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