************************* HYPERIMMUNE GLOBULIN ADJUNCTIVE THERAPY (Sources Sought) National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES $$INDEX R6 12/06/91 **************************************************** CANCER CENTER OUTREACH EDUCATION PROGRAMS (RFA CA-91-23) National Cancer Institute Index: CANCER $$INDEX R7 12/06/91 **************************************************** IMMUNOLOGIC RECOGNITION AND CONTROL OF TUMORS: A BASIS FOR CANCER VACCINES (RFA CA-91-26) National Cancer Institute Index: CANCER $$INDEX R8 01/15/92 **************************************************** LEADERSHIP AND EXCELLENCE IN ALZHEIMER'S DISEASE AWARD (RFA AG-91-12) National Institute on Aging Index: AGING $$INDEX R9 12/30/91 **************************************************** ANIMAL/CELLULAR MODELS FOR STUDIES OF CYSTIC FIBROSIS (RFA HL-91-09-L) National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases Index: HEART, LUNG, BLOOD, DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES $$INDEX R10 11/15/91 *************************************************** MAPPING THE DROSOPHILIA GENOME (RFA HG-91-05) National Center for Human Genome Research Index: HUMAN GENOME ERRATUM $$INDEX E1 ************************************************************* NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS (RFA CA-91-19) National Cancer Institute Index: CANCER $$INDEX END ************************************************************ NOTICES $$N1 BEGIN ************************************************************* NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN IN STUDY POPULATIONS P.T. 34, II; K.W. 1014002, 1014006 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration The National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) recognize that most researchers adequately and appropriately consider gender representation in clinical research design. Nevertheless, the following statement is published as a reiteration and further interpretation of the existing NIH/ADAMHA policy concerning inclusion of women in study populations. Clinical research findings should be of benefit to all persons at risk of the disease, regardless of gender. This policy was previously published in the NIH Guide for Grants and Contracts on October 24, l986; January 23, l987; March 27, l987; January l5, l988; and June l6, l989. For the purpose of this policy, clinical research includes human studies of etiology, treatment, diagnosis, prevention, and epidemiology of disease, including but not limited to clinical trials. While this policy statement refers to inclusion of women, applicants are strongly reminded that a similar policy exists regarding the inclusion of minorities (NIH Guide for Grants and Contracts - September 25, l987; January l5, l988; and June l6, l989). Both policies must be considered when preparing clinical research applications/proposals for submission to the NIH/ADAMHA. Public concern requires that clinical studies include both genders in such a way that results are applicable to the general population; exceptions would be those diseases or conditions that occur only in one gender. Therefore, applications/proposals for NIH/ADAMHA support of clinical research should employ a study design with gender representation appropriate to the known incidence/prevalence of the disease or condition being studied. If inclusion of women is impossible or inappropriate with respect to the purpose of the research, the health of the subjects, or other reasons, or if in the only study population available there is a disproportionate representation of one gender, these reasons for excluding women or men must be well explained and justified by the applicant. Similar justification is required if women will not be included in numbers appropriate to the incidence/prevalence of the disease. In conducting peer review for scientific and technical merit, members of Initial Review Groups (IRGs)/Technical Evaluation Groups (TEGs) will be instructed to evaluate the proposed gender composition of the study population. 1) If there is an inadequate number of women in a study design AND this affects the potential to answer the scientific question(s) addressed, that will be considered a weakness or deficiency in the study design and should be reflected in the assigned score given to the application/proposal, and in the summary statement of the review. 2) If an applicant proposes that there is justification for conducting a study in men only, or in a study population in which the proportion of women does not reflect the gender prevalence of the disease or condition under study, a strong scientific rationale, an explanation of the need to protect the health of the subjects, or other well-supported justification must be provided. The IRG/TEG will be instructed to evaluate the merit of such justifications. Appropriate justification will not adversely affect the assigned score. The NIH/ADAMHA will not fund such applications/proposals unless the justification provided is compelling. 3) If the gender composition of the study population is not described, BUT the study otherwise has the potential to answer the scientific question(s) posed and translate the findings to all persons at risk of the disease, the omission will be documented by the Executive Secretary of the IRG/TEG in an administrative note, and will not adversely affect the scientific assessment and the assigned score. If there is inadequate information on the study population to allow evaluation of the scientific question(s), the review may be deferred. The NIH/ADAMHA funding components will not fund/award grants or contracts until the applicant provides sufficient information on the study population to assure compliance with the NIH/ADAMHA policy on inclusion of women in study populations. Since the need to modify sample design could delay award and affect the costs of the study, applicants are strongly advised to address this issue in the initial submission. If costs or study designs are significantly affected by such modification, submission of an amended application/proposal for IRG/TEG review and/or reconsideration by the appropriate National Advisory Council or Board may be necessary. Whenever there are scientific reasons to anticipate differences between men and women with regard to the hypothesis under investigation, applicants should consider the inclusion of an evaluation of gender differences in the proposed study. However, if men and women are enrolled in numbers that reflect the gender proportion of the disease under study, it is not an automatic requirement for the study design to include statistical power for men and women separately. It is important to note that regardless of the program relevance of the proposed research, the NIH/ADAMHA funding components will not fund/award grants or contracts that do not comply with this policy. $$N1 END *************************************************************** $$N2 BEGIN ************************************************************* ADAMHA/NIH POLICY CONCERNING INCLUSION OF MINORITIES IN STUDY POPULATIONS P.T. 34, FF; K.W. 1014002, 1014006 Alcohol, Drug Abuse, and Mental Health Administration National Institutes of Health There are clear scientific and public health reasons for specifically including members of minority groups in study populations. Accordingly, the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) and the National Institutes of