From owner-sci-resources@net.bio.net Fri Nov 01 22:00:00 1996 Path: biosci!biosci!not-for-mail From: "John M. Hawdon" Newsgroups: bionet.sci-resources Subject: Research in China for US Scientists Date: 1 Nov 1996 16:58:37 -0800 Organization: Yale Medical Helminthology Laboratory Lines: 30 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55e6bt$b0b@net.bio.net> NNTP-Posting-Host: net.bio.net FUNDING OPPORTUNITY FOR PARASITIC DISEASE RESEARCH IN P.R. CHINA - FOR U.S. SCIENTISTS Through an NIH-funded Tropical Medicine Research Center Grant, funds are available for U.S.scientists who wish to pursue 4 to 8 month research projects in the People's Republic of China.U.S. scientists will have opportunities to use the Institute of Parasitic Diseases (Chinese Academy of Preventive Medicine) in Shanghai, as well as provincial institutes as their base of operation. Up to U.S. $ 18,000 will be provided for scientists to spend between 4 to 8 months conducting research. Funds will be used to cover salary, housing and supplies.U.S. scientists at the post-doctoral to full professor level will be considered. This is an excellent opportunity for conducting university sabbatical research. For further information contact either Prof. George Davis, Ph.D. Pilsbry Chair of Malacology Academy of Natural Sciences Tel. 215-299-1132 fax. 215-299-1170 or Peter Hotez, M.D., Ph.D. Medical Helminthology Laboratory Depts. Pediatrics and Epidemiology Yale University School of Medicine Tel. 203-737-2749 fax. 203-785-7552 email: hotez@biomed.med.yale.edu From owner-sci-resources@net.bio.net Sun Nov 03 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 2 November 1996 Date: 4 Nov 1996 15:54:11 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 83 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55lvn3$s8e@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending November 2, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-38- SSR 96-13 NSF-CGP Science and Engineering Fellows Program - Teleost Cardiac Peptides File size (bytes): 10573 STIS Filename: int9638.txt Document Type: Program Guideline Title: NSF 97-5 Engineering Research Centers File size (bytes): 45418 STIS Filename: nsf975.txt Title: NSF 97-8 - Group Infrastructure Grants File size (bytes): 16991 STIS Filename: nsf978.txt Document Type: Recruit Title: Computer Specialist, GS-334-11/12 File size (bytes): 9906 STIS Filename: vgs977a.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 12788 STIS Filename: cmmtg.txt Document Type: Program Guideline Title: NSF 96-151-- Summer Programs in Japan and Korea File size (bytes): 85583 STIS Filename: nsf96151.txt Also available: nsf96151.doc nsf96151.pdf ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf96151.txt, the text of your message should be as follows: get nsf96151.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf96151.txt, you would enter: ftp> get nsf96151.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Nov 06 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-96-021 - V25(37) 11/01/96 Date: 6 Nov 1996 19:28:42 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 627 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55rl1a$mqg@net.bio.net> NNTP-Posting-Host: net.bio.net SLEEP ACADEMIC AWARD NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA: HL-96-021 P.T. 34; K.W. 0404009, 0740020 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 9, 1996 Application Receipt Date: January 23, 1997 THIS RFA USES "JUST-IN-TIME" PROCEDURES. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE FOLLOWED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The primary objective of this initiative is to encourage the development and/or improvement of the quality of medical curricula, physician/patient/nurse and community education, and clinical practice for the prevention, management, and control of sleep disorders. A secondary objective is to promote high quality clinical research in sleep. 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, Sleep Academic Award, is related to the priority areas of heart disease and stroke, diabetes, chronic disabling conditions, mental health and disorders, and clinical prevention services. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Institutions Applications may be submitted by any domestic university or school of medicine or osteopathy. Institutions that have not yet developed a curriculum in sleep medicine are especially encouraged to apply. Eligible institutions may submit only one application in each competition. Institutions that are already receiving support from the Sleep Academic Award program may not apply for this competition. Institutions may sponsor a candidate experienced in both medical education and clinical sleep research or a candidate experienced in clinical sleep research if supported by faculty with expertise in medical education. Institutions should also be committed to implementing the curricula development and educational research programs proposed by candidates. In this competition, there is a special interest in receiving applications from minority institutions and institutions with eligible minority faculty members. Candidates A candidate for the Sleep Academic Award must have the following credentials: o knowledge and skills in sleep and sleep disorders medicine and a demonstrated commitment to one or more areas of medical education for students, physicians, patients, nurses, or the public; o sufficient post graduate training and experience in clinical sleep research, clinical practice, and/or medical education to develop and implement a high quality curriculum in sleep and sleep disorders and to provide leadership in clinical research on sleep; o established appointment on the faculty of an accredited school of medicine or osteopathy in the United States, its territories or its possessions; o unqualified support from the Dean and educational leadership of the institution and; o be a citizen or non-citizen national of the United States or have been lawfully admitted to the United States for permanent residence at the time of application. Individuals who have or have had another NIH career development award (K series) or a regular research grant (R01) are eligible for a Sleep Academic Award if the individual meets the requirements of the sleep Academic Award program. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This RFA is part of the Academic Award Program (KO7) of the National Heart, Lung, and Blood Institute. 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 and is non-renewable. Awards will be limited to a maximum of $50,000 for the salary of the Principal Investigator, plus applicable fringe benefits, and a maximum of $30,000 for technical support. Indirect costs may not exceed 8 percent. It is anticipated that support for this program will begin September 30, 1997. Application instructions have been modified to reflect "just-in-time" streamlining efforts being considered by the NIH. The just-in-time concept requires applicants to submit certain materials only when there is the possibility of an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and NHLBI staff. For this RFA, only limited budgetary information is required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and key personnel must be included in the research plan. Instructions for completing the Biographical Sketch have been modified. In addition, the Other Support information and application "Checklist" page are not required as part of the initial application. If the possibility of an award exists, the Budget, Other Support, and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of these modifications to the standard PHS 398 application kit. FUNDS AVAILABLE It is anticipated that in fiscal year 1997, support will be available for total costs of approximately $300,000 and that approximately three to four grants will be awarded under this program. An additional competition will be held in fiscal year 1998. The actual number of awards each year, however, will depend upon the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background Recent estimates suggest that as many as 40 million people may suffer from chronic or intermittent disorders of sleep. Many remain undiagnosed and untreated, the consequences of which include reduced productivity, lowered cognitive performance, increased likelihood of accidents, higher risk of morbidity and mortality and decreased quality of life. It is now apparent that sleep disorders, disturbances of sleep, and sleep deprivation are major public health concerns. Sleep problems occur in both genders, in all races and socioeconomic groups, and increase with age. National attention has been directed to this problem. The National Commission on Sleep Disorders Research submitted their report entitled "Wake Up America: A National Sleep Alert" to the United States Congress in January 1993. The Commission's recommendations include encouraging broader awareness of sleep and training in sleep and sleep disorders, spanning the full range of health care professions, particularly at the primary care level. Several surveys have documented that physician training and knowledge about sleep and sleep disorders is minimal. For example, in 1978 the American Sleep Disorders Association (ASDA) conducted a survey of medical school teaching and found about one third of the medical schools provided between 1-4 hours of teaching in sleep. A more recent (1990) survey found that less than two hours were allocated to teaching about sleep at one third of the medical schools and one third reported no formal teaching about sleep. It was estimated that about 30% of medical students receive no instruction in sleep. These results would suggest that there actually has been a decrease in the amount of medical school training about sleep. The American Thoracic Society (ATS) surveyed pulmonary residency training programs and found that 70% had laboratories, but only 29% had formal training programs about sleep. Of greater concern was that 90% of the trainees diagnosed patients with sleep apnea, but only 33% of the trainees had formal training on how to conduct sleep studies. The major obstacles cited for increasing the attention to sleep in medical schools included low administrative priority, lack of qualified faculty, and limited curriculum time. Given the limited medical school training about sleep and sleep disorders, it is not surprising that several surveys have reported that health practitioners rarely diagnose sleep disorders. In fact, primary care physicians scored less than 50% correctly on factual items for diagnosis and management of sleep disorders. A 1991 Gallup survey showed that primary care physicians failed to correctly diagnose one in three adults with insomnia. Most narcoleptics contact as many as five physicians before a proper diagnosis is made. Clearly, physicians are not well trained or knowledgeable about sleep and sleep disorders. Sleep disorders cut across several medical specialties (e.g., neurology, psychiatry, internal medicine, pulmonary medicine, and otolaryngology etc.), which complicates the development of effective treatment guidelines and research. Although most sleep disorders can be controlled with medical treatment, many patients are not being diagnosed or receiving state-of-the-art medical care. This may be because many people believe that no effective treatments exist and therefore do not seek medical help. Multidimensional research is clearly necessary to improve clinical practice and patient education. Therefore, the aim of this program is to improve the quality of medical education and to stimulate the development of patient and community education, high quality clinical research programs, and clinical practice focused on the control of sleep disorders. Applicants are encouraged to submit program plans in sleep education and applied research that complement each other. Objectives The objectives of the Sleep Academic Award program include the following: o develop high quality curricula in schools of medicine that will significantly increase the knowledge and skills of students, house staff, practicing physicians, and others needed to apply state-of-the-art principles and practice to the prevention, management, and control of sleep disorders; o evaluate the impact of the proposed program and assemble curricular materials that can be adapted and used by other Institutions; o improve communication among specialists in primary care and other specialties to ensure appropriate strategies for the treatment of sleep disorders in patients of various ages and ethnic groups; o foster development of institutional environments facilitating the interchange of information on advances in sleep research and the implementation of improved interdepartmental programs with standardized diagnostic and therapeutic approaches to sleep medicine; o educate community health practitioners and the public about sleep and sleep disorders through the development of outreach programs, especially through the enhancement of sleep education programs in minority medical schools and the communities they serve; o develop the sleep medicine skills of faculty to provide high quality instruction in the diagnosis and management of sleep disorders, with special emphasis on minority faculties; o establish channels of communication between medical educators, institutions, sleep researchers, and community agencies to enhance the transfer of knowledge and ideas on educational requirements and optimal approaches to the prevention and management of sleep disorders; o contribute to public health efforts to address sleep disorders in the United States; o encourage the development of high quality clinical and applied research in the treatment and control of sleep disorders. In this competition, programs targeted to inner city populations and to rural areas needing education about sleep and sleep disorders and to community physicians, nurses, and other health care workers caring for medically undeserved populations are of particular interest. SPECIAL REQUIREMENTS Applicants should develop a comprehensive program that effectively addresses the needs in their area and the objectives of this RFA. The primary focus must be on plans to improve the quality of medical school education on sleep and sleep disorders for students and physicians. Plans and educational materials for curricular improvements must be of a design that facilitates replication at other sites. All applications must also include plans to evaluate the outcome of educational and research initiatives. The responsibilities of the Principal Investigator and key personnel must be specifically stated at the beginning of the research plan and placed in the context of other institutional and research commitments. Since the Sleep Academic Award primarily provides support for the salary of the Principal Investigator, applications that are contingent on receiving support from other agencies and institutions must specifically identify these resources in relationship to the program plan. For revised applications, the comments of the previous review committee should be specifically addressed in a preface to the program plan. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994, (F 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies of the policy from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. Although the Sleep Academic Award is not primarily a mechanism to support research, it is likely that human subjects will be involved. Therefore, protection for human subjects must be addressed, and the approximate percent of women and each minority group that you expect in the total population must be included. LETTER OF INTENT Prospective applicants are asked to submit, by December 9, 1997, a letter of intent that includes a descriptive title of the proposed program plan, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be faxed or sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). These forms are available at most institutional offices of sponsored research and from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, Email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 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, to identify the application as a response to this RFA, check "YES" in item 2 of application page 1 and enter the title "Sleep Academic Award NIH HL-96-021". Use the following modifications in completing the standard PHS 398 application instructions: o BUDGET INFORMATION - No current/future year budgets or justifications (Form Pages 4 and 5) are required in the application. However, the anticipated level of effort in all years and a brief description of responsibilities for the Principal Investigator and all key personnel must be specifically stated at the beginning of the research plan. Necessary budget information will be requested by NHLBI staff if there is a possibility for an award. o BIOGRAPHICAL SKETCH - In addition to the standard information requested on Form Page 6, the applicant should provide the title and source of any sponsored support relevant to the proposed research. o OTHER SUPPORT - No other support information is required on the "Other Support" page (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete other support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o FACE PAGE - Currently, the Division of Research Grants requires that requested costs be reflected on the face page for computer system tracking purposes. Because no budgetary information is required as part of the "streamlined" application, we are requesting that the following amounts be entered on the face page: 7a. Direct Costs for Initial Budget Period - $80,000; 7b. Total Costs for Initial Budget Period - $86,400; 8a. Direct Costs for Proposed Period of Support - $400,000 and; 8b. Total Costs for Proposed Period of Support - $432,000. IT IS UNDERSTOOD THAT THESE LEVELS ARE STRICTLY FOR ADMINISTRATIVE PURPOSES AND THAT ACTUAL AWARD LEVELS ARE SUBJECT TO NEGOTIATION, PRIOR TO AWARD. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. Applications must be received by January 23, 1997. If an application is received after this 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 RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will also 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. o If an application is determined to be unresponsive to the RFA, the principal investigator will be notified and the application returned. The following sections are specific cost guidelines that will apply to those applications selected for award consideration. 1. Principal Investigator's Salary The salary for the Principal Investigator must not exceed the actual institutional salary rates for the effort being devoted to the Academic Award. In addition, salary rates must not exceed an annual salary level of $125,000 plus fringe benefits (a maximum of $50,000 plus fringe benefits for 40 percent effort). A candidate must devote at least 30 percent effort and no greater than 40 percent effort to this award. The combined efforts of any individual, Principal Investigator or key personnel, on the Sleep Academic Award and any other non-NIH or NIH-supported grant(s) or contract(s) must not exceed 100 percent. 2. Program Support Technical support will be provided up to a maximum of $30,000 per year for the following: o personnel, other than the Principal Investigator, if requested for the development, implementation, and evaluation of the program. Collaborations with consultants possessing medical, educational, or evaluative expertise complementary to that of the principal investigator are strongly encouraged. Salaries and the associated costs for any personnel other than the Principal Investigator are limited to the $30,000 per year allowed for technical support. o consumable supplies essential to the proposed program are allowable, but equipment costs are not allowable; o funds for educational development to enable the awardee to develop educational skills; o funds for the Principal Investigator to travel and meet with other investigators and NHLBI staff to exchange ideas, to develop collaborative projects, and to provide for some needed technical support. (Investigators may be requested to meet as a group up to two times a year; $2,000 should be allocated for this purpose.) 3. Indirect Costs Awards will be provided for the reimbursement of actual indirect costs at a rate up to, but not exceeding, eight percent of the total direct costs of each award. 4. Conditions of the Award Institutions must provide documentation that the applicant would have the necessary time and resources to implement the proposed plan. In some cases, it may be necessary for the applicant to be relieved of some responsibilities for the five years of the grant award in order to implement the proposed plan. An institution is expected to apply on behalf of a named individual meeting the criteria for this award. Only one application may be submitted from each eligible institution in each competition. Awards will be limited to one from each eligible school over the life of the award. After the first year, grants will be renewed for a maximum of four years on a noncompetitive basis depending upon progress in meeting the program's objectives and the availability of funds. An annual report that summarizes curriculum development at the institution and other elements of the program plan, outlines future plans, and outlines future plans will be required. This report will serve as the principal basis for renewal of the grant. Awards may not be transferred from one institution to another. If an awardee moves to another institution, the award will continue at the original institution only upon acceptance by the National Heart, Lung and Blood Institute of a suitable replacement proposed by the grantee institution. Such a replacement will not lengthen the overall term of the award. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness to this RFA by NHLBI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Affairs, NHLBI. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI and participating Institutes anticipate funding under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. Review Criteria Applications for this Sleep Academic Award will be evaluated in terms of the following criteria: o qualifications and effort level of the candidate and key personnel, including pertinent experience in teaching, curriculum development, program evaluation, administration, and clinical research program planning and conduct; o plans to develop, improve, and integrate an interdepartmental curricula in sleep medicine with existing institutional training programs for medical students, graduates, and post-graduates; o plans to evaluate all proposed educational interventions, including strategies for both process and impact evaluation; o plans for communication and interdepartmental collaboration between medical specialists in appropriate disciplines to ensure the development, implementation, and evaluation of optimal treatment and educational programs; o plans and ability to work cooperatively with other investigators developing innovative and portable curricular materials in sleep medicine for replication at other sites; o the potential impact of the program on the degree of sleep medicine training and on the prevention, management, and control of sleep disorders within the population to be served; o plans for community outreach or collaborative projects with organizations having responsibility for or interest in sleep disorders, such as community centers, health departments, medical and nursing associations, voluntary health agencies, and home care agencies; o description of the need for this program and the magnitude of sleep disorders within the population to be served; o overall merit and feasibility of the proposed five year plan; o institutional commitment to implement the proposed curriculum and to maintain a program in education about sleep and sleep disorders after the termination of the award. AWARD CRITERIA The anticipated date of award is September 30, 1997. Factors that will be taken into consideration in making awards include the scientific merit of the proposed program as evidenced by the priority score and the availability of funds. Subject to the availability of necessary funds and consonant with the objectives of the Sleep Academic Award, the NHLBI will provide funds for a project period up to five years. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify issues or answer questions from potential applicants is also welcomed. Direct inquiries regarding programmatic issues to: Michael J. Twery, Ph.D. Division of Lung Diseases National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7920 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: TweryM@gwgate.nhlbi.nih.gov James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: Kileyj@NIH.GOV Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7220, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: ScheireJ@NIH.GOV Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: ZimmermR@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Grants are made under the authorization of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended by Public Law 99-158, 42 US 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 to a review by a Health Systems Agency. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Nov 06 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-005 - V25(37) 11/01/96 Date: 6 Nov 1996 19:29:53 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 392 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55rl3h$mtd@net.bio.net> NNTP-Posting-Host: net.bio.net RESEARCH ON ADOLESCENT DRUG ABUSE NIH GUIDE, Volume 25, Number 37, November 1, 1996 PA NUMBER: PA-97-005 P.T. 34, AA; K.W. 0404009 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) is firmly committed to support of research in the area of adolescent drug abuse. The purpose of this program announcement (PA) is to encourage further investigations in this area, particularly with regard to gaps in current knowledge. 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, Research on Adolescent Drug Abuse, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT Mechanisms available for support of this program announcement are the research project grant (R01), the small grant (R03), and the FIRST award (R29). Because the nature and scope of the research proposed in response to this Program Announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Recently released data from the 1995 Monitoring the Future Study and the 1995 National Household Survey on Drug Abuse indicate drug use among youths has increased and the age at which drug use begins has declined. Additionally, among those surveyed there was a decrease in perceived risk-of-harm in using drugs and an increase in the perception that illicit drugs were easy to obtain. Although tobacco, alcohol, and marijuana were the substances most tried, the use of heroin, cocaine, amphetamine and inhalants was also on the rise, as was LSD and other hallucinogens (e.g., MDMA/ecstasy) among a growing number of adolescents who participate in the Rave scene. Studies have examined a wide range of variables, from biogenetic factors to purported macro-environmental influences, to determine what makes one adolescent and not another more vulnerable to initial and continued drug use. Research findings suggest that no one factor accounts for all known causes, consequences, and patterns of drug use. Rather, interacting biological (e.g., genetic influences), psychological (e.g., depression; learning problems), social (e.g., family instability; sexual/physical abuse; gang membership), and environmental (e.g., street violence; neighborhood drug trafficking; poverty) factors appear to put adolescents at risk. Consequently, multiple factors have been considered when interventions were developed that aimed at preventing initial exposure or further escalation of drug use in a teenage population, or at treating adolescents already affected by drug abuse. In terms of prevention, a number of effective universal-level programs have been developed that target adolescents sharing a general risk of drug use. Examples are found in drug-free schools and the national media. Effective selective-level programs, by contrast, have been designed for specific adolescent subgroups demonstrating one or more of the well defined risks or predispositional factors associated with later drug use. Community-sponsored activities such as the big brother/sister organizations are examples. At the indicated-level of prevention intervention, studies have examined programs that target adolescents identified as currently having minimal but detectable signs and symptoms that foreshadow drug abuse and addiction. Although most of these programs have focused on school truants and dropouts, future research is needed to develop effective interventions for the increasing number of drug-using adolescents identified in job corps training and juvenile-court detention programs. Unlike drug prevention efforts, treatment for drug abuse and addiction traditionally has focused on adult-age clients. With the exception of family-based therapy for adolescents, few programs admitted persons under 18 years of age. When they did, components of the program (e.g., methadone maintenance; individual counseling) were based on therapeutic models appropriate for adult addicts. Rarely were human developmental differences identified, then examined in terms of how they might enhance or adversely affect the process or outcome of treatment. Recently, however, a number of modified adult programs (e.g., adolescent therapeutic community) and innovative adolescent-focused behavioral strategies (e.g., life skills training) have been developed, assessed and found to be effective for reducing, but not eliminating drug use. Moderate progress has also been made in developing and assessing behavioral strategies to engage adolescents and their parents in treatment process. Given the increased number of young persons environmentally exposed to and/or directly involved in using drugs, there is currently insufficient scientific knowledge about therapeutic interventions which are cost-effective in treating drug abusing youths in a variety of settings (e.g., outpatient clinic; residential hospital; primary care office practice) or efficacious in treating adolescents with special needs, including those who are runaways or homeless, incarcerated or on probation, gang members, pregnant or parenting, gay or lesbian, HIV positive or diagnosed with a comorbid mental disorder. In addition, more must be learned about drug treatment access, availability and utilization, as well as methods to establish and maintain effective linkages among drug prevention and treatment programs, other health and social services, public education and juvenile justice. Based on the many important developmental differences between adolescents and adults that have been identified in terms of drug use patterns, prevention and treatment, considerable progress has been made over the past decade in developing valid and reliable screening, diagnostic, and survey tools appropriate for use with English speaking youth. Because less attention has been given to gender-, age-, and cultural specificity or to the multiple concomitant problems experienced by drug-involved youths, more studies are required to provide the field with the necessary assessment tools for research and practice. Research Areas of Interest This Program Announcement encourages submission of proposals to study the many remaining issues that relate to adolescent drug abuse. Research topics of interest include, but are not limited to, the following: o Relationship of adolescent drug use initiation, escalation, dependence, withdrawal and relapse to potential acute, intermediate and long-term neurotoxicity, neurological disease and cognitive deficits. o Relationship among adolescent drug use patterns, high HIV-risk sexual behaviors and the adolescent's exposure to drug abuse and violence in the family, peer group and community environment. o Gender- age-, and culture-related differences in the progression, initiation to, antecedents and consequences of, and preventive and therapeutic interventions for drug use, abuse, and dependency. o Personal, social, and environmental resiliency- and protective-factors as they relate to adolescent drug use and addiction. o Language-of-origin, acculturation, assimilation, cultural beliefs and traditional practices, alone or in combination as they affect the outcome of prevention and treatment. o Effectiveness of theory-based, developmentally sensitive, drug abuse prevention programs designed specifically for younger or for older adolescents. o Efficacy of individual, peer group and family behavioral therapies, or combined behavioral- and pharmacotherapies, when delivered in more versus least restrictive environments, designed solely for adolescents or for both youths and adults. o Efficacy of pre-treatment engagement strategies and orientation programs to increase retention in treatment, and post-treatment interventions to prevent relapse to drug use. o Impact of financing on service utilization and cost-effectiveness of adolescent drug treatment programs delivered in settings such as a residential therapeutic community, hospital inpatient ward, outpatient clinic, or integrated into primary care office practice, school-based and juvenile court programs, or social service agencies. o Psychological, familial, social, and environmental factors that affect adolescents' perception and natural history of drug use, unsafe sex, and other HIV-risk behaviors. o Innovative behavioral therapy approaches or multi-component community-based programs aimed at preventing adolescent drug use and other HIV-risk behaviors. o Availability, accessibility, and linkages between drug abuse treatment and related services as they may affect the adolescent's compliance with prescribed psychosocial and pharmacological treatment for HIV/AIDS. o Validity, reliability, and normative data on culture-, gender- and age-specific adolescent subgroups for currently available or newly developed drug-related survey, screening, diagnostic, and motivation-for-treatment assessment instruments. Where appropriate, investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. In high risk populations, investigators are encouraged to assess the effects of new interventions on the acquisition and transmission of HIV. A focus on the provision, organization, and management of HIV/AIDS-related services such as testing and counseling, and services to groups at high risk for HIV/AIDS is encouraged. Applicants are advised to review the existing literature on adolescent drug use and abuse. Applications should reflect appropriate research paradigms, and use most rigorous methodological and analytic designs that are feasible, given the primary research question of interest. Timely reporting of findings is emphasized. Applicants should be willing to participate in research coordination efforts to maximize the utility of the research, including review and dissemination activities. For information on other research topics related to adolescent drug abuse, applicants are encouraged to request copies of program announcements "School-based Prevention Intervention Research" (PA-94-061), "Comprehensive Prevention Research in Drug Abuse" (PA-94-056), and "Drug Abuse Prevention Through Family Intervention" (PA-96-013). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) 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. 5/95) instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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 GRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The completed original application and five legible copies of the PHS 398 form must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit to an appropriate peer review group convened in accordance with the standard peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. R03 applications do not undergo a second-level review. Review Criteria o scientific, technical, or clinical 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 proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elizabeth Rahdert, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: er34g@nih.gov Direct inquires regarding fiscal issues to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 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. Awards must be administered in accordance with the PHS Grants Policy Statement, (revised 4/94), which may be available from your office of sponsored research. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Nov 06 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-97-003 - V25(37) 11/01/96 Date: 6 Nov 1996 19:29:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 356 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55rl2t$msd@net.bio.net> NNTP-Posting-Host: net.bio.net DISCOVERY OF NOVEL PHARMACOTHERAPIES FOR COCAINE DEPENDENCE NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA: DA-97-003 P.T. 34; K.W. 0404001, 0404009, 0755025, 1003006 National Institute on Drug Abuse Letter of Intent Receipt Date: February 13, 1997 Application Receipt Date: March 13, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to encourage applications combining medicinal chemistry and preclinical pharmacology to design, synthesize and test compounds leading to the identification of candidates for advanced preclinical and clinical evaluation as potential pharmacotherapies for cocaine dependence. Pharmacological testing may be conducted using in vitro and/or non-human in vivo procedures. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," PHS-led national activity for setting priority areas. This RFA, Discovery of Novel Pharmacotherapies for Cocaine Dependence, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and FIRST (R29) awards. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is September 30, 1997. Because of 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. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE It is anticipated that approximately $1.5 million will be available to support projects submitted under this RFA. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will vary also. It is anticipated that five to seven awards will be made. RESEARCH OBJECTIVES Background The discovery and development of pharmacotherapeutic agents for cocaine addiction is the predominant focus of the Medications Development Program at NIDA. In the area of cocaine dependence, there currently are no FDA-approved pharmacotherapies. Correspondingly, the clinical needs of cocaine dependent patients are broad; patients would likely benefit from pharmacotherapies acting to interrupt any stage of the cocaine dependence cycle. Following the medication discovery efforts supported by this RFA, it is anticipated that a few "promising" new compounds will advance through development and into clinical trials. NIDA is poised to facilitate this process; through existing NIDA contracts, follow-up behavioral studies may be conducted in rodents and/or monkeys, compound synthesis may be scaled up, and the gamut of safety assessments which might be required by the FDA may be conducted. Information on specific types of follow-up testing which are currently supported through NIDA contracts and agreements may be obtained by contacting the Programmatic Official indicated in the INQUIRIES section below. Areas of Research The primary intent of this RFA is to expand the NIDA Cocaine Treatment Discovery Program (CTDP) by increasing the flow of promising compounds via grant mechanisms. This is an effort to move these project areas in the direction of medicinal chemists working with biochemical and/or behavioral pharmacologists to design, synthesize and carry out sufficient preliminary in vitro and behavioral testing to allow for identification of "promising" candidates for advanced preclinical testing in the CTDP - or for advancement into toxicological testing as a clinical candidate - and to generate a portfolio of integrated research projects that involve single chemist/pharmacologist collaborations (primarily through the R01 mechanism), as well as program projects. Any approach to the design, synthesis, and preliminary testing of compounds with potential for yielding a pharmacotherapy for cocaine addiction in any of its stages (from acute blockage of cocaine effects to modulation of long term craving) is of high interest. Applications are expected to meet basic scientific standards of novelty and merit. Applications in the following areas are of particular interest: o Targeted design, synthesis and testing of potential medications which would act as full agonists, partial agonists, or pure antagonists (or prodrugs whose metabolism would result in such desired activity) at defined receptor targets (e.g., specific subtypes of dopamine receptors, CRF receptors, etc.) or which would act at other biochemical targets (e.g., biogenic amine transporters). The choice of each target must be supported by a strong rationale. Applicants are encouraged to consider the potential usefulness of compounds selective for D1 and/or D3 receptors as medications (e.g., references 1 and 2). o Design, synthesis and testing of potential medications which would produce one or more of the following effects in pharmacological studies: a relatively long duration of action; mild reinforcing and stimulant properties when compared to cocaine; and/or blockade of cocaine's effects in behavioral assays, including self-administration tests. o Molecular modeling as a tool to create small molecule mimetics to characterize the necessary orientation in space and electrostatic interactions of target receptors or transporters (with the choice of biochemical target supported by a strong rationale). o Development and screening of synthetic compound collections or libraries of chemical entities for potential cocaine pharmacotherapies (again, with the choice of biochemical target supported by a strong rationale). Investigators may wish to consider the utilization of robotic systems, as well as the screening of other compound ensembles, such as natural products and fermentation extracts. The application of other chemical diversity methods to the search for a specific activity of interest can also be considered. The above listing of specific research areas is not intended to be all-inclusive but is intended to give the applicant some direction regarding the types of efforts which NIDA may be interested in supporting. All applications should have a component to assess biological activity of synthesized compounds, in particular the generation of in vitro binding and functional activity data as a means of verifying a compound's primary mechanism of action. Behavioral assessment could include the use of animal models which may predict the efficacy of a medication (e.g., effects on cocaine stimulated locomotor activity, effects on cocaine drug discrimination in rodents, effects on cocaine self-administration behavior in rodents, effects in rodent place conditioning procedures, effects in rodent intracranial self-stimulation procedures, and especially effects in animal models of cocaine "craving" or relapse to cocaine use). References 1) Self et.al, Science (1996) 271(5255), p. 1586-9. 2) Caine and Koob, Behavioral Pharmacology (1995), 6, p. 333-347. LETTER OF INTENT Prospective applicants are asked to submit, by February 13, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Bethesda, Maryland, 20892-7710, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 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 2 of the face page of the application form and the YES box must be marked. Applications for the FIRST award (R29) 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 photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-771 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Applications must be received by March 13, 1997. 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 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 Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate advisory council or board. Review Criteria o relevance to the goals and objectives of this RFA; 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 proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of the plans to include both genders as appropriate for the scientific goals of the research (when the research involves human subjects). The initial review group will also examine the provisions for the protection of human and animals subjects, and the safety of the research environment. The review criteria and eligibility requirements for the First Independent Research Support and Transition (FIRST) Award are described in an NIH-wide announcement. The same criteria will be applied in reviewing FIRST award applications received in response to this RFA. However, these applications must also be relevant to the goals and objectives of this RFA. This announcement can be generally obtained from the office of sponsored research at most academic institutions or by calling Dr. Biswas at the address listed under INQUIRIES. AWARD CRITERIA Applications recommended for further consideration by an appropriate Advisory Council will be considered for funding based on the following factors: overall scientific and technical merit of the proposal as determined by peer review; significance and originality of the proposed research; appropriateness of budget estimates; program priorities; and availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse 5600 Fishers Lane, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the inter-governmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early child development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Nov 06 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA RR-97-001 - V25(37) 11/01/96 Date: 6 Nov 1996 19:29:05 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 398 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55rl21$mrh@net.bio.net> NNTP-Posting-Host: net.bio.net EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA: RR-97-001 P.T. 34; K.W. 1002002 National Center for Research Resources Letter of Intent Receipt Date: December 20, 1996 Application Receipt Date: January 24, 1997 PURPOSE The National Center for Research Resources (NCRR) is authorized under Public Law (PL) 103-43, Sections 481A and 481B of the Public Health Service Act (PHS), as amended by the National Institutes of Health (NIH) Revitalization Act, to "make grants to public and nonprofit private entities to expand, remodel, renovate or alter existing research facilities or construct new research facilities" for biomedical and behavioral research and research training. The Fiscal Year 1997 appropriation for the NIH includes $20 million in the budget of the NCRR for extramural facilities construction grants to be awarded competitively, with special provisions made for institutions of emerging excellence, designated under section 739 of the PHS Act as revised in PL 102-408, and the Regional Primate Research Centers (RPRCs). The NCRR is issuing this Request for Applications (RFA) RR-97-001 for support of construction and renovation of facilities for biomedical and behavioral research and research training. ELIGIBILITY REQUIREMENTS Under Section 481A of the PHS Act, domestic, non-Federal, public and private non-profit institutions, organizations, and associations that conduct or support biomedical or behavioral research are eligible to apply, including, for example, allied health professional schools. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications are particularly encouraged from institutions of emerging excellence as defined in the PHS Act, Section 739 as amended by PL 102-408. An institution may submit only one application in response to this RFA; however, applications from RPRCs or recipients of Fiscal Year 1996 PHS Centers of Excellence Awards do not count against the one application limit. Two components of the same institution, e.g., a medical school and a dental school, even if separated geographically, may not submit separate applications. MECHANISM OF SUPPORT This RFA is a one-time solicitation that will use the NIH research facilities construction grant (C06). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed one year and no indirect costs or continuation costs will be awarded. The anticipated award date is September 30, 1997. Matching funds will be required for the specific project awarded. Under Section 481A, up to 50 percent of the necessary and allowable costs of a project may be awarded, or 40 percent of costs proportionate to use in a multi-purpose facility. Under Section 481B, RPRCs may receive up to 80 percent of necessary and allowable costs. The maximum award amount will be $1.5 million for applications from RPRCs, and institutions of emerging excellence under section 739 of the PHS Act as amended by PL 102-408, and $1.0 million for other applicant institutions. A description of the sources of non-Federal funding for the project (both matching funds and funds needed to complete the total project ) must be provided with the application. Applications proposing a Federal share of less than $500 thousand or more than the maximum award amount specified above will not be accepted. Because the nature and scope of the activities proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FUNDS AVAILABLE Based on the Fiscal Year 1997 budget, up to $20 million will be available for this initiative. Twenty-five percent of these funds are targeted for institutions of emerging excellence, and $2.5 million of the total amount available is set aside for the purpose of improving the research facilities of the RPRCs as outlined in Section 481B of Title IV of the PHS Act as amended. It is anticipated that approximately 15 new awards at different levels will be made. RESEARCH OBJECTIVES The main objective of this program is to facilitate the conduct and enhancement of PHS-supported biomedical and behavioral research by supporting the costs of designing and constructing non-Federal basic and clinical research facilities to meet the biomedical or behavioral research, research training, or research support needs of an institution or a research area at an institution, and for the purchase of essential associated fixed research equipment. Applications are particularly encouraged from institutions of emerging excellence as defined in the PHS Act, Section 739 as amended by PL 102-408. Applications for genetic research facilities from institutions with demonstrated expertise in human genetics are also encouraged. Facility construction that may be supported under this program includes construction of new facilities, additions to existing buildings, completion of uninhabitable "shell" space in new or existing buildings, and major alterations and renovations. Support for instrumentation or equipment that usually would be requested as part of a research project grant will not be provided, and neither land acquisition nor off-site improvements will be supported. LETTER OF INTENT Prospective applicants are asked to submit, by December 20, 1996, a letter of intent that includes a brief description of the type of facility proposed and the areas of research or research support to be conducted in the proposed facility, the name, address, and telephone number of the Principal Investigator, 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, the information that it contains allows NCRR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Charles L. Coulter Research Facilities Improvement Program National Center for Research Resources 6705 Rockledge Drive, Room 6142 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 Email: charlesc@ep.ncrr.nih.gov APPLICATION PROCEDURES Applicants must use Standard Form 424, "Application for Federal Assistance." Application forms and special instructions for completing them must be requested from the program official listed under INQUIRIES. Individuals considering applying are advised to consult with appropriate officials at their institution before completing the application forms. Submit a signed, typewritten original of the application, including appendices, and one signed photocopy, including appendices, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (express/courier) At the time of submission, one additional copy of the application (with appendices, if any) must be sent under separate cover to: Dr. D.G. Patel Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6018 - MSC 7965 Bethesda, MD 20892-7965 Email: dgpatel@ep.ncrr.nih.gov Applications must be received by January 24, 1997. 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 RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. o Intergovernmental Review -- Executive Order 12372 Applicants are required to comply with Executive Order (E.O.) 12372 as supplemented by DHHS 45 CFR Part 100, Intergovernmental Review of Department of Health and Human Services Programs and Activities. E.O. 12372 sets up a system for State and local government review of proposed Federal assistance applications. Applicants (other than federally-recognized Indian tribal governments) should contact their State Single Point of Contact (SPOCs) as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC of each affected State. A current list of SPOCs is included in the application kit. The SPOC must be given 60 days to review a construction grant application. Applicants are to provide the SPOC with a copy of the application NOT LATER THAN the time the application is submitted to the Division of Research Grants, NIH. Applications submitted to NIH in response to this solicitations must contain either SPOC comments or documentation indicating the date on which the application was submitted to the SPOC for review. The SPOC comment period ends 60 days after the application receipt date. The granting agency does not guarantee to "accommodate or explain" for State process recommendations it receives after that date. All SPOC comments must be forwarded to both the applicant and to the NCRR contact given below. If comments are provided by the SPOC, the applicant may wish to submit to the NIH a statement of its reaction to the comments and any appropriate changes to its application. If no response is received from the SPOC by the end of the 60 days allotted for review of the application, the applicant must notify the NIH that no response was received. o Public Disclosure Applicants must also make a public disclosure of the project by publication and describe its environmental impact at the time the SPOC is notified. It is suggested that the notice be published in a large-circulation newspaper in the area. This public disclosure is required by Section 102 of the National Environment Policy Act (NEPA) of 1969 and by Federal Executive Order 11514. One example of a suitable disclosure statement follows: "PUBLIC NOTICE" "Notice is here by given that the Uptown Medical School proposes to construct additional space, partially utilizing Federal funds. The proposed construction project is the addition of 2,700 square feet connected to the existing Allen Building, which is located 5333 Main Street, Downtown, Ohio. "The Medical School has evaluated the environmental and community impact of the proposed construction. There will be construction noise and increased construction traffic during the construction period. No significant permanent environmental impacts are foreseen. All building permits and zoning approvals have been obtained. In accordance with Federal Executive Order 11514, which implements the NEPA of 1969, any individual or group may comment on, or request information concerning, the environmental implications of the proposed project. Communications should be addressed to the Office of Planning, Uptown Medical School, and be received by (date). The Federal grant application may be reviewed at the Office of the Dean, school of Medicine, 5333 Main Street, during working hours." o Design Standards Design requirements are imposed to protect the health and safety of persons using the proposed facility, assure that the new facility is accessible to and useable by the physically handicapped, control the project's impact on the natural environment, conserve energy resources, achieve economy in construction costs, and protect against natural disasters such as earthquake and flood. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants and responsiveness by NCRR. Those applications judged to be unresponsive, incomplete, or ineligible will be returned to the applicant. Applications that are complete and responsive will be reviewed for scientific and technical merit by the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities established for this purpose by the NCRR. The second level of review will be conducted by the National Advisory Research Resources Council. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria Applications will be evaluated on the basis of criteria intended to assess the following overall questions: (1) How will the proposed change in the research environment facilitate the applicant institution's ability to conduct, expand, improve, or maintain biomedical/behavioral research? (2) How will the proposed project meet national unmet health needs for biomedical/behavioral research, research training and/or research support facilities? Thus, reviewers will consider the following factors: o The impact of the proposed construction on existing and future PHS-supported biomedical and behavioral research, research training and/or research support activities. o For institutions with limited PHS support, the impact of the proposed construction on the planned advancement or expansion of the research and research training activities. o Appropriateness and suitability of the proposed facilities, including safety and biohazard aspects, for the research to be conducted and/or research support and training to be provided. o Specific deficiencies in the existing research facilities that would be remedied and the impact of the proposed project on current and future research activities. o The appropriateness of the proposed physical location and layout of the new facility and the reasonableness of the proposed time-course, cost and sequence for the construction. o Adequacy of the proposed administrative arrangements with respect to institutional commitment to use the space for biomedical/behavioral research, research training and/or research support and the capabilities of the Principal Investigator and staff for scientific and fiscal administration of the facility. AWARD CRITERIA Factors considered in making awards include the merit of the proposal; the needs of the institution, with special consideration for institutions designated as institutions of emerging excellence and for RPRCs; the commitment of the institution; the availability of funds; and overall programmatic priorities including geographic distribution of the awards. Award Conditions Prior to award, an applicant must provide an assurance that required matching funds are available and that additional funds have been secured to meet project costs in excess of the Federal award and non-Federal matching amounts. Advertisement for construction bids and construction can be initiated only after receipt of the construction grant award and subsequent approval of the working drawings and specifications by NIH staff. Early in the design process, applicants are encouraged to review the "Public Health Service Grants Policy Statement," DHHS Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994 as updated; the sections related to public policy requirements and construction are particularly relevant. NO REQUESTS TO INITIATE CONSTRUCTION, CONSISTENT WITH PUBLIC HEALTH SERVICE POLICY, WILL BE ENTERTAINED PRIOR TO RECEIPT OF A CONSTRUCTION GRANT AWARD FROM NIH AND SUBSEQUENT APPROVAL OF WORKING DRAWINGS AND SPECIFICATIONS BY NIH STAFF. The Principal Investigator should be a highly placed institutional official, at the level of Dean or equivalent, who has the responsibility for allocation of space for the program(s) of biomedical or behavioral research and research training addressed in the submitted application. The facility must be utilized for biomedical or behavioral research purposes for which it was constructed for at least 20 years beginning 90 days following completion of the construction project. The NIH staff will evaluate use of the facility periodically to assure its continued use for the approved purposes. Failure to comply with the 20 year utilization requirement will result in recovery of the Federal share of the value of the facility in accordance with Federal Regulation 45 CFR 74.32. INQUIRIES Inquiries concerning this RFA are encouraged. A technical workshop to assist applicants unfamiliar with the requirements for extramural construction applications and to clarify any issues or questions from potential applicants will be held on December 8-9, 1996 in Bethesda, MD. For additional information regarding the workshop, please call (301) 435-1302. A summary of the presentations and issues discussed will be provided upon request for those unable to attend. Direct inquiries regarding programmatic issues, requests for application Standard Form 424 and special application instructions, and SPOC comments, if any, to: Dr. Charles L. Coulter Research Facilities Improvement Program National Center for Research Resources 6705 Rockledge Drive, Room 6142 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 FAX: (301) 480-3770 Email: charlesc@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal domestic Assistance No. 93.214. 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 and Public Law 103-43, 42 USC 241, 285, and 481) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Applicants are required to comply with Executive Order 12372 as supplemented by DHHS 45 CFR Part 100, Intergovernmental Review of Health and Human Services Programs and Activities. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Nov 06 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 37, pt. 1of1, 1 November 1996 Date: 6 Nov 1996 19:28:00 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 665 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55rl00$moa@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 37 - November 1, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** NIAID PROGRAM ANNOUNCEMENTS: UPDATE National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 01/14/97 ************************************************ SHORT-TERM TRAINING FOR ORAL HEALTH CLINICAL TRIALS (RFA DE-97-001) National Institute of Dental Research INDEX: DENTAL RESEARCH $$INDEX R2 01/23/97 ************************************************ SLEEP ACADEMIC AWARD (RFA HL-96-021) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX R3 01/24/97 ************************************************ EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS (RFA RR-97-001) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX R4 03/13/97 ************************************************ DISCOVERY OF NOVEL PHARMACOTHERAPIES FOR COCAINE DEPENDENCE (RFA DA-97-003) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P1 ********************************************************** RESEARCH ON ADOLESCENT DRUG ABUSE (PA-97-005) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES (PAR-97-006) National Cancer Institute INDEX: CANCER ERRATA $$INDEX E1 ********************************************************** ANABOLIC HORMONES IN BONE: BASIC RESEARCH AND THERAPEUTIC POTENTIAL (PA-96-076) National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research National Institute on Aging INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; DENTAL RESEARCH; AGING THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** NIAID PROGRAM ANNOUNCEMENTS: UPDATE NIH GUIDE, Volume 25, Number 37, November 1, 1996 P.T. 34; K.W. 1014006 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) published the notice, Continuation and Inactivation of NIAID Program Announcements, in the NIH GUIDE, Vol. 25, No. 18, June 7, 1996. This notice addresses three topics: (1) it defines the effect of continuation and inactivation of program announcements on the potential for funding of grant applications; (2) it announces a new NIAID policy - that most future NIAID Program Announcements (PAs) will remain active for three years; and (3) it updates the listing of NIAID Program Announcements (PAs) being continued and being inactivated. 1. PA CONTINUATION AND INACTIVATION NIAID gives special consideration for funding, including award of grants beyond the NIAID percentile and priority score paylines, to applications submitted in response to active (new and continuing) PAs. NIAID supports highly scientifically meritorious applications in all areas of research within its mission. PA inactivation simply means that special consideration for funding beyond normal paylines will NO LONGER be given to applications on the research topics identified in the inactivated PAs. However, such applications will be accepted, reviewed, and considered for funding according the usual procedures. 2. NIAID THREE YEAR PROGRAM ANNOUNCEMENTS Historically, NIAID PAs have been issued for different durations. Some were issued as open-ended PAs; that is, investigators could continue to submit applications in response to a PA until NIAID announced its termination in the NIH Guide. Others were issued for one or two or three years of receipt dates following publication. Henceforward, virtually all new NIAID PAs will be issued for three years of standard receipt dates following their publication in the NIH Guide for Grants and Contracts. Each PA will identify the receipt dates for applications. This will ensure that there is adequate time for investigators to develop and propose their research plans at the same time as ensuring that PAs are not kept active beyond their useful life. 3. NIAID PA CONTINUATIONS AND INACTIVATIONS. NIAID will continue to support selected previously published PAs and is inactivating other older PAs. Further, additional PAs will be inactivated and new ones published in the future as NIAID continues to adjust and expand the use of PAs to inform the scientific community of its areas of current research emphasis (See NIH Guide, Volume 25, April 19, 1996 for NIAID Notice on Program Announcements and Research Emphasis Areas). A listing of all active NIAID PAs plus a listing of future PAs given concept approval by the National Advisory Allergy and Infectious Diseases Council is kept current and can be found on the NIAID WWW site at: http://www.niaid.nih.gov/newsletter/maya/pa-table.htm Clicking on the title of any active PA will link the user to the full text of the PA. CONTINUATIONS. NIAID will continue to give special consideration for funding to applications in response to the following PAs. For each PA, the number, title, and date of publication in the NIH Guide for Grants and Contracts is cited below. In addition to finding a PA via the NIAID WWW site (see above), PAs can be obtained from the NIH Grants and Contracts Home Page (http://www.nih.gov:80/grants). On this home page, for PAs published in 1994 or earlier, select "NIH GUIDE FOR GRANTS AND CONTRACTS"; then select "NIH Guide-Flat Text Files Printed Edition"; then select the publication date(s) for the PA(s) in which you are interested. For PAs published in 1995 and 1996, select "Program Announcements-Full Text." AND ALL NIAID PROGRAM ANNOUNCEMENTS PUBLISHED IN THE NIH GUIDE AFTER SEPTEMBER 6, 1996. PA-93-041 Minority Investigators in Asthma and Allergy, January 22, 1993 PA-93-108 Behavioral Research in Sexually Transmitted Diseases, September 3, 1993 PA-94-019 Infectious Causes of Diarrhea/Wasting Syndrome in People with AIDS, December 17, 1993 PA-94-062 Environmental Agents and Asthma, April 29, 1994 PA-94-092 New Insights into Chronic Fatigue Syndrome, August 4, 1994 PA-94-095 Drug Discovery for Opportunistic Infections Associated with AIDS, September 16, 1994 PAR-95-047 National Cooperative Drug Discovery Groups, HIV Treatment, April 14, 1995 PA-95-062 Fellowships and Career Development in Inflammatory Bowel Disease, May 19, 1995 PA-96-014 Models for HIV Disease and AIDS-related Malignancies, January 26, 1996 PAR-96-031 NIDDK-NIAID International Collaboration: Small Grant Awards, March 8, 1996 PA-96-048 Expanded Research on Emerging Diseases, May 3, 1996 PA-96-051 Role of Microbes in Autoimmune and Immune-Mediated Diseases, May 10, 1996 PA-96-053 Gender in the Pathogenesis of Autoimmunity: Mechanisms, May 10, 1996 PAR-96-060 Acute Infection and Early Disease Research Network, June 28, 1996 PA-96-061 Modern Vaccines for Mycoses and Measles, June 21, 1996 PA-96-067 Molecular Correlates of Pathogenesis in Parasitic Diseases, July 26, 1996 PA-96-068 Innovative Drug Discovery Research in AIDS Opportunistic Infections, August 2, 1996 PA-96-069 Collaborations for Advanced Strategies in Opportunistic Infections, August 9, 1996 PA-96-070 Chronic Fatigue Syndrome Pathophysiology, August 16, 1996 PA-96-072 Mechanisms of AIDS Pathogenesis, September 6, 1996. INACTIVATIONS. The following program announcements (PAs) are being inactivated; NIAID will no longer give special consideration for funding to applications in response to these PAs. This notice is effective immediately and applies to the application receipt deadlines of February 1, 1997 and after. ALL NIAID-SPONSORED PAs PUBLISHED IN THE NIH GUIDE FOR GRANTS AND CONTRACTS PRIOR TO NOVEMBER 6, 1992. PA-93-014 The Immunology of Aging, November 6, 1992 PA-93-034 Mucosal Immunity in the Urogenital Tract, January 8, 1993 PA-93-037 Asthma as a T-Cell-Mediated Disease, January 15, 1993 PA-93-042 Cytokines and Adhesion in Allergy and Inflammation, January 22, 1993 PA-93-049 Neurological Aspects of Lyme Disease, February 6, 1993 PA-93-061 Congenital Cytomegalovirus: Study of Infection and Sequelae, March 5, 1993 PA-93-085 Biological Factors Influencing Sexual Transmission of HIV, May 21, 1993 PA-93-090 Basic Rubella Research Leading to Improved Rubella Vaccines, June 4, 1993 PA-93-096 Research on DNA Vaccines for Infectious Diseases, June 18, 1993 PA-93-105 Helicobacter Pylori Pathogenesis, August 8, 1993 PA-93-114 Autoimmune Endocrine Disease, September 24, 1993 PA-94-023 HIV-Related Therapeutics in Drug Users, January 7, 1994 PA-94-049 Studies on Environmental Toxicants and the Immune System, March 18, 1994 INQUIRIES For questions or further information, contact: Office of the Director Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 3C20 Bethesda, MD 20892-7610 Telephone: (301) 496-7291 FAX: (301) 402-0369 Email: ac20a@nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN DE-97-001 FULL-TEXT ************************************** SHORT-TERM TRAINING FOR ORAL HEALTH CLINICAL TRIALS NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA AVAILABLE: DE-97-001 P.T. 44; K.W. 0715148, 0755015 National Institute of Dental Research Letter of Intent Receipt Date: December 15, 1996 Application Receipt Date: January 14, 1997 PURPOSE The National Institute of Dental Research (NIDR) invites new and competing applications proposing National Research Service Award (NRSA) Short-Term Training in Oral Clinical Trials (T35) programs. The objective is to provide short-term training for oral health research personnel interested in becoming active members of teams that conduct oral, dental and craniofacial clinical trials sponsored by government and industry. It is anticipated that approximately $90,000 will be available to make three awards. 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), NRSA - Institutional Training Awards, is related to the priority area of oral health. 