From owner-sci-resources@net.bio.net Mon Feb 01 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 31 January 1993 Message-ID: Date: 2 Feb 93 06:41:08 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 66 ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 92-139 Academic Research Infrastructure Program File size (bytes): 35714 STIS Filename: nsf92139 Title: NSF 93-6 - EHR Activities for Women and Girls in Science, Engineering, and Mathematics File size (bytes): 66413 STIS Filename: nsf936 Document Type: Recruit Title: Director, Division of Research, Evaluation and Dissemination File size (bytes): 6908 STIS Filename: vep933 Title: Head, Office of Systemic Reform (OSR) File size (bytes): 6865 STIS Filename: vep934 ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vep934, the text of your message should be as follows: get vep934 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vep934, you would enter: ftp> get vep934 WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Wed Feb 03 22:00:00 1993 Path: biosci!NSF.GOV!parzberg From: parzberg@NSF.GOV (Peter Arzberger) Newsgroups: bionet.sci-resources Subject: nsf9310 - NSF 93-10 GRAND CHALLENGE APPLICATIONS GROUPS (fwd) Message-ID: Date: 4 Feb 93 02:58:16 GMT Sender: kristoff@net.bio.net Reply-To: Peter Arzberger Distribution: bionet Lines: 351 Title : NSF 93-10 GRAND CHALLENGE APPLICATIONS GROUPS Type : Program Guideline NSF Org: CISE / ASC Date : February 3, 1993 File : nsf9310 GRAND CHALLENGE APPLICATIONS GROUPS Fiscal Year 1993 Program Announcement a component of the U.S. High Performance Computing and Communications Program NATIONAL SCIENCE FOUNDATION The National Science Foundation (NSF) announces opportunities for group oriented research for Fiscal Year 1993 in connection with the U.S. High Performance Computing and Communications (HPCC) Program. Six to eight proposals are expected to receive funding as Grand Challenge Application Groups as a result of the opportunities described in this announcement. Seven awards were made under this activity in Fiscal Year 1992. Activities supported under this announcement are expected to achieve significant progress on (1) fundamental problems in science and engineering whose solution could be advanced by applying high performance computing techniques and resources, and (2) enabling technologies which facilitate those advances. In addition, it is anticipated that these activities will generate significant new research in mathematics, computer science, engineering and other scientific disciplines. This HPCC activity will provide funding for multidisciplinary groups of scientists, engineers, mathematicians and computer scientists to apply emerging high performance computing and communications systems to advance the solution of diverse science and engineering problems. The emphasis will be on support for groups requiring HPCC capabilities, where such focused, cross disciplinary support is generally unavailable or difficult to obtain. Any area of science and engineering supported by NSF is eligible for funding under this solicitation. Grand Challenge Applications Groups are expected to employ testbed systems exploiting new and emerging computer and communications architectures to prepare the groundwork for the HPCC goal of sustained teraflop computing on important application problems by the mid 1990's. Projects funded through this effort will focus on the fusion of disciplinary research with emerging high performance computing environments and architectures, within the framework of the HPCC program goals. It is anticipated that projects will include aspects of design of models, algorithms and software, as well as problem solving environments, to fully realize the potential of parallel, distributed and heterogeneous computing systems on Grand Challenge Application problems and enabling technologies. These opportunities for support have been created through the cooperation of disciplinary sub-activities within NSF and other federal agencies participating in the HPCC program. This Federal interagency HPCC program seeks to expand U.S. technological leadership, speed the pace of innovation, and spur gains in U.S. productivity and competitiveness through advances in high performance computing and communications. The program responds to the opportunities for advances inherent in the use of advanced computer models incorporating the basic science of parallel processing and the improved productivity derived by the interaction of people who are spatially separated sharing networked access to information processing and computing resources. Additional information on NSF HPCC activities in conjunction with the interagency HPCC effort can be obtained from the NSF HPCC Coordinators listed as contacts in this document. Supported Activities Proposers are encouraged to provide innovative, collaborative approaches to formulating solutions to Grand Challenge problems. Among the activities that are appropriate for support include: research time for individual investigators, postdoctoral researchers, graduate students, HPCC equipment, testbed development, access to high performance computing systems, networking and communications, supplemental HPCC educational activities, and salary for technical support personnel. Criteria for Review All proposals to NSF are subject to the review criteria described in the NSF brochure, Grants for Research and Education in Science and Engineering (GRESE), NSF 92-89. Single copies of this brochure are available at no cost from the NSF Forms and Publications Unit, (202) 357-7861, or via e-mail (Bitnet: pubs@nsf or Internet: pubs@note.nsf.gov). The review criteria in GRESE deal with: quality of scientific effort proposed; competence of investigators; relevance of research; and impact on infrastructure. Proposals for Grand Challenge Applications Groups will also be subject to specific criteria that reflect the objectives of the interagency HPCC program: potential for impact in a critical area of science and engineering; creating significant interaction between focused scientific and engineering applications and computational activities that has broad implications in high performance computational activities beyond the specific scientific or engineering problem area or discipline being studied; development of new computational techniques for high performance systems with potential benefit for the broader scientific community; record of accomplishment and potential for advancing frontiers of high performance parallel, distributed or heterogeneous computing environments; extent to which the research proposed provides a testbed for the deployment of new high performance computing and communications systems; educational activities to increase the research participation and training of students and researchers. Reviewers will also consider the extent of involvement of women and minorities at all levels of the groups; innovative partnerships with national laboratories and private industry; and institutional participation and budgetary levels. Proposal Submission, Review and Award Processes Review of proposals will be coordinated across the Foundation, across all programs related to the proposed project. Proposals reviewed under this solicitation that overlap other inter-agency or NSF initiatives such as Global Change or Advanced Materials and Processing, will be referred to these activities for joint consideration. A combination of mail, panel, and site visit review may be used as needed. Awards are planned to be jointly funded between the programs involved, and coordinated among Federal inter-agency HPCC programs. Awards are planned to be in the range of $300,000 to $800,000 per year for a period of three to five years, but there are no firm restrictions on size or duration. The number and size of awards will be based on the quality and potential impact of the proposals reviewed, and the availability of funds. Preproposals Preproposals will be used to facilitate planning by NSF and to minimize work on potential proposals that are inappropriate or less likely to be competitive. Proposers interested in submitting a formal proposal must submit 12 copies of a preproposal by March 15, 1993 to: HPCC/GCAG Coordinator NSF, Room 417 1800 G Street, N.W. Washington D.C. 20550 The preproposal must contain the following information in the order indicated: 1 Page Title of group activity List of PI and Co-PI's with departmental and institutional affiliations Mailing and e-mail addresses, phone and FAX numbers, of PI only Abstract 3-4 Pages Outline of project plan Evidence of multidisciplinary interactions 1 Page Estimated first year budget (not binding on final proposal) 1 Page List of individuals with whom the PI or Co-PI's have had a close working relationship in the last 48 months Following Biographical sketch as per GRESE with a limitation Pages of 2 pages per PI and Co-PI's Since preproposals are not formal proposals, participant or institutional agreements are not necessary at this stage. Preproposals will be reviewed by a panel. The outcome of this review process will determine which groups will be encouraged to submit formal proposals. Groups not receiving encouragement are not prohibited from formally applying. It is anticipated that the results from the preproposal review will be announced during the first week of May. Final Proposal Deadline The deadline for receipt of proposals is June 16, 1993. Fifteen copies of final proposals, including one copy bearing original signatures and institutional approval, must be mailed to: HPCC/GCAG Coordinator NSF, Room 417 1800 G Street, N.W. Washington D.C. 20550 Only one copy of NSF Form 1225, Information about Principal Investigator/Project Director should be sent attached to the original signed copy. Proposals must be: i) received by NSF no later than June 16, 1993; ii) postmarked no later than five (5) days prior to the deadline date; or iii) sent via commercial overnight mail no later than two (2) days prior to the deadline date to be considered for an award. Proposals submitted in response to this announcement must be prepared and submitted in accordance with the guidelines provided in the NSF brochure, GRESE (92-89). However, the following are exceptions to the guidelines and specific to this activity only: the project description is limited to 15 pages (single spaced); each PI and Co-PI may use up to an additional 2 pages each to describe results under prior NSF support, focusing on those results relevant to the proposed project. Except for the above, proposals not conforming to these guidelines will be returned to the proposer. The review process will be concluded by mid-summer 1993, with announcement planned for September 1993. Inquiries For details on the U.S. High Performance Computing and Communications Program see the OSTP FCCSET report by the Committee on Physical, Mathematical, and Engineering Sciences entitled "Grand Challenges 1993: High Performance Computing and Communications." Copies can be obtained from the Directorate for Computer and Information Science and Engineering, NSF, 1800 G Street, NW, Room 306, Washington DC 20550. Inquiries relative to this announcement should be addressed via electronic mail to: hpccgrps@nsf.gov (Internet) or hpccgrps@nsf (Bitnet). Written inquiries may be made to HPCC/GCAG Coordinator NSF, Room 417 1800 G Street, N.W. Washington D.C. 20550 Related Computational Science and Engineering Activities The HPCC program at NSF is coordinated across all disciplinary research directorates to encourage joint review and support of proposals with ongoing computational science and engineering programs. All NSF disciplines continue to support base activities in computational science and engineering research within their disciplinary research programs in addition to their involvement with this Grand Challenge Applications Group activity. The Grand Challenge Applications Groups represent one, but not the only approach to support HPCC activities. CONTACT PERSONS AND RELATED ACTIVITIES General information on the HPCC program may be obtained from the NSF coordinator; particulars on a specific directorate's involvement from the relevant directorate level coordinator; and advice on specific projects from the appropriate disciplinary program manager. The NSF directorates are: BIO (Biological Sciences), CISE (Computer & Information Science & Engineering), EHR (Education and Human Resources), ENG (Engineering), GEO (Geosciences), MPS (Mathematical and Physical Sciences), and SBE (Social, Behavioral and Economic Sciences) NSF HPCC Coordinator: Merrell Patrick, (202) 357-7936, mpatrick@nsf BIO HPCC Coordinator: Peter Arzberger, (202) 357-7652, parzberg@nsf CISE HPCC Coordinator: Susan Gerhart, (202) 357-9747,sgerhart@nsf EHR HPCC Coordinator: Nora Sabelli, (202) 357-7751,nsabelli@nsf ENG HPCC Coordinator: Lawrence Goldberg, (202) 357-9618,lgoldber@nsf GEO HPCC Coordinator: Clifford Jacobs, (202) 357-9889, cjacobs@nsf MPS HPCC Coordinator: Robert Eisenstein, (202) 357-7985, reisenst@nsf SBE HPCC Coordinator: Paul Chapin, (202) 357-7696, pchapin@nsf Selected Computational Science and Engineering Activities Computational Biology, BIO: Peter Arzberger, (202) 357-7652, parzberg@nsf Computational Chemistry, MPS: Richard Hilderbrandt, (202) 357-7951, rhilderb@nsf Computational Engineering, ENG: George Lea, (202) 357-9618, glea@nsf Computational Materials, MPS: G. Bruce Taggart, (202) 357-9789, gtaggart@nsf Computational Mathematics, MPS: Alvin Thaler, (202) 357-3691, thaler@nsf Michael Steuerwalt, (202) 357-3691, msteuerw@nsf Computational Physics, MPS: Richard Isaacson, (202) 357-3464, isaacson@nsf Information, Robotics & Intelligent Systems, CISE: Y.T. Chien, (202) 357-9572, ytchien@nsf New Technologies, CISE: Robert Voigt, (202) 357-7727, rvoigt@nsf Numeric, Symbolic and Geometric Computation, CISE: Kamal Abdali, (202)357-7345, kabdali@nsf Theory of Computing, CISE: Dana Richards, (202) 357-7345, richards@nsf Computational Neuroscience, BIO: Donald Edwards, (202) 357-7040, dedwards@nsf The National Science Foundation (NSF) provides awards for research in the sciences and engineering. The awardee is wholly responsible for the conduct of such research and preparation of the results for publication. The Foundation, therefore, does not assume responsibility for such findings and their interpretation. The Foundation welcomes proposals on behalf of all qualified scientists and engineers, and strongly encourages women, minorities and persons with disabilities to compete fully in any of the the research and research-related programs described in this document. In accordance with Federal statutes and regulations and NSF policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, denied the benefits of, or be subject to discrimination under, any program or activity receiving financial assistance from the National Science Foundation. Facilitation Awards for Handicapped Scientists and Engineers provide funding for special assistance or equipment to enable persons with disabilities (investigators and other staff, including student research assistants) to work on an NSF project. See program announcement NSF 91-54, or contact the Facilitation Awards Coordinator, Directorate for Education and Human Resources, Washington, DC 20550, (202) 357-7461. The Foundation has TDD (Telephonic Device for the Deaf) capability, which enables individuals with hearing impairment to communicate with the Division of Personnel and Management about NSF programs, employment, or general information. The telephone number is (202) 357-7492. (202) 357-7492 This program is described in the Catalog of Federal Domestic Assistance category 47.070, Computer and Information Science and Engineering. Electronic Dissemination You can get information fast through STIS (Science and Technology Information System), NSF's online publishing system, described in NSF 91-10 (Revised 10/4/91) the "STIS flyer" (elsewhere in this publication). To get more copies of the flyer, call the NSF Publications Section at (202) 357-7861. For an electronic copy, send an e-mail message to stisfly@nsf.gov (Internet) or stisfly@nsf (Bitnet). Ordering by Electronic Mail If you are a user of electronic mail and have access to either Bitnet or Internet, you may order publications electronically. Bitnet users should address requests to pubs@nsf. Internet users should send requests to pubs@nsf.gov. In your request, include the NSF publication number and title, number of copies, your name, and a complete mailing address. Publications will be mailed with 2 days of receipt of request. NSF 93-10 OMB 3145-0058 P.T. 34 K.W. 1004000 From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 3, 5 February 1993 Message-ID: Date: 6 Feb 93 00:58:11 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1240 $$XID NIHGUIDE 19930205 V22N05 P3O3 ************************************ On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement (Surgical Management of the Epilepsy) in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies of it to the Division of Research Grants. If the application is for a program project or center grant, please send the original and three copies to the Division of Research Grants. An additional two copies of the program project or center grant application sent to the address below would be useful for expediting the processing of these applications for multidisciplinary efforts. REVIEW CONSIDERATIONS Research project grant (R01) applications and FIRST award (R29) applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant (P01) and center grant (P50) applications will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate national advisory council. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review, o availability of funds, and o program balance among research areas. INQUIRIES Questions concerning scientific aspects may be addressed to: Charlotte B. McCutchen, M.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 114 Bethesda, MD 20892 Telephone: (301) 496-1917 FAX: (301) 496-9916 Questions concerning fiscal aspects may be addressed to: Patricia Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, Number 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. $$P5 END ************************************************************ $$P6 BEGIN PA-93-51 ************************************************* RESEARCH GRANTS RELATED TO NARCOLEPSY NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-51 P.T. 34; K.W. 0715187, 0755030 National Institute of Neurological Disorders and Stroke National Institute of Mental Health PURPOSE The Division of Convulsive, Developmental, and Neuromuscular Disorders; National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) are revising and reissuing a NINDS program announcement on narcolepsy published in the NIH Guide to Grants and Contracts, Vol. 19, No. 15, April 13, 1990, to notify the scientific community of continuing NINDS/NIMH interest in the submission of research project grant applications related to narcolepsy. 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 priorities. This program announcement is related to the priority area of narcolepsy. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-0) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are eligible for research project grants (R01) only. Applications from minority institutions, minority individuals, and women are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the investigator-initiated research project grant (R01), the First Independent Research Support and Transition (FIRST) award (R29), the program project grant (P01), and the center grant (P50). As consistent with the aforementioned mechanisms, the Principal Investigator or program director, as well as any participating investigators, will plan, direct, and perform the research. Applicants for program project grants should contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH OBJECTIVES Background Narcolepsy is a neurological condition characterized by irresistible episodes of sleep. The classic symptoms of narcolepsy are: (1) sleep attacks - sudden urges to sleep; (2) cataplexy - sudden generalized or partial flaccid paralysis; (3) hypnagogic hallucinations - sleep onset hallucinations; and (4) sleep paralysis - generalized paralysis before or at the time of falling asleep or on awakening. Narcolepsy has its typical onset in adolescence and young adulthood. There is an average 15-year delay between onset and correct diagnosis, that may contribute substantially to the disabling features of the disorder. Cognitive, educational, occupational, and psychosocial problems associated with the excessive daytime sleepiness of narcolepsy have been documented. For these to occur in the crucial teen years when education, development of self-image, and development of occupational choice are taking place is especially damaging. While cognitive impairment does occur, it may only be a reflection of the excessive daytime somnolence. The prevalence of narcolepsy in the United States has been estimated to be as high as one per 1,000. It is a major reason for patient visits to sleep disorder centers, and with its onset in adolescence, it is also a major cause of learning difficulty and absenteeism from school. Normal teenagers often already experience excessive daytime sleepiness because of a maturational increase in physiological sleep tendency accentuated by multiple educational and social pressures; this may be disabling with the addition of narcolepsy symptoms in susceptible teenagers. In clinical practice, the differentiation between narcolepsy and other conditions characterized by excessive somnolence may be difficult. Treatment options are currently limited. There is a paucity in the literature of controlled double-blind studies of possible effective drugs or other forms of therapy. Mechanisms of action of some of the few available therapeutic agents have been explored but detailed studies of mechanisms of action are needed before new classes of therapeutic agents can be developed. The neural control of normal sleep states and the relationship to narcolepsy are only partially understood. In humans, narcoleptic sleep is characterized by a tendency to go abruptly from a waking state to rapid eye movement (REM) sleep with little or no intervening non-REM sleep. The changes in the motor and proprioceptive systems during REM sleep have been studied in both human and animal models. During normal REM sleep, spinal and brainstem alpha motor neuron hypopolarization produces almost complete atonia of skeletal muscles via an inhibitory descending reticulospinal pathway. Acetylcholine may be one of the neurotransmitters involved in this pathway. In narcolepsy, the reflex inhibition of the motor system seen in cataplexy is believed identical to that seen in normal REM sleep. Despite the experimental evidence in human narcolepsy that there may be an inherited basis for at least some forms of narcolepsy, the mode of inheritance remains unknown. Research Goals and Scope The goal of this announcement is to stimulate research in both basic and clinical aspects of narcolepsy. The scope of this program encompasses both animal and human studies, that would utilize a variety of experimental approaches and methods. If experimental studies on human subjects are proposed, the protocols should contain recruitment procedures to encourage the participation of women and minorities. Examples of areas of potential research include studies on the pathophysiology of narcolepsy; abnormalities of circadian rhythms, particularly anatomical and biochemical substrates; the molecular genetics of narcolepsy; and the development of new therapies. New, more sensitive, and specific objective diagnostic procedures need to be developed and validated. While studies in the naturally occurring narcoleptic dog model suggest an autosomal recessive mode of transmission in that model, genetic analysis of cohorts of narcoleptic patients and identification of informative families are needed to define the mode of inheritance and to facilitate the search for gene markers. STUDY POPULATIONS POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention strategies), diagnosis, or treatment of diseases, disorders, or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded; however, every effort should be made to include human tissues from women and racial or ethnic minorities when it is important to apply the results of the study broadly. This directive should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully. Since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. If the required information is not contained within the application, the review will be deferred until the information is provided. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the institutional office of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Applicants for program project grants (P01) should request, from the address below, a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. 6/92). Receipt dates for new research project grant (R01) applications and FIRST (R29) awards and for program project (P01) and center grant (P50) applications are February 1, June 1, and October 1. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and the name of this Program Announcement (Narcolepsy) in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies of it to the Division of Research Grants. REVIEW CONSIDERATIONS Research project grant (R01) applications and FIRST award (R29) applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Program project grant (P01) and center grant (P50) applications will be reviewed according to the practice of the Institute to which the application is assigned. The second level of review will be by the appropriate national advisory council. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions quality of the proposed projects as determined by peer review, availability of funds, and program balance among research areas. INQUIRIES Questions concerning neurological/neuroscientific aspects of this Program Announcement may be addressed to: Charlotte B. McCutchen, M.D. Division of Convulsive, Developmental, and Neuromuscular Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 114 Bethesda, MD 20892 Telephone: (301) 496-6701 FAX: (301) 402-0302 Questions concerning psychiatric aspects of the Program Announcement may be addressed to: Susan Blumenthal, M.D. Basic Prevention and Behavioral Medical Research Branch National Institute of Mental Health Parklawn Building, Room 11C06 Rockville, MD 20857 Telephone: (301) 443-4337 FAX: (301) 443-4822 Questions concerning fiscal aspects of this Program Announcement may be addressed to: Patricia Driscoll Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance, Number 93.853, Clinical Research Related to Neurological Disorders, and 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. $$P6 END ************************************************************ $$XID RFA PA9347 PA-93-47 P1O1 ***************************************** PREVENTING ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-47 P.T. 34, FF; K.W. 0404003, 0414014, 0411005 National Institute on Alcohol Abuse and Alcoholism PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites researchers to submit research grant applications related to the prevention of alcohol-related problems among ethnic minority groups of African Americans, Americans, Asian Americans, and Pacific Islanders. Most of these groups are at elevated risk for specific alcohol problems or may have changing patterns of increased alcohol consumption. All of these minority groups require the development and evaluation of culturally relevant programs of alcohol abuse prevention. NIAAA promotes innovative prevention research within a broad range of populations and is particularly interested in receiving methodologically sound and conceptually grounded outcome-oriented research applications. The primary objective of this program announcement is to expand the limited information available about the prevention of alcohol-related problems among ethnic minorities . While differential rates of alcohol problems have been well documented within minority communities, the link between ethnic identity and successful alcohol abuse prevention interventions has not. Research proposed within the domain of this program announcement should address factors that facilitate or impede the development, implementation, and evaluation of prevention strategies among diverse sociocultural populations. Attention should be focused on (1) the culturally-appropriate development or adaptation of interventions within these minority settings and (2) how ethnic minority identity relates to prevention research outcomes. In general, the impact of ethnicity on alcohol use and prevention of its abuse should be studied within a particular context, such as, alcohol availability control, server training, price increases, media messages, or psychosocial antecedents of high-risk behavior. 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, Preventing Alcohol-Related Problems Among Ethnic Minorities, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign public and private non-profit and for-profit organizations, such as, universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01), small grant (R03), or FIRST award (R29). Applicants for R01s may request support for up to five years. The average direct cost per year for R01s is approximately $220,000. Small Grants are limited to two years for up to $50,000 per year for direct costs. FIRST award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST awards and small grants cannot be renewed, but grantees may apply for R01 support to continue research on the same topics. Annual continuation awards will be made subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES Background Information on Alcohol-Related Problems and Use Among Ethnic Minorities In the United States, alcohol use is involved in nearly 100,000 deaths annually, including approximately one-half of the nearly 45,000 fatalities in traffic crashes; 27,000 deaths due to cirrhosis of the liver; and a high proportion of the deaths due to homicide, suicide, drowning, falls, burns, and other accidents. Alcohol abuse results in alcohol-related injuries and violence, marital discord, job loss, and serious medical consequences including birth defects. Alcohol-related problems and costs are unevenly distributed across racial and ethnic groups this uneven distribution may be related to cultural differences in drinking patterns. Surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among African Americans, Hispanic Americans, and Native Americans. In contrast, Asian Americans and Pacific Islanders have been found to have lower levels of alcohol use. However, recent evidence indicates that consumption may be increasing among these two groups. African Americans Alcohol-related Problems: African Americans comprise the largest ethnic minority in the United States, accounting for 12 percent of the total population. Results of a 1983 national study of drinking problems and patterns found that African Americans, especially males, are at high risk for acute and chronic alcohol-related diseases; such as, cirrhosis, alcoholic fatty liver, hepatitis, heart disease, and cancers of the mouth, larynx, tongue, esophagus, and lung. High rates of problem drinking and alcoholism in high-density, urban African American communities have been associated with assaults, homicides, accidents, trouble with the law, and family problems. Several studies have concluded that African Americans are at greater risk of accidents due to drinking than Caucasians. Patterns of Consumption: While overall rates of alcohol consumption are similar for African American males and Caucasian males, the two groups differ with respect to the age distribution of drinking and related problems. Among Caucasian males, frequent heavy drinking is most prevalent between 18 and 29 years of age; among African American males in that age group, heavy drinking is less frequent. Between 30 and 39, the rates of heavy consumption continue to be high for Caucasian males; however those of African American males rise sharply, surpassing those of Caucasians. Rates of heavy consumption gradually decrease for men of both races after 40. Racial differences in consumption patterns are even more pronounced among women, but in the opposite direction: i.e., African American women tend to drink less. Nearly half of African American women were found to be abstainers, compared with one-third of Caucasian women. A smaller proportion of African American women than Caucasian women are heavy drinkers. African American women in the 18-29 age group are significantly less likely to drink at all or to drink heavily than are Caucasian women. Prevention Research: An intensive search of the prevention research literature identified a number of primary and secondary prevention efforts focused on alcohol-related problems in the African American population of the United States, but none reported a systematic evaluation of program effects. Among the 130 demonstration projects initiated by the Office for Substance Abuse Prevention (OSAP) in 1987, 24 focus on African American high-risk youth and their families. Comparisons between the different minority-based demonstration projects have not been extensively reported. Studies of African Americans might focus fruitfully on men who are moderate drinkers, since African Americans are experiencing higher rates of alcohol-related problems than Caucasians with similar levels of consumption, for reasons that are not clearly understood. The increase in heavy drinking and alcohol-related problems among African Americans and Hispanics during their 30s suggests the need for interventions with this age group. Hispanic Americans Alcohol-related Problems: The growing Hispanic population consists of several distinct groups (Mexican Americans, Puerto Ricans, Cuban Americans, and persons from other countries of Central America, South America, and the Caribbean). These groups now comprise nine percent of the U.S. population. Hispanic males suffer disproportionately from alcohol dependence and problems related to alcohol abuse compared with African American and Caucasian males in the United States. Several studies suggest that Mexican American men drink more and are more likely to have alcohol-related problems than men in other major Hispanic subgroups. In contrast, Hispanic women are at lower risk for alcohol dependency and alcohol-related problems than are Caucasian women in the U.S. population. Nevertheless, the proportion who drink and have alcohol problems has been rising among second and third generation Hispanic women, as has the proportion experiencing related family problems. Patterns of Consumption: Several epidemiological studies have found that alcohol-use patterns among Hispanics differ somewhat from Caucasians. Specifically, Hispanic males drink less frequently but consume larger amounts, have more instances of very heavy or binge drinking, and have more instances of alcohol-related problems that continue throughout adulthood than Caucasian males. Hispanic females abstain or drink infrequently, usually in a family context. Consumption rates among Mexican American females are somewhat higher than those of females in other Hispanic groups. Hispanic drinking patterns are related to degree of acculturation, although the relationship differs by gender and nationality group. Male immigrants appear to quickly adopt a drinking pattern that blends the high frequency characteristic of U.S. male drinking with the Hispanic high quantity-per-occasion practice. Among Hispanic females, acculturation is associated with increases in both the proportion of women who drink and the amount they consume. In contrast to the men, however, this change in drinking patterns usually occurs in the first generation born in the United States rather than in the immigrant generation. Prevention Research: A comprehensive review of alcohol prevention programs targeted at Hispanic populations found that only one of these (the Ganadores "Winners" project) was systematically evaluated. The interventions implemented in that program included mass media messages and community-based activities designed to increase awareness of the dangers of alcohol and to change attitudes toward alcohol use and drinking behavior. The community activities included dissemination of educational materials and oral presentations by community leaders designed to make people think more about their own drinking. The program resulted in an increase in reported awareness and knowledge of the dangers of alcohol, but it did not change drinking behavior. Nine other current projects aimed at alcohol prevention among Mexican Americans have been recently described but have not been evaluated. Several aspects of the Mexican American culture may have implications for alcohol abuse prevention strategies and research. For example, cultural values may affect the identification of heavy drinking and the recognition of alcohol abuse as a health problem. There is a need to address the role of cultural values as contributors to (and potential moderators of) problematic drinking practices. In addition, interventions designed to increase awareness of the seriousness of alcohol problems should be tested. Where appropriate, research on alcohol use and abuse by Hispanics should also examine changes in immigrants' attitudes toward drinking. Native Americans Alcohol-related Problems: The Native American population consists of approximately two millon people and over 300 distinct tribal and ethnic groupings within the continental United States and Alaska. It is a young, diverse, rapidly growing population living in urban, rural, and reservation settings. Data for 1978-1980 and 1983-1985, indicate that alcohol abuse is a contributing factor in 4 of the 10 leading causes of death for Native Americans: accidents, chronic liver disease and cirrhosis, homicide, and suicide. Accidents are still among the leading causes of death for Native Americans. An estimated seventy five percent of all traumatic deaths and suicides among Native Americans are alcohol-related. Deaths from alcohol-related causes are particularly prevalent in the 25 to 44 age group. Many tribes, particularly in the West, have dramatically higher accident mortality rates than the national average. Fatal accidents among Native Americans are 2.2 to 2.3 times the national average. Patterns of Consumption: Alcohol use varies tremendously from tribe to tribe. Some tribes have a smaller proportion of drinking adults than the U.S. population, while others have more drinkers. Differences in drinking patterns may also relate to reservation and urban settings. The majority of Native American youth report experimentation with alcohol. Drinking among Native American youth is especially serious since mortality from alcohol-related causes is most common in younger years. Heavy recreational and binge drinking may account for unusually high rates of alcohol-related arrests and accidental deaths among young Native American males. In general, Native American women drink considerably less than men, but the prevalence of drinking among women is growing rapidly in some tribes, which may help account for the increase in the reported incidence of Fetal Alcohol Syndrome (FAS). Prevention Research: Most primary prevention programs aimed at Native Americans in recent years have been school-based, youth-oriented programs emphasizing information about the effects and consequences of alcohol and other substance abuse. Their specific effectiveness is largely unknown, as is the effectiveness of school-based programs in general. Several programs designed to provide youth with coping skills, however, have reliably documented systematic research efforts. For example, a modest success was reported for a bicultural skills-enhancement program delivered in reservation and non-reservation settings in the Pacific Northwest. At a six-month follow-up, the test group had better knowledge of drug effects, better interpersonal skills for managing pressures to use alcohol and other drugs, and lower rates of alcohol, marijuana, and inhalant use than the control group. Native American communities also have instituted community-wide prevention programs using local resources and Federal Government funds. A 1986-1987 survey of community programs funded by the Indian Health Service (IHS) identified a total of 312 communities involved in community-based alcohol/substance abuse prevention and intervention programs. These programs provided a variety of services, including alcohol and drug education activities designed to build self-esteem and coping skills, improve decision-making skills, and promote family bonding and enrichment. However, no systematic evaluation of the effects of these programs was reported in the presentation of survey results. In 1983, the IHS introduced a program to prevent FAS by providing Native American communities throughout the country with the knowledge, skills, and strategies to initiate prevention measures on their own. The chief element of the program was the training of cadres of trainers/advocates in all local communities served by the IHS to impart FAS information to a variety of audiences. Evaluation results showed a significant gain in knowledge and retention over an extended period of time by the target populations. Asian Americans and Pacific Islanders Alcohol-related Problems: The 7.3 million Asian Americans and Pacific Islanders now comprise 2.9 percent of the U.S. population. In the past decade, the size of the Asian/Pacific population has more than doubled, and its diversity has greatly expanded. Currently available data describe low rates of alcohol-related problems among Asian/Pacific Americans, even among those identified as heavy drinkers. This finding has been attributed to ethnic differences in physiological reactions (i.e., the "flushing response") as well as sociocultural and environmental factors. Among the cultural factors contributing to low rates of alcoholism are norms that permit drinking, particularly at social functions, but that discourage drinking to excess, and tight family and community regulation of alcohol use. These factors have been combined into a "reciprocity model" explaining the alcohol consumption of Asians. It has been suggested that the growing numbers and heterogeneity of Asian immigrants, as well as the progressive assimilation of Asian Americans into American value systems, will lead to increases in drinking problems among recent Asian immigrants. Patterns of Consumption: Studies consistently suggest that Asian Americans use and abuse alcohol less frequently than non-Asian individuals. In one study examining differences in alcohol consumption among residents of Hawaii, researchers found that Native Hawaiians and Caucasians reported higher levels of alcohol use than Chinese Americans, Japanese Americans, and Filipino Americans. In several studies focusing on drinking patterns among Asians in the United States, however, the view of Asian/Pacific Americans as non-drinkers was questioned. In an examination of Chinese, Japanese, Korean, and Filipinos in Los Angeles, variations in drinking patterns by ethnicity as well as by age and sex were found. These data suggest that Asian Americans display diverse drinking styles, including a relatively high proportion of heavy drinkers among Japanese and Filipino men. The same study found that those Asian/Pacific Americans most likely to drink are men under the age of 45 who have higher social status. Their attitudes toward alcohol use were permissive and their friends tolerant of drinking. Prevention Research: Low rates of alcohol-related problems have contributed to the paucity of prevention research targeted at the various Asian/Pacific subpopulations. Six of the ongoing Center for Substance Abuse Prevention demonstration projects, however, are targeted at Asian/Pacific youth and community groups. Areas of research interest Despite the relatively large number of findings describing broad ethnic differences in drinking behaviors and alcohol-related problems, the nature of the linkage between ethnic identity and alcohol use or abuse has not been established. There are few theoretical paradigms to guide research into these variations. However, there is a need to understand the relationships in order to increase the potential effectiveness of prevention strategies within communities. The paucity of rigorous research on the prevention of alcohol-related problems indicates a need for a variety of prevention and pre-prevention studies directed specifically to these populations. Environmental Prevention Strategies A systematic program of research that investigates the effectiveness of environmental prevention strategies in minority settings is needed to explore interventions that are designed to change the incentives, opportunities, risks, and expectations that surround drinking. This includes examinations of the impact on African American, Hispanic, Native American, Pacific Islanders, and Asian communities (or high-risk groups within them) of national, State, or community-wide policies designed to control alcohol availability and reduce demand for such products. Policy changes might be expected to have diverse effects on minority ethnic populations because of differences in sociocultural patterns of drinking, as well as differences in the manner in which such policies are viewed in different communities and the ways they are enforced. Availability Control: Strategies that might be tested in ethnic minority contexts that attempt to control the physical, social, and economic availability of alcoholic beverages include: (1) strengthening and/or enforcing alcohol beverage control (ABC) laws regulating the hours of operation and the location and number of outlets for sales of alcoholic beverages; (2) enhancing enforcement of minimum drinking age laws; (3) implementing server training programs; and (4) raising taxes on alcoholic beverages. Examination of Media Messages: It is widely believed that the mass media have an important impact on perceptions, attitudes, and beliefs regarding alcohol although research evidence is equivocal. There has been increasing concern in the past decade about whether the alcohol industry has tailored advertising to specific ethnic communities. This suggests the need to explore the effects of focused advertising on the definitions of appropriate drinking behaviors specific to minority subcultures and to age, sex, and socioeconomic subpopulations within ethnic groups. Research is needed on reactions of ethnic groups to public service messages and fictional television and radio programming related to alcohol. Who are the most credible communicators within various ethnic groups--and which media channels (print, television, radio) have the most