Health (NIH) require that applications/proposals for clinical research must give appropriate attention to inclusion of minorities in study populations, unless compelling scientific or other justification for not including minorities is provided. For the purpose of this policy, minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics), and clinical research includes human studies of etiology, treatment, diagnosis, prevention, and epidemiology of diseases, disorders and conditions, including but not limited to clinical trials and research on health service and its impact on disease. Grants, cooperative agreements, and contracts are covered by this policy. This statement is published as a reiteration and further interpretation of the existing ADAMHA/NIH policy concerning inclusion of minorities in study populations. This policy was previously published in the NIH Guide for Grants and Contracts on September 25, 1987, Vol. 16, No. 32; January 15, 1988, Vol. 17, No. 2; and June 16, 1989, Vol. 18, No. 21. While the focus of this policy is on inclusion of minorities in general population studies, ADAMHA and NIH also encourage attention to gaps in knowledge about specific U.S. racial/ethnic minorities and health problems that significantly affect them. Examples of these problems include but are not limited to: cancer, substance abuse, heart disease and stroke, homicide and accidents, diabetes, infant mortality, and acquired immunodeficiency syndrome (AIDS). Addressing these gaps may be appropriate justification for focusing a particular study on a single racial/ethnic group. While this policy statement refers to inclusion of minorities, applicants are strongly reminded that a similar policy exists regarding women (NIH Guide for Grants and Contracts - October 24, 1986, Vol. 15, No. 22; January 23, 1987, Vol. 16, No. 3; January 15, 1988, Vol. 17, No. 2; June 16, 1989, Vol. 18, No. 21; and August 24, 1990, Vol. 19, No. 31). Both policies must be considered when preparing research applicants/proposals for submission to ADAMHA/NIH. Applicants for grants/cooperative agreements and offerors for contracts should be aware that in attempting to include minority groups in a particular study, attention must be paid to research design and sample size issues. ADAMHA and NIH recognize that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. In all applications or proposals for clinical research, applicants must describe the anticipated race/ethnic composition of the study population. In conducting peer review for scientific and technical merit, members of Initial Review Groups (IRGs)/Technical Review Groups (TEGs) will be instructed to evaluate the appropriateness of the proposed minority composition: 1) If there is insufficient attention to inclusion of minorities in a study design AND this affects the potential to answer the scientific question(s) addressed, that will be considered a weakness or deficiency and must be reflected in the assigned score given to the application/proposal, and in the summary statement of the review. 2) However, if an applicant proposes that there is justification for conducting a study where there will be limited minority participation or inclusion of only one racial/ethnic group, a strong scientific rationale or other well-supported justification must be provided. The IRG/TEG will be instructed to evaluate the merit of such justifications. Appropriate justification will not adversely affect the assigned score. The ADAMHA/NIH will not fund/award such applications unless the justification is compelling. 3) For grant and cooperative agreement applications, if there is inadequate information on the study population to allow evaluation of the scientific question(s), the review will be deferred or the application returned. It is important to note that the ADAMHA/NIH funding components will not fund/award grants, cooperative agreement, or contracts that do not comply with this policy. $$N2 END *************************************************************** $$N3 BEGIN ************************************************************* REMINDER: REQUIREMENT FOR PROGRAMS ON THE RESPONSIBLE CONDUCT OF RESEARCH IN NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING PROGRAMS P.T. 44; K.W. 1014004, 1014006 National Institutes of Health Alcohol, Drug Abuse, and Mental Health Administration As stated in the NIH Guide for Grants and Contracts, Vol. 18, No. 45, December 22, 1989, administrative guidelines for the National Research Service Award (NRSA) institutional training grant applications submitted to the National Institutes of Health (NIH) and Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) have been revised "to require that a program in the principles of scientific integrity be an integral part of the proposed research training effort". This requirement applies to all competing training grant applications received after July 1, 1990. The principal goal of the NRSA grant mechanisms is to train scientists for future careers in biomedical and behavioral research. An important factor in biomedical and behavioral research is the need to maintain the highest levels of integrity in the conduct of research. The research training environment in the university setting provides a powerful context in which to promote responsible research practices. NIH and ADAMHA recognize that the scientific community is at an early stage of developing information and methods that pertain specifically to training in research ethics for trainees. Not all methods will work in all training situations given the heterogeneity among disciplines and professions. There are many models and paradigms. Appreciation of the heterogeneity among the biomedical and behavioral research components within the institutions calls for flexibility in approaches to effective education and training models. Institutions must accept primary responsibility and be allowed to develop their own ways of promoting responsible conduct of research in conjunction with their training programs. Scientific and administrative leaders of the university or from outside (as consultants or speakers) could be a visible part of this effort. Applicants are urged to discuss the development of methods on this important topic with their colleagues and also look to the professional associations for guidance as well as discussions with NIH and ADAMHA staff. An array of methods might be used at various training levels. It was stated in the NIH Guide for Grants and Contracts, December 22, 1989 notice: "Most universities and academic institutions have practices and procedures to ensure the responsible conduct of research. These may include informal seminars and presentations on conflict of interest, data recording and retention, professional standards and codes of conduct, responsible authorship, institutional policies and procedures for handling allegations of misconduct, policies regarding the use of human and animal subjects, etc. or formal courses on bioethics, research conduct, the ideals of science, etc." For the first 18 months of implementation of this requirement, it is expected that institutions will be given considerable flexibility in order to encourage innovation in the development of methods for providing training in scientific integrity. However, descriptions of formal or informal activities related to incorporation of efforts relevant to the responsible conduct of research (i.e., "the