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 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-18J Bethesda, MD 20892-6402 Telephone: (301) 594-2618 or 594-7710 FAX: (301) 480-8318 Email: liptonj@de45.nidr.nih.gov $$R1 END ************************************************************ $$R2 BEGIN HL-96-021 FULL-TEXT ************************************** SLEEP ACADEMIC AWARD NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA AVAILABLE: HL-96-021 P.T. 34; K.W. 0404009, 0740020 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: December 9, 1996 Application Receipt Date: January 23, 1997 PURPOSE The primary objective of this initiative is to encourage the development and/or improvement of the quality of medical curricula, physician/patient/nurse and community education, and clinical practice for the prevention, management, and control of sleep disorders. A secondary objective is to promote high quality clinical research in sleep. A candidate for the Sleep Academic Award must have knowledge and skills in sleep and sleep disorders medicine and be a member of the faculty in an accredited school of medicine or osteopathy in the United States, its territories or possessions. The candidate must also have sufficient experience and training in clinical sleep research, clinical practice, and/or medical education to implement a high quality curriculum in sleep and sleep disorders as well as the unqualified support from the Dean and the educational leadership of the institution is also required. The mechanism of support is the Academic Award Program (K07) of the National Heart, Lung, and Blood Institute. The total project period may not exceed five years and is non-renewable. The estimated funds (total costs) available for fiscal year 1997 will be $300,000. It is anticipated that three to four grants will be awarded this year and in an additional competition to be held during fiscal year 1998. 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, Sleep Academic Award, is related to the priority areas of heart disease and stroke, diabetes, chronic disabling conditions, mental health and disorders, and clinical prevention services. 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 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. James P. Kiley, Ph.D. National Center on Sleep Disorders Research National Heart, Lung, Blood Institute 6701 Rockledge Drive, Suite 7024, MSC-7920 Bethesda, MD 20892-7920 Telephone: (301) 435-0199 FAX: (301) 480-3451 Email: Kileyj@NIH.GOV $$R2 END ************************************************************ $$R3 BEGIN RR-97-001 FULL-TEXT ************************************** EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA AVAILABLE: RR-97-001 P.T. 34; K.W. 1002002 National Center for Research Resources Letter of Intent Receipt Date: December 20, 1996 Application Receipt Date: January 24, 1997 PURPOSE The National Center for Research Resources (NCRR) is authorized under Public Law (PL) 103-43, Sections 481A and 481B of the PHS Act, as amended by the National Institutes of Health (NIH) Revitalization Act, to "make grants to public and nonprofit private entities to expand, remodel, renovate or alter existing research facilities or construct new research facilities" for biomedical and behavioral research and research training. The Fiscal Year 1997 appropriation for the NIH includes $20 million in the NCRR budget for extramural facilities construction grants to be awarded competitively, with special provisions made for institutions of emerging excellence, designated under section 739 of the PHS Act as revised in PL 102-408, and the Regional Primate Research Centers (RPRCs). The NCRR is issuing this Request for Applications (RFA) for support of construction and renovation of facilities for biomedical and behavioral research and research training. It is anticipated that 15 new awards (C06) at different levels will be made. INQUIRIES Inquiries concerning this RFA are encouraged. A technical workshop to assist applicants unfamiliar with the requirements for extramural construction applications and to clarify any issues or questions from potential applicants will be held on December 8-9, 1996 in Bethesda, Maryland. For additional information regarding the workshop, call (301) 435-1302. A summary of the presentations and issues discussed will be provided upon request for those unable to attend. The RFA, which describes the objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov); and by mail and email from the program contact listed below. Dr. Charles L. Coulter Research Facilities Improvement Program National Center for Research Resources 6705 Rockledge Drive, Room 6142 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 FAX: (301) 480-3770 Email: charlesc@ep.ncrr.nih.gov $$R3 END ************************************************************ $$R4 BEGIN DA-97-003 FULL-TEXT ************************************** DISCOVERY OF NOVEL PHARMACOTHERAPIES FOR COCAINE DEPENDENCE NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA AVAILABLE: DA-97-003 P.T. 34; K.W. 0404001, 0404009, 0755025, 1003006 National Institute on Drug Abuse Letter of Intent Receipt Date: February 13, 1997 Application Receipt Date: March 13, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to encourage applications combining medicinal chemistry and preclinical pharmacology to design, synthesize and test compounds leading to the identification of candidates for advanced preclinical and clinical evaluation as potential pharmacotherapies for cocaine dependence. Pharmacological testing may be conducted using in vitro and/or non-human in vivo procedures. It is anticipated that approximately $1.5 million will be available to fund between five to seven research project grants (R01) and FIRST (R29) awards. 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, Discovery of Novel Pharmacotherapies for Cocaine Dependence, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse 5600 Fishers Lane, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 Email: jb168r@nih.gov $$R4 END ************************************************************ $$P1 BEGIN PA-97-005 FULL-TEXT ************************************** RESEARCH ON ADOLESCENT DRUG ABUSE NIH GUIDE, Volume 25, Number 37, November 1, 1996 PA AVAILABLE: PA-97-005 P.T. 34, AA; K.W. 0404009 National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) is firmly committed to support of research in the area of adolescent drug abuse. The purpose of this program announcement (PA) is to encourage further investigations in this area, particularly with regard to gaps in current knowledge. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Research on Adolescent Drug Abuse, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Elizabeth Rahdert, Ph.D. Division of Clinical and Services Research 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: er34g@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-006 FULL-TEXT ************************************* SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES NIH GUIDE, Volume 25, Number 37, November 1, 1996 PA AVAILABLE: PAR-97-006 P.T. 34; K.W. 0715035, 0755015 National Cancer Institute Application Receipt Dates: May 15, September 15, January 15 PURPOSE The Division of Cancer Treatment Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) announces a small grants program to encourage the submission of small grant applications for new therapeutic clinical trials of malignancies that take advantage of recent laboratory developments. New and experienced investigators in relevant fields and disciplines (clinical, surgical, and radiation oncology) may apply for small grants to test new treatment strategies in patients or do pilot clinical studies. This PA supersedes PAR-95-023, Small Grants for Therapeutic Clinical Trials of Malignancies, which was published in the NIH Guide for Grants and Contracts, Vol. 24, No. 3, January 27, 1995. 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, Small Grants for Therapeutic Clinical Trials, 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 202/512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ms. Diane Bronzert or Dr. Roy Wu Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV or WUR@DCT.NCI.NIH.GOV $$P2 END ************************************************************ ERRATA $$E1 BEGIN P1 19961004 APPEND PA-96-076 BOTH *************************** ANABOLIC HORMONES IN BONE: BASIC RESEARCH AND THERAPEUTIC POTENTIAL NIH GUIDE, Volume 25, Number 37, November 1, 1996 PA NUMBER: PA-96-076 P.T. 34; K.W. 0760025, 0715031 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research National Institute on Aging This correction is issued for PA-96-076, which was published in the NIH Guide, Vol. 25, No. 33, October 4, 1996. The programmatic contact for the National Institute on Aging for this PA was given incorrectly. The correct contact should be: Frank Bellino, Ph.D. Biology of Aging Program National Institute on Aging Gateway Building, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: bellinof@gw.nia.nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Wed Nov 06 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-97-001 - V25(37) 11/01/96 Date: 6 Nov 1996 19:28:22 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 535 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <55rl0m$mpb@net.bio.net> NNTP-Posting-Host: net.bio.net SHORT-TERM TRAINING FOR ORAL HEALTH CLINICAL TRIALS NIH GUIDE, Volume 25, Number 37, November 1, 1996 RFA: DE-97-001 P.T. 44; K.W. 0715148, 0755015 National Institute of Dental Research Letter of Intent Receipt Date: December 15, 1996 Application Receipt Date: January 14, 1997 PURPOSE The National Institute of Dental Research (NIDR) invites new applications for National Research Service Award (NRSA) Short-Term, Institutional Training Programs in the design and conduct of oral, dental and craniofacial clinical trials. The objective of the programs to be supported through this Request for Applications (RFA) is to provide short-term training for oral health research personnel interested in becoming active members of teams that conduct clinical trials sponsored by government and industry. Background The need for an increased number of appropriately trained personnel in clinical or patient-oriented research (POR) has been highlighted in numerous recent reports and studies. POR is defined as "research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomenon) for which the investigator (or colleague) directly interacts with human subjects in either an outpatient or an inpatient setting" (NIH, 1994). The personnel need for POR is especially great in oral, craniofacial and dental health research. The responsibility for ensuring the availability of sufficient numbers of competent POR clinical scientists to meet the expanding opportunities resulting from basic and clinical research rests with the government, academia, and industry. Strong recommendations that the NIDR encourage the training and career development of clinical investigators, and specifically of personnel knowledgeable about clinical trials, have been made by the NIDR Dental Research Programs Advisory Committee, the National Advisory Dental Research Council, the Institute of Medicine (IOM) task force on clinical research in dentistry (which was part of the 1994 study by the IOM Committee on Addressing Career Paths for Clinical Research), and at an NIDR meeting in 1993 on training requirements for dental oral, and craniofacial clinical trials. This RFA is one of several NIDR initiatives to address these critical needs in POR. The objective is to help develop a cadre of well-trained investigators who are knowledgeable about the design and conduct of clinical trials in oral health research, and who can function as effective members of clinical trial teams. Programs must be relevant to the research goals of the NIDR. Primary emphasis is placed upon understanding, preventing, diagnosing and treating craniofacial, oral, and dental diseases and disorders. Current special areas of interest include: inherited diseases and disorders, including the development of teeth and bone; emerging and re-emerging infectious diseases, including bacterial, viral, fungal and parasitic disorders and AIDS; neoplastic diseases; chronic disabling diseases, such as osteoporosis and related bone disorders, temporomandibular joint disorders, pain, neuropathies and neurodegenerative diseases, and other systemic disorders with oral manifestations; biomimetics, tissue engineering and biomaterials; and behavior, health promotion, and environment. 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, Short-Term Training for Oral Health Clinical Trials, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private institutions such as dental schools, dental research institutions, schools of public health and universities. Consortia arrangements are encouraged. An institution may have no more than three concurrent NRSA short-term training grants from the NIDR: one conventional grant for dental students; one for training of women and minority dental students; and one resulting from this RFA. Trainee Eligibility Preference for training must be given to individuals who: (1) have received a D.D.S./D.M.D., Ph.D., both an R.D.H. and Master's degree, or equivalent degrees from an accredited domestic or foreign institution; (2) hold postdoctoral, resident, or faculty appointments in dental, dental hygiene, medical, or public health schools, advanced dental education/research institutions, or universities, or private industry positions that are involved with clinical trials; and (3) demonstrate a commitment to clinical oral health research. Consideration also may be given to those who recently have completed a graduate program related to oral health or a clinical dental specialty program, but have not yet obtained a full-time research position. Trainees must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551 or I-151) at the time of appointment. Non-citizen nationals, although not citizens of the United States, owe permanent allegiance to the U.S. They are generally born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT Awards made as a result of this RFA will be the National Institutes of Health (NIH), NRSA Short-Term Institutional Research Training Grant (T35). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the program director. The total project period for applications submitted in response to this RFA must be five years. This RFA is a one-time solicitation. Awards may be renewable depending on program needs, availability of funds, and submission of a successful competing application. It is anticipated that awards will be made by September 15, 1997. FUNDS AVAILABLE The NIDR expects to make up to three new awards, each with five positions, at a total first year cost of approximately $90,000 for all awards, in response to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific and educational merit. Although this program is provided for in the financial plans of the NIDR, these awards are contingent upon the availability of funds. RESEARCH OBJECTIVES The program must provide opportunities for individuals with a variety of training, research, and clinical backgrounds to develop skills in the design and conduct of clinical trials for dental, oral and craniofacial conditions. There is no expectation that these short-term training programs will allow participants to serve as principal investigators or directors of clinical trials immediately. The courses are expected to enable trainees to become active and integral members of clinical trials teams, be able to evaluate and interpret published reports of clinical trials critically, and be able to communicate these skills to predoctoral and postdoctoral students, oral health professionals, and scientists in private industry. The program must include a core curriculum of formal instruction in the design, conduct, analysis, and presentation of results from single center and multicenter clinical trials. Topics such as the following should be included: study organization and administration, including roles and responsibilities of team members; developing specific aims and primary and secondary endpoints for the trial; principles of hypothesis testing; importance and use of preliminary studies; preparing a detailed clinical protocol (containing at least inclusion and exclusion criteria, patient assignment procedures, study designs and potential biases, randomization, sample size calculations); issues related to patient availability, recruitment, and retention; data integrity, management, quality control, and analysis; appropriate use of oral, dental, and craniofacial indices and measures; quality assurance of biological specimens and other individual measures, such as radiographs; protection of human participants, biohazard safety of employees and subjects, informed consent and assent, ethics in research and scientific integrity, responsible conduct of research; statutory mandates, such as the inclusion of women and minority subjects in trials funded by the NIH; the need for and purposes of a data and safety monitoring board; government regulatory issues, especially from the Food and Drug Administration; and issues related to trials performed by private industry. There should be opportunities for practical experiences such as observing and participating in various phases of ongoing clinical trials. The training program director will be responsible for the selection and appointment of trainees and for the overall direction of the program. Each applicant may request up to five positions for each year over the five-year period. The number of positions awarded will be determined by the initial review group's assessment of scientific and educational merit, program needs, and the availability of funds. The length of the short-term training experience and of trainee support may vary from one to three months per year and the training must be full-time, during this period. Successful trainees may be reappointed for a continuing course of training, not to exceed two appointments. Program directors and potential trainees should be aware that an individual may receive up to three years of NRSA support at the postdoctoral level, including any combination of support from institutional training awards and individual fellowship awards. Appointments on these short-term training programs will be included in the calculation of the total period of NRSA support. Extensions beyond the three year period require a waiver from the NIDR. However, well-qualified potential trainees may anticipate favorable consideration of a waiver request. People receiving support under individual or other institutional NRSA training grants are not eligible for appointment to these short- term programs. Training grants may not be used to support studies leading to a D.D.S./D.M.D. or other similar professional degrees, or to support residencies, or other training for dentists providing care to patients where the majority of their time is spent in non-research clinical training. However, if a specified period of full-time research training is creditable toward specialty board certification, the training grant may support such research training if the trainee has shown a clear interest in a research career. Applicants are reminded of the importance the NIDR places on recruitment and retention of women and underrepresented minorities to sponsored training and career development programs. Where feasible, women and minority mentors should be involved as role models. Additional information regarding NRSA Institutional Research Training Grants is given in the NIH Guide for Grants and Contracts (NIH Guide), Vol. 23, No. 21, June 3, 1994. Copies of the NIH Guide are usually available in the office of sponsored research of most academic institutions and from the Office of Grants Information, Division of Research Grants, at the address below. Stipends and Other Training Costs For postdoctoral trainees, the annual stipend is determined by the number of years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research, including industrial; teaching; internship; residency; clinical practice; or other time spent in a health-related field beyond that of the qualifying doctoral degree. Stipends will be prorated on a monthly or weekly basis. The postdoctoral annual stipends are as follows: Years of Relevant Experience Stipend Less than 1 year $19,608 1 20,700 2 25,600 3 26,900 4 28,200 5 29,500 6 30,800 7 or more 32,300 Stipends may be supplemented by an institution from non-Federal funds. Other NIH funds may not be used to supplement stipends. Non-NIH Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which the supplemental funds are derived. An individual may make use of Federal educational loan funds or Department of Veterans' Affairs benefits when permitted by those programs. Under no circumstance may the condition of stipend supplementation detract from or prolong the training. Institutional costs of $2,500 per year per postdoctoral trainee ($1,500 per year per predoctoral trainee), prorated on a weekly or monthly basis, may be requested to defray the cost of training related expenses, such as tuition, fees, supplies, consultant costs, equipment, and other expenses. Fringe benefits are not provided by this award. No allowance will be provided for dependents or for an individual's travel to the training site. An indirect cost allowance based on eight percent of total allowable direct costs or actual indirect costs, whichever is less, may be requested. Payback Provisions All postdoctoral trainees must sign an agreement to fulfill NRSA payback requirements. They incur one month of payback obligation for each month of support in the first twelve months of support. This obligation will be satisfied by continuing on a NRSA training grant for an additional 12 months. For payback obligations which are not satisfied in this way, trainees must engage in biomedical or health-related behavioral research and or teaching for a period equal to the period of support up to 12 months. The obligated service must be undertaken continuously within two years after termination of support. Individuals who fail to fulfill the obligation through service must pay back the total amount of funds paid to the individual for the obligation period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years of the date the United States becomes entitled to recover such amount. Under certain conditions,the Secretary of Health and Human Services may extend the period for starting service or for repayment, permit breaks in the period of service or repayment, or otherwise waive or suspend the payback obligation of an individual. Officials of the applicant organization responsible for recruitment of trainees should familiarize themselves with the terms of the payback service requirement and explain them carefully to prospective trainees before an appointment to the training grant is offered. For additional information, including the grounds for approving extensions of support and payback provisions, refer to the announcements in the NIH Guide, "National Research Service Awards - Guidelines for Individual Awards - Institutional Grants," Special Edition, Volume 13, No. 1, January 6, 1984, and "Modification of the NRSA Service Payback Obligation," Volume 22, No. 27, July 30, 1993. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508- 14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 15, 1996, a letter of intent that includes a descriptive title of the proposed short-term training program, the name, address, and telephone number of the Program Director, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDR 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 James A. Lipton, D.D.S., Ph.D. at the address under INQUIRIES. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact Dr. Lipton early in the planning phase of application preparation. Such contact may help ensure that applications are responsive to this RFA. Applications must be submitted on the grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the and from Dr. Lipton at the address listed under INQUIRIES. Each applicant may request up to five positions for each of the five years of the award. The exact length of the proposed training experience is left to the discretion of the applicant and may vary from one to three months. The budget request must correspond to the proposed training period(s). A plan must be included for the recruitment of women and individuals from minority groups that are nationally underrepresented in these sciences. No awards will be made to applications lacking this component. Applications must include a description of formal and or informal activities related to instruction about the responsible conduct of research to be incorporated into the proposed research training program. Information must be provided on the rationale, subject matter, appropriateness, format, and the frequency and duration of instruction; and the amount and nature of faculty participation. No award will be made if an application lacks this component. Information regarding, "Modification of Existing Review Criteria for NRSA Institutional Research Training Grants," is given in the NIH Guide, Vol. 21, No. 11, March 20, 1992. To identify the application as a response to this RFA, check "YES" on item 2a of the face page of the application and enter "RFA: DE-97-001, Short-term Training for Oral Health Clinical Trials." 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. 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 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application also must be sent to: H. George Hausch, Ph.D. Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44F 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2372 This RFA is for a single competition. Applications must be received by January 14, 1997. If an application is received after that date it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications will be reviewed for completeness and responsiveness to the RFA by DRG and NIDR staff. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Remaining applications may be subjected to triage by a special grants review committee, convened by the NIDR Scientific Review Section, to determine their merit, relative to others received in response to the RFA. The NIDR will withdraw applications judged to be noncompetitive and notify the applicant. Applications judged to be competitive will be evaluated for scientific and technical merit by the review committee. The following review criteria will be applied: o The proposed research training and program design; the core curriculum; the opportunities for observing and participating in various phases of ongoing clinical trials; the quality of such practical experiences; the appropriateness of the length of the proposed training program; the unique or innovative aspects of the training program. o The qualifications of the program director and participating faculty including the roles of specific instructors or preceptors, their time commitment, ability to compete for research support, current clinical trials activities and experience in graduate clinical research training. o Procedures for recruitment and selection of trainees, including women and minorities; availability of high-quality candidates; and how the trainees will be mentored and their progress monitored. o Training environment: institutional commitment, the quality of the facilities, and the availability of research support; level of ongoing clinical research activity; availability of equipment, facilities, and clinical resources. o The quality of instruction in the responsible conduct of research and scientific integrity. Secondary review will be by the National Advisory Dental Research Council. Among the information the Council considers will be the report of the special review committee on the plans for recruiting women and individuals from underrepresented minority groups. The NIDR will notify the applicant of the Council's action shortly after its meeting. Schedule Letter of Intent Receipt Date: December 15, 1996 Application Receipt Date: January 14, 1997 Initial Review Group Meeting: February or June 1997 Council Meeting: June or September 1997 Earliest Date of Award: September 15, 1997 AWARD CRITERIA Funding decisions will be based on the recommendations of the special review committee and the National Advisory Dental Research Council. The earliest award date is September 15, 1996. The NIDR appreciates the value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-18J, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2618 or 594-7710 FAX: (301) 480-8318 Email: LIPTONJ@DE45.NIDR.NIH.GOV Direct inquiries pertaining to grants management issues to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-44A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service (PHS) Act as amended (42 USC 288), Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Nov 11 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-006 - V25(37) 11/01/96 Date: 11 Nov 1996 16:25:07 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 443 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <568g53$nur@net.bio.net> NNTP-Posting-Host: net.bio.net SMALL GRANTS FOR THERAPEUTIC CLINICAL TRIALS OF MALIGNANCIES NIH GUIDE, Volume 25, Number 37, November 1, 1996 PA NUMBER: PAR-97-006 P.T. 34; K.W. 0715035, 0755015 National Cancer Institute Application Receipt Dates: May 15, September 15, January 15 PURPOSE The Division of Cancer Treatment Diagnosis and Centers(DCTDC), National Cancer Institute (NCI) announces a small grants program to encourage the submission of small grant applications for new therapeutic clinical trials of malignancies that take advantage of recent laboratory developments. New and experienced investigators in relevant fields and disciplines (clinical, surgical, and radiation oncology) may apply for small grants to test new treatment strategies in patients or do pilot clinical studies. This PA supersedes PAR-95-023, Small Grants for Therapeutic Clinical Trials of Malignancies, which was published in the NIH Guide for Grants and Contracts, Vol. 24, No. 3, January 27, 1995. 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, Small Grants for Therapeutic Clinical Trials, 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 202/512-1800). 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 or local governments, and eligible agencies of the Federal government. Applications may be from a single institution or several institutions (collaborating institutions, consortia, clinical trials cooperative groups), if appropriate. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of the program will be through the National Institutes of Health (NIH) small grants (R03) mechanism. The small grants research program provides limited funds (maximum of $50,000 direct costs per year) for short-term (not to exceed two years) research projects. These grants are non-renewable and continuation of projects developed under this program will be through the regular grant program. Applicants will be responsible for the planning, direction, and execution of the proposed project. Applications submitted in response to this program announcement will compete for funds with all other R03 grant applications assigned to the NCI. The award of grants in response to this program announcement is also contingent upon the availability of funds. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (rev. 4/94). RESEARCH OBJECTIVES Background The NCI supports an extensive network of clinical and laboratory research studies related to cancer therapy through contracts, grants, and cooperative agreements. At present, there is no mechanism targeted to stimulate the communication of promising and potentially relevant new developments between the laboratory and the clinical setting. There is a need for a mechanism to fund short-term clinical studies and obtain preliminary clinical data rapidly. It is expected that these R03 grants will serve as a basis for planning future clinical research grant applications (R01) or NCI cooperative clinical trial group studies. The small grants (R03) mechanism provides research support specifically limited in time and amount for studies in categorical program areas (see Research Goals and Scope). Small grants provide flexibility for initiating preliminary, short-term studies and are non-renewable. Furthermore, the time interval from application to funding is shortened under the R03 mechanism, thus allowing new ideas to be investigated or pursued in a more expeditious manner. The Cancer Therapy Evaluation Program, DCTDC, NCI has targeted the use of the small grants mechanism to support single or several institutions to perform therapeutic clinical trials to test new ideas. Support is needed to encourage new, as well as, experienced investigators to test new treatment approaches. Research Goals and Scope The aim of this initiative is to support therapeutic clinical trials of malignancies to move new treatment strategies more rapidly from the laboratory into the clinic. Clinical studies must involve human subjects and be therapeutic in design. The clinical studies must be based on a strong rationale and preclinical data should support the underlying hypotheses. The research plan should be focused on the clinical trial proposed. New clinical therapeutic trials employing drugs, biologics, radiation, or surgery whether used as a single agent/modality or in combination are appropriate. Investigators should be able to identify sufficient numbers of patients to complete the trial in a timely manner. Laboratory studies may also be proposed to conduct pharmacokinetic, pharmacodynamic, immunologic, and other important correlative studies in the cancer patients receiving therapy. 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. 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 agreement from either the GCRC program director or Principal Investigator must be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 4928 of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Applications must be received by the following receipt dates: May 15, September 15, and January 15. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: asknih@odrockm1.od.nih.gov. The title and number of this Program Announcement must be typed in Section 2 on the face page of the application. Submit a signed, typewritten original of the application, and three signed, exact photocopies, in one package: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) 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 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express mail) Special Instructions for the Completion of the PHS 398 Application "Just-in-time" (JIT) is an initiative of the National Institutes of Health (NIH) Extramural Reinvention Laboratory under the auspices of the National Performance Review and government-wide efforts to create a government that works better and costs less. JIT postpones the collection of certain information that currently must be included in all competing applications when submitted. The information for the applications with a likelihood of funding is submitted "just-in time" for awards to be made. This program announcement is incorporating JIT procedures as described below. In responding to the program announcement, the instructions given below should replace the normal instructions for specific sections of the PHS 398 application form (rev. 5/95). Some sections are modified and others in the application do not need to be completed for the submission of the application but WILL be requested if your application receives a priority score in the fundable range. For all other items in the application, follow the usual instructions in the PHS 398 booklet. FACE PAGE (Form AA) - The title and number of the PA must be typed in line 2. Failure to do so could result in delayed processing of your application such that it may not reach the review committee in time for review. The Social Security Number (SSN) of the Principal Investigator should not be included on the Face Page. It should be provided along with the applicant's name at the top of the Personal Data form page only (Form KK). FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD Do not complete form page 4 of the PHS 398 (rev. 5/95). It is not required nor will it be accepted at the time of application. Form EE - Page 5 - BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do not complete the categorical budget table on form page 5 in the PHS 398 (rev. 5/95). Only the requested total direct costs for each year and total direct costs for the entire proposed period of support should be shown. Begin the budget justification in the space provided, using continuation pages as needed. Budget Justification o List the name, role on project and percent effort for all project personnel(salaried or unsalaried) and provide a narrative justification for each person based on his/her role on the project and proposed level of effort. o Identify all consultants by name and organizational affiliation and describe the services to be performed. o Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project that would be considered unusual for the scope of research. No specific costs for items or categories should be shown. o Indirect costs will be calculated at the time of the award using the institution's actual indirect cost rate. Applicants will be asked to identify the indirect cost exclusions prior to award. o If consortium/contractual costs are requested, provide the percentage of the subcontract total costs (direct and indirect) relative to the total direct costs of the overall project. The subcontract budget justification should be prepared following the instructions provided above. Form FF - Page 6- BIOGRAPHICAL SKETCH A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. o Complete the education block at the top of the form page; o List current position(s) and those previous positions directly relevant to the application; o List selected peer-reviewed publications directly relevant to the proposed project, with full citation; o Provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. Title, principal investigator, funding source, and role on project must be provided. Form GG - Page 7 - OTHER SUPPORT - Do not complete. Updated information will be requested by NCI staff from only those applicants being considered for funding. Form HH - Page 8 - RESOURCES AND ENVIRONMENT - Complete item(s) only if proposed research requires specialized resources unique for the proposed research. SPECIFIC INSTRUCTIONS - RESEARCH PLAN (Booklet Pages 15-19) - Applications in response to this PA should be concise and substantially shorter than regular grant applications. Items 1-4 may not exceed 16 pages in total. Item 1 - Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. Item 2 - Background and Significance - In three pages or less, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the PA; and, (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish your specific aims. Items 3-4 - Progress Report/Preliminary Studies, Research Design and Methods - In twelve pages or less, complete as instructed on pages 16-17 of the PHS 398 booklet. The investigator may use this section to address the following: o preliminary studies pertinent to the application; o rationale and hypothesis for the clinical trial and laboratory studies. o general methods that will be utilized; provide specific details for those techniques which are unique or where a significant departure >From a generally accepted technique is important for reviewers to know; o outcome measures that will be used to assess the success or failure of each set of experiments (include statistical analyses for laboratory and clinical studies); o plans for the rigorous data management and verification of research data; o potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. Items 5-6 - Human Subjects, Vertebrate Animals - Complete as described on pages 17-18. State clearly the plans for early detection of and protection against adverse effects on human subjects. Describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection of such subjects. Use a format like the Annual Report Format for Gender and Minority Inclusion on pg. 31. Item 7 - Consultants/Collaborators - Biographical sketches should conform to the brief format described previously for Form FF. Item 8 - Consortium, Contractual Arrangements - In one page or less, provide a brief explanation of the programmatic, fiscal, and administrative arrangements made with collaborating organizations. Item 9 - Literature Cited - In two pages or less, give full literature citations including the title of the article. SPECIFIC INSTRUCTIONS - APPENDIX (Page 19) - Up to five publications, manuscripts submitted or accepted for publication, patents, invention reports should be provided. Clinical protocol(s) must be included in this section. SPECIFIC INSTRUCTIONS - CHECKLIST (Form II) - Do not complete. Information will be requested by NCI staff from only those applicants being considered for funding. If you or your business office have any questions regarding these instructions, please contact program staff listed under INQUIRIES. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate review group at the Division of Extramural Activities, National Cancer Institute, in accordance with standard peer review procedures. Foreign grant applications will also be reviewed by the National Cancer Advisory Board. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. Review Criteria o Importance, timeliness, and clinical merit of the clinical trials o Scientific and technical merit and relevance of proposed patient monitoring or laboratory studies 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 the resources necessary to perform the research o Quality of data verification and management plans and statistical analysis The initial research group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NCI. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. 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: Ms. Diane Bronzert or Dr. Roy Wu Division of Cancer Treatment National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: BRONZERD@DCT.NCI.NIH.GOV WUR@DCT.NCI.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Victoria Price Grants Administration Branch National Cancer Institute Executive Plaza South, Room 252 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 56 FAX: (301) 496-8601 Email: PRICEV@GAB.NCI.NIH.GOV 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, Part A (Public Law 78-410, as amended, Public Law 99-158, 42 USC 241 and 285) 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Nov 11 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 38, pt. 1of1, 8 November 1996 Date: 11 Nov 1996 16:26:31 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 500 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <568g7n$o40@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 38 - November 8, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** CHANGES IN NINDS NRSA AND CAREER DEVELOPMENT PROGRAMS National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/27/97 ************************************************* TECHNOLOGIES FOR GENOME ANALYSIS (RFA HG-97-001) National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH $$INDEX R2 06/13/97 ************************************************* NEUROBIOLOGICAL SUBSTRATES OF COGNITIVE FUNCTIONING IN DRUG ADDICTION (RFA DA-98-001) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P1 ********************************************************** JOINTLY SPONSORED NIH PREDOCTORAL TRAINING PROGRAM IN THE NEUROSCIENCES (PAR-97-007) National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of General Medical Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research INDEX: AGING; CHILD HEALTH, HUMAN DEVELOPMENT, DEAFNESS, OTHER COMMUNICATION DISORDERS DENTAL RESEARCH; GENERAL MEDICAL SCIENCES; MENTAL HEALTH; NEUROLOGICAL DISORDERS, STROKE; NURSING RESEARCH THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** CHANGES IN NINDS NRSA AND CAREER DEVELOPMENT PROGRAMS NIH GUIDE, Volume 25, Number 38, November 8, 1996 P.T. 22, 44, 34; K.W. 1002030, 1014006 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS) announces several important changes in its training and career development programs. These changes result from discussions with the National Advisory Neurological Disorders and Stroke Council and from the recommendations of a NINDS Workshop on Training and Development. The changes affect both the National Research Service Award (NRSA) Program (fellowships and institutional training grants) and Career Development Award Programs (K-series awards). These changes are effective with the February 1, 1997 receipt date for Career Development Awards and the May 10, 1997 receipt date for NRSA Training Grants. NATIONAL RESEARCH SERVICE AWARD (NRSA) A. INSTITUTIONAL TRAINING GRANTS (T32) - Under a new program of Institutional National Research Service Awards, NINDS will accept applications for the following types of training grants: Predoctoral training grants associated with Ph.D. programs offering broadly-based predoctoral training in the neurosciences. These training grants will be offered as part of a new Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences that is jointly sponsored by NIA, NICHD, NIDCD, NIDR, NIGMS, NIMH, NINDS, and NINR. Highly-focused postdoctoral training grants offering training in a particular specialized area of neuroscience research. A portion of these grants will be reserved for programs that focus on clinical research or research on specific neurological disorders or problems. It is expected that most of the slots on these clinically focused grants will be awarded to trainees with M.D. degrees. Broadly-based postdoctoral training programs that include postdoctoral training for both Ph.D. and M.D. degree holders. These grants are meant to encourage the integration of basic scientists and clinical researchers into a single neuroscience training community. B. INDIVIDUAL POSTDOCTORAL FELLOWSHIPS (F32) - National Research Service Awards for individual postdoctoral fellowships will remain unchanged. NINDS expects to make a modest increase in the number of these awards. CAREER DEVELOPMENT AWARDS A. DEVELOPMENT AWARDS FOR CLINICAL SCIENTISTS - The NINDS will offer two career development awards, the Mentored Clinical Scientist Development Award (MCSDA - K08) and the Independent Scientist Award (ISA - K02). The new MCSDA program will provide three years of support for research training. To be eligible, application must be made within three years of completing clinical training, which is defined as residency training and, if applicable, an additional year of clinical fellowship. M.D., M.D./Ph.D. and other health profession degree holders (e.g., D.D.S., D.O., D.V.M. and Dr. P.H.) are eligible. The new ISA program is a five year award directed to those holding M.D., M.D./Ph.D. and other health professional degrees (e.g., D.D.S., D.O., D.V.M. and Dr. P.H.) who are beginning their careers as independent researchers. To be eligible, application must be made within six years of completing clinical training, which is defined as residency training and, if applicable, an additional year of clinical fellowship. Both the MCSDA and the ISA will provide support for salary and related fringe benefits as well as an annual research allowance. B. The NINDS will continue its Mentored Research Scientist Development Award (MRSDA - K01) programs in their present form as follows: Ernest Everett Just Faculty Research Career Development Award, which is designed to foster the development of neuroscience research faculty at historically black colleges and universities. Re-Entry into the Neurological Sciences Award (RENS) program, which supports individuals who have experienced a three to eight year interruption in their neuroscience research careers for family or other reasons and seek to accomplish a re-entry into such research careers. INQUIRIES Inquiries regarding this notice may be directed to: Joseph S. Drage, M.D. Division of Extramural Activities National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 1016 Bethesda, MD 20892-9190 Telephone: (301) 496-4188 FAX: (301) 402-4370 Email: jd66x@nih.gov $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN HG-97-001 FULL-TEXT ************************************** TECHNOLOGIES FOR GENOME ANALYSIS NIH GUIDE, Volume 25, Number 38, November 8, 1996 RFA AVAILABLE: HG-97-001 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research Letter of Intent Receipt Date: February 27 1997 Application Receipt Date: March 27, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate the development of genomic-scale technologies for the study of genome function and sequence variation. Within the next decade, it is anticipated that the complete DNA sequences of the human and numerous model organisms will be determined and available for comprehensive analysis. The next challenge lies in systematically decoding the genomic information, e.g., finding all the genes and understanding how their gene products function; defining common alleles and haplotypes, and associating them with phenotypes; and analyzing the conservation of genes and other features among species. Such analyses will facilitate the understanding of biological processes important in human health and disease, and the development of improved diagnoses, preventative strategies and therapies. The tools needed to analyze genomic DNA efficiently are just beginning to emerge and many more robust technologies are needed. The Human Genome Project has been successful in generating information and resources rapidly and economically, in part, by developing and applying high-throughput and efficient technologies. Therefore, the NCHGR seeks the development of technologies that can be applied in similar ways to the rapid and efficient analysis of genome function and sequence variation. 