impact? Institutions: Within ethnic communities, institutions such as churches, business groups, schools, and local political bodies may play important roles in addressing alcohol problems. Little is known about whether and in what ways such influence is exerted in ethnic communities to address alcohol problems. To what extent have institutions such as the beverage and hospitality industries contributed to or deterred prevention efforts through; for example, server training programs or the sponsorship of cultural and athletic events? To what extent have organizations such as Mothers Against Drunk Driving (MADD) gained support in implementing prevention programs in minority communities? Server Training: Those who are responsible for serving alcohol have the opportunity to influence individuals' drinking. Recently, server training programs have been implemented to teach those who serve alcohol in bars and restaurants how to moderate patrons' drinking. The few studies to date suggest that such programs have been effective in reducing the rate and amount of consumption by patrons and the probability of patron intoxication. There is a need to test these findings among minority populations. Price Increases: Econometric studies have suggested that an increase in the prices of alcoholic beverages would result in decreases in consumption, alcohol-involved automobile crashes, and rates of cirrhosis mortality. Projections based on these studies have indicated that a tax on beer amounting to 35 percent of the retail price would halve the number of alcohol-related fatalities among 16-to 20-year-old drivers. Research is needed to determine whether these relationships and projections also apply to various ethnic minority groups. Prevention Strategies Focusing on the Individual Prevention efforts targeted at individuals, distinct from those that target changes in the environment, have attempted to change consumption practices by increasing individual knowledge of alcohol effects and by altering attitudes about the use of alcohol. These efforts usually involve the use of media campaigns and school-based instructional programs. Such programs have sometimes produced desired changes in knowledge and attitudes, but have not been able to document long-term behavior changes. School-based programs that teach youth peer pressure resistance and social competence skills for avoiding the use of alcohol and other drugs show promise but have only demonstrated moderate or short-lived effects. Even this conditional effectiveness, however, has not been established for ethnic minority students and calls for further research. The study of how ethnicity affects individual differences in drinking behavior may involve the statistical modeling of personality variables, alcohol use patterns, and prediction of prevention outcomes. In general, the most effective studies of these interrelationships are longitudinal and may monitor a wide range of variables, including income level, availability of alcohol, peer and adult influences, intention to drink, and other identified risk factors (low academic achievement, lack of prohibitions, early alcohol use, low self-esteem, psychopathology, poor family relations, lack of socialization, other drug use, etc.). These constructs allow for a more precise examination of the relationship between ethnicity and effective prevention outcomes. Identifying High-Risk Groups: Within each ethnic minority, it is important to target some intervention efforts at youth and pregnant women. This may call for creative techniques for identifying and engaging these groups in interventions. For example, since school-based programs are the most popular form of intervention, additional strategies may need to be developed to reach students who have dropped out of school. The usefulness of brief questionnaires in targeting high-risk individuals within these populations should be evaluated. Programs to prevent Fetal Alcohol Syndrome might seek to identify individuals who would participate in a support network to facilitate abstinence during pregnancy. Such a network could include peer counseling, family involvement, and community-wide interventions (i.e., a comprehensive, multiple system strategy). Identifying Protective Factors: Research on alcohol-related problems tends to focus on identifying stressful events and other factors that place individuals at high risk. A promising alternative approach is to explore coping resources and protective factors that have reduced alcohol problems among minority individuals, particularly those exposed to "high-risk" environments. Protective factors may function both at the individual level--by influencing personal decisions about engaging in risk-taking behavior--and at the social level--through the perception of social support from friends and family and through family characteristics. Strategies for Program Development One possible research strategy involves taking interventions from programs that have been successfully tested in the general community and adapting those interventions for use with ethnic minorities. Programs using the social influence model that have shown positive outcomes might be adapted for implementation with one or more ethnic minority groups (such as the Midwestern Prevention Project is attempting to do). Another possible research approach is systematic testing of prevention programs that appear to have been successfully implemented within ethnic communities but were tested on only a limited scale and/or not systematically evaluated at all. Examples of these include the community-based programs implemented by the Indian Health Service and various demonstration programs that employ social learning models and are targeted at high-risk youth. Similarly, it may be useful to design strategies for increasing awareness of health-related alcohol problems and understanding of the relationship between cultural attitudes and the social/physical environment and alcohol abuse. It may be necessary to determine how the target groups define "excessive" or "inappropriate" alcohol use, before developing educational materials about the prevention of alcohol-related health problems such as cirrhosis. Methodological Issues: Mediating Factors In the development of grant applications researchers may also choose to focus on particular cross-cutting issues concerning the design of ethnically-based programs. Recent research has focused on the methodological pitfalls of attempting to distinguish the effects of ethnicity from other demographic variables such as age, gender, and socioeconomic status and mediating processes such as acculturation. These variables may make it difficult to identify the unique importance of ethnicity in prevention outcomes. Differences in how the researcher and the subject define ethnicity may also impact the interpretation of research results. Furthermore, variations between individuals in how they define their cultural origin may mediate the effects of interventions that rely on culture specific messages. Immigration and Acculturation: The differences observed in drinking patterns of ethnic groups by residence and immigrant cohort suggest the need for further studies of the factors surrounding urbanization, immigration, and acculturation as they relate to alcohol use. To fully understand acculturation, it is also necessary to consider the effects of such factors as immigrants' economic status, social interaction patterns, employment opportunities, and access to alcoholic beverages as intervening variables in the change process. Stages of acculturation, heterogeneity of ethnic groups and individual differences in ethnic identification may confound measures of acculturation. Different ethnic groups may also experience different stresses surrounding their cultural identity. It is important that these psychological mediators and stressors be identified and examined. For example, members of ethnic minorities living in a larger society are, to varying degrees, bicultural. Bicultural membership may produce unique stresses (or provide protective advantages) affecting alcohol consumption. Research is needed to address the effect of biculturality on alcohol consumption. In particular, the possible contribution of value conflicts to alcohol-related problems in different social situations needs to be explored. Alcohol Consumption Patterns: There may be special problems associated with using measures of alcohol consumption formulated for the dominant majority culture. For example, the consistency of consumption, the standard drink equivalents, and the standard time frame referred to may be less familiar and less relevant to some ethnic groups. Moreover, the pattern of heavy drinking followed by periods of abstinence may not be captured by consumption measures based on regular recall periods, or by those that produce a volume-based measure. In general, the validity of standard tests and measuring instruments may have to be explicitly established for the relevant ethnic populations. Peer Group and Cohort Comparisons: Research is needed to determine the norms and values prevalent in specific age and generational cohorts in each of the ethnic minority populations as these norms and values relate to alcohol use and risk-taking. Without knowledge of cultural differences in the development of drinking careers, it is difficult to select appropriate interventions across different age groups. For example, cultural differences in susceptibility to peer pressure will alter the design of interventions that might impede the formation of alcohol-using "peer clusters" and encourage the formation of "peer clusters" that provide sanctions against alcohol use. These interventions may be developmentally appropriate at one age but not another within different cultures. Cultural Sensitivity, Cultural Competence: There is widespread agreement that prevention research on ethnic minorities requires an acquaintance with the culture of the target group. Concern with issues of cultural sensitivity suggests the need to consider, for example, inclusion of members of target minority groups in the planning and implementation of research programs or the use of the language of the target group in communications, data collection, or administration of standardized measures. Both cultural sensitivity and methodological considerations suggest that a clear cooperative arrangement between community organizations or agencies and researchers is an essential ingredient for the successful implementation and evaluation of an intervention strategy. Methodological Considerations Studies concerning the prevention of alcohol-related problems among ethnic minorities must be conceived and executed so as to satisfy the usual criteria of scientific merit. Careful attention should be paid to the specific design requirements for adequate statistical power, particularly if comparisons between or within ethnic minority groups are planned. Research designs that require comparison groups should carefully consider the selection of appropriate control groups, the possibility of differential influence of psychiatric and other drug use patterns, and the effects of possible differential attrition at outcome. Evaluation of Prevention Interventions: Prevention research involving interventions must include comprehensive evaluation components that are conceptually and procedurally integrated into the overall research program. The three areas of evaluation (formative, procedural-or process, and outcome) provide information relevant to the interpretation of the research findings. Evaluation bears directly upon the verification of the research hypotheses connecting interventions to outcomes. Formative evaluation involves community members in the identification of critical issues that should be researched and in the evaluation of instruments and procedures for appropriateness to the particular community. Procedural evaluation refers to the periodic monitoring of the implementation of interventions during the course of the research to assure adherence to protocol and to document what actually was being done or delivered. Outcome evaluation is concerned with determining whether the program achieved its objectives, i.e., whether the outcomes hypothesized to be caused or produced by the interventions did in fact occur. This phase of the evaluation process requires the specification of a verifiable causal linkage between the interventions and the events or behaviors whose encouragement or avoidance is the ultimate target of the interventions. Cross-Institute or Center Areas of Interest Projects may be submitted under this announcement that address issues in common with other agencies. For example, the Center for Substance Abuse Prevention (CSAP), which was an original co-funding agency for the earlier Request for Applications in this area, may be interested in funding the intervention component of an NIAAA prevention research grant responsive to this announcement. CSAP has initiated many prevention service demonstration projects focused on high-risk youth and their families, including prevention projects targeted at ethnic minority groups. It is conceivable that an applicant could carry out the research in the context of a CSAP Community Partnership grant, High Risk Youth grant or other initiative. This would have the benefit of providing a potential applicant with a pool of clients from an ongoing community intervention. Preapplication consultation with the appropriate individual listed below is strongly encouraged. Applications are considered for acceptance and assigned according to standing PHS referral guidelines. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study: special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials and applies to men and women of all ages. If one gender and/or minority group are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear, compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design or sample size appropriate for the scientific objectives of the study. Applications for support of research involving human subjects must use a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypotheses under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minority group is impossible or inappropriate with respect to the purpose of the research because of 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. The NIH funding components will not make awards of grants, cooperative agreements, or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. Protection of Human Subjects The Department of Health and Human Services (DHHS) has regulations for the protection of human subjects which include additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects), including those pertaining specifically to children, are available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B47, Bethesda, Maryland 20892, telephone 301-496-7041. Specific questions concerning protection of human subjects in research may be directed to the staff members listed under INQUIRIES. An applicant organization proposing to conduct nonexempt research involving human subjects must file an Assurance of Compliance with the Office for Protection from Research Risks (OPRR). As part of this assurance, which commits the applicant organization to comply with the DHHS regulations, the applicant organization must appoint an institutional review board (IRB) which is required to review and approve all nonexempt research activities involving human subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. The number and title of the announcement must be typed in item number 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate national advisory council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended by the Council may be considered for funding. Second level review of small grants (R03s) is by NIH staff. REVIEW CRITERIA Criteria for scientific/technical merit review of applications for regular research grants (R01) will include: 1. The overall scientific and technical merit and significance of the proposed research. 2. The appropriateness and adequacy of the research design, including the adequacy of mechanisms for the implementation of any intervention and the methodology proposed for collection and analysis of data. 3. The adequacy of the qualifications and relevant research experience of the principal investigator and key research personnel. 4. The availability and adequacy of facilities, general environment for the conduct of the proposed research, other resources, and any collaborative arrangements necessary for the research. 5. The appropriateness of budget estimates for the proposed research activities. 6. Where applicable, the adequacy of procedures to protect human subjects. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03) and FIRST awards (R29) are contained in the respective program announcements, available from: National Clearinghouse for Alcohol and Drug Information (NCADI) P.O. Box 2345 Rockville, MD 20892 Telephone: (301) 468-2600 or 1-800-729-6686 AWARD CRITERIA Applications recommended for approval by the appropriate advisory council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, program needs and balance, and the availability of funds. Terms and Conditions of Support Grant funds may be used for expenses clearly related and necessary to carry out research projects, including both direct costs, which can be specifically identified with the project, and allowable indirect costs of the institution. Research grant support may not be used to establish, add a component to, or operate a prevention, rehabilitation, or treatment service program. Support for research-related prevention, rehabilitation, or treatment services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. Grants will be administered in accordance with the PHS Grants Policy Statement (rev 10/90) which should be available from your office of sponsored research. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elsie Taylor or Kendall Bryant, Ph.D. Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 Inquiries relating to fiscal matters may be directed to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 Inquires relating to prevention service demonstration projects and evaluation may be directed to: Armando Pollack Special Assistant to the Director of Community Prevention and Training Center for Substance Abuse Prevention Rockwall II Building, 9th floor 5600 Fishers Lane Rockville MD 20857 Telephone: (301) 443-0369 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service, Sections 301 and 405, and administered under the PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 2, 5 February 1993 Message-ID: Date: 6 Feb 93 00:56:14 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1499 $$XID NIHGUIDE 19930205 V22N05 P2O3 ************************************ larger societal factors upon the onset, casual use, escalation to use, maintenance, development of dependence, cessation of use, and relapse of drugs among ethnic/racial minority groups and other underserved populations. These studies should be based upon a multidimensional and multidisciplinary perspective where the exploration of drug use will be grounded within a person-in-situation-environment configuration with reciprocal interactions existing among and within the various systems an individual interacts. Especially encouraged is research that investigates resiliency and protective factors among minority children who may otherwise be at high risk of using drugs but do not. Studies that help in the development of information which can lead to the early identification of those at risk of drug use and abuse among the various ethnic/racial groups and underserved populations are particularly needed. Studies that provide data on identifying the motivating factors responsible for the cessation of drug use among school dropouts, children of drug users, longtime drug addicts, young African-American, Asian American and Hispanic male and female adults are also invited. Projects are encouraged to utilize qualitative and quantitative methods in combination; a reliance on retrospective data is discouraged. Community-based studies with matched control groups where feasible are encouraged; longitudinal efforts and secondary analysis of existing data studies also are supported as appropriate. Also encouraged are studies that critically validate the cultural relevance of current methodological approaches and those that utilize rigorous research designs within the context of their data collection activities. Epidemiologic studies Patterns and prevalence of drug use related studies: Research in this area seeks to evaluate whether the patterns, including the sequencing and multiple use and abuse of drugs of ethnic/racial minority youth, school dropouts, gang members, children of drug users, and homeless youth differs from non-minority youth as reported by drug abuse researchers. Also encouraged are studies that gather information on the prevalence of drug use among Asian American, Hispanic individuals of South, Central American, and Caribbean extraction, migrant workers, and U.S.-Mexican border populations. Consequences related studies: Research in this area concentrates on providing information on the impact that drug use has upon the emotional and economic well-being of minority individuals, their families, and communities. Research on the interrelationship between drug abuse and violence, including domestic violence among ethnic/racial minority youth, school dropouts, gang members is particularly encouraged. Research in this program component may include studies on the effects that drug abuse and related criminality has upon the social and economic well-being of minority neighborhoods. Encouraged also are studies that investigate to what extent drug use and drug dealing is responsible for violence reported among ethnic/racial minority groups and other underserved populations. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. 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, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of 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. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated below and in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional business offices or offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, Maryland 20892, telephone 301/496-7441. The title and number of this announcement must be typed in item 2a on the face page of the application for PHS 398. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five legible copies of the application form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCESS The Division of Research Grants, NIH, serves as a central point for receipt of applications. Applications will be assigned in accordance with established Public Health Service referral guidelines and will be reviewed by an initial review group (IRG) for scientific and technical merit in accordance with the standard NIH peer review procedures. AWARD CRITERIA Applications will compete for available funds with all other applications recommended for further consideration and assigned to the appropriate institute. R03 applications do not receive a second level review. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Mario R. De La Rosa, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse Rockwall II, Suite 615 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2974 Direct inquiries regarding fiscal matters to: Mrs. Shirley Denney Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A54 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under the authority of Section 301 of the Public Health Service Act (42 USC 241). 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. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-47 FULL-TEXT *************************************** PREVENTING ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA AVAILABLE: PA-93-47 P.T. 34, FF; K.W. 0404003, 0414014, 0411005 National Institute on Alcohol Abuse and Alcoholism THE PROGRAM ANNOUNCEMENT ANNOUNCED (PA) IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE PA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites researchers to submit research grant applications related to the prevention of alcohol-related problems among ethnic minority groups of African Americans, Hispanic Americans, Native Americans, Asian Americans, and Pacific Islanders. Most of these groups are at elevated risk for specific alcohol problems or may have changing patterns of increased alcohol consumption. All of these minority groups require the development and evaluation of culturally relevant programs of alcohol abuse prevention. NIAAA promotes innovative prevention research within a broad range of populations and is particularly interested in receiving methodologically sound and conceptually grounded outcome-oriented research applications. The primary objective of this program announcement is to expand the limited information available about the prevention of alcohol-related problems among ethnic minorities. While differential rates of alcohol problems have been well documented within minority communities, the link between ethnic identity and successful alcohol abuse prevention interventions has not. Research proposed within the domain of this program announcement should address factors that facilitate or impede the development, implementation, and evaluation of prevention strategies among diverse sociocultural populations. Attention should be focused on (1) the culturally-appropriate development or adaptation of interventions within these minority settings and (2) how ethnic minority identity relates to prevention research outcomes. In general, the impact of ethnicity on alcohol use and prevention of its abuse should be studied within a particular context such as, alcohol availability control, server training, price increases, media messages, or psychosocial antecedents of high-risk behavior. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Preventing Alcohol-Related Problems Among Ethnic Minorities, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY Applications may be submitted by domestic and foreign public and private non-profit and for-profit organizations, such as, universities, colleges, hospitals, research institutes and organizations, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign applicants are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISMS OF SUPPORT Research support may be obtained through applications for a regular research grant (R01), small grant (R03), or FIRST award (R29). Applicants for R01s may request support for up to five years. The average direct cost per year for R01s is approximately $220,000. Small grants (R03) are limited to two years for up to $50,000 per year for direct costs. FIRST award applications must be for five years. Total direct costs for the five-year period may not exceed $350,000 or $100,000 in any one budget period. FIRST award and small grants cannot be renewed but grantees may apply for R01 support to continue research on the same topics. RESEARCH OBJECTIVES Background Information on Alcohol-Related Problems and Use Among Ethnic Minorities In the United States, alcohol use is involved in nearly 100,000 deaths annually, including approximately one-half of the nearly 45,000 fatalities in traffic crashes; 27,000 deaths due to cirrhosis of the liver; and a high proportion of the deaths due to homicide, suicide, drowning, falls, burns, and other accidents. Alcohol abuse results in alcohol-related injuries and violence, marital discord, job loss, and serious medical consequences including birth defects. Alcohol-related problems and costs are unevenly distributed across racial and ethnic groups. This uneven distribution may be related to cultural differences in drinking patterns. Surveys have found disproportionately high levels of alcohol consumption and alcohol-related problems among African Americans, Hispanic Americans, and Native Americans. In contrast, Asian Americans and Pacific Islanders have been found to have lower levels of alcohol use. However, recent evidence indicates that consumption may be increasing among these two groups. Areas of Research Interest Despite the relatively large number of findings describing broad ethnic differences in drinking behaviors and alcohol-related problems, the nature of the linkage between ethnic identity and alcohol use or abuse has not been established. There are few theoretical paradigms to guide research into these variations. However, there is a need to understand the relationships in order to increase the potential effectiveness of prevention strategies within communities. The paucity of rigorous research on the prevention of alcohol-related problems indicates a need for a variety of prevention and pre-prevention studies directed specifically to these populations. Environmental Prevention Strategies A systematic program of research that investigates the effectiveness of environmental prevention strategies in minority settings is needed to explore interventions that are designed to change the incentives, opportunities, risks, and expectations that surround drinking. This includes examinations of the impact on African American, Hispanic, Native American, Pacific Islanders, and Asian communities (or high-risk groups within them) of national, State, or community-wide policies designed to control alcohol availability (e.g., server training) and reduce demand for such products (e.g., price increases). Policy changes might be expected to have diverse effects on minority ethnic populations because of differences in sociocultural patterns of drinking, as well as differences in the manner in which such policies are viewed in different communities and the ways they are enforced. Prevention Strategies Focusing on the Individual Prevention efforts targeted at individuals, distinct from those that target changes in the environment, have attempted to change consumption practices by increasing individual knowledge of alcohol effects and by altering attitudes about the use of alcohol. These efforts usually involve the use of media campaigns and school-based instructional programs. Such programs have sometimes produced desired changes in knowledge and attitudes, but have not been able to document long-term behavior changes. School-based programs that teach youth peer pressure resistance and social competence skills for avoiding the use of alcohol and other drugs show promise but have only demonstrated moderate or short-lived effects. Even this conditional effectiveness, however, has not been established for ethnic minority students and calls for further research. The study of how ethnicity affects individual differences in drinking behavior may involve the statistical modeling of personality variables, alcohol use patterns, and prediction of prevention outcomes. In general, the most effective studies of these interrelationships are longitudinal and may monitor a wide range of variables, including income level, availability of alcohol, peer and adult influences, intention to drink, and other identified risk factors (low academic achievement, lack of prohibitions, early alcohol use, low self-esteem, psychopathology, poor family relations, lack of socialization, other drug use, etc.). These constructs allow for a more precise examination of the relationship between ethnicity and effective prevention outcomes. Strategies for Program Development One possible research strategy involves taking interventions from programs that have been successfully tested in the general community and adapting those interventions for use with ethnic minorities. Programs using the social influence model that have shown positive outcomes might be adapted for implementation with one or more ethnic minority groups. Another possible research approach is systematic testing of prevention programs that appear to have been successfully implemented within ethnic communities but were tested on only a limited scale and/or not systematically evaluated at all. Examples of these include the community-based programs implemented by the Indian Health Service and various demonstration programs that employ social learning models and are targeted at high-risk youth. Similarly, it may be useful to design strategies for increasing awareness of health-related alcohol problems and understanding of the relationship between cultural attitudes and the social/physical environment and alcohol abuse. It may be necessary to determine how the target groups define "excessive" or "inappropriate" alcohol use, before developing educational materials about the prevention of alcohol-related health problems such as cirrhosis. Cross-Institute or Center Areas of Interest Projects may be submitted under this announcement that address issues in common with other agencies. For example, the Center for Substance Abuse Prevention (CSAP), which was an original co-funding agency for the earlier Request for Applications in this area, may be interested in funding the intervention component of a NIAAA prevention research grant responsive to this announcement. CSAP has initiated many prevention service demonstration projects focused on high-risk youth and their families, including prevention projects targeted at ethnic minority groups. It is conceivable that an applicant could carry out the research in the context of a CSAP Community Partnership grant, High Risk Youth grant or other initiative. This would have the benefit of providing a potential applicant with a pool of clients from an ongoing community intervention. Preapplication consultation with the appropriate individual listed below is strongly encouraged. Applications are considered for acceptance and assigned according to standing PHS referral guidelines. STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN RESEARCH 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 Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available from most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. The number and title of the announcement must be typed in item number 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the form PHS 398 must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Applications received under this announcement will be assigned to an Initial Review Group (IRG) in accordance with established PHS Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate national advisory council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended by the Council may be considered for funding. The second level review of small grants (R03s) is by NIH staff. REVIEW CRITERIA Criteria for scientific/technical merit review of applications for research project grants (R01) will include: 1. The overall scientific and technical merit and significance of the proposed research. 2. The appropriateness and adequacy of the research design, including the adequacy of mechanisms for the implementation of any intervention and the methodology proposed for collection and analysis of data. 3. The adequacy of the qualifications and relevant research experience of the principal investigator and key research personnel. 4. The availability and adequacy of facilities, general environment for the conduct of the proposed research, other resources, and any collaborative arrangements necessary for the research. 5. The appropriateness of budget estimates for the proposed research activities. 6. Where applicable, the adequacy of procedures to protect human subjects. 7. Conformance of the application to the NIH policy on inclusion of women and minorities in study populations. The review criteria for small grants (R03) and FIRST awards (R29) are contained in the respective program announcements, available from: National Clearinghouse for Alcohol and Drug Information (NCADI) P.O. Box 2345 Rockville, MD 20892 Telephone: (301) 468-2600 or 1-800-729-6686 AWARD CRITERIA Applications recommended for approval by the appropriate advisory council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and request for the Program Announcement to: Elsie Taylor or Kendall Bryant, Ph.D. Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13C-23 Rockville, MD 20857 Telephone: (301) 443-1677 Inquiries relating to fiscal matters may be directed to: Elsie Fleming Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 16-86 Rockville, MD 20857 Telephone: (301) 443-4703 Inquires relating to prevention service demonstration projects and evaluation may be directed to: Armando Pollack Special Assistant to the Director of Community Prevention and Training Center for Substance Abuse Prevention Rockwall II Building, 9th floor 5600 Fishers Lane Rockville MD 20857 Telephone: (301) 443-0369 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service, Sections 301 and 405, and administered under the PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. $$P2 END ************************************************************ $$P3 BEGIN PA-93-48 ************************************************* BASIC AND APPLIED STUDIES ON ANTIPROGESTINS NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-48 P.T. 34; K.W. 0413002, 0760025, 0750020, 0710110 National Institute of Child Health and Human Development PURPOSE The National Institute of Child Health and Human Development (NICHD) invites investigator-initiated research grant applications to conduct basic research on antiprogestins and to explore the potential clinical utilization of antiprogestins in the treatment of a variety of reproductive disorders as well as for contraception. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Basic and Applied Studies on Antiprogestins, is related to the priority areas of family planning, prevention of teenage pregnancies and unintended pregnancies. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications for research grants may be made by public and private, for-profit and non-profit organizations, such as universities, colleges, hospitals, and laboratories. Women and minority investigators, in particular, are encouraged to apply. Applicants for First Independent Research Support and Transition (FIRST) Awards (R29) must meet specific eligibility requirements. In addition, foreign applicants are not eligible for the FIRST Award. MECHANISM OF SUPPORT Mechanisms available for the support of this program are the traditional research project grant (RO1), and the FIRST Award (R29). RESEARCH OBJECTIVES Summary The purpose of this initiative is to stimulate research that will attempt to further characterize and define the mechanism(s) of action of antiprogestins, their use for treatment of disorders of the reproductive system, and their utility for application as contraceptive agents or in facilitating parturition. It is recognized that this class of compounds may act through a variety of mechanisms, some of which may not involve antagonism of the progesterone receptor system. Background Progesterone plays a crucial role in female reproduction. Some of the important reproductive events attributable to progesterone influence include: (1) regulation of cellular function via control of synthesis of specific proteins, (2) ovulation induction, (3) regulation of tubal transport of fertilized ova, (4) transformation of the endometrium for implantation, and (5) maintenance of pregnancy. Because these reproductive events physiologically involve progesterone mediated regulatory events, antiprogestins can be utilized to antagonize progesterone actions in a manner regulating or blocking gonadal, uterine or cervical functions associated with the menstrual, conception, and parturition processes. These effects offer promise for molecular, preclinical and clinical applications in the fields of veterinary and human medicine. In addition to interfering with the effects of progesterone on normal physiological events, antiprogestins could be utilized therapeutically when the presence of progesterone is contraindicated. It has been suggested, but not fully documented, that antiprogestins could be utilized for treatment of endometriosis, breast cancer, meningiomas and other disorders. Existing evidence indicates that certain antiprogestins can inhibit estrogenic, glucocorticoid and androgenic actions. These activities may be differential among various antiprogestins. The molecular basis of antiprogestin action is not fully known. Whether antiprogestins bind solely to progesterone receptors or to other functionally related sites is not clear. Displacement of bound progesterone from its receptor sites indicates that the antiprogestin enters the target cells and interacts with specific progesterone-binding sites without exhibiting agonistic activity. Scope Some examples of research topics that would be considered responsive to this solicitation include, but are not limited to, the following: o Clarification of the intracellular mode of progesterone action. o Understanding ovulatory function and dysfunction. Pituitary gonadotropin secretion appears to be modulated in part by progesterone. Antiprogestins could help to determine the effects of this and other regulatory factors in normal and aberrant gonadotropin secretion and the relationship of the mechanism to some forms of ovulatory dysfunction. o Studies on implantation. Information could be gained to further the understanding of: (a) uterine receptivity for blastocyst implantation, (b) decidualization of the endometrium, (c) significance of the morphological parameters that are used for "dating" of endometrial maturation and (d) clarification of mechanisms by which progesterone may render the uterus an immunologically privileged site. o Clarification of the roles of progesterone accumulating neurons in reproductive neuroendocrinological phenomena, such as sexual behavior, ovulation, and feedback mechanisms in the hypothalamo-pituitary-gonadal axis. o Studies on gamete maturation, interaction, fertilization and activation of development. o Effects on sperm. There is preliminary evidence that progesterone is involved in sperm capacitation and changes in sperm motility in the female tract. Whether antiprogestins could affect male fertility by altering sperm maturation or the fertilizing capacity of spermatozoa is not known. o Studies on blocking ovulation. o Post-coital emergency contraception (morning-after pill). o Mini-pill or sequential contraceptive pill regimen. o Cervical dilatation and induction of parturition. o Treatment of endometriosis. Antiprogestins may have a beneficial effect in the medical treatment of endometriosis through suppression of pituitary gonadotropin secretion and the resulting inhibition of follicular development and ovulation, as well as noncompetitive antiestrogenic actions that inhibit endometrial proliferation. o Medical treatment of uterine fibroids. o Ovarian hyperstimulation syndrome treatment. These areas of interest are not listed by priority and they are only suggested examples of areas of research that could be undertaken under this program announcement. Applicants are encouraged to propose other areas that are related to the objectives and the scope described above. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, such issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 (rev. 9/91) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. The NICHD has received assurance from the pharmaceutical manufacturers of mifepristone and onapristone that they will assist in this research effort by making supplies of the antiprogestin available for funded projects. Applicants are encouraged to contact NICHD staff, who will facilitate access and referral to the appropriate industry officials to discuss the proposed research and the compounds available. Direct inquiries regarding programmatic issues regarding contraceptive development, basic and reproductive disorder research, or gestational and pregnancy research, respectively, to: Nancy J. Alexander, Ph.D. Contraceptive Development Branch Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, MD 20892 Telephone: (301) 496-1661 Michael E. McClure, Ph.D. Reproductive Sciences Branch Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B91A Bethesda, MD 20892 Telephone: (301) 496-6515 Donald McNellis, M.D. Pregnancy and Perinatology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03 Bethesda, MD 20892 Telephone: (301) 496-5575 Direct inquiries regarding fiscal matters to: Melinda Nelson Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07 Bethesda, MD 20892 Telephone: (301) 496-5001 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864, Population Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ $$P4 BEGIN PA-93-49 ************************************************* NEUROLOGICAL ASPECTS OF LYME DISEASE NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-49 P.T. 34; K.W. 0715125, 0715038, 0785055, 0755020, 0765033, 0710070 National Institute of Neurological Disorders and Stroke National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Allergy and Infectious Diseases (NIAID) invite research grant applications seeking support of a wide spectrum of research directed at generating improved knowledge concerning Lyme disease of the nervous system. Lyme borreliosis is a multi-system disease caused by the spirochete Borrelia burgdorferi. It may affect skin, joints, heart, eye, and the nervous system. Reported neurological consequences of Lyme borreliosis may range from minor to serious. The infectious vector is a tick commonly harbored by many sylvatic and domestic animals, but the principal reservoirs of the adult infective tick are deer and field mice. Well described neurological disorders, meningoradiculitis and chronic neuropathy in patients with acrodermatitis chronica atrophicans, and an array of central and peripheral nervous system complications of Lyme disease have all been found to result from borrelia infection. Between 1982 and 1990 over 30,000 Lyme borreliosis cases were reported in the U.S. Reported neurological manifestations of the disease include one or more of the following: meningitis, cranial neuritis, radiculoneuritis, peripheral neuropathy, meningoencephalitis, myelitis, ataxia, psychoses, encephalopathy, cognitive abnormalities, pain, fatigue, and sleep disorder. It has been reported that up to half of patients with late Lyme neuroborreliosis (LNB) may exhibit encephalopathy evidenced by impairment of memory and intellect. Encephalopathy is probably caused by subacute infection of the central nervous system. Some patients may display small white matter lesions visualized by magnetic resonance imaging. Cerebrospinal fluid abnormalities may include lymphocytic pleocytosis, intrathecal IgA, IgG, and IgM synthesis, anti-myelin basic protein antibodies, oligoclonal bands, and increased total protein. CSF anti -B. burgdorferi specific antibody is helpful in diagnosing the disease but may only be indicative of exposure, not necessarily of active disease. Peripheral blood may have B. burgdorferi specific antibody and reactive T cells. None of the laboratory diagnostic tests is totally reliable because of false negative and positive readings. The cause of damage to the nervous system is unknown. It may be due to direct damage from spirochetes, tissue inflammation, or immune response, separately or in combination. Diagnosis of Lyme neuroborreliosis is a major challenge because neurological signs and symptoms may imitate those of multiple sclerosis, peripheral neuropathy, Guillain-Barre syndrome, neurosyphilis, and many other diseases of the nervous system. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Neurological Aspects of Lyme Disease, is related to the priority area of infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority institutions, minority individuals, and women are particularly encouraged. Foreign institutions are not eligible for FIRST Independent Research Support and Transition Awards (R29) or Research Program Projects (P01). MECHANISM OF SUPPORT Research support may be requested through application for an individual investigator-initiated research project grant (R01). Applications from new investigators who have not received previous PHS research grant support may apply for a First Independent Research Support and Transition (FIRST) award (R29). FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. To apply for the support of a more broadly based multidisciplinary research program, the Research Program Project (P01) mechanism is suggested. NINDS also provides support for the career development of clinical investigators (K08) and support for clinical investigators through individual fellowships (F32) and institutional national research service awards (T32). RESEARCH OBJECTIVES Neurological involvement is a frequent clinical manifestation of Lyme disease. In addition, it has been suggested that the CNS may serve as a reservoir for persistent infection. Central issues about neurological aspects of Lyme disease are unresolved, including the definition of the neurological disease in adults and children in the U.S., the appropriate criteria to use for diagnosis, and the optimal choice and duration of therapy. The pathogenetic mechanisms which produce central and peripheral nervous system syndromes are unknown; in particular, the etiology of persistent post-infectious symptoms and their optimal management is unclear. Examples of research goals, many of which could be studied in humans as well as animal models and tissue cultures and are appropriate for pursuing an application in response to this PA, include, but are not limited to: o The epidemiology of the neurological aspects of Lyme disease, especially in endemic areas. Identification of neurological syndromes in children and adults that can be reliably attributed to this disorder, including both primary and post-infectious syndromes. o Studies of diagnostic laboratory abnormalities which correlate with the various syndromes, including cerebrospinal fluid, serum, neurophysiological, and neuroimaging testing. o Studies of mechanisms of pathogenesis in development of encephalopathy, encephalomyelitis, and neuropathies. o Characterization of the severity and frequency of cognitive impairments in LNB, and studies of correlated laboratory parameters, and their response to therapy. o Studies of immune-mediated and other pathogenic mechanisms role in injury to the nervous system. This may involve spirochete interactions with the immune system, and definition of immune and inflammatory abnormalities, including studies of auto-antibodies, cytokines, cellular immune responses, and immune complexes. o Development of effective treatment regimen(s). Optimization of antibiotics, drug dosage, and treatment duration. Development of therapeutic approaches for patients who have persistent neurological symptoms. This could be accomplished by controlled clinical trials. o Studies of the molecular basis for B. burgdorferi neurotropism and the role of strain differences in pathogenesis. o Development of reliable animal models for studies of the nervous system infection and studies of viral latency neuropathogenicity. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaska Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted for any of the three application receipt dates: February 1, June 1, and October 1. NINDS Application Guidelines (rev. 4/92) for Program Project (P01) and Center (P50) grants are available upon request from the Program Administrator identified below. Application kits are available at most business and grants and contracts offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. On the face page, item 2a, of the application, the word "yes" must be checked and the title and number of the announcement typed in the space provided: "Neurological Aspects of Lyme Disease" PA-93-49. The original and five copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** The Division of Research Grants, NIH, serves as central point for receipt of applications. 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. If so, a letter of collaboration from the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Applications received under this PA will be assigned to the Initial Review Group (IRG) in accordance with established PHS referral guidelines. The IRGs, which are composed primarily of non-federal scientific and technical experts, will review the applications for scientific and technical merit. Following IRG review, the applications will receive a second-level review by one or more appropriate Advisory Councils. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions quality of the proposed projects as determined by peer review; availability of funds; and program balance among research areas. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. A. P. Kerza-Kwiatecki Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 804 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Dr. Robert L. Quackenbush Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A04 Bethesda, MD 20892 Telephone: (301) 496-7728 FAX: (301) 402-2508 Direct inquiries regarding fiscal matters to: Ms. Laura Williams Grants Management Branch, Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Mr. Todd Ball Grants Management Section National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 Bethesda, MD 20892 Telephone: (301) 496-7075 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.853 and 93.854 and 93.856 - Microbiology and Infectious Disease Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, Public Law 97-219, as amended by Public Law 99-158, 42 USC 241 and 285), Public Law 99-500; and Report 99-711 to accompany HR 5233 and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************ $$P5 BEGIN PA-93-50 ************************************************* RESEARCH GRANTS RELATED TO THE SURGICAL MANAGEMENT OF EPILEPSY NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-50 P.T. 34; K.W. 0715060, 0785210, 0785035 National Institute of Neurological Disorders and Stroke PURPOSE The Division of Convulsive, Developmental, and Neuromuscular Disorders; National Institute of Neurological Disorders and Stroke (NINDS) is revising and reissuing an existing NINDS program announcement published January 8, 1988 to notify the scientific community of continuing NINDS interest in research addressing the surgical management of epilepsies. Background Intractable epilepsy remains a significant health problem despite the availability of several efficacious antiepileptic medications and of blood level monitoring to increase therapeutic effectiveness. Partial epilepsy affects about 0.5 percent of the American population (about 800,000 persons). An estimated 350,000 patients in the United States with partial seizures are intractable to medical therapy. Over 100,000 of these patients in the United States are currently considered candidates for management by surgical therapy. Complex partial seizures may arise from any portion of the brain (occipital, frontal, or temporal lobes). In reported series, 60 to 90 percent excellent control of seizures have resulted from careful selection of patients for resection of a temporal lobe epileptic focus. Frontal lobe resections have a lesser success rate. Failures are attributed to inadequate focus localization (focus beyond the extent of resection or the presence of other unappreciated foci). Surgery is considered for patients if seizures persist after an adequate trial of the correct antiepileptic drugs for the patients' seizure type have been administered at an adequate dosage producing adequate blood levels. Extensive presurgical investigations are required to localize the seizure focus. Intensive monitoring of the EEG and videotaping of many of the patient's typical seizures usually provides the first evidence of a potential surgical candidate. Other clinical and experimental studies are employed to define underlying structural abnormalities (angiography, computerized tomography, magnetic resonance imaging), altered metabolism (positron emission tomography), or impaired function (evoked potentials, neuropsychological evaluation). An international conference for epilepsy surgery was held in February 1986. The conference highlighted the unique opportunity that exists for collaboration between basic and clinical neuroscientists to characterize the biochemistry, microanatomy, physiology and pharmacology of specific human brain regions by studying tissue samples resected at surgery. The need for prospective surgical therapy studies with well-defined entrance criteria and rigorously standardized outcome measures was also emphasized. This conference resulted in two publications. In March 1990, a National Institutes of Health Consensus Conference addressed the issue of Surgery for Epilepsy. The Consensus Panel made six recommendations for directions for future research. (1) Surgery is beneficial for selected patients, but the optimal timing of surgery is not known. Patients considered for temporal lobe resection tend to have had uncontrolled (intractable) epilepsy for 10 to 20 years. (2) Investigators differ in the selection of tests for preoperative evaluation. Studies are needed to assess the value of ictal EEG surface recordings, invasive intracranial electrode recording, PET or SPECT. This would require standardization of definitions, data collection, and central analysis of the data. (3) An outcome assessment method that combines validated measures already used to assess general health status and function in a population of patients with other chronic conditions, with special items that are sensitive to the unique characteristics of people with epilepsy and those close to them is needed. (4) Psychiatric and behavioral functions should be systematically assessed before surgery and during followup to determine whether there are specific contraindications to any particular surgical procedure and whether these procedures subsequently affect behavior. (5) In temporal lobe surgery for partial seizures, standard and "tailored" resections are used by different groups but the results are apparently similar. The circumstances in which each technique is maximally effective should be clarified by standardized data collection including documentation of extent of surgical resection and multivariate analysis so that an appropriate trial may ultimately be planned, if needed. (6) Because epilepsy surgery now may be used more often in children than in the past, studies to determine the effects of uncontrolled seizures and antiepileptic drug therapy on the developing brain are needed. In February of 1992 a second international conference on epilepsy surgery was convened. The conference highlighted new areas of potential clinical research including identification of operable syndromes, timing of surgical intervention, comparison of medical versus surgical therapy, outcome evaluation and cost effectiveness. The 1992 conference again highlighted the unique opportunity for collaboration between basic and clinical neuroscientists. Particular opportunities would seem to exist in the basic science disciplines of electrophysiology, anatomy, immunohistochemistry,biochemistry, pharmacology and molecular biology. 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 priorities. This program announcement, Research Grants Related to the Surgical Management of Epilepsy, is related to the priority areas of the epilepsies. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-0) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are eligible to apply for research project grants (R01) only. Foreign institutions are not eligible for First Independent Research Support and Transition Awards (R29). Applications from minority institutions, minority individuals, and women are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the traditional investigator-initiated research project grant (R01), the First Independent Research Support and Transition (FIRST) award (R29), the program project grant (P01), and the center grant (P50). As consistent with the aforementioned mechanisms, the Principal Investigator or program director, as well as any participating investigators, will plan, direct, and perform the research. Applicants for program project and center grants should contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH GOALS AND SCOPE The goal of this research activity is to explore the use of various modalities of surgery for the treatment of different seizure types. The research scope of this program encompasses both animal and human studies, utilizing a variety of experimental approaches and methods. Clinical investigators are encouraged to (a) define specific criteria or clinical syndromes for selecting the use of the various surgical procedures, (b) determine the optimal means of evaluating surgical candidates to localize the seizure focus, (c) define the long-term improvement and/or adverse effects by appropriately designed, standardized, and validated follow-up measures, and (d) establish age-related indications for surgery in the pediatric age group to assure appropriate neuro-developmental timing of the procedure for different types of epilepsy, and also establish age-appropriate pre- surgical evaluation, surgical procedures, and post-surgical follow-up. Collaborative clinical investigations to achieve an adequate and appropriate study population are encouraged. Basic science investigators are encouraged to utilize the human model to explore all aspects of epilepsy particularly in the areas of developmental neurobiology, neural science, cellular pathology and neuropharmacology. Examples of potential research areas include, but are not limited to pathogenesis of mesial temporal sclerosis; relative roles of decreased inhibition versus increased excitation in seizure generation, likely mechanisms of hypersynchrony and; localization of normal human cerebral function. STUDY POPULATIONS POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups; however, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention strategies), diagnosis, or treatment of diseases, disorders, or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded; however, every effort should be made to include human tissues from women and racial or ethnic minorities when it is important to apply the results of the study broadly. This directive should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully. Since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' population, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. If the required information is not contained within the application, the review will be deferred until the information is provided. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the business offices of most institutions eligible to receive Federal grants and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. Applicants for program project grants should request, from the program contact listed under INQUIRIES, a copy of the NINDS Guidelines: Program Project and Research Center Grants (rev. 6/92). Receipt dates for new research project grant (R01) applications and FIRST awards (R29) and for program project (P01) and center grant (P50) applications are February 1, June 1, and October 1. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 1, 5 February 1993 Message-ID: Date: 6 Feb 93 00:55:22 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1506 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. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930205 V22N05 P1O3 ************************************ X-comment: RFAs described: NR-93-002, NR-93-003, HD-93-011, CA-93-09, PA-93-47 NIH GUIDE - Vol. 22, No. 5 - February 5, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** THE NATIONAL CELL CULTURE CENTER National Center for Research Resources INDEX: RESEARCH RESOURCES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** QUALITY CONTROL AND MODEL DEVELOPMENT IN RODENTS AND TUMOR CELLS (RFP NCI-CM-47000-28) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** PROSTAGLANDINS EXCRETION IN PREECLAMPSIA (RFP NICHD-DESPR-93-02) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 04/29/93 ************************************************* COMMUNITY INTERVENTIONS IN ADOLESCENT HEALTH PROMOTION (RFA NR-93-002) National Center for Nursing Research INDEX: NURSING RESEARCH $$INDEX R4 04/29/93 ************************************************* STUDIES OF CLINICAL OUTCOMES AND NURSING PRACTICE (RFA NR-93-003) National Center for Nursing Research INDEX: NURSING RESEARCH $$INDEX R5 05/25/93 ************************************************* BIOMATERIALS TO RESTORE FUNCTION IN PEOPLE WITH PHYSICAL DISABILITIES (RFA HD-93-011) National Institute of Child Health and Human Development National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: CHILD HEALTH, HUMAN DEVELOPMENT; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R6 06/10/93 ************************************************* PHASE II TRIALS OF NEW ANTI-CANCER AGENTS (RFA CA-93-09) National Cancer Institute INDEX: CANCER ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** DRUG USE AND ABUSE IN MINORITY AND UNDERSERVED POPULATIONS (PA-93-46) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** PREVENTING ALCOHOL-RELATED PROBLEMS AMONG ETHNIC MINORITIES (PA-93-47) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX P3 ********************************************************** BASIC AND APPLIED STUDIES ON ANTIPROGESTINS (PA-93-48) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX P4 ********************************************************** NEUROLOGICAL ASPECTS OF LYME DISEASE (PA-93-49) National Institute of Neurological Disorders and Stroke National Institute of Allergy and Infectious Diseases INDEX: NEUROLOGICAL DISORDERS, STROKE; ALLERGY, INFECTIOUS DISEASES $$INDEX P5 ********************************************************** RESEARCH GRANTS RELATED TO THE SURGICAL MANAGEMENT OF EPILEPSY (PA-93-50) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX P6 ********************************************************** RESEARCH GRANTS RELATED TO NARCOLEPSY (PA-93-51) National Institute of Neurological Disorders and Stroke National Institute of Mental Health INDEX: NEUROLOGICAL DISORDERS, STROKE; MENTAL HEALTH This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** THE NATIONAL CELL CULTURE CENTER NIH GUIDE, Volume 22, Number 5, February 5, 1993 P.T. 34; K.W. 0780000, 0780015, 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 and Canada, has been established to alleviate the shortage of facilities and expertise required to meet the cell culture needs of the biomedical research community. The Cell Culture Center is supported by a cooperative agreement award from the National Center for Research Resources, NIH. Specifically, the Cell Culture Center supports basic biomedical research by providing investigators with the following customized services: o Large quantity production of mammalian cells in suspension or monolayer cultures. Quantities range from 10 to 300 liters, which can be provided on a weekly basis. 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. A request form, obtained from the Cell Culture Center, must contain a description of the relevant research project. Following approval of the request 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. INQUIRIES Direct programmatic inquiries regarding this research resource to: Louise E. Ramm, Ph.D. Biological Models and Materials Research Program National Center for Research Resources Westwood Building Room 8A07 Bethesda, MD 20892 Telephone: (301) 402-0630 Direct requests for applications and resource inquiries to: Dr. Mark Hirschel Director, National Cell Culture Center 8500 Evergreen Boulevard Minneapolis, MN 55433 Telephone: 1-800-325-1112 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN RFP NCI-CM-47000-28 ************************************* QUALITY CONTROL AND MODEL DEVELOPMENT IN RODENTS AND TUMOR CELLS NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFP AVAILABLE: NCI-CM-47000-28 P.T. 34; K.W. 0755020, 1002002, 0780015 National Cancer Institute The Development Therapeutics Program (DTP), Division of Cancer Treatment, (DCT), National Cancer Institute (NCI), is interested in organizations that have the necessary experience, scientific and technical personnel, and facilities to evaluate the activity of potential anti-neoplastic compounds against in vitro cell lines and in vivo tumor systems. Maintenance of the integrity and reliability of the in vivo tumor systems is necessarily dependent upon rigorous quality control of the tumors and host animals. Further, kinetic data obtained during tumor analyses are used to assist in drug treatment scheduling and interpretation of drug testing results. This project is required so that variations in laboratory data can be identified and analyzed as to cause, e.g., animal source, tumor source, or laboratory technique. In addition, in vivo testing protocols must be established for candidate tumor models from the human tumor cell disease-oriented screening panel to provide the necessary follow-up of active materials identified for development as candidates for possible clinical trial. The Contractor will be required to perform the following specific tasks: perform tumor cell kinetic studies, including determination of doubling times and labeling indices for all tumor lines available for use in the in vivo testing program; develop working protocols suitable for drug testing using tumor models designed by the NCI Project Officer; test both standard agents and new agents identified in the in vitro prescreen in in vivo protocols developed for DTP; evaluate the response of host animals from all animal supply sources to appropriate tumor lines; evaluate the drug response and growth characteristics of tumors routinely used in the Program; evaluate the efficacy of current and new COPs for maintaining pathogen-free tumor lines and/or animals prior to their use in the Program; prepare and maintain in vitro tumor cell cultures in support of the in vivo program; and develop new or modify existing protocols with the goal of establishing a minimal challenge model for use in early in vivo screening of anticancer drug candidates. The government will designate and supply the agents to be tested. The successful offeror will be expected to provide all equipment, solvents, reagents, and animal facilities needed to conduct this type of work. It is expected that one cost-reimbursement contract, completion form, will be awarded as a result of the solicitation. This contract is planned to be incrementally funded over a five-year period. The proposed contract project represents a recompetition of Southern Research Institute, Contract N01-CM-97553. This project requires that the following restriction be applied: "The NCI signs legally binding agreements with certain suppliers (often pharmaceutical or chemical companies), these agreements state that all information submitted by the supplier will be held confidential. Structural characteristics may have to be revealed in the event that reformulation, solubility, or preliminary pharmacokinetic studies are done to assure/improve proper dosing regimens and treatment schedules. Pharmaceutical or chemical companies could obtain valuable data on new leads through this mechanism. Therefore, in order to honor the confidentiality agreements made with suppliers, the NCI believes that such information on compounds cannot be disclosed to potential competitors of the supplier. Thus, pharmaceutical and chemical companies must be excluded from competition on the above referenced RFP. For purposes of this exclusion, a pharmaceutical or chemical company is defined as "an organization that manufactures and/or sells drugs and chemicals to the general public for profit." All responsible sources may submit a proposal that will be considered by the NCI. This announcement is not a request for proposal (RFP). RFP NCI-CM-47000-28 will be available on or about February 1, 1993, with a response date of March 18, 1993, for the receipt of proposals. INQUIRIES Copies of the RFP may be obtained by written request to: Ms. Carolyn Barker Research Contracts Branch Treatment Contracts Section National Cancer Institute Executive Plaza South, Room 603 Bethesda, MD 20892 $$R1 END ************************************************************ $$R2 BEGIN RFP NICHD-DESPR-93-02 ************************************ PROSTAGLANDINS EXCRETION IN PREECLAMPSIA NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFP AVAILABLE: NICHD-DESPR-93-02 P.T. 34; K.W. 0760065, 0775020 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) is planning a study to determine whether or not urinary excretion of prostaglandin metabolites is altered in preeclamptic patients before the clinical onset of disease, and to determine the effect of oral calcium supplementation during pregnancy on the excretion of these metabolites. This will be a nested case control study using stored urine specimens collected at specified times during pregnancy from pregnant women participating in the NICHD Trial of Calcium for Preeclampsia Prevention (CPEP). This trial, which recently has been initiated by the NICHD at five universities across the country, is a randomized clinical trial designed to determine whether or not oral calcium supplementation will prevent preeclampsia. The contractor will be expected to measure metabolites of prostacyclin and thromboxane in approximately 700 urine specimens selected by the Project Officer over the course of two years. The NICHD expects to make one award from this solicitation. This announcement is a new solicitation. The issuance of this Request for Proposals (RFP) will be on or about February 19, 1993, and proposals are due by 4:00 p.m. (local time), April 16, 1993. A short-form version of the RFP will be provided first. This includes the Statement of Work, Technical Reporting Requirements, Background Information, and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full-text version of the RFP must be requested, in writing, for those organizations interested in responding. INQUIRIES Organizations desiring a copy of the short-form RFP may send their written request to: Mrs. Lynn Salo Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 7A07 Bethesda, MD 20892 FAX: (301) 402-3676 FAX requests are acceptable. All requests must cite the RFP number NICHD-DESPR-93-02 and include two self-addressed mailing labels. All sources that consider themselves qualified are encouraged to submit a proposal. This advertisement does not commit the government to make an award. $$R2 END ************************************************************ $$R3 BEGIN NR-93-002 FULL-TEXT ************************************** COMMUNITY INTERVENTIONS IN ADOLESCENT HEALTH PROMOTION NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA AVAILABLE: NR-93-002 P.T. 34, AA; K.W. 0403004, 0745035, 0404000 National Center for Nursing Research Letter of Intent Receipt Date: March 25, 1993 Application Receipt Date: April 29, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Center for Nursing Research (NCNR) invites submissions of R01 applications for investigations of community based interventions for health promotion and disease prevention in older children and adolescents (ages 8-18). The purpose of this RFA is the development and testing of community based interventions that focus on helping older children and adolescents adopt and maintain health-promoting cognitive and behavioral patterns. Health promotion strategies could take place in traditional and nontraditional settings, with focus, if possible, on highly vulnerable youth, including minority, economically disadvantaged, and disabled subgroups. 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, Community Interventions in Adolescent Health Promotion, is related to the priority areas of health promotion in educational and community based programs, and preventive services for HIV infection and sexually transmitted diseases. Potential applicants may obtain a copy of the "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed three years. This RFA is a one-time solicitation. The anticipated average direct cost award per year will range from $150,00 to $180,00. The anticipated award date will be September 30, 1993. FUNDS AVAILABLE Approximately one million dollars in total costs for the first year will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four to five applications will be funded for a three year period. RESEARCH OBJECTIVES The research objectives of this RFA are to: (1) develop and test family, school, and community strategies for adopting and maintaining health-promoting behaviors among youth in traditional health care settings; and (2) develop and test alternative health promotion models and outreach strategies in urban and rural settings such as youth-serving community agencies, shelters for runaways and the homeless, malls, churches, and youth-employing worksites. For the purposes of this RFA, the age group of older children and adolescents encompasses ages 8-18. Studies are needed to identify traditional health care settings and nontraditional settings that, when combined with appropriate health promotion strategies, might offer the greatest potential for effectively reaching vulnerable youth. Recognizing that the multidisciplinary nature of health promotion research requires a blending of research expertise from many disciplines, collaboration with colleagues in the biomedical and social sciences is encouraged. Examining the health behaviors of children and adolescents within a developmental perspective interact to influence health behavior and outcomes. Such research has great potential for making significant contributions to the state of the science of health promotion for older children and adolescents. To develop a scientific base for practice, research is needed on the effects of health beliefs, actual and perceived options, behaviors, and on health promoting interventions. Of special concern are the highly vulnerable youth including young people who are members of minority subgroups, immigrants, economically disadvantaged, homeless, and disabled. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 25, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and consultants, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCNR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Chief, Office of Scientific Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 Telephone: (301) 496-0472 FAX: (301) 480-4969 APPLICATION PROCEDURES Applications must be received by April 29, 1993. If an application is received after that date, it will be returned. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441. REVIEW CONSIDERATIONS Applications will be evaluated according to the review criteria stated in the RFA for scientific and technical merit by an appropriate peer review group convened by the Office of the Review, National Center for Nursing Research. Applications may be subjected to triage by peer review group to determine their scientific merit relative to their applications received in response to this RFA. Criteria for triage will be the same as those noted above. The second level of review will be provided by the National Advisory Council for Nursing Research. AWARD CRITERIA The anticipated date of award is September 30, 1993. Decisions to make awards are based on the scientific merit of the application reflected in the priority score, availability of funds within NCNR for this purpose, and NCNR research program priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. NCNR program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Martha Ann Carey, Ph.D., R.N. Health Promotion/Disease Prevention Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 402-3293 Direct inquiries regarding fiscal and administrative matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 496-0237 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN NR-93-003 FULL-TEXT ************************************** STUDIES OF CLINICAL OUTCOMES AND NURSING PRACTICE NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA AVAILABLE: NR-93-003 P.T. 34; K.W. 0785130, 0755018 National Center for Nursing Research Letter of Intent Receipt Date: March 26, 1993 Application Receipt Date: April 29, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRES, BELOW. PURPOSE The National Center for Nursing Research (NCNR) invites research grant applications to investigate methodological and measurement issues that occur when studying clinical outcomes that result from nursing care. The intent of this RFA is to support methodological research that facilitates the collection and analysis of data to be used to answer questions about the effectiveness of clinical intervention strategies. Specific measurement issues to be supported include examination of existing or development of new clinical outcomes measures to determine their sensitivity, appropriateness, validity and reliability for differentiating and measuring the influence of nursing practice. 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, Studies of Clinical Outcomes and Nursing Practice, is related to most of these priority areas. Potential applicants may obtain a copy of the "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private, organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one time solicitation. The total project period for applications submitted in response to the present RFA may not exceed four years. The anticipated average direct cost award per year is $75,000. The anticipated award date will be September 30, 1993. FUNDS AVAILABLE It is estimated that up to $600,000 dollars will be available to fund the first-year total costs of applications submitted in response to this RFA. It is anticipated that five to six applications will be funded. RESEARCH OBJECTIVES The research objectives for this RFA are to: (1) develop and test methods to assess the effect of clinical interventions on outcomes of patients receiving nursing care; and (2) examine existing or develop new measures of clinical outcomes to determine their appropriateness, sensitivity, validity and reliability in measuring the effect of nursing care. This initiative is based on the recommendations of an NCNR sponsored conference held in 1992 to review the state-of-the-science of patient outcomes research, specifically focusing on the effectiveness of nursing practice. The proceedings of this conference, "Patient Outcomes Research: Examining the Effectiveness of Nursing Practice," are available from the NCNR program contact listed under INQUIRIES. This publication contains all the scientific papers presented at the conference, including analyses of current approaches to methods and measurement in clinical outcomes research. The NCNR is interested in methodological studies that consider ways of measuring the effect of nursing practice on the outcomes of clinical care. This information is needed to assist in improving quality of care, to increase knowledge about the most appropriate use of clinical intervention strategies, and to inform overall clinical decision making. All populations who are recipients of nursing care and who receive nursing interventions are appropriate target populations of studies in response to this RFA (for example, populations with clinical conditions such as pain, pressure ulcers, urinary incontinence, nausea and vomiting, depression, fatigue, and illness-related stress; or who are receiving nursing home care, home care or acute care). Applicants are encouraged to take an interdisciplinary approach in the design of the studies proposed and to include interdisciplinary scientific team members. It is anticipated that applications submitted in response to this RFA will focus on quantitative approaches to study designs. Additional information about the research objectives is contained in the RFA. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 26, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and consultants, the participating institution(s), and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is extremely helpful in planning for the review of applications. It allows NCNR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Ethel Jackson, D.D.S. Chief, Office of Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 APPLICATION PROCEDURES Applications must be received by April 29, 1993. If an application is received after that date, it will be returned without review. The research grant application form PHS 398 (rev. 9/91) is to be used to apply for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-496-7441. REVIEW CONSIDERATIONS Applications will be evaluated according to the review criteria stated in the RFA for scientific and technical merit by an appropriate peer review group convened by the Office of Review, National Center for Nursing Research. Applications may be subjected to triage by the peer review group to determine their scientific merit relative to other applications received in response to this RFA. Criteria for triage will be the same as those noted in above. The second level of review will be provided by the National Advisory Council for Nursing Research. AWARD CRITERIA The anticipated date of award is September 30, 1993. Decisions to make awards are based on the scientific merit of the application reflected in the priority score, availability of funds with NCNR for this purpose, and NCNR research program priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The program staff welcomes the opportunity to clarify any issues or questions from potential applicants. Inquiries regarding programmatic issues and requests for the RFA may be directed to: Patricia Moritz, Ph.D., RN Nursing Systems Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (303) 844-6163 (for discussion of scientific matters) Telephone: (301) 496-0523 (for copies of the RFA) Requests for copies of the conference proceedings, "Patient Outcomes Research: Examining the Effectiveness of Nursing Practice," may be directed to: Office of Information and Legislative Affairs National Center for Nursing Research Building 31, Room 5B13 Bethesda, MD 20892 Telephone: (301) 496-0207 Direct inquiries regarding fiscal and administrative matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 496-0237 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN HD-93-011 FULL-TEXT ************************************** BIOMATERIALS TO RESTORE FUNCTION IN PEOPLE WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA AVAILABLE: HD-93-011 P.T. National Institute of Child Health and Human Development National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: April 26, 1993 Application Receipt Date: May 25, 1993 THE REQUEST FOR APPLICATION (RFA) ANNOUNCED IN THE NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite research grant applications to develop new biomaterials that will be used to improve function in people with physical disabilities. The goal of this RFA is to stimulate high risk, innovative research projects that will provide preliminary data leading to the development of novel materials designed to restore, improve, or enhance function lost as a consequence of injury, disease, or congenital disorder. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This RFA, Biomaterials to Restore Function in People with Physical Disabilities, is related to the priority areas of chronic and disabling conditions and the goal to reduce health disparities among Americans. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) investigator-initiated research project grant (R01) mechanism. Applications submitted in response to the present RFA may not exceed two years and the total direct costs for the first year may not exceed $50,000 and a total of $100,000. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The earliest anticipated award date will be September 1993. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Applications submitted in response to this announcement will compete for direct costs of approximately $500,000 from the NICHD and $150,000 from the NIAMS that have been made available for this purpose in Fiscal Year 1993. It is expected that 10 awards will be made by the NICHD and three by the NIAMS. The number of awards depends upon the overall scientific merit of the proposals, their relevance to the stated goal of the announcement, and the availability of funds. RESEARCH OBJECTIVES Between 35 and 43 million Americans have one or more conditions that result in a limitation of life activities. The annual disability-related costs to the nation are in excess of $170 billion. These limitations may result from either injury, disease or birth defect. During the past decade, remarkable advances have been made in biotechnology and in characterizing tissue interactions. These advances now permit the development of novel biocompatible materials that can lead to the restoration of function in persons with physical disabilities. The goal of the NCMRR is to promote research that will lead to the replacement, enhancement or restoration of function in persons with physical disabilities in order to maximize their functional capabilities, both immediately after the onset of the disabling condition and throughout the lifespan. The NCMRR has identified seven research priority areas. This RFA will address three of these areas: the improvement of mobility, the whole body systems response to chronic injury, and advances in assistive technologies. Included in the goals of the NIAMS are promoting and funding research on the basic biology, injury, and chronic diseases of structural and connective tissues, such as bone, muscle, ligament, tendon, cartilage, and skin. As such, research on novel biomaterials may be targeted to the treatment of these conditions. The purpose of this RFA is to develop a grant program that will provide funds to support exploratory studies leading to the development of novel genetically engineered biomaterials, to encourage research into the modification of biological products that can be used to stimulate the regeneration of tissues, and to produce delivery vehicles that will supply gene products necessary to maintain function or reduce the process of further injury. The following list of topic areas, though not inclusive, serves as a guide for potential applications under this grant program: o development of coating materials that will render implanted devices biocompatible o development of modified extracellular matrix materials that can serve as substrates or scaffolding that will enhance regeneration of neurons, supporting cells, and other soft tissues after long-term injury o development of ion-sensitive films/materials that can be attached to biological membranes to detect and enhance residual neuronal activity in chronically injured systems o identification of novel biopolymers that can act as microcapsules to provide slow release of genetically modified gene products o development of genetically engineered stem cells that can be targeted to appropriate organs in order to restore missing structures o development of skin substitutes for healing of decubitus ulcers o development of implantable or cutaneous biosensors to detect pressure and cutaneous breakdown o modification of natural products to reduce scarring both in the nervous system and in soft tissues o development of materials to immunologically isolate implanted materials o development of genetically modified cell lines that can be introduced into sites of injury and tissue loss to stimulate regeneration of neurons, muscle, and connective tissues o development of biomaterials that will improve sphincter function STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a special justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Potential applicants are strongly encouraged to submit a letter of intent by April 26, 1993. The letter of intent is requested for planning purposes only and should include the name of the Principal Investigator, a descriptive title of the potential application, identification of the organization involved and the RFA number and title. The letter of intent is to be addressed to Dr. Danuta Krotoski at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). This application form is available in the business or grants and contracts office at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The receipt deadline for applications prepared in response to this RFA is May 25, 1993. Late applications will not be accepted. REVIEW CONSIDERATIONS Applications will be reviewed by staff of the Institute for responsiveness to the RFA. Applications deemed non-responsive will be returned to the applicant. Responsive applications may be evaluated by preliminary triage in a peer review group to determine their scientific merit relative to other applications received in connection with this RFA. NIH staff will withdraw from competition those applications judged to be non-competitive. The applicant and their institutional business official will be notified in such instances. Those applications judged to be competitive will be further evaluated for technical and scientific merit by a special review panel convened for this purpose by the Division of Scientific Review, NICHD. Review criteria will be those normally used by the NIH to evaluate investigator-initiated applications. Following the initial review by the special review committee, all applications will be reviewed by the NICHD and NIAMS National Advisory Councils. INQUIRIES Written and telephone requests for the RFA may be directed to: Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Plaza South, Room 450 W Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 or Stephen Gordon, Ph.D. Chief, Musculoskeletal Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 407A Bethesda, MD 20892 Telephone: (301) 402-3338 For fiscal and administrative inquiries regarding this announcement, potential applicants may write or call: Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F Bethesda, MD 20892 Telephone: (301) 496-1303 or Carol Clearfield Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 726 Bethesda, MD 20892 Telephone: (301) 402-3360 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.929 (Medical Rehabilitation Research) and 93.846 (Arthritis and Musculoskeletal and Skin Disease Research). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R5 END ************************************************************ $$R6 BEGIN CA-93-09 FULL-TEXT *************************************** PHASE II TRIALS OF NEW ANTI-CANCER AGENTS NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA AVAILABLE: CA-93-09 P.T. 34; K.W. 0755015, 0740015, 0740020 National Cancer Institute Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: June 10, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites applications from single institutions or consortia of institutions wishing to perform scientifically directed Phase II trials of promising anti-cancer agents particularly in, but not limited to, tumors of special interest such as breast, ovarian, lung, and urologic cancers and to conduct laboratory studies in support of the clinical trials such that their conduct leads to a greater understanding of the relationship between drug administration and biological changes in patients. 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, Phase II Trials of New Anti-Cancer Agents, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Domestic for-profit and non-profit organizations such as universities, colleges and hospitals and governments and their agencies are eligible to apply. Applications from minority individuals and women are encouraged. An applicant may consist of a single institution or a consortium of institutions for the purpose of accessing a sufficient patient population. An applicant functions as an integrated unit with a common goal and is under the guidance and direction of a single Principal Investigator. Participation by foreign institutions in the non-clinical aspects of this project is acceptable. All accrued patients must be treated in the United States. MECHANISM OF SUPPORT Support of this program will be through the cooperative agreement (U01), an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in the section SPECIAL REQUIREMENTS, Terms of Cooperation, Nature of Participation by NCI Staff. Applicants will be responsible for the planning, direction, and execution of the proposed project. There is no intent, real or implied, for NCI staff to direct awardee activities or to limit the freedom of investigators. It is anticipated that the average amount of the total direct costs per year for each award will range from $150,000 to $200,000. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. It is anticipated that six to eight awards will be made. The total project period for applications submitted in response to the present RFA may not exceed four years. The earliest feasible start date for the initial awards will be April 1, 1994. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The purpose of this RFA is to provide support for Phase II scientifically-directed clinical trials with investigational anti-cancer agents. Specifically, the objectives of Phase II trials are: (a) when testing new agents that have just completed Phase I trials, to confirm that the dose and schedule chosen can be safely administered in subsequent Phase II trials; (b) to determine the antitumor activity of existing antitumor agents that can be administered in significantly higher doses when used with colony stimulating factors or other factors that modulate toxicity or antitumor activity; (c) to determine the antitumor activity of combinations of antitumor agents and modalities; (d) to determine the spectrum of antitumor activity for new agents in selected human cancers; and (e) to gain further insight into the pharmacokinetics and metabolism of the therapeutic agent, its mechanisms of action and/or toxicity and identification of the particular patient population most likely to benefit from its effects through the performance of parallel biological studies. Research Goals and Scope The aims of this initiative are: (1) to provide support for Phase II trials of promising new anti-cancer agents, particularly in, but not limited to, tumors of special interest such as breast, ovarian, lung, and urologic cancers; and (2) to provide support for appropriate laboratory correlative studies in cancer patients receiving these anti-cancer agents. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship between drug administration and biological changes in patients. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted anti-cancer agents, including monitoring of metabolites and intracellular products when appropriate, or other relevant pharmacology correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the agent in individual patients entered into the Phase II trial (e.g., changes in signal transduction pathways, immune modulation, induction or suppression of specific gene function, other indicators of differentiation induction, or induction of apoptosis). Specific objectives and scientific approaches will be investigator-originated and should reflect the creativity and capability of the investigators. This RFA provides an opportunity for clinical and laboratory investigators within an institution or consortia of institutions to develop a program in drug development which utilizes the strengths of pre-existing basic scientific expertise and available clinical resources. The applicant/awardee Principal Investigator will select the specific agents to be tested in accord with their area of scientific interest and expertise and will develop a series of appropriate phase II trials with supporting protocol documents. The NCI may provide NCI-sponsored IND agents or provide assistance to the awardee by sponsoring or co-sponsoring other selected agents. Each Phase II awardee/consortium will be expected to complete on average two to three Phase II trials per year, with each trial encompassing 20 to 40 patients. In all categories of diseases, the awardee must select those patients for trial with the best performance status and with the minimum amount of prior treatment that is consistent with ethical medical practice. Sufficient numbers of patients should be available in order to allow completion of the trials in a timely manner. These trials should also include evaluation of laboratory parameters which reflect the biological or biochemical effects of therapy in a relatively homogeneous group of patients as preparations for larger studies which may show correlations with response or toxicity. Studies of regional drug administration will be permitted upon documentation of expertise with necessary techniques of drug delivery and pharmacology and evidence that this therapeutic approach might yield meaningful therapeutic benefit to patients. Similarly, exploration of the upper end of the dose-response curve, using appropriate approaches for protection of normal tissues, may be permitted in suitably documented circumstances. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. David R. Parkinson at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. Applications must be received by June 10, 1993. If an application is received after that date, it will be returned. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are judged to be non-responsive will be returned by the NCI. Applications judged to be non-responsive to this RFA may be submitted as an investigator initiated regular research grant (R01) or program project grant (P01) at the next receipt date. The application would require modification in accordance with either the R01 or P01 guidelines. The revised application would not be considered an application for a cooperative agreement nor would it be considered a response to an RFA. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff (see INQUIRIES). Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria for scientific/technical review by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged and may be directed to the program staff listed below. The program staff welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues and requests for the RFA to: Dr. David Parkinson Chief, Investigational Drug Branch National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-5223 FAX: (301) 480-4663 Direct inquiries regarding fiscal matters to: Joan Metcalfe Grants Management Specialist National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 28 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-46 ************************************************* DRUG USE AND ABUSE IN MINORITY AND UNDERSERVED POPULATIONS NIH GUIDE, Volume 22, Number 5, February 5, 1993 PA NUMBER: PA-93-46 P.T. 34; FF; K.W. 0404009, 0408006, 0417000 National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to encourage research on the extent and nature of drug use and abuse among ethnic/racial minority groups and other underserved populations. As defined in this announcement, ethnic/racial minority groups include African-American, American Indian and Alaska Native, Asian American and Pacific Islander, and Hispanic. Underserved populations include, but are not limited to, school dropouts, gang members, the homeless, migrant workers, prostitutes, children of drug users, recent immigrant groups, the unemployed or working poor, the elderly, veterans, incarcerated adults and juveniles, the mentally ill, or other vulnerable groups. Research on the drug-using behavior of the ethnic/racial minority groups and other underserved populations mentioned is important because of the significant social, economic, and cultural differences existing among and between these population groups; the growing importance of these population groups upon the social, economic, and cultural well-being of our society; and the potentially unique nature of drug-using behaviors among each of the minority groups and other underserved populations. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Drug Use and Abuse in Minority and Underserved Populations, is related to the priority area of alcohol and other drug abuse. 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 foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) awards (R29). MECHANISM OF SUPPORT Support mechanisms include research projects (R01), small grants (R03), and FIRST awards (R29). RESEARCH OBJECTIVES Summary Background investigation into the extent and nature of drug use/abuse behavior among the various ethnic/racial minority groups and other underserved populations is the focus of the ethnic/racial minority and other underserved populations research program at the National Institute on Drug Abuse (NIDA), Epidemiologic Research Branch. In the past this program has provided financial and technical support to studies exploring the prevalence of drug use/abuse among school dropouts, gang members, the homeless, and American Indian, Hispanic, and African-American high school seniors. This program has also funded studies investigating the role of familial factors, religious involvement, and acculturation related stress in the drug use behavior of African-American and Hispanic adolescents. The findings from this research have provided evidence suggesting that American Indian high school seniors are more likely than any other ethnic/racial minority group seniors to use and abuse licit and illicit drugs. Other results from this research have also suggested that a strong relationship exists between dropping out of school and drug use/abuse, and that homeless individuals and gang members have a very high rate of drug use/abuse. Further, the data collected from this research seem to indicate that stress due to assimilation into American society and lack of family cohesiveness and support may be related to the drug-using behavior of Hispanic and African-American youth. Despite these recent research advances, there continues to be a lack of research on the patterns, causes, and consequences of drug use and abuse among ethnic/racial minority groups and other underserved populations. Of foremost concern is the lack of culturally relevant and theoretically driven research on the underlying factors responsible for the drug-using behavior of individuals belonging to the various ethnic/racial minority groups and other underserved populations. The majority of past and current studies on the drug-using behavior of these populations are exploratory in nature and lack a theoretical foundation. Moreover, many of these studies are not culturally relevant and many have been able to gain only limited access to ethnic/racial minority communities or underserved populations. Furthermore, these study results are most often based upon non-random samples and retrospective collection of drug use data. Also needed is research that will further explore the changing patterns of drug use and abuse among the various ethnic/racial and other underserved groups and the consequences associated with these drug-using patterns among these different populations. Applications submitted should focus on exploring the etiology, patterns, or consequences of drug use among each of the population groups listed above or any other group that may be vulnerable to the use and abuse of drugs. Applications that focus on exploring the underlying individual, familial, psychiatric, psychological, cultural, socioeconomic, and co-morbidity factors and circumstances that expose or protect individuals belonging to these populations from or to the use of illicit drugs are particularly encouraged. Studies that focus on the relationship between drug use/abuse and violence and other related consequences due to drug use are also encouraged. Areas of Research Interest: Etiologic studies Familial and peer related studies: Research in this area should focus on the role that such factors as lack of family support including ineffective parenting and lack of mutual parent-child attachment and warmth, family violence, and lack of male role models have upon the initiation, continuation, escalation, and cessation of drug use among ethnic/racial minority groups and other underserved populations. Encouraged also are studies that investigate the impact that poor parental supervision, parental and older sibling or other relative drug use, breakdown of the extended family system, the changing role of the mother and father within the family system, and parents' socioeconomic status have upon the drug-using behavior of these population groups. Studies that explore the relationship between drug use and abuse, peer influence and association with drug-using peers among ethnic/racial minority youth are also appropriate for this research. Cultural related studies: Research in this area should focus on exploring the importance of cultural values and attitudes toward drug use, acculturation related stress, or loss of cultural identification upon the drug-using behavior of the various ethnic/racial minority groups previously identified. Of particular interest are studies that explore the role of cultural values that may protect ethnic/racial minority female, particularly those belonging to recent immigrant groups, from the use and abuse of drugs. Also needed is research that investigates whether or not a subculture of drug use exists among the various underserved population groups. Methodological studies that seek to develop scales to measure accurately the complex and multidimensional nature of the construct of culture among each of the various racial/ethnic minority groups are also encouraged. Community and societal related factor studies: Research in this area centers on exploring the impact that factors such as the availability and price of drugs and drug distribution networks, local laws against the use and selling of drugs, neighborhood attitudes and social norms and mores related to drug using/dealing, poor school systems, and a lack of adequate community recreational and employment opportunities have upon the drug use behavior of ethnic/racial minority groups and other underserved populations. Encouraged also are studies that investigate the role that racism, negative social sanctioning by established social institutions such as schools and social service programs, law enforcement programs/strategies, membership in gangs and organized criminal associations, lack of religious affiliations, and feelings of powerlessness toward society have upon the drug-using behavior of the identified population groups. Individual psychology and developmental vulnerability related studies: Research in this area concentrates on studies of the impact of psychological, developmental, and psychopathological factors upon the use and eventual abuse of drugs. Feelings of low self-esteem, depression, low self-efficacy, aggressive, or noncompliant behavior, coping styles, misperceptions of harmful consequences, maturation-related transitions from infancy to adulthood, psychopathological conditions, and other related psychological problems also are appropriate study foci. Of interest are studies that investigate the interactive roles of intrapersonal, interpersonal, familial, cultural community, and other From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 4, 5 February 1993 Message-ID: Date: 6 Feb 93 00:59:18 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1241 $$XID RFA CA9309 CA-93-09 P1O1 ***************************************** PHASE II TRIALS OF NEW ANTI-CANCER AGENTS NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA: CA-93-09 P.T. 34; K.W. 0715035, 0755015, 0740020 National Cancer Institute Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: June 10, 1993 PURPOSE The Division of Cancer Treatment (DCT), National Cancer Institute (NCI) invites applications from single institutions or consortia of institutions wishing to perform scientifically directed Phase II trials of promising anti-cancer agents particularly in, but not limited to, tumors of special interest such as breast, ovarian, lung, and urologic cancers and to conduct laboratory studies in support of the clinical trials such that their conduct leads to a greater understanding of the relationship between drug administration and biological changes in patients. The numbers of promising new agents with novel mechanisms of action has increased in recent years, and many of these new agents can only be accurately evaluated in patients in whom the cancer cells have been biologically characterized (e.g., for the presence of a specific gene, cytoplasmic protein, or cell surface receptor to which the agent is targeted). The increasing numbers of promising new agents with novel mechanisms of action and the large number of institutions both capable of and interested in conducting Phase II clinical trials of cancer therapies in parallel with appropriate biological studies of the cellular target of the particular agent makes it desirable to expand NCI support in this area. Institutions responding to this RFA should be able to perform Phase II trials in parallel with pharmacological, immunological, biochemical, or other appropriate biological studies of the cancer cells from individual patients. 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, Phase II Trials of New Anti-Cancer Agents, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Domestic for-profit and non-profit organizations such as universities, colleges and hospitals and governments and their agencies are eligible to apply. Applications from minority individuals and women are encouraged. An applicant may consist of a single institution or a consortium of institutions for the purpose of accessing a sufficient patient population. An applicant functions as an integrated unit with a common goal and is under the guidance and direction of a single Principal Investigator. Participation by foreign institutions in the non-clinical aspects of this project is acceptable. All accrued patients must be treated in the United States. MECHANISM OF SUPPORT Support of this program will be through the Cooperative Agreement (U01), an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of NCI staff involvement is described in the section SPECIAL REQUIREMENTS, Terms of Cooperation, Nature of Participation by NCI Staff. Applicants will be responsible for the planning, direction, and execution of the proposed project. There is no intent, real or implied, for NCI staff to direct awardee activities or to limit the freedom of investigators. Under the Cooperative Agreement, a relationship exits between the recipient of the award and the NCI, in which the recipient is responsive to the requirements and conditions set forth in the RFA. Specifically, the Principal Investigator defines the details for the project within the quidelines of the RFA, retains primary responsibility for the performance of the activity, and agrees to accept close coordination, cooperation and assistance of the NCI extramural staff (through the NCI Program Director) in all aspects of scientific and technical management of the project in accordance with the Terms of Cooperation. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. However, if it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review according to the procedures described in Review Considerations, Part A. It is anticipated that the average amount of the total direct costs per year for each award will range from $150,000 to $200,000. FUNDS AVAILABLE Approximately $2,000,000 in total costs per year for four years will be committed to specifically fund applications submitted in response to this RFA. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. It is anticipated that six to eight awards will be made. The total project period for applications submitted in response to the present RFA may not exceed four years. The earliest feasible start date for the initial awards will be April 1, 1994. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background The purpose of this RFA is to provide support for Phase II scientifically-directed clinical trials with investigational anti-cancer agents. New therapeutic agents for cancer are initially investigated in patients by means of Phase I clinical trials designed to evaluate the pharmacology, toxicities, and biological effects of the agents. Agents that have favorable characteristics in the Phase I setting are then studied in Phase II trials designed to characterize their anti-tumor activity. If efficacy is established in a particular tumor site in Phase II testing, it may be necessary to study the agent alone, or in combination in further Phase II or even large scale randomized Phase III trials. Specifically, the objectives of Phase II trials are: a. when testing new agents that have just completed Phase I trials, to confirm that the dose and schedule chosen can be safely administered in subsequent Phase II trials; b. to determine the antitumor activity of existing antitumor agents that can be administered in significantly higher doses when used with colony stimulating factors or other factors that modulate toxicity or antitumor activity; c. to determine the antitumor activity of combinations of antitumor agents and modalities; d. to determine the spectrum of antitumor activity for new agents in selected human cancers. e. to gain further insight into the pharmacokinetics and metabolism of the therapeutic agent, its mechanisms of action and/or toxicity and identification of the particular patient population most likely to benefit from its effects through the performance of parallel biological studies. Recent advances in understanding of the pathobiology of malignancy are leading to the development of a wide range of novel anti-cancer therapeutic agents which require Phase II testing. These agents include new classes of cytotoxic agents derived from natural products, agents acting via immune-stimulatory effects, and agents targeted specifically to novel cancer cell targets, including surface receptors, signal transduction molecules, transcriptional factors, and particular DNA and RNA sequences. Furthermore, mechanisms of action of these new anti-cancer agents available for clinical study include not only the mediation of anti-cancer effects through classic direct anti-RNA or DNA synthesis cytotoxic mechanisms and indirect immunologic mechanisms, but also through growth inhibition by interruption of specific oncogene-associated biochemical functions, biochemical reversal of drug resistance to other anti-cancer agents, inhibition of protein synthesis through targeted toxins, induction of differentiation and/or programmed cell death (apoptosis), and through anti-tumor angiogenesis. In addition, new strategies to overcome resistance to conventional cancer therapeutic approaches are also of interest. In an attempt to reduce the time period between new drug discovery and the general introduction of an effective new therapy to patients, the NCI offers assistance at many levels to investigators attempting to develop active new cancer therapies. In addition to the funding assistance offered to the investigator(s) by this RFA, NCI may sponsor (in the Food & Drug Administration sense) or co-sponsor the agents under development. An organization or individual who assumes legal responsibilities for supervising or overseeing clinical trials with investigational agents is termed a sponsor. As sponsor of an investigational drug, DCT and specifically, CTEP, is responsible for seeing that clinical trials proceed safely and rationally from the initial dose-finding studies through to a definitive evaluation of the role of the new drug in the treatment of one or more specific cancer(s). Fulfillment of this goal obviously requires the active participation of CTEP staff throughout the entire process. NCI sponsorship of investigational agents increases the likelihood that agents will be further developed so that they will ultimately be broadly available for use in cancer treatment and will accelerate the time frame in which this process would occur. B. Research Goals and Scope The aims of this initiative are: (1) to provide support for Phase II trials of promising new anti-cancer agents, particularly in, but not limited to, tumors of special interest such as breast, ovarian, lung, and urologic cancers; and (2) to provide support for appropriate laboratory correlative studies in cancer patients receiving these anti-cancer agents. The laboratory studies should be in support of the clinical trial, such that their conduct leads to a greater understanding of the relationship between drug administration and biological changes in patients. Laboratory studies would include pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted anti-cancer agents, including monitoring of metabolites and intracellular products when appropriate, or other relevant pharmacology correlative studies. Measurement of particular biological responses would also be desirable particularly when this information would be relevant to the interpretation of the success or failure of the agent in individual patients entered into the Phase II trial (e.g., changes in signal transduction pathways, immune modulation, induction or suppression of specific gene function, other indicators of differentiation induction, or induction of apoptosis). Specific objectives and scientific approaches will be investigator-originated and should reflect the creativity and capability of the investigators. This RFA provides an opportunity for clinical and laboratory investigators within an institution or consortia of institutions to develop a program in drug development which utilizes the strengths of pre-existing basic scientific expertise and available clinical resources. The applicant/awardee Principal Investigator will select the specific agents to be tested in accord with their area of scientific interest and expertise and will develop a series of appropriate phase II trials with supporting protocol documents. The NCI may provide NCI-sponsored IND agents or provide assistance to the awardee by sponsoring or co-sponsoring other selected agents. Each Phase II awardee/consortium will be expected to complete on average two to three Phase II trials per year, with each trial encompassing 20 to 40 patients. In all categories of diseases, the awardee must select those patients for trial with the best performance status and with the minimum amount of prior treatment that is consistent with ethical medical practice. Sufficient numbers of patients should be available in order to allow completion of the trials in a timely manner. These trials should also include evaluation of laboratory parameters which reflect the biological or biochemical effects of therapy in a relatively homogeneous group of patients as preparations for larger studies which may show correlations with response or toxicity. Studies of regional drug administration will be permitted upon documentation of expertise with necessary techniques of drug delivery and pharmacology and evidence that this therapeutic approach might yield meaningful therapeutic benefit to patients. Similarly, exploration of the upper end of the dose-response curve, using appropriate approaches for protection of normal tissues, may be permitted in suitably documented circumstances. The Principal Investigator will ensure that these Phase II trials conform to accepted standards of patient care. For example, patients should: a. have a microscopically confirmed diagnosis of cancer; b. be staged by conventional methods and found to have disseminated disease not amenable to curative intent therapy with surgery and/or radiotherapy; c. have already received and failed appropriate initial systemic treatment. For diseases for which active systemic treatment exists (e.g., the acute leukemias, diffuse non-Hodgkin's lymphomas, Hodgkin's disease, testicular cancer, limited small cell lung cancer, ovarian carcinoma), patients should have received the minimum extent of prior treatment compatible with current ethical standards of care, and should have a high performance status. For other diseases in which only partially effective non-curative therapy is available (e.g., carcinomas of the head and neck, hormone-refractory prostatic carcinoma, bladder and stomach cancer, sarcomas), entry of patients with no prior therapy may be appropriate. d. receive appropriate initial and follow-up, hematologic, biochemical, radiologic. and immunologic investigations; and e. have given a signed informed consent indicating that they are aware of the investigational nature of the studies involved. Each applicant institution is responsible for coordination of protocol development and submission, study conduct, quality control and study monitoring, collection of data, data management and analysis, adherence to NCI requirements for investigational agents, adherence to FDA/DHHS regulations, and performance reporting of data from the Phase II trials. An applicant may consist of a consortia of institutions, each contributing scientific expertise and/or appropriate patient populations. Multi-institution studies must be conducted in accordance with the "DCT GUIDELINES FOR MULTICENTER INVESTIGATIONAL AGENT STUDIES" (available upon request from Dr. David Parkinson at address below). For selected Phase I and selected Phase II studies with NCI-sponsored investigational agents, the NCI has contracted for a Clinical Trials Monitoring Service (CTMS) to document regulatory compliance, to maintain a computerized data base of the biweekly Phase I/II investigator data submissions, and to produce periodic routine reports of the results and special reports as necessary. For selected Phase II studies, the awardee institution's source documentation will be reviewed on-site three times per year by the CTMS. Each applicant institution is responsible and accountable for both the use of the funds provided and for the performance of the cooperative agreement supported activity. SPECIAL REQUIREMENTS A. Minimal Requirements for Application 1. Investigators should include in the APPENDIX of the cooperative agreement application draft copies of proposed protocols that might be undertaken in the first year and should identify the particular areas of laboratory expertise which would be utilized in the performance of these trials. 2. The applicant must demonstrate in the application the ability to meet the following requirements: a. documented numbers of eligible patients with a history of adequate accrual to complete on average two to three Phase II trials annually. b. laboratory support within the institution to perform pharmacokinetic studies of cytotoxic, immune-modulating, differentiation-inducing, and/or targeted anti-cancer agents, including monitoring of metabolites and intracellular products when appropriate, or other relevant pharmacology correlative studies; c. technical expertise and evidence of specific focus (e.g., pathology, immunopathology, molecular biological support) within the institution which would allow the measurement of biological response particularly when this information would be relevant to the interpretation of the success or failure of the agent in individual patients entered into the Phase II trial (e.g., changes in signal transduction pathways, immune modulation, induction or suppression of specific gene function, other indicators of differentiation induction, or induction of apoptosis); d. adequate central data collection and processing capabilities as well as biostatistical expertise and the capability to meet FDA requirements for the conduct of research using investigational agents. These specifically include: 1) Supplying required information via study summary reports to CTEP and the capability to transmit patient data to the NCI's Clinical Trials Monitoring Service (CTMS) on a biweekly basis for selected trials. 2) prompt reporting of ADRs to CTEP for investigational agents supplied by NCI in accordance with the CTEP guidelines (mailed annually to all registered investigators). e. adequate pathology support for tumor classification and for banking and distribution of tumor tissues for concurrent and future studies. f. adequate mechanisms in place to ensure that all patients: 1) have histologically confirmed diagnosis of cancer; 2) have refractory disease not amenable to therapy with curative intent using surgery, chemotherapy, and/or radiotherapy or any other form of known effective therapy; 3) have acceptable performance status and acceptable renal, liver, and hematologic function; and 4) have given signed informed consent in accordance with 45 CFR 46, Protection of Human Subjects, indicating that they are aware of the investigational nature of the studies involved. g. adequate mechanisms for monitoring accrual performance and criteria for continued participation by each participating institution. 3. The applicant institution and each participating institution associated with an applicant consortium must demonstrate the ability to meet the following requirements: a. Evidence of a level of supportive care appropriate for the treatment of patients with advanced malignancies; b. Adequate patient accrual with annual monitoring to assure continued enrollment of patients on Phase II trials. c. Intensive care and blood bank facilities on-site and functioning 24 hours per day. d. Adequate physician, nursing and data management resources to comply with all data reporting requirements (through the PI) of NCI-sponsored Phase II trials. e. Appropriate drug accountability procedures as required for utilization of NCI-supplied investigational agents. 4. In the case of consortium applications, the applicant must demonstrate how it will collect, analyze and report data from Phase II trials; and how it will coordinate protocol development and submission, study conduct, quality control and study monitoring, data management and analysis, adherence to requirements regarding investigational drug management and federally mandated regulations, and protocol and progress reporting. 5. All costs required for these studies must be included in the application and must be fully justified. These costs include the additional costs of clinical research associated with Phase II studies including costs for patient accrual, sample handling, laboratory studies, quality assurance, data management and data analysis, study monitoring, travel, an on-site audit program and the biweekly electronic data submissions to the NCI's Clinical Trials Monitoring Service when required. For Phase II trials with DCT IND agents for which the awardee is responsible for providing the on-site monitoring, the awardee shall contract with the NCI's Clinical Trials Monitoring Service for the performance the audits. The awardee(s) will be expected to provide two audits per institution during the cooperative agreement period and to request funding accordingly. Funds requested for the audit program will be restricted for this purpose only. The on-site audit requirements are described in the section entitled SPECIAL REQUIREMENTS, TERMS OF COOPERATION, RESPONSIBILITIES OF AWARDEE. 6. If capitation costs are requested as reimbursement for patient accruals, the cost per patient must be broken down and justified, e.g.: a. estimate of physician time spent on research (e.g., to obtain informed consent, to fill out data forms, and others) and the resultant cost. Time spent delivering standard medical care is not allowable. b. estimate of data manager or nurse time to meet research requirements (e.g., compiling and mailing data, specimens) and the resultant cost. c. cost of mailing or handling research-related patient specimens, forms, materials (e.g., slides, X-ray) d. other consultant costs (e.g., pathology, radiology). 7. Travel funds for one meeting per year for two representatives from an Institution should be included in the budget. The applicant should also request funding for the initial Phase II strategy meeting. B. Terms of Cooperation The following Terms of Cooperation are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74 and 92, and other HHS, PHS and NIH grant administration policy statements. The NCI arbitration process for the cooperative agreement in no way affects the rights of awardees to appeal selected post award administrative decisions in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. Nature of Participation By NCI Staff The role of the Cancer Therapy Evaluation Program (CTEP) staff as described throughout these terms of cooperation is to assist and facilitate but not to direct research activities. This cooperative agreement is part of a larger program of investigational agent development in the NCI. Each of the CTEP staff listed below has very specific and well defined responsibilities in terms of investigational agent development and the role of DCT as a drug sponsor as defined in CFR 21 Part 312. 1. CTEP as a Scientific Resource for NCI-supported Phase II Clinical Trials Investigations The NCI Program Director (see INQUIRIES) will serve as a resource available to the Principal Investigator (PI) for specific scientific information with respect to treatment regimens and clinical trial design. The NCI Program Director will assist the PI as appropriate in developing information concerning the scientific basis for specific trials and also will be responsible for advising the PI of the nature and results of relevant trials being carried out nationally or internationally. The NCI Program Director will also provide updated information on the efficacy and toxicity of investigational new agents supplied to the PI under an Investigational New Drug (IND) Application sponsored by the DCT. The NCI Program Director will sponsor an initial Phase II strategy meeting with the PIs to review the research plans proposed by each individual research group to ensure that they are compatible with the overall goals of the RFA, to ensure avoidance of duplication of effort with other ongoing clinical trials and to ensure the most effective use of available resources including investigational agents. An arbitration system, as detailed below, will be available to resolve disagreements between the NCI and the awardee institution(s). The NCI Program Director will sponsor annual Phase II strategy meetings to review relevant scientific information, to review progress in the clinical trials, and to review the status of newly available investigational agents in order to plan future activities. 2. CTEP Assistance in Protocol Development A protocol is the detailed written plan of a clinical experiment. The protocol must be mutually acceptable to the PI and to the CTEP Protocol Review Committee (PRC), which must review and approve every protocol involving DCT investigational agents. The PRC is chaired by the Associate Director, CTEP, and is comprised of professional staff of the DCT including drug monitors, disease coordinators, regulatory staff, pharmacy staff and ad hoc reviewers external to NCI when deemed appropriate by the PRC chairperson. Communication at the various stages of protocol development is encouraged as necessary to promote protocol development and implementation. All protocols should be preceded by a written declaration of interest in conducting a particular study from the PI using the format described in the GUIDELINES FOR SUBMITTING LOIs - Letter of Intent/INVESTIGATIONAL DRUG TRIAL (available upon request from Dr. David Parkinson at the address below). The LOI should be sent to the CTEP LOI Coordinator who receives, logs in and schedules LOIs for review by the PRC (see RESPONSIBILITIES OF AWARDEES). The PRC will formally review the LOI. Following LOI review, the NCI Program Director will provide a Program response to the PI and will address the following issues: a) the existence and nature of concurrent clinical trials in the area of research, pointing out possible duplication of effort; b) information including relevant pharmacokinetic and pharmacodynamic data concerning investigational agents; c) availability of investigational agents, including biologic response modifiers; d) the scientific rationale and value of the proposed study, the design, the statistical requirements; and e) the implementation of the study, if indicated. The LOI mechanism is designed for preliminary review and is recommended to expedite protocol development and implementation and to facilitate agreement on study priority and design (see the DCT Investigator's Handbook, pp 32-35, available on request from Dr. David Parkinson at the address below, for further discussion of these mechanisms). 3. CTEP Review of Proposed Protocols The awardee protocols will be reviewed by the PRC which meets weekly. It will be chaired by the Associate Director, CTEP. Ad hoc reviewers, external to NCI, will be utilized when deemed appropriate by the PRC chairperson. An Investigational Drug Branch (IDB) Physician (Drug Monitor) is assigned to each DCT IND agent to assist in the coordination of its development. Following the review of the protocol by the PRC, the NCI Program Director will provide the PI with a consensus review prepared by the IDB Drug Monitor. The consensus review describes required or recommended modifications and other suggestions, as appropriate. The NCI Program Director will not serve as the consensus reviewer. (See the DCT Investigator's Handbook, for further information regarding protocol review at CTEP). The major considerations relevant to Protocol Review by CTEP include: a) the strength of the scientific rationale supporting the study; b) the medical importance of the question being posed; c) the avoidance of unnecessary duplication with other ongoing studies; d) the appropriateness of study design with respect to development of the IND agent; e) a satisfactory projected accrual rate and follow-up period; f) patient safety; g) compliance with federal regulatory requirements; h) adequacy of data management; and i) appropriateness of patient selection, evaluation, assessment of toxicity, response to therapy and follow-up. If a proposed protocol is disapproved, the specific reasons for lack of approval will be communicated by the NCI Program Director to the PI as a consensus review within 30 days of protocol receipt by the NCI. The NCI Program Director will be available to assist the PI in developing a mutually acceptable protocol, consistent with the research interests, abilities and strategic plans of the PI and of the NCI. Disagreements arising pursuant to protocol approval will be submitted to an arbitration panel to determine the suitability of a protocol that has been disapproved. An arbitration panel composed of one awardee institution nominee, one NCI nominee, and a third member with clinical trials expertise chosen by the other two nominees will be formed to review the CTEP decision and recommend an appropriate course of action to the Director, DCT. These special arbitration procedures in no way affect the awardee's right to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. NCI will not provide investigational agents or permit expenditure of NCI funds for a protocol that it has not approved unless CTEP's disapproval has been modified by the arbitration process outlined above. 4. CTEP Review of Quality Control and Study Monitoring The Head, Quality Assurance and Compliance Section (QACS), RAB, CTEP will review and provide advice, through the NCI Program Director, regarding mechanisms established by the awardee institution for study monitoring including the awardee's on-site monitoring program. (See 9. CTEP Review of Federally Mandated Regulatory Requirements.) 5. CTEP Review of Data Management and Analysis The Chief, Biometrics Research Branch (BRB), CTEP will review awardee institution mechanisms for data management and analysis. (See RESPONSIBILITIES OF AWARDEES). When deemed appropriate, the Chief, BRB will make recommendations to the PI, through the NCI Program Director, to ensure that data collection and management procedures are: a) adequate for quality control and analysis; b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and c) sufficiently uniform across the consortia participants. 6. Access to Data The NCI will have access to all data generated under this cooperative agreement and will periodically review the data. Data must also be available for external monitoring as required by NCI's Drug Master File Agreement with the FDA relative to the responsibility of the NCI as an IND agent sponsor. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies. 7. CTEP Involvement in Protocol Closure The NCI Program Director will monitor protocol progress. When a study involves a DCT IND agent, the Head, QACS and the IDB Drug Monitor as well as the NCI Program Director will monitor protocol progress. The NCI Program Director or the IDB Drug Monitor may request that a protocol be closed to accrual for reasons including: a) insufficient accrual rate; b) accrual goal met; c) poor protocol performance; d) patient safety and regulatory concerns; e) study results are already conclusive; f) emergence of new information that diminishes the scientific importance of the study question; and g) failure to collect data in a timely manner. NCI will not provide investigational agents or permit expenditures of NCI funds for a study after requesting closure (except for patients already on-study). If disagreements develop over NCI-recommended study closure for reasons other than patient safety or regulatory concerns, NCI will establish an arbitration process identical to that described above for protocol disapproval. 8. CTEP involvement in Investigational New Drug Applications a. The NCI will have the option to cross file or independently file an IND on investigational agents evaluated in the Phase II Clinical Trials. This would apply to agents not primarily developed in the NCI drug development program. b. The NCI Program Director assisted by the Chief, Regulatory Affairs Branch (RAB), CTEP, will advise investigators of specific requirements and changes in requirements concerning IND sponsorship that the FDA may mandate. Investigators performing trials under cooperative agreements will be expected, in cooperation with the NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. c. Investigators performing NCI funded Phase II Clinical Trials will be advised by the NCI Program Director of potential studies that will be relevant to new avenues of cancer therapy. When this involves investigational agents, the NCI Program Director assisted by the Chief, RAB, CTEP will advise the investigators of the specific clinical information that will be needed from the clinical trials for that information to be acceptable to the FDA for inclusion in a new drug application (NDA). 9. CTEP Review of Federally Mandated Regulatory Requirements The Head, QACS, through the NCI Program Director, will advise the PI regarding mechanisms to meet FDA regulatory requirements for studies involving DCT-sponsored investigational agents and the Office for Protection from Research Risks (OPRR) requirements for the protection of human subjects by the awardee institutions. (See RESPONSIBILITIES OF AWARDEES). For specific Phase I and Phase II trials with NCI-sponsored investigational agents, the NCI has contracted for a Clinical Trials Monitoring Service (CTMS) to document regulatory compliance, to maintain a computerized data base and to produce periodic routine reports of the results and special reports as necessary. For specific Phase II trials, the NCI Program Director shall assign CTMS monitoring if the PRC expresses concern with excessive toxicity. For these trials, source documentation will be reviewed on-site three times per year by the CTMS. For Phase II trials with DCT IND agents not requiring the above described monitoring, NCI will delegate to the awardee the task of providing an independent audit of each research study. The NCI's Clinical Trials Monitoring Service (CTMS) contractor shall be used to conduct these audits. The staff of QACS will perform random audits of the awardee to assure that the awardee is performing the delegated audit duties. Audit schedules and final audit reports will be provided to QACS, CTEP. Institutional responsibilities for monitoring are described below under RESPONSIBILITIES OF AWARDEES Section 7.c). 10. CTEP Review of Progress Progress will be reviewed at least annually by the NCI Program Director on the basis of the information provided at the annual Phase II strategy meetings, in the continuation application, in the study summary reports submitted to the IDB Drug Monitor or by CTMS reports. In addition, periodic accrual information may be requested from the PI by the NCI Program Director for all active studies when deemed appropriate. Insufficient patient accrual or progress, or noncompliance with the terms of award, including these Terms of Cooperation, may result in a reduction of budget, withholding of support, suspension or termination of the award. Responsibilities of Awardees It is the responsibility of the PI to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The PI shall, with CTEP assistance, develop Phase II protocols for clinical cancer research in accord with its research interests, abilities and goals and in accord with research goals established at the Phase II strategy meetings and submit them to CTEP (either to the Letter of Intent (LOI) Coordinator or to the CTEP Protocol and Information Office, the receiving office for all protocols sent to CTEP) for review as appropriate prior to their implementation. 1. Protocol Development The PI shall designate a Protocol Chairperson for each proposed study. The PI will be responsible for communication with the appropriate CTEP staff. The PI, with CTEP assistance, is responsible for coordinating protocol development, protocol submission, study conduct, quality control and study monitoring, drug ordering, data management and analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug management and federally mandated regulations and protocol and performance reporting. 2. Protocol Submission The PI will submit protocols to the CTEP Protocol and Information Office in a timely fashion for review and approval by NCI. All protocols should be preceded by a written LOI for Investigational Drug Trials from the PI to the CTEP LOI Coordinator declaring interest in conducting a particular study. The LOI shall describe the hypothesis to be investigated, the general design of the contemplated trial plus relevant information on accrual capabilities to document feasibility. Protocols from multi-institution consortia will be developed and submitted and studies will be conducted in accordance with the "DCT GUIDELINES FOR MULTICENTER INVESTIGATIONAL AGENT STUDIES" (available upon request from Dr. David Parkinson at the address below). The PI will communicate the results of the NCI review of protocols to the consortia institutions. 3. Quality Control The awardee institution will establish mechanisms for quality control of therapeutic and diagnostic modalities employed in its trials. Quality control at a minimum must consist of: a. Pathology: Verification of pathologic diagnosis in cases where known variability in the accuracy of histologic diagnosis is a potentially serious problem and where pathology data may provide important prognostic information. b. Radiation Therapy: Review (either concurrent or retrospective) of port films and compliance with protocol- specified doses for individual patients, where relevant. Determination of adequacy of radiation delivery with the assistance of the Radiological Physics Center (RPC), whose functions usually include equipment dosimetry, periodic institutional visits and other aspects of physics review. c. Chemotherapy: Review of flow sheets with determination of protocol compliance in dose administration and dosage modification. d. Surgery: Assessment of adequacy of protocol-specified surgical procedures (where relevant) through review of operative notes and study-specific surgical forms. 4. Study Conduct and Monitoring The awardee institution will establish mechanisms for study monitoring. The awardee is responsible for ensuring accurate and timely knowledge of the progress of each study through: a. registration, tracking and reporting of patient accrual and adherence to defined accrual goals; b. ongoing assessment of case eligibility and evaluability; c. timely medical review and assessment of patient data; d. rapid reporting of treatment-related morbidity (adverse drug reactions) and measures to ensure communication of this information to all parties; e. interim evaluation and consideration of measures of outcome, as consistent with patient safety and good clinical trials practice; f. timely communication of results of studies; g. an on-site monitoring program (see 7.c) below); and h. establishing data management support capabilities that ensure that data will be submitted via electronic transfer biweekly to NCI's Clinical Trials Monitoring Service (CTMS) if appropriate. (See 7.d. below). 5. Data Management and Analysis The awardee institution will develop procedures to ensure that data collection and management are: a) adequate for quality control and analysis; b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and c) sufficiently uniform across the consortia institutions. 6. Investigational Drug Management Investigators performing trials under cooperative agreements must be NCI registered investigators (Form FDA 1572) and will be expected to implement CTEP requirements described in the DCT Investigators' Handbook for storage and accounting for investigational agents, to abide by NCI/HHS Drug Accountability Records (DAR) procedures, and to comply with all FDA requirements for investigational agents. 7. Compliance with Federally Mandated Regulatory Requirements The awardee institution is responsible for establishing procedures for all participating institutions to comply with FDA regulations for studies involving investigational agents and OPRR requirements for the protection of human subjects. These procedures are: a. methods for assuring that the awardee institution and each institution where investigators are conducting Phase II trials has a current, approved assurance on file with the OPRR; that each protocol is reviewed and approved by the responsible Institutional Review Board (IRB) prior to patient entry; that each protocol is reviewed at least annually by the IRB so long as the protocol is active; that amendments are approved by the IRB; that each investigator is registered with the Drug Management and Authorization Section (DMAS), CTEP with a current form FDA 1572 on file; and that each patient (or legal representative) gives written informed consent prior to entry on study. b. a system for assuring timely reporting of all serious and unexpected toxicities to the IDB, CTEP according to CTEP guidelines (mailed annually to all registered investigators). This may require reporting Adverse Drug Reactions (ADRs) by telephone to the IDB Drug Monitor within 24 hours of the event and requires a written report to follow within 10 working days. c. an on-site monitoring program which assures that a sampling of records at each participating institution is audited at least two times during the cooperative agreement period. The on-site audit will address issues of data verification, protocol compliance and compliance with regulatory requirements for the protection of human subjects and investigational agent accountability. Any serious problems with data verification or compliance with Federal regulations must be reported to the Head, QACS immediately. Otherwise, written reports must be submitted within six weeks of each audit. All audit schedules are to be provided to the Head, QACS at least 4 weeks prior to the date of the audit. d. For the specific Phase II trials that require monitoring by the CTMS three times per year, information must be provided via electronic transfer to the CTMS at two week intervals and includes: registration of each patient entered onto a Phase II protocol within the previous two week period, and all data obtained on each registered patient within the previous two weeks as specified by the NCI/DCT Standard Case Report Form and the individual protocol. 8. Progress Review For multi-institution trials, the PI will establish a mechanism for assessing performance of its consortia participants, with particular attention to accrual of adequate numbers of eligible patients onto consortium trials, timely submission of required data and conscientious observance of protocol requirements. This mechanism will include a procedure for recommending an adjustment of institutional funds within the consortium as appropriate for the level of participation in consortium activities, including (but not limited to) accrual. If the Progress Review indicates poor performance by a participating institution, the awardee may replace the institution. Any changes in the participating institutions should be noted in the application for continuation grant (PHS 2590 Rev 9/91). If during the course of the budget period the awardee chooses to change consortium institutions, the new consortium must have an approved Assurance of Compliance for the Protection of Human Subjects on file with OPRR. The awardee will be responsible for assuring that no patients are accrued to a protocol at a participating institution until the protocol has been reviewed and approved by the IRB. If a change in consortium institution involves adding a foreign consortium, a change in key personnel, or change of scope or research objectives, the awardee must request the prior approval of the NCI. The procedure for requesting prior approval is described in the "Methods for Grantees to Request Approvals", PHS Grants Policy Statement, p. 8-6. 9. Attendance at Meetings The PI or appropriate representative(s) of the awardee institution, shall attend the initial Phase II strategy meeting. At the initial strategy meeting, the PIs and the NCI Program Director, assisted by other CTEP staff, will review the research plans proposed by each individual research group to ensure that they are compatible with the overall goals of the RFA, to ensure avoidance of duplication of effort and to ensure the most effective use of available resources including investigational agents. The PI or appropriate representative shall attend the annual Phase II strategy meetings to review relevant scientific information, to review progress in the clinical trials, and to review the status of newly available investigational agents in order to plan future activities. 10. Reporting Requirements Reporting requirements will be in agreement with FDA regulations and NCI procedures. Annual progress reports will be submitted to the NCI and will include at a minimum summary data on protocol performance by the awardee and each participating institution. In addition, study summary reports will be requested prior to the due date of the annual report to the FDA required of IND sponsors. A system for providing such information in a timely manner must be in place. 11. Publication of Data Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgement of NCI support. The NCI will have access to all data generated under this cooperative agreement and may periodically review the data. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and women of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in the Research Plan, 1-4, AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1993, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. David R. Parkinson at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441; and from the NCI Program Director named below. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Because the Terms of Cooperation discussed above will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with staff involvement. Submit a signed, typewritten original of the application, including the Checklist, and three signed single-sided photocopies, in one package with the appendices to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 650 6130 Executive Boulevard Rockville, MD 20892 Applications must be received by June 10, 1993. If an application is received after that date, it will be returned. If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS A. Review Procedure Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are judged to be non-responsive will be returned by the NCI. Applications judged to be non-responsive to this RFA may be submitted as an investigator initiated regular research grant (R01) or program project grant (P01) at the next receipt date. The application would require modification in accordance with either the R01 or P01 guidelines. The revised application would not be considered an application for a Cooperative Agreement nor would it be considered a response to an RFA. Questions concerning the responsiveness of proposed research to the RFA are to be directed to program staff (see INQUIRIES). Applications may be triaged by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical review by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review will be provided by the National Cancer Advisory Board. B. Review Criteria The factors considered in evaluating the scientific merit of each application will be: 1. scientific, technical, medical significance and originality of proposed research as reflected in the protocols, research plans and strategies that address the clinical and laboratory considerations for Phase II studies using cytotoxic and biologic agents alone or in combination; evidence that the proposed scientific studies would contribute to a greater understanding of the nature of the therapeutic agent which may include but are not limited to an understanding of its mechanism of action, mechanisms of resistance, or differences among patients with respect to pharmacology or metabolism. 2. appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research including: a. adequacy of plans for the development, implementation and analysis of Phase II clinical trials b. adequacy of plans for correlative laboratory studies and evaluation of the data with respect to treatment administration or treatment outcome c. adequacy of statistical approach for correlating research studies with treatment outcomes in Phase II trials. d. adequacy of plans for effective collaboration among laboratory, clinical, and statistical investigators. e. adequacy of mechanisms for quality control, study monitoring, data management and reporting, data analysis, investigational drug management, and compliance with regulatory requirements 3. qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively, in the area of the proposed research including: a. experience and competence of the Principal Investigator and clinical investigators in the development, implementation and analysis of Phase II trials. b. adequacy of proposed time commitment by the Principal Investigator and Co-Investigators. c. experience in the daily management and treatment of patients with various malignant tumors and assessment of eligibility/evaluability of these patients in cancer clinical trials. d. experience of the investigators in obtaining blood and/or tissue specimens for research purposes from patients entered onto clinical trials and the evaluation of those data with respect to treatment administered or treatment outcome. e. experience in performance of laboratory/correlative studies relevant to the development of a class of anticancer therapeutic agents and evaluation of the data with respect to treatment administration or treatment outcome. 4. availability of resources necessary to perform the research including: a. adequacy of the available facilities for clinical and laboratory/correlative studies, data management resources, and patient population. b. demonstration of availability of and access to appropriate numbers of patients eligible to receive defined treatments on phase II clinical trials and to appropriate human tissue with the associated pathological data and clinical follow-up. c. For multi-institutional applications: 1) adequacy of mechanisms for coordination of patient entry and review of trial results as the study progresses; 2) adequacy of methods for collection of data collection and reporting from each institution ; and 3) for studies in which blood or tissue samples will be obtained from patients, adequacy of methods for shipment of specimens from the institution to the appropriate laboratory. 5. adequacy of provisions for the protection of human subjects and the humane treatment of animals (if laboratory studies involving animals are proposed). 6. Adequacy of the plans for inclusion of women and minorities. 7. Commitment to accept provisions outlined under Terms of Cooperation. The reviewers will also judge the appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is April 1, 1994. In addition to the technical merit of the application, NCI will consider how well the Applicant Institution met the goals and objectives of the program as described in the RFA, availability of resources, and balance of study populations. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA and inquiries about whether or not specific proposed research would be responsive are strongly encouraged and may be directed to the program staff listed below. The program staff welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Dr. David Parkinson Chief, Investigational Drug Branch Cancer Therapy Evaluation Program National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-5223 FAX: (301) 480-4663 Direct inquiries regarding fiscal matters to: Joan Metcalfe Grants Management Specialist National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 28 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV Sections 301, 410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC 285a) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 5, pt. 5, 5 February 1993 Message-ID: Date: 6 Feb 93 01:00:56 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1199 $$XID RFA HD93011 HD-93-011 P1O1 *************************************** BIOMATERIALS TO RESTORE FUNCTION IN PEOPLE WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA: HD-93-011 P.T. National Institute of Child Health and Human Development National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: April 26, 1992 Application Receipt Date: May 25, 1993 PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) and the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) invite research grant applications to develop new biomaterials that will be used to improve function in people with physical disabilities. The goal of this RFA is to stimulate high risk, innovative research projects that will provide preliminary data leading to the development of novel materials designed to restore, improve, or enhance function lost as a consequence of injury, disease, or congenital disorder. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This Request for Applications (RFA), Biomaterials to Restore Function in People with Physical Disabilities, is related to the priority areas of chronic and disabling conditions and the goal to reduce health disparities among Americans. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) investigator initiated research project grant (R01 ) mechanism. Applications submitted in response to the present RFA may not exceed two years and the total direct costs for the first year may not exceed $50,000 and a total of $100,000. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The earliest anticipated award date will be September 1993. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Applications submitted in response to this announcement will compete for direct costs of approximately $500,000 from the NICHD and $150,000 from the NIAMS that have been made available for this purpose in Fiscal Year 1993. It is expected that 10 awards will be made by the NICHD and three by the NIAMS. The number of awards depends upon the overall scientific merit of the proposals, their relevance to the stated goal of the announcement, and the availability of funds. RESEARCH OBJECTIVES Background Between 35 and 43 million Americans have one or more conditions that result in a limitation of life activities. The annual disability-related costs to the nation are in excess of $170 billion. These limitations may result from either injury, disease or birth defect. During the past decade, remarkable advances have been made in biotechnology and in characterizing tissue interactions. These advances now permit the development of novel biocompatible materials that can lead to the restoration of function in persons with physical disabilities. The goal of the NCMRR is to promote research that will lead to the replacement, enhancement or restoration of function in persons with physical disabilities in order to maximize their functional capabilities, both immediately after the onset of the disabling condition and throughout the lifespan. The NCMRR has identified seven research priority areas. This RFA will address three of these areas: the improvement of mobility, the whole body systems response to chronic injury, and advances in assistive technologies. Included in the goals of the NIAMS are promoting and funding research on the basic biology, injury, and chronic diseases of structural and connective tissues, such as bone, muscle, ligament, tendon, cartilage, and skin. As such, research on novel biomaterials may be targeted to treatment of these conditions. Scope The purpose of this RFA is to develop a grant program that will provide funds to support exploratory studies leading to the development of novel genetically engineered biomaterials, to encourage research into the modification of biological products that can be used to stimulate the regeneration of tissues, and to produce delivery vehicles that will supply gene products necessary to maintain function or reduce the process of further injury. The following list of topic areas, though not inclusive, serves as a guide for potential applications under this grant program: o development of coating materials that will render implanted devices biocompatible o development of modified extracellular matrix materials that can serve as substrates or scaffolding that will enhance regeneration of neurons, supporting cells, and other soft tissues after long-term injury o development of ion-sensitive films/materials that can be attached to biological membranes to detect and enhance residual neuronal activity in chronically injured systems o identification of novel biopolymers that can act as microcapsules to provide slow release of genetically modified gene products o development of skin substitutes for healing of decubitus ulcers o development of implantable or cutaneous biosensors to detect pressure and cutaneous breakdown o modification of natural products to reduce scarring both in the nervous system and in soft tissues o development of materials to immunologically isolate implanted materials o development of genetically modified cell lines that can be introduced into sites of injury and tissue loss to stimulate regeneration of neurons, muscle, and connective tissues o development of biomaterials that will improve sphincter function STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS It is NIH policy that applicants for NIH clinical research grants will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group together with a rationale for its choice. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included on the grant application form PHS 398 in Sections 1-4 of the research plan and summarized in Section 5, (Human Subjects). Applicants are urged to carefully assess the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial or ethnic minority populations (i. e., Native Americans [including American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics]. The rationale for limiting studies to one minority population group should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies on etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissue from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, applicants must discuss the relevance of research involving foreign population groups to the United States populations, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Potential applicants are strongly encouraged to submit a letter of intent by April 26, 1993. The letter of intent is requested for planning purposes only and should include: the name of the Principal Investigator, a descriptive title of the potential application, identification of the organization involved and the RFA number and title. The letter of intent is to be addressed to Dr. Danuta Krotoski at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). This application form is available in the business or grants and contracts office at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The receipt deadline for applications prepared in response to this RFA is May 25, 1993. Late applications will not be accepted. This is a one-time announcement. The RFA label available in the 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 in that it may not reach the review committee in time for evaluation. Check "yes" in item 2a on the face sheet of the application and type "Biomaterials to Improve Function in People with Physical Disabilities." The outside of the application packages should also be marked "Response to RFA HD-93-011. The original and three copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the application must be sent under separate cover to: Susan Streufert, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03F Rockville, MD 20892 REVIEW CONSIDERATIONS Applications will be reviewed by staff of the NICHD for responsiveness to the RFA. Applications deemed non-responsive will be returned to the applicant. In the event that an application is returned, the applicant has the option to resubmit it for review in competition with unsolicited applications at the next review cycle. The DRG will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Responsive applications may be evaluated by a preliminary triage in a peer review group to determine their scientific merit relative to other applications received in connection with this RFA. NIH staff will withdraw from competition those applications judged to be non-competitive. The Principal Investigator and his/her institutional business official will be notified in such instances. Those applications judged to be competitive will be further evaluated for technical and scientific merit by a special review panel convened for this purpose by the Division of Scientific Review, NICHD. Review criteria will be those normally used by the NIH to evaluate investigator-initiated research grant applications, including: o Thorough knowledge of scientific literature in appropriate fields o Scientific, technical, or medical significance and originality of proposed research o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research o Qualifications and research experience of the Principal Investigator and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to perform the research o Appropriateness of the proposed budget and duration in relation to the proposed research Following the initial review by the special review committee, all applications will be reviewed by the NICHD or NIAMS National Advisory Councils. AWARD CRITERIA Awards will be made on the basis of the quality of the proposed project as determined by peer review, program balance among research areas, and level of funding set aside for this RFA. INQUIRIES Requests for additional information and descriptions of proposed research projects may be directed to: Danuta Krotoski, Ph.D. Chief, Basic Rehabilitation Medicine Research Branch National Institute of Child Health and Human Development Executive Plaza South, Room 450W Bethesda, MD 20892 Telephone: (301) 402-2242 or Stephen Gordon, Ph.D. Chief, Musculoskeletal Diseases Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 407 Bethesda, MD 20892 Telephone: (301) 402-3338 For fiscal and administrative inquires, applicants may write or call: Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F Bethesda, MD 20892 Telephone: (301) 496-1303 or Carol Clearfield Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room D Bethesda, MD 20892 Telephone: (301) 402-3360 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.929 (Medical Rehabilitation Research) and 93.846 (Arthritis and Musculoskeletal and Skin Disease Research). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA NR93003 NR-93-003 P1O1 *************************************** STUDIES OF CLINICAL OUTCOMES AND NURSING PRACTICE NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA: NR-93-003 P.T. 34; K.W. 0785130, 0755018 National Center for Nursing Research Letter of Intent Receipt Date: March 26, 1993 Application Receipt Date: April 29, 1993 PURPOSE The National Center for Nursing Research (NCNR) invites research grant applications to investigate methodological and measurement issues that occur when studying clinical outcomes that result from nursing care. The intent of this Request for Applications (RFA) is to support methodological research that facilitates the collection and analysis of data to be used to answer questions about the effectiveness of clinical intervention strategies. Specific measurement issues to be supported include examination of existing or development of new clinical outcomes measures to determine their sensitivity, appropriateness, validity, and reliability for differentiating and measuring the influence of nursing practice. 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, Studies of Clinical Outcomes and Nursing Practice, is related to most of these priority areas. Potential applicants may obtain a copy of the "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit or non-profit, public and private, organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation and it anticipated that most of the awards will be for new (Type 1) applications. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to customary peer review procedures. The total project period for applications submitted in response to the present RFA may not exceed four years. Because the nature and scope of the research proposed in response to the RFA may vary, it is anticipated that the size of an award will vary also. The anticipated average direct cost award per year is $75,000. The anticipated award date will be September 30, 1993. FUNDS AVAILABLE It is estimated that up to $600,000 dollars will be available to fund the first-year total costs of applications submitted in response to this RFA. It is anticipated that five to six applications will be funded. 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 NCNR, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES 1. Develop and test methods to assess the effect of clinical interventions on outcomes of patients receiving nursing care. 2. Examine existing or develop new measures of clinical outcomes to determine their appropriateness, sensitivity, validity and reliability in measuring the effect of nursing care. This initiative is based on the recommendations of an NCNR sponsored conference held in 1992 to review the state-of-the-science of patient outcomes research, specifically focusing on the effectiveness of nursing practice. The proceedings of this conference, "Patient Outcomes Research: Examining the Effectiveness of Nursing Practice," are available from the NCNR program contact listed under INQUIRIES. This publication contains all the scientific papers presented at the conference, including analyses of current approaches to methods and measurement in clinical outcomes research. The NCNR is interested in methodological studies that consider ways of measuring the effect of nursing practice on the outcomes of clinical care. This information is needed to assist in improving quality of care, to increase knowledge about the most appropriate use of clinical intervention strategies, and to inform overall clinical decision making. All populations who are recipients of nursing care and who receive nursing interventions are appropriate target populations of studies in response to this RFA (for example, populations with clinical conditions such as pain, pressure ulcers, urinary incontinence, nausea and vomiting, depression, fatigue, and illness-related stress; or who are receiving nursing home care, home care or acute care). Applicants are encouraged to take an interdisciplinary approach in the design of the studies proposed and to include interdisciplinary scientific team members. It is anticipated that applications submitted in response to this RFA will focus on quantitative approaches to study designs. The traditional approaches to examining clinical outcomes have focused on measures of mortality, morbidity, and disability. These approaches are used on groups of individuals across settings who have common diagnoses or clinical conditions, frequently using existing databases, such as the Medicare administrative files. More recently other measures of clinical outcomes, such as quality of life, functional status, health status, and patient satisfaction have been used. Questions have been posed about the extent to which these approaches to measuring patient outcomes are sensitive to the influence of nursing practice, particularly the results of nursing interventions. Considering ways to distinguish the influence of clinical care provided by clinicians of various disciplines, particularly nurses, on patient outcomes from a measurement perspective may assist in the development of more effective treatments and interventions. Examination of more recent measures from the perspective of appropriateness, sensitivity, validity and reliability in determining the influence of nursing practice on clinical outcomes is needed. An example of an issue important to outcome measurement that needs to be developed is symptom intensity. The management of clinical symptoms is a major concern of nurses in clinical practice, and a number of clinical interventions strategies have been tested for commonly occurring symptoms. Measures of symptom intensity are available for some symptoms, such as pain and pressure ulcers. Studies are needed that examine existing or new measures of symptom intensity as clinical outcomes measures that may capture the results of nursing interventions. Studies of clinical outcomes have used existing data sets as sources of information, such as those for Medicare recipients. Other types of existing data sets include those developed from hospital medical records using the discharge summary or registries of patients with specific diagnoses or receiving specific treatments. These data sets are rich in clinical information, but they rarely have information specific to the nursing care planned for or received by the persons whose medical records are included in the data sets. Studies focused on developing proxy measures for nursing care in such data sets could facilitate the use of existing data sources in clinical outcomes research. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS' NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of disease, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies, If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by March 26, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the names of other key personnel and consultants, the participating institution(s), and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is extremely helpful in planning for the review of applications. It allows NCNR staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Ethel Jackson, D.D.S. Chief, Office of Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used to apply for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449 Bethesda, MD 20892, telephone 301-496-7441. The RFA label available in the application form must be affixed to the bottom of the face page. Failure to use this label could delay processing of the application such that it may not reach the review committee in time for review. In addition, on line 2a of the face page of the application, enter "Studies of Clinical Outcomes and Nursing Practice, NR-93-003" in the provided space and the YES box must be marked. Submit a signed original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ethel Jackson, D.D.S. Chief, Office of Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 If the applicant has an approved assurance covering the research, the applicant must provide it with the application certification of Institutional Review Board (IRB) approval if human subjects are involved. These reviews and approvals should occur prior to submission of the application for award and the certifications should be submitted with the application. There is no 60 day grace period for RFAs. If human subjects will be subjects of the research at performance sites other than the applicant organization, the applicant must identify, in the application, the assurance status of each participant. Failure to provide required certifications in the application could result in delay of an award. Instructions regarding inclusion of human subjects are given on pages 22-23 and 25-26 of PHS 398 (rev. 9/91). Applications must be received by April 29, 1993. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications submitted to the NIH will be reviewed according to customary NIH peer review procedures. Review Procedure. Upon receipt, applications will be reviewed by the NCNR for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the scientific intent identified in the RFA or to the time frame and budget guidelines, the NCNR will return it to the applicant. Applications may be subjected to triage by a peer review group to determine their scientific merit relative to other applications received in response to this RFA. Criteria for triage will be the same as the review criteria listed below. The NIH will administratively withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional official. Those applications judged to be complete, responsive, and competitive will be further evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NCNR. The second level of review will be provided by the National Advisory Council for Nursing Research. Review Criteria. Applications will be reviewed in accord with the usual NIH peer review criteria: o scientific and technical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; and o appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is September 30, 1993. Decisions to make awards are based on the scientific merit of the application reflected in the priority score, availability of funds with NCNR for this purpose, and NCNR research program priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The program staff welcomes the opportunity to clarify any issues or questions from potential applicants. Inquiries regarding programmatic issues, requests for the RFA may be directed to: Patricia Moritz, Ph.D., R.N. Nursing Systems Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (303) 844-6163 (for discussion of scientific matters) Telephone: (301) 496-0523 (for copies of the RFA) Requests for copies of the conference proceedings, "Patient Outcomes Research: Examining the Effectiveness of Nursing Practice," may be directed to: Office of Information and Legislative Affairs National Center for Nursing Research Building 31, Room 5B13 Bethesda, MD 20892 Telephone: (301) 496-0207 Direct inquiries regarding fiscal and administrative matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 496-0237 Schedule Letter of Intent Receipt Date: March 26, 1993 Application Receipt Date: April 29, 1993 Initial Review: July 1993 Secondary Review: September 1993 Anticipated Award Date: September 30, 1993 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361, Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review, April 6, 1988. $$XID RFA NR93002 NR-93-002 P1O1 *************************************** COMMUNITY INTERVENTIONS IN ADOLESCENT HEALTH PROMOTION NIH GUIDE, Volume 22, Number 5, February 5, 1993 RFA: NR-93-002 P.T. 34, AA; K.W. 0403004, 0745035, 0404000 National Center for Nursing Research Letter of Intent Receipt Date: March 25, 1993 Application Receipt Date: April 29, 1993 PURPOSE The National Center for Nursing Research (NCNR) invites submissions of R01 applications for investigations of community based interventions for health promotion and disease prevention in older children and adolescents (ages 8-18). The purpose of this Request for Applications (RFA) is the development and testing of community based interventions that focus on helping older children and adolescents adopt and maintain health-promoting cognitive and behavioral patterns. Health promotion strategies could take place in traditional and nontraditional settings, with focus, if possible, on highly vulnerable youth, including minority, economically disadvantaged, and disabled subgroups. 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, Community Interventions in Adolescent Health Promotion, is related to the priority areas of health promotion in educational and community based programs, and preventive services for HIV infection and sexually transmitted diseases. Potential applicants may obtain a copy of the "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed three years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Because the nature and scope of the research proposed may vary, it is anticipated that the size of the award will vary also. The anticipated average direct cost award per year will range from $150,00 to $180,00. The anticipated award date will be September 30, 1993. FUNDS AVAILABLE Approximately one million dollars in total costs for the first year will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four to five applications will be funded for a three year period. 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 NCNR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES o Develop and test family, school, and community strategies for adopting and maintaining health-promoting behaviors among youth in traditional health care settings such as emergency facilities, school-based clinics, and medical offices. o Develop and test alternative health promotion models and outreach strategies in urban and rural settings such as youth-serving community agencies, shelters for runaways and the homeless, malls, churches, and youth-employing worksites. Studies are needed to identify traditional health care settings and nontraditional settings that, when combined with appropriate health promotion strategies, might offer the greatest potential for effectively reaching vulnerable youth. Recognizing that the multidisciplinary nature of health promotion research requires a blending of research expertise from many disciplines, collaboration with colleagues in the biomedical and social sciences is encouraged. Health promotion is recognized as a high priority in health research. More than the absence of disease, health is a positive process of reaching one's potential in nonphysical as well as physical areas that is mediated by the biological, cognitive, psychological, social systems such as family, neighborhood, community, race, culture. Health professionals have demonstrated the importance of intervening to promote health and prevent disease rather than delaying intervention until after a disease process has begun. Health promotion is particularly important for older children and adolescents. For the purposes of this RFA, the age group of older children and adolescents encompasses ages 8-18. Most causes of mortality and morbidity in older children and adolescents are due to behavior and lifestyle factors and are, therefore, preventable. Many of the behavior patterns developed in late childhood and adolescence carry over into adulthood, and most of the leading health problems of adults, such as heart disease and obesity, are associated with behaviors initiated early in life. Positive changes in health values, attitudes, and habits in childhood and adolescence are likely to result in a healthier adulthood. Nursing practice offers many opportunities for health promotion in this age group. Nurses come into direct contact with older children, adolescents, and their caregivers in a wide range of health, educational, and health service settings. The field of nursing contributes a special breadth and depth to health promotion through an understanding of developmental changes and the integration of their effects on health and health-related lifestyles. Nurses serve in the roles of counselors, advocates, educators, and caregivers. Older children and adolescents typically have difficulty applying their potential for more complex thinking to practical decisions involving health issues--such as substance use, sexual behavior, and driving a motor vehicle. Such decisions are especially problematic when made under stressful and time-limited circumstances. Factors that help youth use their increased cognitive capacities in daily life include: (1) practice with effective simulations of real situations, and (2) opportunities to learn cognitive processes (thinking skills) and relevant content (knowledge) simultaneously, rather than acquiring thinking skills independently of the context in which they will be implemented. Such findings have significant implications for health promotion research and interventions. Advances in developmental theories can inform the study of basic explanatory mechanisms of behavioral acquisition, change, and maintenance in late childhood and adolescence. Examining the health behaviors of children and adolescents within a developmental perspective facilitates exploration of how internal factors (individual genetic profiles and biological, emotional and cognitive processes) interact to influence health behavior and outcomes. Such research has great potential for making significant contributions to the state of the science of health promotion for older children and adolescents. In order to have a solid scientific base for practice, much remains to be learned about the differences and commonalities across health beliefs, actual and perceived options, behaviors, and effective health promoting interventions in this population. Of special concern are the highly vulnerable youth including young people who are members of minority subgroups (African American, Native American, Hispanic, and Asian American youth), immigrants, economically disadvantaged, homeless, and disabled. Design and implementation of effective health promotion programs will require examining the unique cultural factors that influence health. Research methods must be adapted to provide meaningful and accurate data about differences between and within ethnic and gender subgroups of young people; culturally and gender sensitive health promotion interventions aimed at ethnic minority youth must be designed and tested. A detailed understanding also is needed of the constraints and opportunities for promoting healthy lifestyles among youth in rural settings. Guidance and recommendations for this RFA have been provided by the Priority Expert Panel on Health Promotion for Older Children and Adolescents convened by the National Center for Nursing Research, NIH. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of disease, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by March 25, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and consultants, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCNR staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ethel B. Jackson, D.D.S. Chief, Office of Scientific Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 Telephone: (301) 496-0472 FAX: (301) 480-4969 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ethel B. Jackson, D.D.S Chief, Office of Scientific Review National Center for Nursing Research Building 31, Room 5B25 Bethesda, MD 20892 If the applicant has an approved assurance covering the research, the applicant should provide the application certification of Institutional Review Board (IRB) approval if humans are involved. These reviews and approvals should occur prior to submission of the application for award and the certifications should be submitted with the application. There is no 60 day grace period for RFAs. If humans will be subjects of the research at performance sites other than the applicant organization, the applicant must identify, in the application, the assurance status of each participant. Failure to provide required certifications in the application could result in delay of an award. Instructions regarding inclusion of human subjects are given on pages 22-23 and 25-28 of PHS 398 (rev. 9/91). Applications must be received by April 29, 1993. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NIH staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCNR staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications may be triaged by an NCNR peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by NCNR. The second level of review will be provided by the NCNR advisory council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o scientific and technical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The anticipated date of award is September 30, 1993. Decisions to make awards are based on the scientific merit of the application reflected in the priority score, availability of funds within NCNR for this purpose, and NCNR research program priorities. INQUIRIES Written amd telephone inquiries concerning this RFA are encouraged. NCNR program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Martha Ann Carey, Ph.D., R.N. Health Promotion/Disease Prevention Branch National Center for Nursing Research Westwood Building, Room 754 Bethesda, MD 20892 Telephone: (301) 402-3293 Direct inquiries regarding fiscal and administrative matters to: Sally A. Nichols Grants Management Officer National Center for Nursing Research Westwood Building, Room 748 Bethesda, MD 20892 Telephone: (301) 496-0237 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 Nursing Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Fri Feb 05 22:00:00 1993 Path: biosci!agate!spool.mu.edu!sdd.hp.com!saimiri.primate.wisc.edu!usenet.coe.montana.edu!news.u.washington.edu!raven.alaska.edu!news.acns.nwu.edu!uicvm.uic.edu!u29242 From: U29242@uicvm.uic.edu Newsgroups: bionet.sci-resources Subject: format of NIH ressearch proposal Message-ID: <93037.081657U29242@uicvm.uic.edu> Date: 6 Feb 93 14:16:57 GMT Organization: University of Illinois at Chicago Lines: 11 This may seem somewhat strange however here it goes. I was given a project by my advisor to design a research proposal. Nothing strange there, or in the next sentence. He said for "kicks" I should format it in the NIH style of research proposals. OK, now here is the question. How is this done? If there are any standard guides to research proposal writing I am unaware of them. Any help would be greatly appreciated. I know that this may be the wrong group to post to but it really was the closest area I could think of for an answer. My thanks in advance, Ray u29242@uicvm.uic.edu From owner-sci-resources@net.bio.net Sat Feb 06 22:00:00 1993 Path: biosci!CU.NIH.GOV!CZJ From: CZJ@CU.NIH.GOV Newsgroups: bionet.sci-resources Subject: Re: format of NIH ressearch proposal Message-ID: <9302070433.AA16003@net.bio.net> Date: 7 Feb 93 04:28:04 GMT Sender: daemon@net.bio.net Distribution: bionet Lines: 21 > > This may seem somewhat strange however here it goes. I was given a > project by my advisor to design a research proposal. Nothing strange > there, or in the next sentence. He said for "kicks" I should format it > in the NIH style of research proposals. OK, now here is the question. > How is this done? If there are any standard guides to research proposal > writing I am unaware of them. Any help would be greatly appreciated. I > know that this may be the wrong group to post to but it really was the > closest area I could think of for an answer. > My thanks in advance, > Ray > u29242@uicvm.uic.edu > > There is a standard proposal kit put out by NIH. The instructions are contained in the kit. You can get it from the sponsored programs office at your University. Jim Cassatt From owner-sci-resources@net.bio.net Sun Feb 07 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 7 February 1993 Message-ID: Date: 8 Feb 93 22:25:36 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 128 ** NEW DOCUMENTS ON STIS ** Document Type: EPS Title: Electronic Proposal Submission (EPS) Unix Binaries File size (bytes): 1268 STIS Filename: epsbin Also available: epsbin.sun epsbin.aix epsbin.nxt Document Type: General Publication Title: NSF 92-143 PUBLICATIONS OF THE NATIONAL SCIENCE FOUNDATION File size (bytes): 64193 STIS Filename: nsf92143 Document Type: Organization Title: NSF Statement of Organization File size (bytes): 69985 STIS Filename: org0293 Document Type: Press Release Title: UNDERSTANDING CHANGES IN COASTAL ENVIRONMENTS- NSF'S LMER PROGRAM File size (bytes): 8417 STIS Filename: pr9310 Title: Joint Federal Projects to Highlight Connections File size (bytes): 4179 STIS Filename: pr9311 Title: NSF Report Shows Return to Slow Growth in National R&D Funding File size (bytes): 4741 STIS Filename: pr9312 Document Type: Program Guideline Title: NSF 93-10 GRAND CHALLENGE APPLICATIONS GROUPS File size (bytes): 15983 STIS Filename: nsf9310 Title: NSF 93-8 - For U.S. WOCE Survey of the Indian Ocean for WOCE Core Project #1 (Addendum to NSF 92-81) File size (bytes): 10954 STIS Filename: nsf938 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 1382 STIS Filename: cmpublic Document Type: EPS Title: NSF Electronic Proposal Submission Project General Information File size (bytes): 4747 STIS Filename: epsflyer Also available: epsflyer.ps Title: NSF Electronic Proposal Submission Project (EPS) Information File size (bytes): 19443 STIS Filename: epsinfo Also available: epsinfo.ps Title: Subscribing to the EPS-L Mailing List File size (bytes): 1923 STIS Filename: epslist Title: Electronic Proposal Submission (EPS) Programs, Version 4 File size (bytes): 2736 STIS Filename: epsprog4 Also available: epsprog4.exe epsprog4.trz Document Type: STIS Title: Getting STIS Documents Via Direct E-Mail File size (bytes): 4393 STIS Filename: stisdirm ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve stisdirm, the text of your message should be as follows: get stisdirm Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve stisdirm, you would enter: ftp> get stisdirm WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Tue Feb 09 22:00:00 1993 Path: biosci!waite.adelaide.edu.au!jgray From: jgray@waite.adelaide.edu.au (John Gray) Newsgroups: bionet.sci-resources Subject: subscription Message-ID: <9302100703.AA06720@schooner.waite.adelaide.edu.au> Date: 10 Feb 93 07:03:32 GMT Sender: daemon@net.bio.net Distribution: bionet Lines: 2 I wish to subscribe to SCIENCE RESOURCES. My name is John Gray. Email: jgray@waite.adelaide.edu.au From owner-sci-resources@net.bio.net Tue Feb 09 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 6, pt. 3, 12 February 1993 Message-ID: Date: 10 Feb 93 23:00:14 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1061 $$XID RFA AI9311 AI-93-11 P1O1 ***************************************** THE CAUSES AND CONSEQUENCES OF THYMUS INVOLUTION NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFA: AI-93-11 P.T. 34; K.W. 0705040, 1002061, 0765035 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 21, 1993 PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for studies focused on the causes and consequences of thymus involution. The purpose of research dealing with thymus involution is to achieve an understanding of this still largely mysterious phenomenon. It is essential to determine whether normal thymus involution is a vital physiological process that contributes to sustained vigor of the immune system or, by contrast, leads to subtle pathological activities of the immune system. Given that there are approaches to preventing, retarding or reversing thymus involution, it is important to determine whether or not interfering with the process of involution has desirable and beneficial effects on the immune system. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), The Causes and Consequences of Thymus Involution, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private, foreign and domestic, for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) (R29) awards. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanisms of support for this program will be the research project grant (R01) and the FIRST award (R29). The regulations and policies that govern the research grant programs of the National Institutes of Health will prevail. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. The budget request for an R29 application is restricted to the amount allowed by NIH for R29s. The budget request for an R01 application should not exceed $200,000 total direct costs in the first year. Neither type of application should request more than 4 percent annual inflationary increases in future years. This RFA is a one-time solicitation. Future competing continuation applications will be considered unsolicited and compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $800,000. In fiscal year 1994, the NIAID plans to award at least three projects (R01s or R29s) submitted in response to 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 NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years, and availability of funds. RESEARCH OBJECTIVES Background In both humans and laboratory animals, the thymus begins to decrease in size and cellularity at a time that coincides roughly with sexual maturity. The decrease in size/weight is accompanied by altered histoarchitecture, especially reduction in the volume of the medulla and thinning of the cortical region. Histologically, it appears that the thymus nearly stops generating and exporting T cells. Thymus involution is not accompanied by a reduction in the number of peripheral T cells, either in humans or mice. Either the atrophied thymus can continue to generate sufficient numbers of T cells or there are extra-thymic sites of T cell generation. Evidence for the latter is accumulating. For example, the adult athymic ("nude") mouse displays a significant number of T cells (up to half the number in euthymic controls). As animals and humans progress from adolescence to adulthood and middle life, generation of T cells from extra-thymic sites may become substantial, possibly reflecting the waning export of T cells by the thymus. Recent publications strongly suggest that the liver may serve as a site of T cell generation, especially during stress. T cells originating from extrathymic sites may display a propensity for recognizing self-antigens. During the lifetime of mice and humans, there occurs a significant change in relative proportions of subsets of CD4+ T cells. There is a significant increase in the relative (and absolute) number of CD44+ (Pgp-1+) memory or activated T cells and a decrease in the numbers of naive T cells. This is accompanied by a change in the potential for elaboration of different cytokines; in particular, there is an increase in potential for generating IFN~ and a decrease in production of IL-2. The normal physiological causes of thymus involution remain obscure. Similarly, obscurity surrounds the mechanism for maintaining an essentially constant number of peripheral T cells throughout life. How is the number of T cells counted and adjusted in the face of apparent declining thymus export of T cells? Equally obscure are the reasons for the transient thymus involution (with constant peripheral T cell number) that occurs during pregnancy. Furthermore, there is no satisfactory explanation for the exquisite susceptibility to xenobiotics such as dioxins and nickel ions, nor is it known why exposure to ionizing radiation apparently rejuvenates the atrophic thymus. These and many other questions deserve systematic investigation. Research Objectives and Scope Projects that clearly will enhance understanding of the causes and physiological/pathological significance of thymus atrophy and will promote reasonable approaches to preventing or treating immunological diseases are encouraged. Research areas of interest include, but are not limited to: o Studies aimed at determining the causes of thymus involution; its impact on the rate and magnitude of change in the export of T lymphocytes; and the chronological age and physiological stage at which T cell generation/export reaches a nadir; o Evaluations of the immunological consequences of the decline and minimization of T cell generation/export by the thymus (e.g., changes in the T cell repertoire; changes in immunological potential; changes in the potential for self-reactivity and pathological autoimmunity; similarities and differences between natural thymus involution and adult thymectomy); o Explorations of extrathymic sites for locations of T cell generative potential, and characterization of the T cells generated at those sites; o Identification and analysis of long-lasting subsets of T cell precursors that may be located and/or generated in peripheral lymphoid or other tissues; o Development of procedures to delay thymus involution or to rejuvenate the involuted thymus, and evaluation of the immunological consequences of prolonged or restored thymus function; and o Analyses of factors that control the mass of the thymus and that influence the survival and duration of function of thymus grafts implanted into thymectomized recipients, genetically-athymic recipients and recipients in which the thymus has involuted. The scope of this RFA does not include studies on aging of the immune system. If such applications are received, the Division of Research Grants (DRG) will assign them to the National Institute on Aging as unsolicited applications. Budget requests should include, in the third year, travel funds for the Principal Investigator to attend a two-day meeting in the Washington, DC area to review progress and remaining knowledge gaps and discuss future scientific opportunities with all Principal Investigators supported under this RFA, as well as other scientists conducting research related to the objectives and scope of this RFA. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale MUST be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, 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 must be included in the form PHS 398 in items 1-4 of the Research Plan AND summarized in item 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of U.S. racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, and Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, clinical samples which may be coded for use by the applicant but could be identified by another source are not excluded. Every effort should be made and documented to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the U.S. populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Peer review groups need adequate information about the composition of proposed study populations in all applications involving human subjects. To avoid delays in review of such applications, the NIAID advises that, as a minimum, the application should contain demographic data about the clinic and/or in-patient population from which study subjects will be drawn: average hospital admissions per year; percentage distribution of Black/Hispanic/other minority/non-minority populations; gender; etc. Studies using non-hospital populations, such as community-based studies, should provide similar data about populations in the area or region from which the study subjects will be drawn. In the absence of current data, historical demographic information and/or previous recruitment data for similar studies from the proposed study sites should be provided. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 09/91). Item 2a on the face page of the application must be marked "Yes" and the RFA number and the words "THE CAUSES AND CONSEQUENCES OF THYMUS INVOLUTION" must be typed in. These application forms may be obtained from the institution's office of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applications must be received by July 21, 1993. Applications that are not received from the applicant organization by the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 09/91) application kit, will be judged to be non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. FIRST award (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, single-sided photocopies, in one package to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. 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. If so, letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and by NIAID staff for responsiveness. Those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be either returned without review or referred to the DRG as an unsolicited application, to be scheduled for initial review at the next DRG review cycle. Those applications that are complete and responsive may be subjected to a triage by an NIAID peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. The factors to be considered in the evaluation of scientific merit of each application will be those used by NIH in the review of research project grant applications, including: the originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; the adequacy and suitability of the facilities; and the adherence, whenever appropriate, to NIH guidelines concerning adequate representation of women and minorities in clinical research. The following factor does not influence the priority score, but is nonetheless carefully considered by the initial review group: the appropriateness of the requested budget to the work proposed. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit, as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Joseph F. Albright, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A22 Bethesda, MD 20892 Telephone: (301) 496-7551 FAX: (301) 402-2571 Direct inquiries regarding review issues, address the Letter of Intent to, and mail the two copies of the application to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal and administrative matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 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 Solar Building is: 6003 Executive Boulevard Rockville, MD 20852 Schedule Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 21, 1993 Scientific Review Date: October 1993 Advisory Council Date: February 1994 Earliest Award Date: April 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$XID RFA CA9314 CA-93-14 P1O1 ***************************************** ADULT SURVIVORS OF CANCER NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFA: CA-93-14 P.T. 34; K.W. 0715035, 0414014, 0415002 National Cancer Institute Letter of Intent Receipt Date: March 16, 1993 Application Receipt Date: May 21, 1993 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites investigator-initiated grant applications for research directed at decreasing the functional and psychosocial morbidity associated with cancer survivorship, i.e., in persons who have completed therapy and have a good prognosis for cure or long-term survival. Applicants are requested to develop, implement, and evaluate interventions aimed at improving the rehabilitation and quality of life of cancer survivors related to psychosocial sequelae, vocational rehabilitation, or adaptation to long-term functional impairment. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Adult Survivors of Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000 (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) research project grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this RFA should not exceed four years. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. The anticipated amount of the direct costs per award will vary from $100,000 to $300,000. Allowable direct costs for the intervention will NOT include payment for cancer screening tests or services and procedures which are a routine part of cancer treatment and patient care. Expenses incurred in development and implementation of the proposed research, including baseline and follow-up surveys, design of materials, and professional education are allowable costs. Budgets should include travel funds for the Principal Investigator and co-investigators to one two-day meeting in Bethesda, MD, to facilitate discussions with program staff and to foster sharing of work in progress with other researchers. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research grant applications and be peer reviewed by a chartered study section in the Division of Research Grants (DRG), NIH. However, if it is determined that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. FUNDS AVAILABLE Total costs of $2,500,000 per year for four years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that four or five awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background About 440,000 Americans or four out of 10 patients who were diagnosed with cancer in 1991 will be alive five years after diagnosis (1). The trends in overall cancer survival rates show a greater increase when they are adjusted for the primary cancer site distribution. For example, SEER data demonstrate significant improvements in the five year relative survival rates in melanoma, breast, uterus, prostate, testis, bladder, Hodgkin's disease and non-Hodgkin's lymphoma, from 1974-76 to 1981-87, (2). However, even with this improvement, the literature offers few reports of research documenting effective interventions to alleviate problems in this group of people. Problems facing long-term survivors are being recognized and reported in the descriptive literature. The survivors face a multitude of physical, emotional, and social stresses from the effects of treatment, changes in lifestyle, disruption of home and family roles and the fear of recurrence. The cancer survivor deals not only with physical morbidity, but faces the risk of psychological and social morbidity as well (3, 4). Cancer survivors often live with compromise. They are challenged by changes in their endurance and strength, reproductive capacity, sexuality, and body image (3, 5). Cancer can be understood as a disease with both physical and psychosocial sequelae. Much is known about the physical late effects of cancer and its treatment; less is known about the psychosocial morbidity of these physical sequelae. Though cancer survivors appear to function quite adequately in their daily lives, they may experience periods of distress that can be relieved (4). The problems of the cancer survivor are not extensions of the problems of the cancer patient in treatment. They are qualitatively different: more diverse, less "medical," difficult to anticipate, and less extreme. There is a trend in these problems away from illness-related ones and toward societal, interpersonal ones (4,6,7,8,9,10). A summary of the literature on physiologic sequela (11) recognizes the need for research to minimize potential unwanted effects of therapy , both immediate and long term. The present concept addresses the late effects and sequela of treatment which affect the functional ability and quality of life of cancer survivors. An overview of the psychosocial implications of long-term survival of adults who have had cancer gives direction for important interventions that require attention (12). Although most patients improve from baseline measures of psychological distress, there is evidence that 20 percent to 30 percent of patients continue to experience clinically significant distress and poorer well-being long after diagnosis (4, 13). The long-term cancer survivor may face physical and/or psychosocial complications that can be delayed as much as 20 years or more. Cancer survivors are now speaking up on their own behalf about the need for a continuing support network and the need for research to address ongoing informational, educational, psychological, and social concerns following cancer diagnosis and treatment (14). Research Goals and Scope The goals of this research initiative are to improve quality of life by decreasing the functional and psychosocial morbidity associated with cancer survivorship through the development and testing of interventions which facilitate rehabilitation of adult cancer survivors and enhance their re-entry into society. The specific objectives of the research are: o To define and explore the functional and psychosocial issues facing adult cancer survivors and the barriers to reintegration into society. o To develop and evaluate specific interventions to enhance adaptation to long term physical impairment, vocational rehabilitation, psychosocial adjustment and/or return to pre-diagnosis life style. This concept invites R01 applications to test interventions in a two phase approach: o Descriptive phase to gather detailed baseline information and refine the proposed interventions as indicated by findings; o Evaluative phase in which the intervention is implemented and its impact is assessed. The application should define the population, identify the problem, describe the intervention and outline the evaluation plan. Applications should reflect a strong research orientation with attention to quality of life and its dimensions reflected by psychosocial variables, vocational rehabilitation, and adaptation to long term physical impairment or functional rehabilitation. Study Design For the purposes of this RFA, adult survivors are defined as persons diagnosed and treated for cancer after age 21, who have completed therapy and have a good prognosis for cure or long-term survival. The study sample can be homogeneous on specific characteristics related to disease, treatment, age or culture. Groups can be defined by (1) primary cancer site with similar treatment approaches facing common issues (e.g., gynecological malignancies, malignancies treated with bone marrow transplantation); (2) age cohort facing similar life events (e.g., return to work or retirement, family responsibilities); (3) cultural and ethnic influences. The research hypotheses should be based on relevant conceptual models or theories and should address issues in at least one of the following areas: o Long term physical impairment. o Self-image, sexuality, reproductive potential. o Interpersonal relationships and social functioning (family, close friends, broader social groups). o Vocational rehabilitation, employment or insurability. o Medical uncertainties (relapse, late complications, second malignancies). o Cultural and ethnic background and values as influences on adaptation to cancer. The proposed interventions may be (1) newly developed, (2) adapted from experience with other groups of cancer patients, or (3) drawn from those which have been shown to have been of benefit in the long-term rehabilitation of patients in other disease categories. Interventions may be drawn from other disciplines in the social sciences. Short, time limited interventions with clear end-points or long term, continuous interventions where the effect can be measured within the study time frame are equally acceptable. The proposed intervention must be described in detail in the proposal. This intervention research may incorporate a descriptive phase for collection of baseline data, or a short pilot phase for refining the proposed intervention. In the descriptive phase, interviews, surveys, focus groups or other sociologic approaches may be suitable. Applicants are expected to have a foundation of previous work which will require a minimal descriptive, exploratory phase before moving to the intervention and evaluation phases. However, the principal focus of the research should be to predict problems and evaluate interventions to accomplish the rehabilitation and reintegration of the adult survivor of cancer. Study Evaluation Existing measures of the outcome variables of interest, (i.e., direct or indirect measures of quality of life and its domains) with established validity and reliability must be used (15, 16, 17). These may be drawn from other disciplines in the social sciences. Investigators are expected to select endpoints that reflect the quality of long-term survival, for example: functional status, changes in use of services, or degree of return to pre-morbid lifestyle, work and activities. The design may include qualitative or quantitative methodologies and must include a systematic documentation of the problem. An experimental design is the preferred approach; however, quasi-experimental designs may be appropriate in some circumstances. Outcome variables must be clearly defined and assessed by valid and reliable techniques. Analysis will include descriptions of the population of adult survivors and the needs identified by this group. Usual evaluative methods can be used to determine the effectiveness of interventions. Some of these evaluative methods may be drawn from education, social sciences or health services research. Investigators are expected to select endpoints that reflect the quality of long-term survival, i.e., quality of life and/or its specific domains related to the intervention (16, 17, 18, 19). Additional end points could include functional status, changes in use of services, or degree of return to pre-morbid lifestyle, work and activities. Confounding variables such as programs available within the community should be considered when assessing the outcomes. Quantitative methods should be used to determine efficacy. Qualitative methods may be included to enhance the understanding and interpretation of the quantitative findings and enrich the interpretation of the data. The approach should be interdisciplinary in nature and have the potential to be transferred effectively to diverse practice settings. Collaboration with oncology subspecialists, social workers, vocational counselors, health services researchers, health economists, physical and occupational therapists, psychologists, health educators and other interested disciplines should be sought as appropriate to address the complexity of the issues identified in the hypotheses. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations [i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics]. The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the Research Plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by March 16, 1993 a letter of intent that includes a descriptive title of the proposed research; the name, address, telephone ,and FAX numbers of the Principal Investigator; the names of other key personnel; the participating institution(s); and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it contains information that is helpful in planning for the review. The letter of intent allows NCI staff to estimate the potential review workload and helps to avoid conflict of interest in the review. The letter of intent is to be sent to: Claudette Varricchio, D.S.N, R.N., O.C.N., F.A.A.N. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. The application package is available at most institutional offices of sponsored research; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441; and from the NCI Program Director named below. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA number and title must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to the DRG at the address below. The photocopies must be clear and single-sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 650 Bethesda, MD 20892 Applications must be received by close of business, May 21, 1993. If an application is received after that date, it will be returned to the applicant. The DRG will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision to an already reviewed application, but such an application must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Review Procedure Upon receipt, applications will be reviewed initially by the DRG for completeness. An incomplete application will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. Applications will be judged to determine how well they meet the goals and objectives of the program as described in the RFA. Applications judged non-responsive will be returned, but may be submitted as investigator-initiated research grant applications at the next regular receipt date. Questions concerning the relevance of proposed research to the RFA may be directed to the Program Directors listed under INQUIRIES. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to triage applications on the basis of relative competitiveness and to eliminate those applications which are clearly not competitive. The NCI will withdraw from further competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board will consider the special needs and the research priorities of the Institute. Review Criteria Applications responsive to this competitive solicitation will be reviewed in accordance with the criteria stated below: o Scientific merit of the research design, clinical significance and originality of the proposed intervention, including outcome measures and the feasibility of the procedures to be used. o Appropriateness and adequacy of the experimental approach and methodology proposed to the goals and objectives of the RFA. o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research. Inclusion of professionals representing diverse disciplines, as appropriate, on the leadership level. o Availability and proposed use of multidisciplinary expertise from related fields of behavioral and social sciences, health services evaluation, and specialized health care professionals as appropriate for the focus of the proposed research. o Availability of resources necessary to perform the research. o Feasibility of applying successful interventions in community practice settings. o Adequacy of the proposed means for protecting against hazardous or unethical research procedures. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each scored application. AWARD CRITERIA The anticipated date of award is April 1, 1994. The following factors will be considered in making funding decisions: (1) the scientific merit of the proposed project as determined by peer review; (2) availability of funds; and (3) program balance among research areas as described in the RFA. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, and inquiries about whether or not specific proposed research would be responsive, are encouraged and may be directed to the Program Directors at the addresses provided below. Program Directors welcome the opportunity to clarify any scientific or programmatic issues or questions from potential applicants. Claudette Varricchio, D.S.N, R.N., O.C.N., F.A.A.N. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Written and telephone inquiries of a budgetary, administrative, and/or policy nature may be directed to: Mrs. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800 FAX: (301) 496-8601 The National Center for Nursing Research is also interested in research focused on adult survivors of cancer. Inquiries may be made to: June R. Lunney, Ph.D., R.N. Acute and Chronic Disease Branch National Center for Nursing Research Building 31, Room 5B09 Bethesda, MD 20892 Telephone: (301) 496-0523 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research, and 93.361, Nursing Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 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. References 1. American Cancer Society. 1991, Cancer Facts and Figures. American Cancer Society, New York, NY., p. 3. 2. National Cancer Institute, Division of Cancer Prevention and Control, Surveillance Program. 1991, Cancer Statistics Review, 1973-1988. US Dept. of Health and Human Services, NIH Pub. No 91-2789. 3. Rose, MA. 1989, Health Promotion and Risk Prevention: Applications for Cancer Survivors, Oncology Nursing Forum, 16:3, 335-340. 4. Smith, K, Lesko, LM. 1988, Psychosocial Problems in Cancer Survivors. Oncology, 2:1, 33-40. 5. Broder S. 1991, The Human Costs of Cancer and the Response of the National Cancer Program. Cancer. 67: 1716-1717. 6. Cella, DF. 1987, Cancer Survival: Psychosocial and Public Issues. Cancer Investigation, 5:1, 59-67. 7. Berry, DL, Catanzaro, M. 1992, Persons With Cancer and Their Return to the Workplace. Cancer Nursing. 15:1, 40-46. 8. Johansson, S, Steineck, G, Hursti, T, Fredrikson, M, Furst, CJ, Peterson, C. 1992, Aspects of Patient Care. Cancer Nursing. 15:1, 54-60. 9. Hoffman, B. 1991, Employment Discrimination: Another Hurdle for Cancer Survivors. Cancer Investigation. 9:5, 598-595. 10. Schmale, AH, Morrow, GR, Schmitt, MH, Adler, LM, Enelow, A, Murawske, BJ, Gates, C. 1983, Well-Being of Cancer Survivors. Psychosomatic Medicine. 45:2, 163-169. 11. Loescher, LJ, Welch-McCaffrey, D, Leigh, SA, Hoffman, B, Meyskens, FL. 1989, Surviving Adult Cancers. Part 1: Physiologic Effects. Annals of Internal Medicine, 111:5, 411-432. 12. Welch-McCaffrey, D, Hoffman, B, Leigh SA, Loescher, LJ, Meyskens FL. 1989, Surviving Adult Cancer. Part 2: Psychosocial Implications. Annals of Internal Medicine 111:6, 517-524. 13. Ell, K, Nishimoto, R, Morvay, T, Mantell, J, Hamovitch, M. 1989, A Longitudinal Analysis of Psychological Adaptation Among Survivors of Cancer. Cancer. 63:406-413. 14. Gerlach, RW, Gambosi, JR, Bowen, RH. 1990, Cancer Survivors' Needs Reported by Survivors and their Families. Journal of Cancer Education. 5:1, 63-70. 15. Marshall, PA. 1990, Cultural Influences on Perceived Quality of Life. Seminars in Oncology Nursing 6:4, 278-284. 16. Osoba, D. 1991, Effect of Cancer on Quality of Life. CRC Press, Inc. Boston, MA. 17. Spiker, B. 1990, Quality of Life Assessments in Clinical Trials. Raven Press, New York. 18. Wilkin, D., Hallan, L., Doggett, M. 1992. Measures of need and outcome for Primary Health Care. Oxford University Press, Oxford. 19. Heithoff, KA, Lohr, KN, eds, 1990.Effectiveness and Outcomes in Health Care. Washington, DC, National Academy Press. From owner-sci-resources@net.bio.net Tue Feb 09 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 6, pt. 2, 12 February 1993 Message-ID: Date: 10 Feb 93 22:58:36 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 808 $$XID NIHGUIDE 19930212 V22N06 P2O2 ************************************ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic public and private non- profit organization and by for-profit organizations, including universities, colleges, hospitals, laboratories, units of State and local governments, tribal governments and tribal organizations, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISMS OF SUPPORT Research support may be requested through applications for a regular research grant (R01), a small grant (R03), the FIRST award (R29), a cooperative clinical research grant (R10), and research demonstrations (R18). Because the nature and scope of the research proposed in response to this announcement will vary, it is anticipated that the size of the awards will also vary. However, for fiscal year 1993, Congress directed NIMH to spend $15 million on behavioral research on rural and Native American mental health issues. RESEARCH OBJECTIVES Much about the mental health needs of American Indians, Alaska Natives, and Native Hawaiians is unknown. Little is known about the epidemiology and prevention of adult or child mental disorders; co-occurring substance abuse disorders; family violence and family dysfunction; cultural, economic, or geographic barriers to care; appropriateness and effectiveness of treatment; need for services; and service use patterns. To begin to address these issues, NIMH, in conjunction with the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse, issued a program announcement in March 1990, "Epidemiologic and Services Research on Mental Disorders that Co-occur with Drug and/or Alcohol Disorders Among American Indians, Alaska Natives, and Native Hawaiians." The purpose of that announcement was to encourage investigators to test further the reliability and validity of current psychiatric and service system measures for native populations and to begin to estimate the prevalence of disorders and service use. This announcement is intended to stimulate a broader range of mental health research related to American Indians, Alaska Natives, and Native Hawaiians. By addressing issues relating to epidemiology, prevention, family and individual coping styles and resiliency, family violence, and service use, treatment, and quality of care, progress can be made toward improving the quality of life of American Indians, Alaska Natives, and Native Hawaiians whose lives are affected by mental illness, co-occurring substance abuse disorders, and often-related family dysfunction. In part, this announcement was developed in coordination with the Mental Health Programs Branch of the Indian Health Service (IHS). A copy of the Native American Mental Health Research Agenda, which was developed in 1988 by the Mental Health Program Branch of the IHS and is an Appendix to the National Plan for Native American Mental Health Services (April 1990), may be obtained by contacting the NIMH program staff member listed under INQUIRIES. Listed below are examples from research topic areas in which knowledge about the mental health needs of and quality of care provided to American Indians, Alaska Natives, and Native Hawaiians is lacking. The list of examples is illustrative, not exhaustive; it is expected that additional important research topics will be identified by researchers who respond to this announcement. Investigator-initiated projects may focus on: Basic Psychosocial Processes o Individual and family coping styles and their association with the development of behavior problems and depression in American Indian, Alaska Native, and Native Hawaiian children and adolescents o Child-rearing practices and individual, family, and community characteristics associated with adaptive individual functioning among American Indian, Alaska Native, and Native Hawaiians o The influence of cultural definitions of normal and abnormal behavior among American Indian, Alaska Native, and Native Hawaiian peoples on symptom expression o The impact of social networks and supports used by American Indian, Alaska Native, and Native Hawaiians as buffers against stressful circumstances and experiences Basic Prevention and Behavioral Medicine o The role of environmental stressors, such as economic strain or family disruption, in the etiology of physical and mental disorders among American Indians, Alaska Natives, and Native Hawaiians o Psychobiological mechanisms in medical illnesses among American Indian, Alaska Native, and Native Hawaiians o Psychological and behavioral consequences of physical illnesses and/or substance abuse for individual American Indian, Alaska Native, and Native Hawaiians and their families Epidemiology o The incidence and prevalence of mental disorders and their risk factors, including co-occurring substance abuse disorders, among American Indian, Alaska Native, and Native Hawaiians o The incidence and prevalence of mental disorders among American Indian, Alaska Native, and Native Hawaiians with chronic physical health problems Prevention o The modification of significant cultural, social, and psychological factors associated with suicide and suicidal behavior among American Indians, Alaska Natives, and Native Hawaiians o The safety and effectiveness of culturally specific preventive interventions aimed at suicidal behavior, depression, and alcohol and other substance abuse o The enhancement of individual and family styles of coping with behavior problems and depression in American Indian, Alaska Native, and Native Hawaiian children and adolescents Family and community violence o The prevalence of physical and sexual abuse of women, children, and adolescents o The role of physical and sexual abuse in the suicidal behavior among American Indian, Alaska Native, and Native Hawaiian adolescents o The prevalence of serious violent behavior within American Indian, Alaska Native, and Native Hawaiian communities and the role of substance abuse in violence Service use and quality of care o The effect of social, economic, cultural, and psychological factors on choice of care-giver for mental health problems and treatment outcomes o Assessment of the reliability, validity, and cost- effectiveness of various methods used to screen for mental disorders, substance abuse, and family violence among American Indian, Alaska Native, and Native Hawaiians o Assessment of the reliability and validity of current diagnostic and assessment instruments and functional assessments for American Indian, Alaska Native, and Native Hawaiian populations in public health and mental health settings o Availability and use of mental health, substance abuse, and social services by American Indian, Alaska Native, and Native Hawaiian persons with mental disorders, particularly with co-occurring substance abuse disorders o The effectiveness of mental health and substance abuse treatments which combine traditional and Western medicine STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires inclusion of minorities and females in research study populations. Since this announcement requests research focusing only on minority populations (American Indians, Alaska Natives, and Native Hawaiians), these instructions apply only to the inclusion of females. Applications in response to this announcement are required to include both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. It is expected that special emphasis will be placed on the need for inclusion of women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender is excluded or is inadequately represented in this research, particularly in proposed population-based studies, clear compelling rationale for exclusion or inadequate representation should be provided. In addition, gender issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applications for support of research must employ a study design with representation of males and females (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women 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 these gender group differences in the proposed study. If adequate inclusion of one gender is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender, the rationale for the study population must be well explained and justified. Control group comparisons are encouraged in all research. For research awards that are covered by these special instructions for this particular announcement, awardees will report annually on enrollment of women and men as subjects. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). The number (PA-93-53) and title of this announcement, "American Indian, Alaska Native, and Native Hawaiian Mental Health Research," must be typed in item 2a on the face page of the application form. Applicants must also specify which support mechanism they are applying under, e.g., FIRST, small grant, R10. Application kits containing the necessary forms may be obtained from IHS Area offices and business offices; offices of sponsored research at most universities, colleges, medical schools, and other major research facilities; and from the Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone 301/443-4414. The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES AND CRITERIA Applications will be reviewed for scientific and technical merit by an initial review group (IRG) composed primarily of non-Federal scientific experts. Final review is by the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Criteria to be considered in evaluating applications for scientific/technical merit include: o Scientific, technical, or medical significance and originality of the proposed research o Appropriateness and adequacy of the research approach and methodology proposed to carry out the research o Qualifications and research experience of the Principal Investigators and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to the research o Appropriateness of the proposed budget and duration in relation to the proposed research o Adequacy of the proposed means for protecting against or minimizing adverse effects to human and/or animal subjects AWARD CRITERIA As part of the NIMH Public-Academic Liaison (PAL) initiative, special encouragement is given to applications that involve active collaborations between academic researchers and public sector agencies in planning, undertaking, analyzing, and publishing research pertaining to persons with severe mental illness. The PAL initiative is based on the premise that important new advances in understanding and treatment of severe mental illness can result from improved linkages between the Nation's scientific resources and the public sector agencies and programs in which many persons with severe mental illness receive their care. The scope of the PAL initiative encompasses public sector agencies of all types that deal with children, adolescents, adults, and elderly persons with severe mental disorders. In addition, preference in funding will be given to projects that include, but do not necessarily focus on, American Indian, Alaska Native, and Native Hawaiians living in urban settings and projects that include females in study populations. Factors considered in determining which applications will be funded include IRG and Council recommendations, PHS program needs and priorities, and availability of funds. INQUIRIES NIMH staff are available for consultation concerning proposal development in advance of or during the process of preparing an application. Applicants with questions about the Indian Health Service and questions about the feasibility of particular research approaches with American Indian and Alaska Native peoples, particularly for research demonstrations, should contact the NIMH staff member listed below. She can provide a list that includes the names, addresses, and phone numbers of the Mental Health Branch Chiefs in the 12 IHS Service Units and of the Chief of the headquarters IHS Mental Health Program Branch. Potential applicants should contact NIMH as early as possible for information and assistance in initiating the application process and developing an application. The NIMH program staff member listed below may be contacted for further information and assistance: Ann A. Hohmann, Ph.D., M.P.H. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 For further information on grants management issues, applicants may contact: Diana S. Trunnell Assistant Chief, Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This announcement is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100, or Health Systems Agency Review. $$P2 END ************************************************************ $$XID RFA CA9315 CA-93-15 P1O1 ***************************************** RESEARCH IN PUBLIC AND PROFESSIONAL EDUCATION FOR THE PREVENTION AND CONTROL OF SKIN CANCER NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFA: CA-93-15 P.T. 34; K.W. 0502017, 0715035, 0715185 National Cancer Institute National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 15, 1993 Application Receipt Date: May 20, 1993 PURPOSE The National Cancer Institute (NCI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications for grants to conduct research on educational strategies for the prevention of melanoma and non-melanoma skin cancers through controlled studies in defined populations. These behavioral studies should be aimed toward reduction of high levels of exposure to natural or artificial ultraviolet light. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Research in Public and Professional Education for the Prevention and Control of Skin Cancer, is related to the priority area of skin cancer risk 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 REQUIREMENTS Applications may be submitted by domestic and foreign non-profit and for-profit organizations and by public and private entities such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority and women investigators are encouraged. Investigators should be capable of assembling a multidisciplinary team including health education specialists responsible for public education interventions, trained medical personnel knowledgeable in skin cancer for professional education interventions, and associated statisticians, research designers, communication specialists, etc., for the successful implementation and reporting of a full-scale research project. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01), and the First Independent Research Support and Transition (FIRST) award (R29). It is anticipated that the average direct costs for each award will be $183,000 per year. This is a one-time solicitation. Future unsolicited competing continuation applications will compete with investigator-initiated applications and will be reviewed according to customary NIH peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be that of the applicant. FUNDS AVAILABLE It is anticipated that three NCI sponsored awards and one or two NIAMS sponsored awards will be made under this RFA, and that the total expenditures for these grants will not exceed $1,500,000 (total costs) for the first year. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this RFA is provided for in the financial plans of the NCI and the NIAMS, awards are contingent on the availability of funds. The project period for studies funded through this RFA may not exceed four years. The anticipated award date is April 1, 1994. RESEARCH OBJECTIVES Skin cancer is the fastest rising and most common form of cancer in the United States, accounting for well over 600,000 new cases reported every year, or about one-third of all cancer incidence. Of these cases, about 75 percent are basal cell and 20 percent are squamous cell carcinomas, both of which are highly treatable and rarely metastasize. The remaining 5 percent of skin cancer cases are malignant melanomas, which are far more lethal and currently account for an estimated 32,000 new cases, and more than 6,700 deaths per year. Between 1973 and 1989, the incidence rate for melanoma increased by 80.6 percent, more than any other cancer site, and far greater than the 16.1 percent increase for all sites combined. The mortality rate during the same period for all races and both sexes was 32.1 percent for melanoma, compared to the 6.1 percent cancer mortality rate for all sites combined. Theoretically, however, most skin cancer morbidity, and almost all skin cancer mortality should be preventable. Solar radiation appears to be the primary risk factor for more than 90 percent of nonmelanoma skin cancer cases, and it has also been linked to melanoma. Evidence for the effect of ultraviolet (UV) light exposure, especially the shorter wavelength UV-B rays, on skin cancer shows that a 1 percent relative increase in UV-B radiation may result in a 2 percent increase in skin cancer incidence. UV-B is the radiation that produces tanning and burning in human skin. Concern about the harmful effects of longer wavelength UV-A rays, which are more common in sunlight though less mutagenic than UV-B rays, is growing among researchers. Overall, data appear to indicate that nonmelanoma skin cancer is related to annual cumulative exposure, and that melanoma may be related to high intensity, intermittent UV radiation exposure (i.e., sunburns) particularly at a young age. Incidence of skin cancer is also influenced by degree of skin pigmentation and sex. Rates are highest for Whites, lower for Asians, and lowest for Blacks. Skin cancer incidence is also highly influenced by intensity of sunlight as a function of proximity to the equator or high altitude. It is hypothesized that there may be a growing risk of increased exposure to UV radiation due to depletion of the Earth's atmospheric ozone. The effects of a significant loss of the ozone layer on human health are not precisely known, but scientists speculate that skin cancer rates could increase as a result. In addition to health risks, the yearly estimated costs of treatment for skin cancer are substantial: approximately $37.6 million for basal cell, $28.2 million for squamous cell, and $99.7 million for malignant melanoma, totalling $165.5 million per year. Despite the hazards of sunlight exposure, National Health and Nutrition Examination Survey self-report data show that a large proportion of the U.S. population engages in moderate to high sunlight exposure: 61.6 percent of white males, 51.2 percent of white females, 49.8 percent of black males, and 41.6 percent of black females. Accordingly, the need for committed national efforts to reduce exposure to sunlight for the purpose of preventing skin cancer is great, and significant progress is clearly necessary. This is reflected in the U.S. Department of Health and Human Services' goal for the year 2000: "Increase to at least 60 percent the proportion of people of all ages who limit sun exposure, use sunscreens and protective clothing when exposed to sunlight, and avoid artificial sources of ultraviolet light (e.g., sun lamps, tanning booths)". Thus, based on current knowledge of the risks for skin cancer, the most prudent step, especially for those with light complexions, males, and children, is to limit or protect against UV radiation exposure. Parents and caregivers should see that children receive limited sun exposure. For adults, decreased exposure to sunlight and artificial sources of UV light, and use of protective clothing or sunscreen products shown to be capable of reducing UV rays is advisable. Special care should also be taken by people in lower latitudes and higher altitudes, and by everyone during the summertime, and during the midday. In addition to primary prevention, screening examinations could reduce the discomfort and cosmetic problems associated with nonmelanoma skin cancer. And most skin cancer deaths could be prevented through early detection of malignant melanoma, where five-year survival rates for localized melanomas may be greater than 90 percent. The appeal of skin cancer screening is great, not only because of this high survival rate, but also because it is noninvasive, quick, regarded as diagnostically reliable, and when part of regular medical practice, has little or no cost. Skin cancer is also probably the foremost cancer that most people can be taught to self-screen for with a moderate degree of reliability. Over 90 percent of melanomas can be recognized by unaided visual examination. This RFA has two major research objectives related to skin cancer prevention: (1) to study the effects of public education interventions aimed at increasing use of sunscreens and protective clothing, limiting exposure to solar radiation, avoiding artificial methods of tanning, teaching skin self-examination, and improving other behaviors related to skin cancer risk reduction; and (2) to study the effects of professional education interventions aimed at increasing caregivers' awareness of skin cancer, their ability to provide advice, and their knowledge on the importance of screening and early detection for the prevention and control of skin cancers. Most research will take place through a facility capable of community-based cancer prevention research, and will consist of intervening and measuring change in a sample drawn from a population shown to be at-risk by the investigator. This includes pilot testing survey instruments and techniques for feasibility and acceptability, validating instruments, and assessing participation and adherence rates. Investigators may develop their own, or select from or adapt existing materials or strategies that have been shown to be effective in reducing exposure to ultraviolet radiation, and informing health professionals about the risks associated with skin cancer and the use of screening and early detection. Techniques for validating effectiveness of methods and materials will be the responsibility of investigators. To ensure results that are representative, investigators should randomize subjects into intervention and control groups. These groups should be matched on risk factors such as skin pigmentation, age, sex, ethnicity, type of UV radiation exposure (solar, artificial, high altitude, etc.), and current or past exposure habits. Experimental groups must also be of sufficient size to provide the statistical power to detect significant differences between groups on variables of interest. Evaluations should be designed to test questions such as: (1) what are the most effective educational conditions that lead to a quantifiable reduction in skin cancer risk behaviors in specific populations?; and (2) what are the most effective educational conditions for increasing professional knowledge on primary prevention, screening, and early detection of skin cancer? The use of intermediary organizations and the formation of public/private partnerships is strongly encouraged. Investigators should strive to bring together diverse groups such as producers of sunscreen products, voluntary organizations, and organizations such as swimming pools, or golf, yacht, or tennis clubs. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants will be required to include minorities and women in study populations so that research findings can be of benefit to all people at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities in studies of diseases that disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear and compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group. In addition, gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included on grant application form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to carefully assess the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial or ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies or etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities to enable results of the study to be applied broadly. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, applicants must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will specifically address whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning a priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. LETTER OF INTENT Prospective applicants are requested to submit, by March 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of the subsequent application, the information that it contains is helpful in planning for the review of applications. It allows NIH staff to estimate the potential review workload, and helps to avoid conflict of interest among reviewers. The letter of intent is to be sent to: D. Michael Anderson, Ph.D., M.P.H. Director, Skin Cancer Prevention Research National Cancer Institute Executive Plaza North, Room 218 Bethesda, MD 20892 Telephone: (301) 496-8577 FAX: (301) 496-8675 or Alan N. Moshell, M.D. Skin Disease Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3342 FAX: (301) 480-7881 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this RFA. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Inquires, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the PHS 398 application kit must be affixed to the bottom of the face page of the application. Omission of this label could result in delayed processing of the application and its failure to reach the review committee in time for review. In addition, the number and title of this RFA must be typed on line 2a on the face page of the application, and the YES box must be marked. A signed, typewritten original of the application, including the Checklist, and three signed copies must be sent or delivered in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 650 Bethesda, MD 20892 Applications must be received by May 20, 1993. An application received after that will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NCI staff for completeness and responsiveness. Incomplete applications will be returned to the sender without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications in the next review cycle. Applications may undergo triage by an NCI peer review group on the basis of relative competitiveness. The NCI will withdraw from further competition those applications judged to be non- competitive for award and notify the application's Principal Investigator and institutional official. Those applications that are judged to be complete and responsive will be evaluated in accordance with the criteria stated below for scientific or technical merit by an appropriate peer review group convened by the NCI. The second level of review will be provided by the National Cancer Advisory Board or the National Arthritis and Musculoskeletal and Skin Disease Advisory Council. Review criteria include, but are not limited to: o scientific significance and originality of proposed research; o appropriateness and adequacy of the experimental design and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly in the area of the proposed research; o availability of resources necessary to carry out the research; o availability of, and capacity to recruit, adequate numbers of subjects for statistically significant research outcomes. The review group will also critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA The anticipated date of award is April 1, 1994. Applications considered responsive will be reviewed by an Initial Review Group (IRG). IRGs are allowed two types of recommendations; they may give an application a priority score, or they may suggest that an application be "not recommended for further consideration" (NRFC). Availability of funds, geographic distribution of awards, characteristics of study populations, and other programmatic priorities are also important criteria in making grant awards. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, whether or not specific proposed research is responsive, the scientific content and objectives of an application, the size and focus of a research program, and the organization of an application, are strongly encouraged and may be directed to: D. Michael Anderson, Ph.D., M.P.H. Director, Skin Cancer Prevention Research National Cancer Institute Executive Plaza North, Room 218 Bethesda, MD 20892 Telephone: (301) 496-8577 or Alan N. Moshell, M.D. Skin Disease Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3342 Requests for information on fiscal policies may be directed to: Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 56 or Diane Watson Extramural Research Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 720 Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. From owner-sci-resources@net.bio.net Tue Feb 09 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 6, pt. 1, 12 February 1993 Message-ID: Date: 10 Feb 93 22:54:42 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1506 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. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930212 V22N06 P1O2 ************************************ X-comment: RFAs described: CA-93-15, CA-93-14, AI-93-11 NIH GUIDE - Vol. 22, No. 6 - February 12, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** TELEPHONE NUMBER CHANGES FOR NIGMS STAFF National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX N2 ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** IN VITRO ANTIVIRAL SCREEN FOR HEPATITIS VIRUSES (RFP NIH-NIAID-DMID-94-03) National Institutes of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** DEVELOPMENT OF A PERCUTANEOUS CONNECTOR SYSTEM (RFP NIH-NIDCD-93-50) National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS $$INDEX R3 ********************************************************** THIN-FILM INTRACORTICAL RECORDING MICROELECTRODES (RFP NIH-NINDS-93-06) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R4 05/20/93 ************************************************* RESEARCH IN PUBLIC AND PROFESSIONAL EDUCATION FOR THE PREVENTION AND CONTROL OF SKIN CANCER (RFA CA-93-15) National Cancer Institute National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: CANCER; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R5 05/21/93 ************************************************* ADULT SURVIVORS OF CANCER (RFA CA-93-14) National Cancer Institute INDEX: CANCER $$INDEX R6 07/21/93 ************************************************* THE CAUSES AND CONSEQUENCES OF THYMUS INVOLUTION (RFA AI-93-11) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** PROSTATE GROWTH IN OLDER MEN: AGE-DEPENDENT MECHANISMS (PA-93-52) National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute INDEX: AGING; DIABETES, DIGESTIVE, KIDNEY DISEASES; CANCER $$INDEX P2 ********************************************************** AMERICAN INDIAN, ALASKA NATIVE, AND NATIVE HAWAIIAN MENTAL HEALTH RESEARCH (PA-93-53) National Institute of Mental Health INDEX: MENTAL HEALTH This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** TELEPHONE NUMBER CHANGES FOR NIGMS STAFF NIH GUIDE, Volume 22, Number 6, February 12, 1993 National Institute of General Medical Sciences On March 26, 1993, NIH will switch to a new telephone system that will change all telephone numbers in the Westwood Building. Listed below are the new numbers for key offices in the National Institute of General Medical Sciences (NIGMS). For the telephone numbers of NIGMS staff not included on this list, call the old number (a recording will give the new number for approximately 6 months) or the NIGMS Office of Research Reports at (301) 496-7301. Director, Ruth L. Kirschstein, M.D. -- (301) 594-7817 Deputy Director, Marvin Cassman, Ph.D. -- (301) 594-7735 Executive Officer, Martha Pine -- (301) 594-7811 Personnel Officer, Howard Chernoff -- (301) 594-7767 Associate Director for Program Activities, W. Sue Shafer, Ph.D. -- (301) 594-7751 Assistant Director for Referral and Liaison, Anthony Rene, Ph.D. -- (301) 594-7706 Assistant Director for Research Training, John Norvell, Ph.D. -- (301) 594-7784 Grants Management Officer, Carol Tippery -- (301) 594-7813 Director, Biophysics and Physiological Sciences Program, James Cassatt, Ph.D. -- (301) 594-7800 Director, Cellular and Molecular Basis of Disease Program, Charles Miller, Ph.D. -- (301) 594-7748 Director, Genetics Program, Judith Greenberg, Ph.D. -- (301) 594-7773 Director, Minority Access to Careers Program, Elward Bynum -- (301) 594-7823 Director, Minority Biomedical Research Support Program, Ciriaco Gonzales, Ph.D. -- (301) 594-7949 Director, Pharmacological Sciences Program, Christine Carrico, Ph.D. -- (301) 594-7808 Chief, Office of Review Activities, Helen Sunshine, Ph.D. -- (301) 594-7803 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS NIH GUIDE, Volume 22, Number 6, February 12, 1993 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 continuing to sponsor a series of workshops on 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: SOUTHWESTERN WORKSHOP DATES: February 12 and 13, 1993 LOCATION Sheraton Tempe Mission Palms Hotel 60 East 5th Street Tempe, AZ 85281 Telephone: (602) 894-1400 SPONSORS Arizona State University, Tempe, AZ Northern Arizona University, Flagstaff, AZ REGISTRATION Ms. Carol Jablonski, IRB Coordinator Office of the Assistant Vice President for Research Arizona State University Tempe, AZ 85287-3403 Telephone: (602) 965-6788 TITLE: Contemporary Issues in Human Subject Research: Challenges for Today's IRBs DESCRIPTION: This program is designed to be a practical working session to explore contemporary issues in human subjects protection including regulations and assurances, categorization of research protocols, uses of special populations, experimental design and scientific merit, fetal tissue research, ethical/legal issues in human subjects research, and conflict of interest. As appropriate, topics will be discussed from the perspective of the clinical researcher and the behavioral/social science researcher. Issues will be discussed in a panel format with ample time for audience questions. An outstanding faculty has been assembled. This program should be of interest to researchers in clinical medicine and the behavioral and social sciences. Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. SOUTHWESTERN WORKSHOP DATES: February 28 thru March 2, 1993 LOCATION San Luis Hotel 5222 Seawall Boulevard Galveston, TX 77551 Telephone: 1(800)-392-5937 SPONSORS The University of Texas Medical Branch at Galveston Galveston, TX 77555-1311 REGISTRATION E. Ray Stinson, Ph.D. Office of Sponsored Programs-Academic The University of Texas Medical Branch at Galveston Galveston, TX 77555-1311 Telephone: (409)-772-3482 TITLE: The Ethics of Clinical Research on Human Subjects: Facing the 21st Century NORTHWESTERN WORKSHOP DATES: May 20 and 21, 1993 LOCATION Sheraton Hotel Anchorage, AK SPONSORS University of Alaska - Anchorage, Anchorage, AK Northwest Indian College, Bellingham, WA Indian Health Services, Tucson, AZ REGISTRATION Mrs. Ann Howell Coordinator of Conferences and Institutes University 2221 East Northern Lights, Suite 205 Anchorage, AK 99508 Telephone: (907) 278-8821 TITLE: Research Benefits and Risks to Individuals and Communities: Legal and Ethical Perspectives DESCRIPTION: This conference will explore the legal and ethical perspectives of social and biomedical research. Protecting the individual rights of human research subjects is of prime concern, but so is protecting the rights of communities of individuals. This is especially true for indigenous peoples. The conference is designed to be of interest to social and biomedical researchers, IRB members, students, agency personnel, indigenous peoples, and others interested in the rights of individuals and communitites. Opportunities for informal discussion and exchange will supplement the panel and breakout group format. Reports from the simultaneous group sessions will be made. INQUIRIES For information regarding these workshop and future NIH/FDA National Human Subjects Protection Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NIH-NIAID-DMID-94-03 ************************************* IN VITRO ANTIVIRAL SCREEN FOR HEPATITIS VIRUSES NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFP AVAILABLE: NIH-NIAID-DMID-94-03 P.T. 34; K.W. 0755060, 1002045, 0760013 National Institutes of Allergy and Infectious Diseases The Enteric Diseases Branch, National Institute of Allergy and Infectious Diseases (NIAID), seeks investigators to perform in vitro screening for compounds for their ability to inhibit the growth, replication, or enzymatic processes of hepatitis viruses, specifically the hepadnaviruses like hepatitis B virus and hepatitis C virus. The contractor will provide the necessary equipment, personnel, facilities, and materials to screen 200 compounds annually. The contractor will be responsible for determining a compound's antiviral activity, cytotoxicity, and selective index. Research on the development of improved screening methodology, basic studies on mechanism of action, and studies of efficacy of drug combinations will be encouraged as an adjunct to the primary antiviral evaluation. Request for Proposals (RFP) NIH-NIAID-DMID-94-03 is now available. Responses are due by close of business on March 25, 1993. It is anticipated that one cost-reimbursement, completion, contract covering the virus classes individually will be awarded for a period of five years. Any responsible offeror may submit a proposal that will be considered by the government. INQUIRIES To receive a copy of this RFP, supply this office with two self-addressed mailing labels. Telephone inquiries will not be honored and all inquiries must be in writing and addressed to: Frank Murphy, Contract Specialist National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard Solar Building, Room 3C07 Bethesda, MD 20892 This advertisement does not commit the government to award a contract. $$R1 END ************************************************************ $$R2 BEGIN NIH-NIDCD-93-50 ****************************************** DEVELOPMENT OF A PERCUTANEOUS CONNECTOR SYSTEM NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFP AVAILABLE: NIH-NIDCD-93-50 P.T. 34; K.W. 0740030, 0706010 National Institute on Deafness and Other Communication Disorders The National Institute of Deafness and Other Communication Disorders (NIDCD), NIH, has a requirement for the design, development, fabrication, and evaluation in animals of a percutaneous connector system for transferring electrical signals through the skin. There is a need for a reliable and effective high-contact-density percutaneous connector system for transferring multichannel signals and power through the skin. Under this project, this system will initially be used in animal experiments related to the development of auditory prostheses. An ultimate goal of this program is for the development of a new percutaneous connector system that can be utilized in neural prostheses, such as auditory prostheses, which are implanted in the human cochlea and in the human cochlear nucleus as well as visual prostheses for blind individuals. Such a percutaneous connector system should permit direct connections between artificial sensors and signal processors located outside the body and electrode arrays implanted in close proximity to sensory neurons. A single award is anticipated with the performance period not to exceed three years. The contractor will be required to come to Bethesda yearly to present progress reports at the Neural Prosthesis Workshop sponsored by the Neural Prosthesis Program. Prospective offerors should have established expertise in biomaterials, bioengineering, and miniature electrical connector technology. This is not a Request for Proposals (RFP). RFP No. NIH-NIDCD-93-50 will be issued on or about February 16, 1993, with April 16, 1993 set as a tentative closing date for receipt of proposals. INQUIRIES To receive a copy of the RFP, submit a written request to the following address and supply two self-addressed mailing labels: Contracts Management Branch, DEA National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 Reference: RFP No. NIH-NIDCD-93-50 This announcement does not commit the NIDCD to make an award. All responsible sources may submit a proposal that will be considered by the government. $$R2 END ************************************************************ $$R3 BEGIN NIH-NINDS-93-06 ****************************************** THIN-FILM INTRACORTICAL RECORDING MICROELECTRODES NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFP AVAILABLE: NIH-NINDS-93-06 P.T. 34; K.W. 0740050, 0706000 National Institute of Neurological Disorders and Stroke The Neural Prosthesis Program of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, is seeking a contract to develop an active multichannel recording microelectrode probe capable of recording from up to 32 sites on multiple penetrating shanks. The broad objective of the project is to develop multi-channel, penetrating microelectrode arrays for intracortical CNS neural recording that will operate reliably in chronic implants. The approach is to integrate micromachined electrode shanks with active electronics and with integral flexible ribbon cables and/or with integral telemetry systems. Personnel with established expertise in micromachining, bioengineering, integrated circuit design, and integrated circuit fabrication are needed. It is anticipated that one award will be made for a period of three years in September 1993. INQUIRIES This is not a Request for Proposals (RFP). To receive a copy of the RFP, submit a written request to the address indicated below and supply this office with two self-addressed mailing labels. An RFP will be issued on or about February 16, 1993 with proposals due on April 19, 1993. All responsible sources will be considered by the agency. Contracting Officer Contracts Management Branch, DEA National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 Attention: RFP No. NIH-NINDS-93-06 $$R3 END ************************************************************ $$R4 BEGIN CA-93-15 FULL-TEXT *************************************** RESEARCH IN PUBLIC AND PROFESSIONAL EDUCATION FOR THE PREVENTION AND CONTROL OF SKIN CANCER NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFA AVAILABLE: CA-93-15 P.T. 34; K.W. 0502017, 0715035, 0715185 National Cancer Institute National Institute of Arthritis and Musculoskeletal and Skin Diseases Letter of Intent Receipt Date: March 15, 1993 Application Receipt Date: May 20, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT PERSON NAMED IN INQUIRIES, BELOW. PURPOSE The National Cancer Institute (NCI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invite applications for grants to conduct research on educational strategies for the prevention of melanoma and non-melanoma skin cancers through controlled studies in defined populations. These behavioral studies should be aimed toward reduction of high levels of exposure to natural or artificial ultraviolet light. 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 in Public and Professional Education for the Prevention and Control of Skin Cancer, is related to the priority area of skin cancer risk 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 REQUIREMENTS Applications may be submitted by domestic and foreign non-profit and for-profit organizations and by public and private entities such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority and women investigators are encouraged. Investigators should be capable of assembling a multidisciplinary team including health education specialists responsible for public education interventions, trained medical personnel knowledgeable in skin cancer for professional education interventions, and associated statisticians, research designers, communication specialists, etc., for the successful implementation and reporting of a full-scale research project. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01), and the FIRST (R29) award. It is anticipated that the average direct costs for each award will be $183,000 per year. This is a one-time solicitation. Future unsolicited competing continuation applications will compete with investigator-initiated applications and will be reviewed according to customary NIH peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be that of the applicant. FUNDS AVAILABLE It is anticipated that three NCI sponsored awards and one or two NIAMS sponsored awards will be made under this RFA, and that the total expenditures for these grants will not exceed $1,500,000 (total costs) for the first year. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this RFA is provided for in the financial plans of the NCI and the NIAMS, awards are contingent on the availability of funds. The project period for studies funded through this RFA may not exceed four years. The anticipated award date is April 1, 1994. RESEARCH OBJECTIVES Skin cancer is the fastest rising and most common form of cancer in the United States, accounting for well over 600,000 new cases reported every year, or about one-third of all cancer incidence. Of these cases, about 75 percent are basal cell and 20 percent are squamous cell carcinomas, both of which are highly treatable and rarely metastasize. The remaining 5 percent of skin cancer cases are malignant melanomas, which are far more lethal and currently account for an estimated 32,000 new cases, and more than 6,700 deaths per year. Between 1973 and 1989, the incidence rate for melanoma increased by 80.6 percent, more than any other cancer site, and far greater than the 16.1 percent increase for all sites combined. The mortality rate during the same period for all races and both sexes was 32.1 percent for melanoma, compared to the 6.1 percent cancer mortality rate for all sites combined. Theoretically, however, most skin cancer morbidity, and almost all skin cancer mortality should be preventable. Solar radiation appears to be the primary risk factor for more than 90 percent of nonmelanoma skin cancer cases, and it has also been linked to melanoma. Overall, data appear to indicate that nonmelanoma skin cancer is related to annual cumulative exposure, and that melanoma may be related to high intensity, intermittent UV radiation exposure (i.e., sunburns) particularly at a young age. Incidence of skin cancer is also influenced by degree of skin pigmentation, sex, and by intensity of sunlight as a function of proximity to the equator or high altitude. Thus, based on current knowledge of the risks for skin cancer, the most prudent step, especially for those with light complexions, males, and children, is to limit or protect against UV radiation exposure. Special care should also be taken by people in lower latitudes and higher altitudes, and by everyone during the summertime, and during the midday. In addition to primary prevention, screening examinations could reduce the discomfort and cosmetic problems associated with nonmelanoma skin cancer. Also, most skin cancer deaths could be prevented through early detection of malignant melanoma, where five-year survival rates for localized melanomas may be greater than 90 percent. This RFA has two major research objectives related to skin cancer prevention: (1) to study the effects of public education interventions aimed at increasing use of sunscreens and protective clothing, limiting exposure to solar radiation, avoiding artificial methods of tanning, teaching skin self-examination, and improving other behaviors related to skin cancer risk reduction; and (2) to study the effects of professional education interventions aimed at increasing caregivers' awareness of skin cancer, their ability to provide advice, and their knowledge on the importance of screening and early detection for the prevention and control of skin cancers. Evaluations should be designed to test questions such as: (1) what are the most effective educational conditions that lead to a quantifiable reduction in skin cancer risk behaviors in specific populations?; and (2) what are the most effective educational conditions for increasing professional knowledge on primary prevention, screening, and early detection of skin cancer? STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are requested to submit, by March 15, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of the subsequent application, the information that it contains is helpful in planning for the review of applications. It allows NIH staff to estimate the potential review workload, and helps to avoid conflict of interest among reviewers. The letter of intent is to be sent to Dr. D. Michael Anderson (NCI) or Dr. Alan N. Moshell (NIAMS) at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying to this RFA. These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Inquires, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-496-7441. Applications must be received by May 20, 1993. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by NCI staff for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI or NIAMS staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications in the next review cycle. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, whether or not specific proposed research is responsive, the scientific content and objectives of an application, the size and focus of a research program, and the organization of an application, are strongly encouraged and may be directed to: D. Michael Anderson, Ph.D., M.P.H. Director, Skin Cancer Prevention Research National Cancer Institute Executive Plaza North, Room 218 Bethesda, MD 20892 Telephone: (301) 496-8577 or Alan N. Moshell, M.D. Skin Disease Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 405 Bethesda, MD 20892 Telephone: (301) 402-3342 Requests for information on fiscal policies may be directed to: Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 56 or Diane Watson Extramural Research Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Westwood Building, Room 720 Bethesda, MD 20892 Telephone: (301) 402-3352 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ $$R5 BEGIN CA-93-14 FULL-TEXT *************************************** ADULT SURVIVORS OF CANCER NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFA AVAILABLE: CA-93-14 P.T. 34; K.W. 0715035, 0414014, 0415002 National Cancer Institute Letter of Intent Receipt Date: March 16, 1993 Application Receipt Date: May 21, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Cancer Institute (NCI) invites investigator-initiated grant applications for research directed at decreasing the functional and psychosocial morbidity associated with cancer survivorship, i.e., in persons diagnosed and treated for cancer after age 21, who have completed therapy and have a good prognosis for cure or long-term survival. 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, Adult Survivors of Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-783-3238. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). The applicant has sole responsibility for planning, direction, and execution of the proposed project. Total project period for applications submitted in response to this RFA should not exceed four years. The anticipated award date is April 1, 1994. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research grant applications and be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Total costs of $2,500,000 per year for four years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that four or five awards will be made. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the awards pursuant to this RFA are also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The objectives of this initiative are to decrease functional and psychosocial morbidity associated with cancer survivorship by developing and testing interventions to facilitate rehabilitation of adult cancer survivors and to enhance their re-entry into society. The specific objectives are: (1) to define and explore functional and psychosocial issues facing adult cancer survivors and the barriers to reintegration into society, and (2) to develop and evaluate specific interventions to enhance adaptation to long term physical impairment, vocational rehabilitation, psychosocial adjustment and/or return to pre-diagnosis life style. Research applications should address issues in at least one of the following areas: long term physical impairment; self-image, sexuality, reproductive potential; interpersonal relationships and social functioning; vocational rehabilitation, employment or insurability; medical uncertainties; cultural and ethnic background and values as influences on adaptation to cancer. The application should define the study population, identify the problem, describe the intervention and outline the evaluation plan. The design must include a testable intervention and a systematic plan of evaluation of the intervention using qualitative and quantitative methods. STUDY POPULATIONS SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES For projects involving clinical research, NIH requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populations for clinical studies, a specific justification for this exclusion must be provided. Applications without documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by March 16, 1993 a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone/FAX numbers of the Principal Investigator, the names of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding and does not enter into the review of a subsequent application, it contains information that is helpful in planning for the review. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to the Program Director named in INQUIRIES. APPLICATION PROCEDURES Applications must be received by close of business May 21, 1993. Application forms (PHS 398, rev. 9/91) and information about application procedures may be obtained from the NCI Program Director named in INQUIRIES and in the RFA. REVIEW CONSIDERATIONS Applications that are competitive and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group according to specific review criteria. A second level of review will consider special needs and research priorities of NCI. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: Claudette Varricchio D.S.N., R.N., O.C.N., F.A.A.N. National Cancer Institute Executive Plaza North, Suite 300 Bethesda, MD 20892 Telephone: (301) 496-8541 Direct inquiries regarding fiscal matters to: Mrs. Eileen M. Natoli National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892 Telephone: (301) 496-7800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Research, and 93.361, Nursing Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 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. $$R5 END ************************************************************ $$R6 BEGIN AI-93-11 FULL-TEXT *************************************** THE CAUSES AND CONSEQUENCES OF THYMUS INVOLUTION NIH GUIDE, Volume 22, Number 6, February 12, 1993 RFA AVAILABLE: AI-93-11 P.T. 34; K.W. 0705040, 1002061, 0765035 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 21, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACTS NAMED IN INQUIRIES, BELOW. PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for studies focused on the causes and consequences of thymus involution. The purpose of research dealing with thymus involution is to achieve an understanding of this still largely mysterious phenomenon. It is essential to determine whether normal thymus involution is a vital physiological process that contributes to sustained vigor of the immune system or, by contrast, leads to subtle pathological activities of the immune system. Given that there are approaches to preventing, retarding or reversing thymus involution, it is important to determine whether or not interfering with the process of involution has desirable and beneficial effects on the immune system. 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, The Causes and Consequences of Thymus Involution, is related to the priority area of diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private, foreign and domestic, for profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply for First Independent Research Support and Transition (FIRST) (R29) awards. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanisms of support for this program will be the research project grant (R01) and the FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. The budget request for an R29 application is restricted to the amount allowed by NIH for R29s. The budget request for an R01 application should not exceed $200,000 total direct costs in the first year. Neither type of application should request more than 4 percent annual inflationary increases for future years. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $800,000. In Fiscal Year 1994, the NIAID plans to award at least three projects (R01s or R29s) submitted in response to this RFA. RESEARCH OBJECTIVES Scope Projects that clearly will enhance understanding of the causes and physiological/pathological significance of thymus atrophy and will promote reasonable approaches to preventing or treating immunological diseases are encouraged. Research areas of interest include, but are not limited to: o Studies aimed at determining the causes of thymus involution; its impact on the rate and magnitude of change in the export of T lymphocytes; and the chronological age and physiological stage at which T cell generation/export reaches a nadir; o Evaluations of the immunological consequences of the decline and minimization of T cell generation/export by the thymus (e.g., changes in the T cell repertoire; changes in immunological potential; changes in the potential for self-reactivity and pathological autoimmunity; and similarities and differences between natural thymus involution and adult thymectomy); o Explorations of extrathymic sites for locations of T cell generative potential, and characterization of the T cells generated at those sites; o Identification and analysis of long-lasting subsets of T cell precursors that may be located and/or generated in peripheral lymphoid or other tissues; o Development of procedures to delay thymus involution or to rejuvenate the involuted thymus, and evaluation of the immunological consequences of prolonged or restored thymus function; and o Analyses of factors that control the mass of the thymus and that influence the survival and duration of function of thymus grafts implanted into thymectomized recipients, genetically-athymic recipients, and recipients in which the thymus has involuted. The scope of this RFA does not include studies on aging of the immune system. If such applications are received, the DRG will assign them to the National Institute on Aging as unsolicited applications. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy requires that applicants for NIH clinical research grants and cooperative agreements include minorities and women in study populations. If women or minorities are excluded or inadequately represented in clinical research, a clear compelling rationale MUST be provided. Applications without such documentation will not be accepted for review. LETTER OF INTENT Prospective applicants are asked to submit, by April 1, 1993, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 09/91). Item 2 on the face page of the application must be marked "Yes" and the RFA number and the words "THE CAUSES AND CONSEQUENCES OF THYMUS INVOLUTION" must be typed in. These application forms may be obtained from the institution's office of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. Applications must be received by July 21, 1993. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and by NIAID staff for responsiveness. Those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be either returned without review or referred to the DRG as an unsolicited application, to be scheduled for initial review at the next DRG review cycle. Those applications that are complete and responsive may be subjected to a triage by an NIAID peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will withdraw from competition those applications judged to be non-competitive for award and will notify the applicant and institutional business officials. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. The factors to be considered in the evaluation of scientific merit of each application will be those used by NIH in the review of traditional research project grant applications. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit, as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues and requests for the RFA may be directed to: Joseph F. Albright, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A22 Bethesda, MD 20892 Telephone: (301) 496-7551 FAX: (301) 402-2571 Direct inquiries regarding review issues, address the Letter of Intent to, and mail the two copies of the application to: Mark Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C22 Bethesda, MD 20892 Telephone: (301) 496-8424 FAX: (301) 402-2638 Direct inquiries regarding fiscal and administrative matters to: Mr. Jeffrey Carow Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 Schedule Letter of Intent Receipt Date: April 1, 1993 Application Receipt Date: July 21, 1993 Scientific Review Date: October 1993 Advisory Council Date: February 1994 Earliest Award Date: April 1994 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R6 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-93-052 ************************************************ PROSTATE GROWTH IN OLDER MEN: AGE-DEPENDENT MECHANISMS NIH GUIDE, Volume 22, Number 6, February 12, 1993 PA NUMBER: PA-93-052 P.T. 34; K.W. 0755030, 0705075, 0715105, 1002008 National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute PURPOSE The National Institute on Aging (NIA) wishes to stimulate basic research on the etiology of the extraordinarily high incidence of benign or malignant prostate growth in older men, and issues relative to clinical consequences and the effectiveness of current and proposed treatment protocols in older men experiencing pathologic or symptomatic effects of benign or malignant growth. The NIA is joined by other NIH components that support prostate-related research: the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports research into basic prostate biology and benign prostatic hyperplasia, and the National Cancer Institute (NCI) supports research into prostate cancer. The focus of the NIA in promoting research into ameliorating the negative health effects of prostate growth in the older male population is on age-related factors and age-dependent processes of prostate growth. New and experienced investigators working in the research areas of prostate cell and molecular biology, prostate biochemistry, clinical studies of prostate pathology, or related areas are invited to apply for grant support to study age-related factors and age-dependent processes in prostate growth that account for the prevalence of these diseases in older men. 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, Prostate Growth in Older Men: Age-Dependent Mechanisms, is related to the priority areas of cancer and chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applicants for K and F awards must be U.S. citizens, non-citizen nationals, or have been lawfully admitted for permanent residence at the time of award. Foreign institutions are not eligible to apply for R29, K08, or K11 awards. MECHANISM OF SUPPORT Support for this program will be by research project grants (R01), First Independent Research Support and Transition (FIRST) awards (R29), Clinical Investigator Awards (K08), Physician Scientist Awards (K11), Individual Postdoctoral Fellowships (F32), Senior Postdoctoral Fellowships (F33), and conference grants (R13). The anticipated average direct cost award for a research project grant is $150,000 per year. RESEARCH OBJECTIVES Background Prostate hyperplasia/hypertrophy (benign or malignant) affects virtually all men by the age of 80, with an increased incidence starting between 30 and 40 years of age. Not all prostate growth requires clinical treatment; yet the extremely high prevalence of this disease with advancing age requires a special research focus to explore the age-dependent mechanisms involved. Prostate growth is substantial during adolescence, reaching a plateau about age 25. Resumption of prostate growth later in life (about age 50) can lead to benign prostatic hyperplasia (BPH), the most common nonmalignant proliferative abnormality found in any internal organ. BPH alone occurs in over 75 percent of men over 50 years of age, reaching 88 percent prevalence by the ninth decade, frequently with clinical symptoms of outlet obstruction that can lead to bladder wall hypertrophy, increased risk of urinary infection, and chronic renal disease. Surgery, hospitalization and other treatment for BPH are estimated to cost over a billion dollars per year. Prostate cancer, which increases faster with aging than any other form of cancer, is the most common cancer in U.S. males, and the second leading cause of cancer death in men, resulting in over 30,000 deaths per year. Older black males have a significantly higher rate of prostate cancer than older white males. This disease also requires over a billion dollars per year in surgery and hospitalization costs. Goals of the program The purpose of this program announcement is to stimulate research into the cause(s) of, and treatments for, the extremely high incidence and prevalence of both benign and malignant prostate growth in older men, using animal and cell culture models, and human tissue samples and clinical studies where applicable. It is imperative that applicants address age-related issues important to prostate growth processes. What is it about aging processes and the properties of the prostate, its environment, and its natural history that promote growth? What are the effects of long term treatment protocols for BPH and prostate cancer in older men? Examples of the types of research requested are provided below. These are examples only and are not meant to restrict the types of projects of interest, provided the focus is on age-related and age-dependent factors in prostate growth. o Molecular genetics/cytogenetics: Is there an increasing tendency for molecular and cytogenetic changes (e.g., oncogene activation, tumor suppressor gene inactivation) with increasing age that are relevant to prostate growth? o Environment/nutritional: Are there environmental/nutritional changes, such as decreased production of vitamin D, that combine with normal aging processes to promote prostate growth? o Cell biology: What is the role of aging processes in programmed cell death and its abrogation by steroids in promoting prostate growth; what is the effect of aging on stem cell proliferation that may lead to prostate growth; what is the effect of aging on angiogenesis within hyperplastic prostate tissue; is there an age-dependence in prostate neuroendocrine cell proliferation associated with prostate growth; are age-dependent processes involved in the increased invasive/metastatic potential of hyperplastic prostate cells; are there changes in prostate stromal-epithelial interactions with aging that lead or predispose to prostate growth? o Hormones/growth factors: Are there age-related changes in sensitivity of prostatic epithelial or stromal cells to hormones or growth factors; what is the role of prolactin in promoting prostate growth and are there age-related changes in prolactin secretion pertinent to prostate growth; what age-related changes in growth factor secretion, sensitivity, and paracrine/autocrine interactions affect prostate growth? o Clinical issues of treatment: How appropriate are current clinical treatment regimens for prostate growth in older men; are there prophylactic treatment regimens to minimize the occurrence of prostate growth with age, such as use of tamoxifen, or retinoids; what are the effects of long term hormonal treatment (e.g., Proscar (finasteride), anti-androgens, LHRH agonists) in older men; how effective, prognostic and specific are prostate specific antigen (PSA) measurements in older men? STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS The inclusion of women is usually standard terminology for all grants and contracts: however, due to the specific subject of this program announcement, i.e., prostate growth, the inclusion of women is not applicable. However, the inclusion of minorities remains relevant. NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities in studies of diseases, disorders and conditions which disproportionately affect them. If minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of racial/ethnic group. In addition, racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES This is an ongoing program announcement. Applications for R and K awards are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Individual Postdoctoral Fellowship National Research Service Award (NRSA) (F32, F33) applications must be submitted on grant application form PHS 416 (rev. 10/91), and will be accepted on the standard deadlines for that mechanism. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of this announcement (PA-93-52, Prostate Growth in Older Men: Age-Dependent Mechanisms) must be typed in Section 2a on the face page of the application. Applications for F32, F33 and R29 awards must include at least three letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned to the appropriate initial review group and funding component on the basis of established Public Health Service referral guidelines. The review criteria are the traditional criteria appropriate to each mechanism. In accordance with the standard NIH peer review procedures, research project grant (R01, R29) and fellowship (F32, F33) applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. All other applications will be reviewed by review groups of the appropriate funding component. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Program balance among research areas within the individual funding components INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding NIA programmatic issues in basic research to: Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Direct inquiries regarding NIA programmatic issues in clinical and disease-oriented research to: Sheryl Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 Bethesda, MD 20892 Telephone: (301) 496-6761 FAX: (301) 402-1784 For programmatic issues related to the NIDDK, direct inquiries to: Leroy M. Nyberg, Jr., Ph.D., M.D. Director, Urology Program National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Suite 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7133 FAX: (301) 402-0223 For programmatic issues related to the NCI, direct inquiries to: Andrew Chiarodo, Ph.D. Division of Cancer Biology, Diagnosis and Centers National Cancer Institute Executive Plaza North, Suite 316 Bethesda, MD 20892 Telephone: (301) 496-8528 FAX: (301) 402-0181 Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants Management Officer National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-2945 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-93-53 ************************************************* AMERICAN INDIAN, ALASKA NATIVE, AND NATIVE HAWAIIAN MENTAL HEALTH RESEARCH NIH GUIDE, Volume 22, Number 6, February 12, 1993 PA NUMBER: PA-93-53 P.T. 34, FE; K.W. 0715129, 0785055, 0745027 National Institute of Mental Health PURPOSE The purpose of this announcement is to encourage research and research demonstration applications for studies among American Indian, Alaska Native, and Native Hawaiian populations of the epidemiology and prevention of mental disorders, co-occurring substance abuse disorders, and suicide; family and individual coping styles and resiliency; family violence; and mental health service use and quality of care. It is the goal of this initiative to improve the care and quality of life of American Indians, Alaska Natives, and Native Hawaiians who suffer from mental illnesses. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Minority Mental Health 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, DC 20402-9325 (telephone 202/783-3238). From owner-sci-resources@net.bio.net Sat Feb 13 22:00:00 1993 Path: biosci!uwm.edu!cs.utexas.edu!hellgate.utah.edu!cc.usu.edu!slp9k From: slp9k@cc.usu.edu (Darrell Fuhriman, Physics & Math Undergrad) Newsgroups: bionet.sci-resources Subject: GEF-- Global environemtal Forum Message-ID: <1993Feb13.164724.63990@cc.usu.edu> Date: 13 Feb 93 22:47:24 GMT Organization: Utah State University Lines: 32 I would like to introduce you to a new and exciting organziation- Global Environemtnal Forum (GEF). GEF is a minority owned an operated environmental and technical information service company. The goal of the company is to provide current environmental and health information that is of interest to the minority communities AfroTech Environmentalist is the first environmental/technical newsletter that focuses specifically on the evnironmental and health issues affecting the African American Community. In addition to raising environmental awareness, educational and mployment opportunities pertaining to the environmental industry will be part of the normal series of articles found in the AfroTech Environmentalist. Subscriptions are $10 a year, with group rates available. For more info or a complimentary copy contact: Darrell Fuhriman slp9k@cc.usu.edu or Global Environmental Forum P.O. Box 4028 Logan, UT 84323-4028 -- ******************************************************************************** Darrell Fuhriman * "We teach them to drop fire on people but, we Intenet: SLP9K@CC.USU.EDU * won't let them write "fuck" on the side of an Bitnet: SLP9K@USU * airplane becuase it's obscene." ******************************************************************************** Disclaimer: This is not a disclaimer From owner-sci-resources@net.bio.net Tue Feb 16 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 14 February 1993 Message-ID: Date: 17 Feb 93 00:19:05 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 129 ** NEW DOCUMENTS ON STIS ** Document Type: Directions Title: NSF Directions Nov-Dec 1992 Issue Volume 5 Number 5 File size (bytes): 38594 STIS Filename: dir9211 Document Type: Letter Title: NSF 93-13 MPS Multi- and Interdisciplinary Research File size (bytes): 3698 STIS Filename: nsf9313 Document Type: Recruit Title: Biochemical and/or Biophysical Science Administrator (Program Director) File size (bytes): 3593 STIS Filename: vex9310 Title: Geneticist (Program Director) File size (bytes): 3428 STIS Filename: vex9311 Title: Geographer (Program Director) File size (bytes): 3445 STIS Filename: vex9312 Title: Decision Sciences Administrator (Program Director) File size (bytes): 3498 STIS Filename: vex9313 Title: Staff Associate for Oversight File size (bytes): 5650 STIS Filename: vex938 Title: Social Scientist File size (bytes): 6375 STIS Filename: vgs9322 Title: Engineer File size (bytes): 6011 STIS Filename: vgs9323 Title: Physical Scientist File size (bytes): 6167 STIS Filename: vgs9324 Title: Mathematician File size (bytes): 6354 STIS Filename: vgs9325 Title: Computer Scientist File size (bytes): 6181 STIS Filename: vgs9326 Title: Biologist File size (bytes): 6121 STIS Filename: vgs9327 Document Type: Report Title: Report of the National Science Board Commission on the Future of the National Science Foundation File size (bytes): 30699 STIS Filename: nsb92196 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 1842 STIS Filename: cmpublic Document Type: Phone Book Title: NSF Alphabetical Listing File size (bytes): 90151 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 91811 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet) or stisinfo@NSF (BITNET). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserv@nsf.gov (Internet) or stisserv@NSF (BITNET). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "firstop@nsf.gov" (Internet) or "firstop@nsf" (BITNET). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet) or "stis@NSF" (BITNET). From owner-sci-resources@net.bio.net Fri Feb 19 22:00:00 1993 Path: biosci!NET.BIO.NET!kristoff From: kristoff@NET.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 22, no. 7, pt. 1, 19 February 1993 Message-ID: Date: 20 Feb 93 09:53:27 GMT Sender: kristoff@net.bio.net Distribution: bionet Lines: 1505 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. ---------------------------------------------------------------------- $$XID NIHGUIDE 19930219 V22N07 P1O2 ************************************ X-comment: RFAs described: AG-93-04, CA-93-19, CA-93-12, HL-93-13L NIH GUIDE - Vol. 22, No. 7 - February 19, 1993 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** CHANGE IN FELLOWSHIP RECEIPT DATES AND USE OF NEW FELLOWSHIP FORM (REV. 10/91) National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** GUIDELINES FOR DEMONSTRATION AND EDUCATION RESEARCH GRANTS National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** EARLY DETECTION RESEARCH NETWORK (MAA NCI-CN-35537-50) National Cancer Institute INDEX: CANCER $$INDEX R2 ********************************************************** ISOLATION AND CHARACTERIZATION OF MHC-BOUND SELF PEPTIDES IN AUTOIMMUNE DISEASE (BAA/RFP NIH-NIAID-DMID-94-15) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** ACQUISITION, CHARACTERIZATION, MAINTENANCE, AND DISTRIBUTION OF HYBRIDOMA CELL LINES AND DATA BANK (RFP NIH-NIAID-DAIT-94-09) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R4 ********************************************************** PREPARATION OF IMMUNOCONJUGATES (RFP NCI-CM-37843-37) National Cancer Institute INDEX: CANCER $$INDEX R5 04/19/93 ************************************************* EXPLORATORY CENTER GRANTS FOR RESEARCH ON HEALTH PROMOTION IN OLDER MINORITY POPULATIONS (RFA AG-93-04) National Institute on Aging INDEX: AGING $ $$INDEX R6 04/29/93 ************************************************* COOPERATIVE BREAST CANCER TISSUE REGISTRY (RFA CA-93-19) National Cancer Institute INDEX: CANCER $$INDEX R7 05/05/93 ************************************************* FOLLOW-UP OF DES-ASSOCIATED CLEAR CELL ADENOCARCINOMA (RFA CA-93-12) National Cancer Institute INDEX: CANCER $$INDEX R8 06/10/93 ************************************************* NON-IMMUNE DEFENSE AGAINST TUBERCULOSIS IN THE LUNG (RFA HL-93-13L) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** AMYOTROPHIC LATERAL SCLEROSIS (PA-93-54) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE This publication is also available electronically to institutions via BITNET or INTERNET. Alternative access is through the NIH Grant Line using a personal computer. Contact Dr. John James at 301/496-7554 for details, or send an E-mail message to ZNS@NIHCU. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** CHANGE IN FELLOWSHIP RECEIPT DATES AND USE OF NEW FELLOWSHIP FORM (REV. 10/91) NIH GUIDE, Volume 22, Number 7, February 19, 1993 P.T. 22; K.W. 0720005, 1014006 National Institutes of Health Effective April 1, 1993, there will be a change in receipt dates for applications to the PHS for individual National Research Service Awards (NRSAs -- fellowships, the F-series awards). This change was made subsequent to the merger of the former Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) research Institutes with the NIH. The three new Institutes, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health, will now expedite the review of NRSA fellowship applications in accordance with this longstanding NIH practice. The new receipt dates will apply to all individual fellowship applications (F-series) submitted to the NIH Institutes and Centers and to the Agency for Health Care Policy and Research. The new receipt dates will be: April 5, August 5, and December 5 NOTE: The most recent application form, PHS 416-1 (rev. 10/91) must be used. Applications using older forms will be returned without review. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** GUIDELINES FOR DEMONSTRATION AND EDUCATION RESEARCH GRANTS NIH GUIDE, Volume 22, Number 7, February 19, 1993 P.T. 34; K.W. 0715040, 0403004, 0502017 National Heart, Lung, and Blood Institute Guidelines for Demonstration and Education Research Grants plus updated supplemental instructions for the preparation of applications for these grants for submission to the National Heart, Lung, and Blood Institute (NHLBI) are available. INQUIRIES All applicants who plan to submit applications for Demonstration and Education Research Grants to NHLBI may obtain a copy by calling the Review Administrator for Demonstration and Education Research, Review Branch, NHLBI (301-496-7363). $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL HUMAN SUBJECTS PROTECTION WORKSHOPS NIH GUIDE, Volume 22, Number 7, February 19, 1993 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 continuing to sponsor a series of workshops on 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 persons and those 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: NORTHWESTERN WORKSHOP DATES: May 19, 20, 21, 1993 LOCATION Sheraton Hotel, Anchorage, AK SPONSORS University of Alaska - Anchorage, Anchorage, AK Northwest Indian College, Bellingham, WA Indian Health Services, Tucson, AZ REGISTRATION Ms. Ann Howell Coordinator of Conferences and Institutes University of Alaska - Anchorage 2221 East Northern Lights, Suite 205 Anchorage, AK 99508 Telephone: (907) 278-8821 TITLE: Basic Training Session - Research Benefits and Risks to Individuals and Communities: Legal and Ethical Perspectives DESCRIPTION: This conference will explore the legal and ethical perspectives of social and biomedical research. Protecting the individual rights of human research subjects is of prime concern, but so is protecting the rights of communities of individuals. This is especially true for indigenous peoples. The conference is designed to be of interest to social and biomedical researchers, IRB members, students, agency personnel, indigenous peoples, and others interested in the rights of individuals and communities. Opportunities for informal discussion and exchange will supplement the panel and breakout group format. Reports from the simultaneous group sessions will be made. Participants will learn how regulations and community participation can protect human subjects in research, explore the notion of protecting communities from research risks, examine the impact of recent court rulings on research risks, interact with others interested in research risk issues, and make recommendations to agency and other personnel. For information regarding these workshops and future NIH/FDA National Human Subjects Protection Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NCI-CN-35537-50 ****************************************** EARLY DETECTION RESEARCH NETWORK NIH GUIDE, Volume 22, Number 7, February 19, 1993 MAA AVAILABLE: NCI-CN-35537-50 P.T. 34; K.W. 0780020, 1002004 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control, in its annual requirement to seek new sources, is soliciting proposals for the Early Detection Research Network (EDRN) to increase the number of Master Agreement (MA) holders originally awarded under MAA No. NCI-CN-15340-04. Current MA holders for this program are not required to submit a proposal. The required service will be defined by Master Agreement Orders issued during the period of performance. The scope of the Master Agreement includes: (1) establishment of a tissue bank of normal, premalignant, and malignant tissues by the collection and storage of tissues and associated fluids in order to identify potential cellular and molecular markers for early detection. Initially, the project will focus on tissues of the colon and rectum, lung, prostate, and urinary bladder. In addition, there will be an associated database with demographic information, exposure to potential carcinogens and risk factors on the subjects from whom specimens have been obtained; and (2) coordinate cellular and molecular studies on these tissues with the goal of developing new procedures assessing the sequence of genetic alterations in protooncogenes, analyzing allelic deletions of suppressor genes, identifying activated oncogenes, identifying oncogene products suitable for evaluating neoplastic progression, and developing cellular and molecular markers that will identify individuals who are at high risk of cancer. INQUIRIES Requests for this solicitation must be in writing and reference MAA No. NCI-CN-35537-50. The Master Agreement Announcement (MAA) will be available approximately February 25, 1993, and responses will be due by COB April 8, 1993. Requests are to be addressed to: Ms. Karen L. McFarlane, Contract Specialist Research Contracts Branch, PCCS National Cancer Institute Executive Plaza South, Room 635 Bethesda, MD 20892 Telephone: (301) 496-8603 $$R1 END ************************************************************ $$R2 BEGIN NIH-NIAID-DMID-94-15 ************************************* ISOLATION AND CHARACTERIZATION OF MHC-BOUND SELF PEPTIDES IN AUTOIMMUNE DISEASE NIH GUIDE, Volume 22, Number 7, February 19, 1993 BAA/RFP AVAILABLE: NIH-NIAID-DMID-94-15 P.T. 34; K.W. 0715015, 0760060, 0755010, 0765033 National Institute of Allergy and Infectious Diseases The Division of Microbiology and Infectious Diseases Program of the National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for Isolation and Characterization of MHC-Bound Self Peptides in Autoimmune Disease. The Clinical Immunology Branch, DMID, NIAID, promotes and supports research leading to the elucidation of the immune mechanisms in disease and in the application of this basic knowledge to the development of new forms of diagnosis and treatment for immunologic diseases. The foci of this Broad Agency Announcement (BAA) are: Research Area A - Isolation, biochemical characterization, and detailed analysis of biological activity of MHC-bound self-peptides linked to the pathogenesis of autoimmune disease and Research Area B - Development and implementation of new experimental systems to test pathogenicity of human lymphoid cells reactive with self-peptides. This NIAID sponsored project will take approximately five years to complete. A cost-reimbursement contract is anticipated. It is anticipated that up to five awards will be made. This is an announcement for an anticipated Broad Agency Announcement (BAA)/Request for Proposal (RFP). BAA/RFP No. NIH-NIAID-DMID-94-15 will be issued on or about February 19, 1993, with a closing date tentatively set for July 6, 1993. INQUIRIES To receive a copy of the RFP, supply this office with two self- addressed mailing labels. All responsible sources may submit a proposal that will be considered. Requests for the RFP may be directed in writing to: Anthony Murray, Contracting Officer Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 This advertisement does not commit the Government to award a contract. $$R2 END ************************************************************ $$R3 BEGIN NIH-NIAID-DAID-94-09 ************************************* ACQUISITION, CHARACTERIZATION, MAINTENANCE, AND DISTRIBUTION OF HYBRIDOMA CELL LINES AND DATA BANK NIH GUIDE, Volume 22, Number 7, February 19, 1993 RFP AVAILABLE: NIH-NIAID-DAIT-94-09 P.T. 34; K.W. 0780015, 0760030 National Institute of Allergy and Infectious Diseases The Division of Allergy and Immunological Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID), has a requirement for the acquisition, storage (in frozen state), and distribution of hybridoma cell lines to scientific investigators and for the operation of the existing hybridoma data bank to acquire and disseminate information about the construction of hybridomas on an international level. The offeror must have the experience to successfully expand acquired hybridoma lines in continuous culture, characterize cell lines with respect to viability, productivity, and absence of microbial contamination, and cryopreserve the lines. The offeror must also have experience in shipping frozen biological material worldwide. Ability to perform extensive computer literature searches and to organize, store and make available to investigators voluminous information about hybridomas is also required. The NIAID-sponsored project will take approximately five years to complete. A cost-reimbursement type contract is anticipated. It is anticipated that one award will be made. This is an announcement for an anticipated Request for Proposal (RFP). RFP No. NIH-NIAID-DAIT-94-09 will be issued on or about February 19, 1993, with a closing date tentatively set for April 19, 1993. INQUIRIES To receive a copy of the RFP, supply this office with two self-addressed mailing labels. All responsible sources may submit a proposal that will be considered. Requests for the RFP are to be directed, in writing, to: Dawn Kotzen, Contract Specialist Contract Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 This advertisement does not commit the Government to award a contract. $$R3 END ************************************************************ $$R4 BEGIN NCI-CM-37843-37 ****************************************** PREPARATION OF IMMUNOCONJUGATES NIH GUIDE, Volume 22, Number 7, February 19, 1993 RFP AVAILABLE: NCI-CM-37843-37 P.T. 34; K.W. 0715035, 0760045 National Cancer Institute The Biological Resource Branch of the Biological Response Modifiers Program Division of Cancer Treatment, National Cancer Institute (NCI), is interested in receiving proposals from, and establishing Master Agreements with, offerors who have the capability in Preparation of Immunoconjugates. The purpose of this procurement is to prepare various preclinical and clinical grade monoclonal antibodies/targeting agents with ligands such as chelating agents, toxins, cytotoxic agents, or other targeting molecules. Although the NCI wishes to be flexible in the nature of their request, it is primarily interested in the preparation of immunoconjugates including monoclonal antibody chelates, that can bind various radionuclides and immunotoxins. Monoclonal antibodies (or other targeting agents) supplied by the NCI will be chemically conjugated to various ligands such as chelating agents and toxins using procedures that have appeared in peer-reviewed journals. It is anticipated that the offeror will prepare milligram quantities (approximately 50 to 1000 mg) each of purified ligand conjugated monoclonal antibodies, antibody fragments, or other targeting molecules as specified by the NCI under conditions of GLP and/or GMP. The offeror will evaluate these immunoconjugates for purity, stability, immuno-reactivity, and other criteria as specified by the NCI for their potential as diagnostic and/or therapeutic agents. Multiple awards may be made to qualified offerors responding to this RFP. Master Agreement Announcement (MAA) No. NCI-CM-37843-37 will be issued upon request on or about March 1, 1993 and proposals will be due approximately six weeks after issuance of the MAA. INQUIRIES To obtain a copy of MAA No. NCI-CM-37843-37 send a written request to: Ms. Patricia Lightner Research Contracts Branch National Cancer Institute Executive Plaza South, Room 603 Rockville, MD 20852 Telephone: (301) 496-8020 No collect calls will be accepted. $$R4 END ************************************************************ $$R5 BEGIN AG-93-04 FULL-TEXT *************************************** EXPLORATORY CENTER GRANTS FOR RESEARCH ON HEALTH PROMOTION IN OLDER MINORITY POPULATIONS NIH GUIDE, Volume 22, Number 7, February 19, 1993 RFA AVAILABLE: AG-93-04 P.T. 34, FF; K.W. 0710010, 0745035 National Institute on Aging Letter of Intent Receipt Date: March 10, 1993 Application Receipt Date: April 19, 1993 THE REQUEST FOR APPLICATIONS (RFA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE RFA FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE This RFA aims to establish Exploratory Centers for Research on Health Promotion in Older Minority Populations. The Exploratory Centers will conduct pilot research and plan for a program of medical, behavioral and social research, medical and psychosocial interventions, and programs of health education and community outreach aimed at improving the health status of older ethnic minority populations. It is anticipated that support of exploratory centers will lead to the development of applications for Research Centers in Health Promotion in Older Minority Populations. 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, Exploratory Center Grants for Research on Health Promotion in Older Minority Populations, is related to the priority areas of diabetes and chronic disabling conditions, cancer, heart disease and stroke, physical activity, and educational and community-based programs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applicants must demonstrate access to and ability to work with the selected minority populations. Applications from minority investigators and institutions, and/or collaborations involving predominantly minority institutions are encouraged, especially those minority institutions with medical and/or clinical components, or programs of medical research oriented to minority populations. Awards will not be made to foreign institutions. MECHANISM OF SUPPORT The support mechanism for this RFA is the exploratory center grant (P20). Such awards cover a variety of research and related activities focused around a common theme or specific area of interest. The Exploratory Center resulting from this RFA should consist of small scale studies of factors influencing health of older minorities, including development and evaluation of interventions based on knowledge of risk factors for ill health, and development of programs of health education aimed at communities of older minorities. In addition, the Exploratory Center will include an administrative and planning core that provides administrative, coordination, research planning, logistical, and methodological support. A maximum of three years support may be requested. The award may be renewed for an additional two years based on competitive application and review. The Exploratory Centers award is expected to lead to a competing continuation application for a P50 Center Grant award. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded in connection with this RFA. A maximum of $500,000 direct costs for the first year excluding all indirect costs requested within the consortium budgets may be requested. FUNDS AVAILABLE An estimated $2,000,000 will be made available in Fiscal Year 1993 for support of awards made under this RFA. It is expected that up to three awards will be made. Requests that exceed this amount will be returned without review. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Awards pursuant to the RFA are contingent upon the availability of funds for the purpose. RESEARCH OBJECTIVES The goal of this RFA is to support the establishment of Exploratory Centers that conduct medical, behavioral and social research and related activities necessary to understanding and improving the health status of minority aging populations. Each center should be organized around a central theme. Such centers should be based on integrated research and related activities relevant to the proposed theme of the research of the center. The application should include an introduction that describes the overall research focus and how the individual projects, including interventions and projects of community education and outreach are linked to the central focus, and how the projects support each other. Individual models will vary, but the centers overall should focus on descriptive as well as hypothesis testing research, pilot/feasibility studies, methodological development, clinical and behavioral interventions, and community outreach and education. Each center must demonstrate strong intellectual leadership and the availability of researchers knowledgeable about health and aging among ethnic minority populations, especially members of the minority group of focus. Through its activities the center should demonstrate the potential to become a major national scientific research resource on health of ethnic/minority older populations. It is anticipated that the future major national research center will be supported through the P50 grant mechanism. Each Exploratory Center must include an administrative core, small scale research and an intervention component, including evaluation of the interventions(s). It is optional that the health education and community outreach component be part of the application package. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO 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 minorities and women in study populations. If minorities or women are not included in the study populations for clinical studies, a specific justification must be provided. This RFA is directed specifically at studies of older minority populations, and includes studies of both males and females. The rationale for focussing on particular ethnic or racial groups must be included. LETTERS OF INTENT Prospective applicants are asked to submit a letter of intent that includes identification of other participating investigators and institutions, and a descriptive title. The NIA requests such letters only for the purpose of providing an indication of the number and scope of applications to be received and, therefore, usually does not acknowledge their receipt. A letter of intent is not binding, will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for application. The letter of intent is to be received no later than March 10, 1993 and is to be sent to Shirley P. Bagley at the address listed under INQUIRIES. APPLICATION PROCEDURES Prospective applicants are advised to communicate with indicated contacts listed in the RFA as early as possible in the planning phase of application preparation. NIA staff are available to assist applicants to ensure that the objectives, structure, and the budget format for the proposed Exploratory Center are acceptable. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. This form is available in the applicant institution's office of sponsored research or business office and from the Office of Grants Inquires, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892-9912, telephone (301) 496-7441. REVIEW CONSIDERATIONS Upon receipt, NIA staff will review applications for completeness and responsiveness. Applications that do not conform to instructions, that are incomplete, nonresponsive to this RFA, or exceed the maximum first year direct cost limit of $500,000 excluding direct costs within consortium budgets will be returned to the applicant without further consideration. Applications may be subjected to triage by a peer review group to determine the scientific merit relative to other applications in response to this RFA. The NIA will withdraw from further competition thos