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, Technologies for Genome Analysis, is related to several priority areas, including cancer, heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. 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 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Elise Feingold, Ph.D. Division of Extramural Research National Center for Human Genome Research 38 Library Drive, Room 614 - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: Elise_Feingold@nih.gov $$R1 END ************************************************************ $$R2 BEGIN DA-98-001 FULL-TEXT ************************************** NEUROBIOLOGICAL SUBSTRATES OF COGNITIVE FUNCTIONING IN DRUG ADDICTION NIH GUIDE, Volume 25, Number 38, November 8, 1996 RFA AVAILABLE: DA-98-001 P.T. 34; K.W. 0404001, 0404009 National Institute on Drug Abuse Letter of Intent Receipt Date: May 13, 1997 Application Receipt Date: June 13, 1997 PURPOSE The National Institute on Drug Abuse (NIDA) invites applications for research projects on the neural substrates of the addictive process relating to cognitive brain functions. Powerful new approaches are now available for exploring brain mechanisms underlying cognitive functions as well as the addictive process and/or its consequence. The purpose of this initiative is to encourage the use of these approaches to broaden our understanding of the relation of drug abuse and addiction with brain mechanisms underlying cognition. The results obtained from these studies should ultimately guide the development of improved drug abuse prevention and treatment strategies by identifying the brain circuits and neurobiological mechanisms specifically affected in addiction disorders. This Request for Applications (RFA) will support individual research project grants and mentored career development awards. Research proposals for projects exploring the physiological, chemical, and structural modifications in the brain associated with cognitive functioning in drug addiction will be considered. It is anticipated that approximately $1.5 million will be available to support approximately six to eight grants submitted under this RFA. 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, Neurobiological Substrates of Cognitive Functions in Drug Abuse Disorders, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Chiiko Asanuma, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-46 Rockville, MD 20857 Telephone: (301) 443-4877 FAX: (301) 443-2317 Email: cs2j@nih.gov $$R2 END ************************************************************ $$P1 BEGIN PAR-97-007 FULL-TEXT ************************************* JOINTLY SPONSORED NIH PREDOCTORAL TRAINING PROGRAM IN THE NEUROSCIENCES NIH GUIDE, Volume 25, Number 38, November 8, 1996 PA AVAILABLE: PAR-97-007 P.T. 44; K.W. 0720005, 1002030, 1014006 National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of General Medical Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research Letter of Intent Receipt Date: March 1 Application Receipt Date: May 10 PURPOSE The National Institute on Aging (NIA), National Institute of Child Health and Human Development (NICHD, National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental Research (NIDR), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute of Nursing Research (NINR) are jointly sponsoring a new neuroscience predoctoral research training program. The aim of the program is to encourage and support broad training in the neurosciences by offering institutions a single comprehensive training grant. Support through the program is focused on the early years of training before full-time thesis research is started. Trainees are expected to be participants in a formal predoctoral curriculum offering broad and fundamental training in the neurosciences. For institutions that presently have multiple training grants with predoctoral trainees in the neurosciences, predoctoral training positions can now be consolidated into a single training grant jointly sponsored by the participating NIH Institutes. Applications will be also accepted from institutions without current training grant support. Existing training grants that have postdoctoral positions may continue, less any predoctoral positions moved to the consolidated application. Depending on the policies of the awarding NIH Institute, other training grants at the applicant institution may continue to support predoctoral trainees involved in thesis research (contact specific NIH Institute staff listed under INQUIRIES). The training grant will support stipend and other training costs according to the current NRSA guidelines ("NIH National Research Service Award Institutional Research Training Grants (T32)," NIH Guide NOTICE - Vol 23, No. 21, June 3, 1994). Awards will be for a period of five years and are renewable. As part of the program all trainees will be encouraged to visit NIH once during their appointment for a two day special orientation and training session sponsored by the participating NIH Institutes. Travel funds to participate may be requested in the budget. At these sessions each NIH Institute will have an opportunity to describe their mission and research interests, a series of research lectures will be given by leading investigators in the NIH Institutes, and an introduction to the NIH grant system will be presented. It is expected that the new training programs will act as a source of trainees and activities that will enhance basic and disease-related neuroscience research that is relevant to the participating NIH Institutes. It is important that the administration of the applicant institution as well as all participating academic units and departments indicate their willingness to support the training goals of the program. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," A PHS-led national activity for setting priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001- 00473-1) through the superintendent of documents, government printing office, Washington DC 20402-9325 (Telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contacts listed below. Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Room 3C307, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: am39m@nih.gov Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A-03 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: ds104i@nih.gov James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-18J, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2618 FAX: (301) 480-8318 Email: liptonj@de45.nidr.nih.gov Alison Cole, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, Room 2As.49K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-1826 FAX: (301) 480-2802 Email: ac29a@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hk11b@nih.gov Robert W. Baughman, Ph.D. Division of Fundamental Neurosciences and Developmental Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 916 Bethesda, MD 20892-9170 Telephone: (301) 496-5745 FAX: (301) 402-1501 Email: rb175y@nih.gov Mary D. Leveck, Ph.D., RN Scientific Program Administrator National Institute of Nursing Research Building 45, Room 3AN-12 - MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Nov 11 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-007 - V25(38) 11/08/96 Date: 11 Nov 1996 16:28:07 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 362 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <568gan$ofj@net.bio.net> NNTP-Posting-Host: net.bio.net JOINTLY SPONSORED NIH PREDOCTORAL TRAINING PROGRAM IN THE NEUROSCIENCES NIH GUIDE, Volume 25, Number 38, November 8, 1996 PA NUMBER: PAR-97-007 P.T. 44; k.w. 0720005, 1002030, 1014006 National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental Research National Institute of General Medical Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research Letter of Intent Receipt Date: March 1 Application Receipt Date: May 10 PURPOSE The National Institute on Aging (NIA), National Institute of Child Health and Human Development (NICHD, National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental Research (NIDR), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), and National Institute of Nursing Research (NINR) are jointly sponsoring a new neuroscience predoctoral research training program. The aim of the program is to encourage and support broad training in the neurosciences by offering institutions a single comprehensive training grant. Support through the program is focused on the early years of training before full-time thesis research is started. Trainees are expected to be participants in a formal predoctoral curriculum offering broad and fundamental training in the neurosciences. For institutions that presently have multiple training grants with predoctoral trainees in the neurosciences, predoctoral training positions can now be consolidated into a single training grant jointly sponsored by the participating NIH Institutes. Applications will be also accepted from institutions without current training grant support . Existing training grants that have postdoctoral positions may continue, less any predoctoral positions moved to the consolidated application. Depending on the policies of the awarding NIH Institute, other training grants at the applicant institution may continue to support predoctoral trainees involved in thesis research (contact specific NIH Institute staff listed under INQUIRIES). The training grant will support stipend and other training costs according to the current NRSA guidelines ("NIH National Research Service Award Institutional Research Training Grants (T32)," NIH Guide NOTICE - Vol 23, No. 21, June 3, 1994). Awards will be for a period of five years and are renewable. As part of the program all trainees will be encouraged to visit NIH once during their appointment for a two day special orientation and training session sponsored by the participating NIH Institutes. Travel funds to participate may be requested in the budget. At these sessions each NIH Institute will have an opportunity to describe their mission and research interests, a series of research lectures will be given by leading investigators in the NIH Institutes, and an introduction to the NIH grant system will be presented. It is expected that the new training programs will act as a source of trainees and activities that will enhance basic and disease-related neuroscience research that is relevant to the participating NIH Institutes. It is important that the administration of the applicant institution as well as all participating academic units and departments indicate their willingness to support the training goals of the program. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," A PHS-led national activity for setting priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001- 00473-1) through the superintendent of documents, government printing office, Washington DC 20402-9325 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Only domestic, non-profit, private or public institutions engaged in health-related education or research are eligible to apply. All of the provisions, eligibility requirements, trainee eligibility and other requirements, levels of stipends, trainee tuition and fees, trainee related expenses, trainee travel to attend meetings, as well as all other rules and regulations of the NRSA programs as articulated in the "NIH National Research Service Award Institutional Research Training Grants (T32)," NIH Guide, Vol 23, No. 21, June 3, 1994, also apply to this program. MECHANISM OF SUPPORT This program will use the National Research Service Award Institutional Research Training Grants (T32) mechanism. The number of grants awarded will depend on funds available. Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences awards may be made for up to five years; the length of the grant period should be consistent with the objectives of the program. LETTER OF INTENT Prospective applicants are strongly encouraged to submit, by March 1, a letter of intent with a description of the proposed training program, including the proposed number of training positions, identification of training grants and training grant slots that will be consolidated, the name, address, and telephone number of the Program Director, the identities of other key faculty and participating departments, and the number and title of this PA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Robert W. Baughman at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The number and title of the program announcement must be typed in Section 2 on the face page of the application. Supplemental application instructions are available and may requested from the program staff listed under INQUIRIES. An original and five legible copies of the completed and signed application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications that meet all of the requirements of this PA will be evaluated by a special emphasis panel convened by the sponsoring NIH Institutes in accordance with the standard NIH peer review procedures. All applications will be evaluated according to the general review criteria outlined in the "NIH National Research Service Award Institutional Research Training Grants (T32)," NIH Guide NOTICE Vol 23, No. 21, page 2, June 3, 1994. Applicants should insure that there are ongoing research programs available to trainees in areas relevant to the missions of one or more of the sponsoring NIH Institutes. Existing training grants that have postdoctoral positions may continue, less any predoctoral positions moved to the consolidated application. Depending on the policies of the awarding NIH Institute, other training grants at the applicant institution may continue to support predoctoral trainees involved in thesis research (contact specific NIH Institute staff listed under INQUIRIES). Applicant institutions with existing training grant(s) with competitive renewal applications (Type 2) due in the spring of 1997 are encouraged to submit the Type 2 renewal application as well as the new "consolidated" application. Schedule Applications for Jointly Sponsored NIH Predoctoral Training Program in the Neurosciences will be accepted and reviewed once a year only according to the following schedule: Letter of Intent Receipt Date: March 1 Application Receipt Date: May 10 Review Meeting: October Council Meeting: January Earliest Possible Start Date: June 1 AWARD CRITERIA Applications should be focused on broadly based training in the first year or two. Such training would include taking core courses, laboratory rotations and multidisciplinary courses, but not full time thesis research. The number of positions requested must be justified in terms of the success of the existing training program and the proposed consolidation of existing training positions. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are strongly encouraged to contact program staff for technical assistance and information concerning current program priorities before applying for an award. Direct inquiries regarding programmatic issues to: Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Room 3C307, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: am39m@nih.gov Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A-03 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: krotoskd@hd01.nichd.nih.gov Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: ds104i@nih.gov James A. Lipton, D.D.S., Ph.D. Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-18J, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2618 FAX: (301) 480-8318 Email: liptonj@de45.nidr.nih.gov Alison Cole, Ph.D. Division of Pharmacology, Physiology, and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, Room 2As.49K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-1826 FAX: (301) 480-2802 Email: ac29a@nih.gov Henry Khachaturian, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-8033 FAX: (301) 443-1731 Email: hk11b@nih.gov Robert W. Baughman, Ph.D. Division of Fundamental Neurosciences and Developmental Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 916 Bethesda, MD 20892-9170 Telephone: (301) 496-5745 FAX: (301) 402-1501 Email: rb175y@nih.gov Mary D. Leveck, Ph.D., RN Scientific Program Administrator National Institute of Nursing Research Building 45, Room 3AN-12 - MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Joe Ellis Office of Extramural Affairs National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 496-3672 Email: je14j@nih.gov Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development Building 61E, Room 8A017 - MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: shawverd@hd01.nichd.nih.gov Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B - MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN-44A, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8303 Email: rubinstein@de45.nidr.nih.gov Ruth Monaghan Grants Management Office National Institute of General Medical Sciences 45 Center Drive, Room 2An.24D, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5135 FAX: (301) 480-2554 Email: rm64j@nih.gov Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Bethesda, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: diana_trunnell@nih.gov Mary Graham Grants Management Branch National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue - Room 1004 Bethesda, MD 20892-9190 Telephone (301) 496-9231 FAX: (301) 402-0219 Email: mg50p@nih.gov Jeff Carow Grants Management Office National Institute of Nursing Research Building 45, Room 3AN12 - MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-5974 FAX: (301) 480-8256 Email: jcarow@ep.ninr.nih.gov AUTHORITY AND REGULATIONS NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. This program is also described under the following numbers in the Catalog of Federal Domestic Assistance: 93.121, 93.172, 93.173, 93.272, 93.278, 93.282, 93.306, 93.361, 93.398, 93.821, 93.837-93.839, 93.846-93.849, 93.853-93.856, 93.859, 93.862-93.868, 93.871, 93.880, 93.894, and 93.929. PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Nov 11 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-98-001 - V25(38) 11/08/96 Date: 11 Nov 1996 16:27:17 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 470 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <568g95$o5n@net.bio.net> NNTP-Posting-Host: net.bio.net NEUROBIOLOGICAL SUBSTRATES OF COGNITIVE FUNCTIONING IN DRUG ADDICTION NIH GUIDE, Volume 25, Number 38, November 8, 1996 RFA: DA-98-001 P.T. 34; K.W. 0404001, 0404009 National Institute on Drug Abuse Letter of Intent Receipt Date: May 13, 1997 Application Receipt Date: June 13, 1997 PURPOSE The National Institute on Drug Abuse (NIDA) invites applications for research projects on the neural substrates of the addictive process relating to cognitive brain functions. Powerful new approaches are now available for exploring brain mechanisms underlying cognitive functions as well as the addictive process and/or its consequence. The purpose of this initiative is to encourage the use of these approaches to broaden our understanding of the relation of drug abuse and addiction with brain mechanisms underlying cognition. The results obtained from these studies should ultimately guide the development of improved drug abuse prevention and treatment strategies by identifying the brain circuits and neurobiological mechanisms specifically affected in addiction disorders. This Request for Applications (RFA) will support individual research project grants and mentored career development awards. Research proposals for projects exploring the physiological, chemical, and structural modifications in the brain associated with cognitive functioning in drug addiction will be considered. 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, Neurobiological Substrates of Cognitive Functions in Drug Abuse Disorders, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for FIRST Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01), exploratory/developmental grant (R21), small grant (R03), and FIRST Award (R29), as well as Mentored Research Scientist Development Award (K01) and Mentored Clinical Scientist Development Award (K08) mechanisms. Most investigator-initiated research is supported by the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. The anticipated award date is around April 1, 1998. The R29, K01, and K08 applications submitted in response to this RFA should use the Just-In-Time (JIT) submission procedures. These procedures were published in the NIH Guide, Volume 25, Number 10, March 29, 1996 with additional instructions published in Volume 25, Number 16, May 17, 1996. Copies of these two NIH Guide notices are available from the contact person listed under INQUIRIES and on the NIH (www.nih.gov) or NIDA (www.nida.nih.gov) Home Pages. The exploratory/developmental grants (R21), small grants (R03), FIRST Awards (R29), the mentored research scientist development awards (K01) and the mentored clinical scientist development awards (K08) have special requirements and criteria. Applicants intending to apply utilizing these mechanisms, are urged to contact the program person listed in INQUIRIES for further information. This RFA is an one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer-review procedures. FUNDS AVAILABLE It is anticipated that approximately $1.5 million will be available to support projects submitted under this RFA. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will vary also. However, it is anticipated that approximately six to eight new awards, ranging in size from $100,000 to $300,000 will be made under this RFA. RESEARCH OBJECTIVES Background Much progress has been made in our understanding of the neural substrates underlying cognitive functions. Still, little is known about the relationship between cognitive processes that are strong, mediating factors in the drug addiction process (such as craving, decision-making, euphoria, expectancy of output, impulsivity, learned associations, reward seeking, and risk assessment) and their precise neural substrates. For example, which neural circuits become modified and are important in the drug addiction process? How do the affected neural activities in these drug abuse- and addiction-associated systems influence normal neural functions in circuits that are thought to mediate higher brain functions such as arousal, attention, learning, memory, or even consciousness? Recent data have begun to indicate that several brain loci typically associated with memory are activated during craving; however, the relationship between drug-related neural events and those subserving different types of learning, memory, and/or emotion in these brain loci remains to be elucidated. Further, the relationship of these drug cue-associated alterations to signal processing in other brain loci mediating specific cognitive functions is also not well understood. Similarities and differences among brain activation patterns, neurochemical events, and structural modifications resulting from the use of different drugs or from drug use under different emotional states and/or vigilance levels need to be investigated. New methodological approaches in basic and clinical neurobiology now provide researchers the capability to investigate how drugs of abuse affect the brain and its function, and at the same time allow for the direct assessment of resultant alterations in cognitive functioning. This RFA provides the unique opportunity for a synergistic interaction between the areas of cognitive and addiction neuroscience in an effort to broaden significantly the understanding of the neurobiological basis of drug use and addiction. The principal goal of the research to be supported by this RFA is to integrate neurobiological research of addiction with advances in cognitive neuroscience. The following examples serve as a guide only and are not meant to constitute an exhaustive list of the types of research questions that are appropriate under this initiative. o Circuits within the brain subserving cognitive processes are likely to be involved in the development and progression of addictive disorders. Which specific brain loci and circuits are affected during each of the different stages of the addiction process? What are the similarities and/or differences in the brain activity patterns identified in association with drug use behavior compared to the activity patterns that are associated with normal cognitive processes? What neurochemical and/or structural substrates are associated with these changes in activity within brain areas involved in cognitive processing? o Drug abuse and addiction affect normal cognitive functions. Are the spatial and temporal distributions of normal brain activities affected by drugs of abuse? Do drugs of abuse alter neural circuits such as those involved in risk assessment, decision-making, or impulsivity? Are drug-related changes in cognitive brain activities more marked during certain phases of the drug addiction process? Do these changes depend on the continued presence of the drug? o Clinical studies have begun to identify activity changes in brain loci associated with shifts in vigilance levels. To understand more fully how drug use might impact on learning, memory, and related cognitive processes, it is important to establish the relationship of drug-induced altered states with the neural correlates of wakefulness, drowsiness, and sleep in human and in non-human, primate subjects. The influence of factors such as motivation, attention, emotional state, relaxation, imagery, etc. on the overall drug-related brain activity level changes is also of interest. Are the activation levels of various brain regions (the mesencephalic reticular formation and the intralaminar thalamus, for example) coordinated during drug use? What is the impact of factors such as emotional state on drug-related activation level changes? o Drugs such as PCP and LSD (and other hallucinogens) are known to produce flashbacks, or a recurrence of symptoms like those produced by the drug long after the drug use experience. What neural circuits are involved in this phenomenon? Marijuana can induce flashbacks in LSD users. What is the mechanism by which marijuana can induce flashbacks in LSD users? o What can drugs of abuse tell us about normal memory functioning? Can they provide clues about enhancing memory or reversing the memory loss associated with dementing disorders such as Alzheimer's disease or with AIDS? For example, novel marijuana receptor antagonists have recently been developed. What are the effects of these compounds on cognition? The opiate antagonist naloxone has also been shown to improve memory performance in several species under a variety of testing conditions. Are there other drugs that can be identified that could lead to therapeutic advances in treating memory loss? o Cholingeric and glutamatergic pathways in the cortex, limbic system, basal ganglia, and thalamus are involved in many aspects of learning, memory, arousal, attention, and sleep, yet little is known about the actions of drugs of abuse on these systems. Certain drugs of abuse such as marijuana and PCP have profound effects on memory and attention and both are thought to impact these two neurotransmitter systems, though a direct relationship has yet to be shown. o Several factors influence individual vulnerabilities to the addictive process in humans, including emotional states and genetic makeup. Are differences in function within brain circuits underlying cognitive processes related to individual vulnerabilities to the addictive process? o Prenatal and/or postnatal exposure to drugs of abuse may influence the development of cognitive brain processes. Are children/adolescents exposed to drugs of abuse different in their cognitive functioning from children/adolescents unexposed to drugs of abuse? Are there any special characteristics in the brain activation patterns associated with drug-seeking behaviors in age groups at high risk for drug taking, such as adolescents in their late teens? o Sex differences may influence susceptibility to addiction disorders. Are there differences between males and females in drug-induced activation patterns in cognitive neural circuits? o Disruption of cognitive functions is often an early symptom of HIV infection. Are the cognitive abnormalities associated with HIV infection in drug users different from the cognitive abnormalities associated with HIV infection in non-drug users? What are the physiological, chemical, and structural modifications in the brain associated with the cognitive disruptions of AIDS dementia in the context of drug use? All applications must address issues of project feasibility, implementation of the study, study design, sampling procedure, instrumentation and management, data collection, tracking of subjects, follow-up, and data analysis, as appropriate. Investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are encouraged to discuss their research plans with the program staff listed under INQUIRIES. Potential applicantss are asked to submit, by May 13, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application is to be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse Parklawn Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2620 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; and from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 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 2 of the face page of the application form and the YES box must be marked. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award application 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, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse Park law Building, Room 10-42 5600 Fishers Lane Rockville, MD 20857 Applications must be received by June 13, 1997. 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 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 Schedule Letter of Intent Receipt Date: May 13, 1997 Application Receipt Date: June 13, 1997 Peer Review Meeting: October/November 1997 Council Review Meeting: January 1998 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NIDA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may 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 that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. REVIEW CRITERIA o relevance of proposed research to the goals and objectives of this RFA; o scientific, technical, or medical significance and impact of the proposed research; o creativity, originality, and the degree of synergy of scientific issues pertaining to the areas of cognitive and addiction neuroscience in the proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to conduct the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the appropriateness of their methodological training and their demonstrated research skill; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relationship to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific and technical merit of the proposal as determined by peer review, availability of funds, program needs and balance, and adequacy of provisions for the protection of human and animal subjects. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. For inquiries on programmatic issues pertaining to human studies, contact: Chiiko Asanuma, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse Parklawn Building, Room 10A-46 Rockville, MD 20857 Telephone: (301) 443-4877 FAX: (301) 443-2317 email: cs2j@nih.gov For inquiries on programmatic issues pertaining to animal studies, contact: Thomas Aigner, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6975 FAX: (301) 594-6443 Email: ta17r@nih.gov For inquiries on fiscal matters, contact: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Nov 11 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HG-97-001 - V25(38) 11/08/96 Date: 11 Nov 1996 16:26:52 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 504 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <568g8c$o4e@net.bio.net> NNTP-Posting-Host: net.bio.net TECHNOLOGIES FOR GENOME ANALYSIS NIH GUIDE, Volume 25, Number 38, November 8, 1996 RFA: HG-97-001 P.T. 34; K.W. 1215018, 0755045 National Center for Human Genome Research Letter of Intent Receipt Date: February 27 1997 Application Receipt Date: March 27, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to stimulate the development of genomic-scale technologies for the study of genome function and sequence variation. Within the next decade, it is anticipated that the complete DNA sequences of the human and numerous model organisms will be determined and available for comprehensive analysis. The next challenge lies in systematically decoding the genomic information, e.g., finding all the genes and understanding how their gene products function; defining common alleles and haplotypes, and associating them with phenotypes; and analyzing the conservation of genes and other features among species. Such analyses will facilitate the understanding of biological processes important in human health and disease, and the development of improved diagnoses, preventative strategies and therapies. The tools needed to analyze genomic DNA efficiently are just beginning to emerge and many more robust technologies are needed. The Human Genome Project has been successful in generating information and resources rapidly and economically, in part, by developing and applying high-throughput and efficient technologies. Therefore, the National Center for Human Genome Research (NCHGR) seeks the development of technologies that can be applied in similar ways to the rapid and efficient analysis of genome function and sequence variation. 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, Technologies for Genome Analysis, is related to the priority areas of cancer, heart disease and stroke, diabetes and chronic disability conditions, and maternal and infant health. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, companies, units of State and local governments, and eligible agencies of the Federal government. Applications from social/ethnic minority individuals, women, and persons with disabilities are encouraged. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01), program project grant (P01) and exploratory/developmental grant (R21) mechanisms. The total project period for an application submitted in response to this RFA may not exceed three years and the direct cost per year for research project (R01) or program project (P01) grants may not exceed $500,000. Exploratory/developmental (R21) grants will be limited to $100,000 direct costs per year for a maximum of two years. The R21 mechanism is used to support highly creative approaches for which substantial preliminary data are not yet available. Specific information about the R21 grant mechanism can be found in the NCHGR Program Announcement PAR-94-046, "Pilot Projects or Feasibility Studies for Genomic Analysis." The R21 grants are not renewable, but future project continuation is possible through other grant mechanisms such as the R01 or P01. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 1997. FUNDS AVAILABLE It is anticipated that approximately $5 million (total costs) will be available for this initiative in fiscal year 1997. Awards pursuant to this RFA are contingent upon the availability of funds for this purpose. The amount of funding for these projects may be increased if a large number of highly meritorious applications are received and if funds are available. Only applications found to be of high scientific merit will be considered for funding and all of the funds will not be spent if there are not enough highly meritorious applications. Funding in future years will be subject to the availability of funds. Because the scope of the research proposed in response to this RFA encompasses the interest of several NIH Institutes and Centers, applications may receive dual assignments based on the established PHS referral guidelines. RESEARCH OBJECTIVES Background The entire DNA sequence of the genomes of several microorganisms, including prokaryotes (H. influenzae and M. genitalium), an archeon (M. jannaschii), and a eukaryote (S. cerevisiae) have recently been determined. Rapid progress has also been made in mapping and sequencing more complex genomes, leading to the expectation that, within the next two to nine years, the DNA sequence of the genomes of C. elegans, D. melanogaster, the human, and perhaps others will be finished. The availability of this information will usher in a new era in biomedical research. A complete genomic DNA sequence comprises the bounded set of genetic instructions of an organism. Once it has been determined, investigators will have access to every genetic element of that organism. This capability opens unparalleled opportunities to study both genomic function and sequence variation. Understanding both function and sequence variation is essential for a comprehensive understanding of the biology of an organism. The amount of information represented by genomic sequence and the underlying clone and map data is enormous, and investigators will need a wide variety of very robust techniques to make maximal use of these new resources. At present, however, the technology for making use of and interpreting the complete genetic "blueprints" is rather limited. Novel and improved technologies, developed to be cost-efficient and applicable at a large scale, have, in large measure, been responsible for the success of the Human Genome Project in producing detailed genomic maps and large amounts of DNA sequence. Analogous "genomic-scale" technologies will be required for the interpretation of the genomic sequence. Although several of these are beginning to emerge, they require further development; beyond them, many more novel approaches are needed. Objectives and Scope The purpose of this RFA is to stimulate the development of novel "genomic-scale" technologies for the study of genomic function and sequence variation. Through this solicitation, NCHGR intends to stimulate the development and implementation of innovative technologies that will facilitate, among other things, the elucidation of the biological roles of gene products and non-coding functional elements; the interactions among functional elements in the cell; the biological consequences of genome organization; the dynamics of polymorphisms in populations; and the functional significance of genomic variation. This RFA is intended to support the development of technologies that will take advantage of the genomic maps and DNA sequences for use in systematic and comprehensive approaches to the study of genomic function and sequence variation. The technologies needed for these analyses are those that are scaleable, rapid, efficient and take advantage of economies of scale. It is envisioned that when such technologies are applied to large-scale analyses, a genome will become annotated with biologic information that will, in turn, serve as a platform for more in-depth, detailed studies. The "process" of technology development can be considered to span a spectrum of stages. Initially, it involves the development of an entirely new methodology (or the significant improvement of an existing methodology) to the point of proof of principle. The method must then be reduced to practice. For such a new method to have a significant impact for genomic studies, it must also be shown that it can be used efficiently on a large-scale, or genomic basis, which requires another level of technology development. This RFA is intended to solicit applications that address any of these phases of technology development. The NCHGR will give priority to the development of technologies that will be used to study the human genome and/or the genomes of S. cerevisiae, C. elegans, D. melanogaster and M. musculus. Technology development projects that utilize other eukaryotic organisms will be considered, but direct applicability of these technologies to the analysis of the human genome must be evident. An important feature of any newly-developed technology will be the ease with which it can be exported into other laboratories, or in other ways made readily accessible to investigators. The development of computational methods for the study of genomic function and variation is encouraged under this solicitation. Local databases necessary to conduct research funded under this RFA will be supported. The development of public, national databases, however, will not be supported under this RFA. In addition, applications proposing to analyze a particular gene, gene product or non-coding functional element will not be considered under this RFA. This RFA seeks applications to develop efficient technologies (both experimental and computational) for, but not limited to, the following areas: o development of single nucleotide polymorphisms in human DNA for genome-wide mapping; o identification and analysis of sequence variations within and among species to study normal and disease states in humans, and evolution; o identification of all functional elements (both coding and non-coding) in the genome; o analysis of the biological role that non-coding functional elements play in the cell; o analysis of expression of gene products (RNA and/or proteins), e.g., measurement of steady-state levels of gene products in a given cell type, temporal or induced changes in patterns of gene product levels, or comparative levels of gene product in different cell types; o analysis of the biological role that gene products (RNA and/or proteins) play in the cell, e.g., analysis of cellular localization of proteins, protein-protein or protein-nucleic acid interactions or comparative analysis of protein sequences and/or structures; and o analysis of genome organization and its effect on cellular functions. These examples are illustrative and should not be viewed as limiting in any way. Novel and innovative technologies to all areas of genome analysis are sought. Applicants should address the following issues: o advantages of the proposed approach over existing approaches; o value of the technology in furthering the understanding of eukaryotic biology; and o plans for making data and resources broadly accessible. The sharing of materials and data in a timely manner has been an essential element in the rapid progress made in genome research. Public Health Service (PHS) policy requires that investigators make the results and accomplishments of funded activities publicly available. The advisors to the NIH and the DOE genome programs have developed a set of guidelines for making data and material resources available to the scientific community in a timely manner. The guidelines call for material and information from genome research to be made available within six months of the time the data or materials are generated; more rapid sharing is encouraged and has become the norm in the genome community. Applications submitted in response to this RFA should include detailed plans for sharing data and materials generated through the grant. Where appropriate, grantees may work with the private sector in making unique resources available to the larger biomedical research community at a reasonable cost. The plans proposed for sharing and data release will be reviewed for adequacy by NIH staff prior to award of the grant and the proposed sharing plan will be made a condition of the award. Applicants may request funds to defray the costs of sharing materials or submitting data. Such requests must be adequately justified. Recently, it has become evident that special human subjects issues are raised by the large-scale sequencing of human genomic DNA because large amounts of DNA sequence information from single individuals may be generated. The NCHGR and the DOE have recently issued a document, "Guidance on Human Subjects Issues in Large-Scale DNA Sequencing" to address these issues. This document can be found on the NCHGR Home Page (http://www.nchgr.nih.gov/Grant_info/Funding/Statements/large_scale.h tml). As a result of the research supported under this RFA, it is possible that an analogous situation might exist, i.e., that a large amount of information about a single individual's genome might be generated and be made publicly available. Applicants should address these special human subjects issues, if applicable. LETTER OF INTENT Because of the specialized interest of this RFA, prospective applicants are strongly encouraged to discuss their research objectives and the appropriate grant mechanism with NIH staff. Prospective applicants are asked to submit, by February 27, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, and the identities of other key personnel and participating institutions. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NCHGR 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: Elise Feingold, Ph.D. Division of Extramural Research National Center for Human Genome Research Building 38A, Room 614, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: Elise_Feingold@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program director listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application, including appendices, must also be sent to: Dr. Ken Nakamura Office of Scientific Review National Center for Human Genome Research Building 38A, Room 613, MSC 6050 38 Library Drive Bethesda, MD 20892-6050 Applications must be received by March 27, 1997. 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 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. The applicants should also ensure that their revised applications respond to the review criteria by which the applications in response to this RFA will be evaluated. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness to the RFA by NIH program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIH 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. Those applications that are complete and responsive will be evaluated for scientific/technical merit in accordance with the criteria stated below by an appropriate peer review group convened by the NCHGR. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. All applications will receive a second level of review by the National Advisory Council for Human Genome Research. Review criteria will include: o scientific and technical merit of the proposed research; o extent to which the experimental approach makes use of and/or adds value to the complete genomic sequence; o value of the forthcoming data and/or technology in furthering the understanding of eukaryotic biology; o value and exportability of the forthcoming methodologies and resources (for software tools, portability at the source code level); o likelihood that the technology will be able to scale to a genomic level efficiently and in a timely manner; o qualifications and research experience of the principal investigator and staff in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans for dissemination of software tools developed under grant support; o adequacy of plans to place data and/or material resources in the public domain in a timely manner; and o adequacy of plans to protect human subjects, if applicable. For R21 applications, preliminary data are not required. However, the applicant does have the responsibility for developing a sound research plan and for presenting any other information that can be considered as evidence of feasibility. AWARD CRITERIA The earliest anticipated date of award is September 30, 1997. Factors that will be used to make award decisions are: o quality of the proposed project as determined by peer review; o balance among the projects in addressing different experimental approaches and their complementarity to other ongoing efforts; o adequacy of data/material release plan; and o availability of funds. Post-award Management During the course of the grant period, technologies will improve and the rate of progress and focus of work supported by the grant(s) may change. It is expected that the principal investigator(s) will make any necessary adjustments in scientific direction to accommodate the changing environment. During the course of the award period, the principal investigator(s) may be invited to meet with NIH program staff in Bethesda, MD to review scientific progress. Other scientists external to and knowledgeable about these studies may also be invited to participate. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: For biological research projects on genome function: Elise Feingold, Ph.D. Division of Extramural Research National Center for Human Genome Research 38 Library Drive, Room 614 - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: Elise_Feingold@nih.gov For biological research projects on sequence variation: Bettie J. Graham, Ph.D. Division of Extramural Research National Center for Human Genome Research 38 Library Drive, Room 614 - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: Bettie_Graham@nih.gov For all computational research projects: David Benton, Ph.D. Genome Informatics Program National Center for Human Genome Research 38 Library Drive, Room 614 - MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 496-7531 FAX: (301) 480-2770 Email: David_Benton@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Grants Management Office National Center for Human Genome Research Building 38A, Room 613, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0733 FAX: (301) 402-1951 Email: Jean_Cahill@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Nov 11 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 9 November 1996 Date: 11 Nov 1996 16:37:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 75 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <568grq$p8h@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending November 9, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Recruit Title: Librarian, GS-1410-13 File size (bytes): 9680 STIS Filename: vgs9712.txt Title: Secretary (Office Automation) File size (bytes): 9686 STIS Filename: vgs9714.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112563 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 128965 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 95-150 ELEMENTARY, SECONDARY, AND INFORMAL EDUCATION Program Announcement and Guidelines File size (bytes): 249484 STIS Filename: nsf95150.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf95150.txt, the text of your message should be as follows: get nsf95150.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf95150.txt, you would enter: ftp> get nsf95150.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-004 - V25(39) 11/15/96 Date: 19 Nov 1996 21:14:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 354 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u42q$eod@net.bio.net> NNTP-Posting-Host: net.bio.net DIABETES ENDOCRINOLOGY RESEARCH CENTERS NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA: DK-97-004 P.T. 04; K.W. 0715075, 0785050 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 12, 1997 Application Receipt Date: March 12, 1997 PURPOSE The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) supports six Diabetes Endocrinology Research Centers (DERCs). These Centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. The NIDDK invites applications for funding of three DERC grants to be competitively awarded in Fiscal Year 1998. 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, Diabetes Endocrinology Research Centers, is related to the priority area of diabetes mellitus. 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) 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT This RFA is a one time solicitation. Support of this program will be through the National Institutes of Health (NIH) center core grant (P30) award. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for an application submitted in response to the RFA may not exceed five years. The maximum dollar request is limited to $750,000 in direct costs for the initial budget period. Budget escalations of four percent may be requested for future years up to the $750,000 limit. The earliest anticipated award date is December 1, 1997. FUNDS AVAILABLE The NIDDK anticipates awarding three DERC Grants in Fiscal Year 1998 on a competitive basis. The receipt of three competing continuation applications is anticipated, which will be in competition together with the other applications received in response to this RFA. The anticipated award will be contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $750,000 in direct costs per year. Any application exceeding the direct cost amount indicated will be returned to the applicant. The NIDDK has allocated $2,830,000 in total costs to support this RFA for Fiscal Year 1998. RESEARCH OBJECTIVES The objectives of the DERCs are to bring together investigators from relevant disciplines in a manner that will enhance and extend the effectiveness of research related to diabetes and its complications. A diabetes center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the DERC is to bring together clinical and basic science investigators in a manner which will enrich the effectiveness of diabetes research. Accordingly, the applicant must clearly state the considerations for center membership. An existing program of excellence in biomedical research in the area of diabetes and related metabolic and endocrine disorders is required. This research should be in the form of NIH-funded research projects, program projects, or other peer-reviewed research that is in existence at the time of submission of a center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants should consult with NIDDK staff concerning plans for the development of a center. The DERCs are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the center. These centers also support a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new diabetes initiatives or feasibility studies. This program is directed at new investigators or for established investigators in other research disciplines whose expertise may be applied to diabetes research. The Center grant may also include limited funds for program enrichment such as seminars, visiting scientists, consultants, workshops, etc. Although funds are not provided directly for training purposes, the core laboratories and program enrichment activities should provide training opportunities for center members. 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 reaching the goals and objectives of the DERC. If so, a letter of agreement >From either the GCRC program director or principal investigator should be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 12, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-F, MSC-6600 Bethesda MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Applicants are strongly encouraged to request a copy of "Guidelines for Diabetes Endocrinology Research Centers." These guidelines contain important suggestions and information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from the program official listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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 2 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, plus three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE, Room 6AS 37-F - MSC 6600 BETHESDA MD 20892-6600 Applications must be received by March 12, 1997. 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 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 previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the national advisory council. REVIEW CONSIDERATIONS BIOMEDICAL RESEARCH: Scientific excellence of the Center's research base that must have a broad and central focus in diabetes and may extend to related research in metabolism and endocrinology. The relevance of the separately funded research to the DERC objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. Potential of the cores for contribution to ongoing research, their appropriateness and relevance, their modes of operation and, suitability of facilities. Renewal applications must include the use, utility, quality control, cost effectiveness, and demonstrated progress of any developmental research in the shared resources. For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. In competitive renewal applications, emphasis is placed on the program as a whole, including past track record and management of the program. RESEARCH TRAINING: Although the Center does not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in diabetes and related metabolic and endocrine disorders will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities is of particular importance. ADMINISTRATION: The scientific and administrative leadership abilities of the DERC Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the DERC program. The appropriateness of the DERC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. Efficiency and effectiveness of use and/or planned use of enrichment funds. Institutional commitment to the program, including lines of accountability regarding management of the DERC grant and a commitment to establish new positions as necessary. AWARD CRITERIA The earliest anticipated date of the award is December 1, 1997. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the proposed Center as determined by peer review o Availability of funds o Program priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Sanford A. Garfield Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE, Room 5AN 24-B, MSC-6600 BETHESDA MD 20892-6600 Telephone: (301) 594-8803 FAX: (301) 480-3503 E-mail: GarfieldS@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Linda Stecklein Grants Management Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8847 E-mail: SteckleinL@ep.niddk.nih.gov Schedule Letter of Intent Receipt Date: February 12, 1997 Application Receipt Date: March 12, 1997 Initial Review Dates: June-July 1997 Second Level Review Dates: September-October 1997 Earliest Anticipated Award Date: December 1, 1997 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 39, pt. 1of1, 15 November 1996 Date: 19 Nov 1996 21:13:42 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 640 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u426$enc@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 39 - November 15, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT - CORRECTION Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 02/11/97 ************************************************ COMMUNITY-BASED PREVENTION/INTERVENTION RESEARCH IN EHS (RFA ES-96- 008) National Institute of Environmental Health Sciences INDEX: ENVIRONMENTAL HEALTH SCIENCES $$INDEX R2 03/12/97 ************************************************ DIABETES ENDOCRINOLOGY RESEARCH CENTERS (RFA DK-97-004) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R3 ********************************************************** DIABETES RESEARCH AND TRAINING CENTER (RFA DK-97-005) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P1 ********************************************************** OSTEOPOROSIS AND FRACTURES IN MEN (PA-97-009) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental Research National Institute of Environmental Health Sciences National Institute of Nursing Research INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; AGING; DIABETES, DIGESTIVE, KIDNEY DISEASES; DENTAL RESEARCH; ENVIRONMENTAL HEALTH SCIENCES; NURSING RESEARCH $$INDEX P2 ********************************************************** NIAID/ASTP MINORITY FELLOWSHIPS IN TRANSPLANTATION (PA-97-010) National Institute of Allergy and Infectious Diseases The American Society of Transplant Physicians INDEX: ALLERGY, INFECTIOUS DISEASES; THE AMERICAN SOCIETY OF TRANSPLANT PHYSICIANS $$INDEX P3 ********************************************************** PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES (PAR-97-011) National Institute on Aging INDEX: AGING THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT - CORRECTION NIH GUIDE, Volume 25, Number 39, November 15, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services A Notice beginning on page 19295 in the May 1, 1996, issue of the Federal Register, entitled "Findings of Scientific Misconduct" and published in the NIH Guide, Vol. 25, No. 15, May 10, 1996 is hereby revised to correct the authorship of a publication referenced in the original printing: P.P. Thomas did not co-author the publication entitled "Gonadotrophin-releasing hormone agonist plus estrogen-progestin 'add-back' therapy for endometriosis-related pelvic pain." Fertility and Sterility 30:236-41, 1993.) INQUIRIES For further information, contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 39, November 15, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made a final finding of scientific misconduct in the following case: Melissa A. Harrington, University of Texas Southwestern Medical Center: Based upon an investigation conducted by the University of Texas Southwestern Medical Center, information obtained by ORI during its oversight review, and Dr. Harrington's own admission, ORI found that Melissa A. Harrington, Ph.D., former postdoctoral research fellow, Department of Pharmacology at the University of Texas Southwestern Medical Center, engaged in scientific misconduct by falsifying the methodology and figures in a manuscript that was accepted for publication in the Journal of Neuroscience (~G`q and G~~ open two Bradykinin-gated potassium channels via a membrane-delimited pathway~). The research was supported by a grant from the National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). Specifically, ORI found that Dr. Harrington had (1) falsely described the addition of GDP to a G-protein subunit buffer, when she had omitted it from some of the experiments; (2) falsified three figures (a) by falsely depicting the course of an electrophysiological response as being due to a combination of two substances that had not been combined and (b) by falsely representing a single channel current record as being an example of a distinct channel type that was elicited by the substance G`q, which had not been added prior to the recording; and (3) intentionally incorporated the falsified data from the experiments in which GDP had been omitted into her statistical descriptions. The Journal of Neuroscience manuscript was withdrawn and was never published. Dr. Harrington has accepted the ORI finding and has entered into a Voluntary Exclusion Agreement with ORI in which she has voluntarily agreed, for the three (3) year period beginning October 23, 1996: (1) to voluntarily exclude herself from serving in any advisory capacity to the Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; and (2) that any institution that submits an application for PHS support for a research project on which the respondent's participation is proposed or which uses the respondent in any capacity on PHS supported research must concurrently submit a plan for supervision of her duties. The supervisory plan must be designed to ensure the scientific integrity of the respondent's research contribution. The institution must submit a copy of the supervisory plan to ORI. INQUIRIES For further information, contact: Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN ES-96-008 FULL-TEXT ************************************** COMMUNITY-BASED PREVENTION/INTERVENTION RESEARCH IN EHS NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA AVAILABLE: ES-96-008 P.T. 34; K.W. 0403004, 0745027, 0725005 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: December 10, 1996 Application Receipt Date: February 11, 1997 PURPOSE NIEHS invites research grant applications addressing development of community-based strategies aimed at prevention and intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. This RFA will support research activities that develop and implement improved prevention and intervention strategies related to environmental health that are designed to include community-based, culturally appropriate approaches applicable to underserved populations. In community-based research, active cooperation and participation of organizations within the community(ies) that is (are) the focus of the study are essential components of the research. Applicants must describe an existing or proposed involvement with one or more community-based organizations in an area having an underserved population adversely impacted by an environmental contaminant. This connection is essential to the development of community-based approaches and should also enhance the potential for long-term impact of the project. This RFA will use the National Institutes of Health exploratory research project grant (R21) mechanism. Applicants who submitted an unsuccessful application in response to RFA ES-96-005 are urged to contact program staff listed under Inquiries to discuss submission of revised applications. The estimated funds (total costs) available for the first year of support for this program are expected to be $1,500,000 in fiscal year 1997. The anticipated number of awards is four. 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-Based Prevention/Intervention Research in Environmental Health Sciences (EHS)," is related to the priority area of Environmental 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov) and by mail from the program contact. Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences Division of Extramural Research and Training P.O. Box 12233, MD 3-04 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-2843 E-mail: DEARRY@NIEHS.NIH.GOV $$R1 END ************************************************************ $$R2 BEGIN DK-97-004 FULL-TEXT ************************************** DIABETES ENDOCRINOLOGY RESEARCH CENTERS NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA AVAILABLE: DK-97-004 P.T. 04; K.W. 0715075, 0785050 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 12, 1997 Application Receipt Date: March 12, 1997 PURPOSE The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) supports six Diabetes Endocrinology Research Centers (DERCs). These Centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. The NIDDK invites applications for funding of three DERC grants to be competitively awarded in Fiscal Year 1998. The grant mechanism to be used is the Core Center Grant (P30). 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, Diabetes Endocrinology Research Centers, is related to the priority area of diabetes mellitus. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (Internet) and by e-mail from the program contact listed below. Dr. Sanford A. Garfield Director, Special Programs Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN-24B 45 CENTER DR MSC-6600 BETHESDA MD 20892-6600 Telephone: (301) 594-8803 FAX: (301) 480-3503 E-mail: GarfieldS@ep.niddk.nih.gov $$R2 END ************************************************************ $$R3 BEGIN DK-97-005 FULL-TEXT ************************************** DIABETES RESEARCH AND TRAINING CENTER NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA AVAILABLE: DK-97-005 P.T. 04, 44; K.W. 0715075 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 12, 1997 Application Receipt Date: March 12, 1997 PURPOSE The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) supports six Diabetes Research and Training Centers (DRTCs). These Centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. The NIDDK invites applications for funding of five DRTC grants to be competitively awarded in Fiscal Year 1998. The grant mechanism to be used will be the Comprehensive Center Award (P60). 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, Diabetes Research and Training Centers, is related to the priority area of diabetes mellitus. 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). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (Internet) and by e-mail from the program contact listed below. Dr. Sanford A. Garfield Director, Special Programs Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Room 5AN.24B 45 CENTER DR MSC-6600 BETHESDA MD 20892-6600 Telephone: (301) 594-8803 FAX: (301) 480-3503 E-mail: GarfieldS@ep.niddk.nih.gov $$R3 end ************************************************************ $$P1 BEGIN PA-97-009 FULL-TEXT ************************************** OSTEOPOROSIS AND FRACTURES IN MEN NIH GUIDE, Volume 25, Number 39, November 15, 1996 PA AVAILABLE: PA-97-009 P.T. 34; K.W. 0715031 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental Research National Institute of Environmental Health Sciences National Institute of Nursing Research PURPOSE This initiative invites applications directed to the study of the basic biology, epidemiology, prevention and treatment of osteoporosis and osteoporosis-related fractures in 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 PA, Osteoporosis and Fractures in Men, is related to the priority areas of diabetes and chronic disabling conditions and special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Joan A. McGowan, Ph.D. Bone Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH Natcher Building, Room 5AS-43E 45 Center Drive, MSC 4500 Bethesda, Maryland 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 E-mail: joan_mcgowan@nih.gov Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1033 FAX: (301) 402-1784 Email: ShermanS@gw.nia.nih.gov Ronald N. Margolis, Ph.D. Chief, Endocrinology Section Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12J 45 CENTER DR Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov Linda A. Thomas, Ph.D. Director, Craniofacial Development and Disorders Program National Institute of Dental Research 45 Center Drive, Room 4AN24J Bethesda, MD 10892-6402 Telephone: (301) 594-2425 FAX: (301) 480-8138 E-mail: THOMASL@DE45.NIDR.NIH.GOV Annette Kirshner, Ph.D. Bone Metabolism Program National Institute of Environmental Health Sciences Box 12233, MD 3-03 Research Triangle Park, North Carolina 27709 Office (919) 541-0488 Fax (919) 541-2843 e-mail: kirshner@niehs.nih.gov Laura James, PhD, RN Division of Extramural Activities National Institute of Nursing Research Building 45, 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5959 FAX: (3010 480-8260 Email: Ljames@ep.ninr.nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-97-010 FULL-TEXT ************************************** NIAID/ASTP MINORITY FELLOWSHIPS IN TRANSPLANTATION NIH GUIDE, Volume 25, Number 39, November 15, 1996 PA AVAILABLE: PA-97-010 P.T. 22, FF; K.W. 0710125, 0745065 National Institute of Allergy and Infectious Diseases The American Society of Transplant Physicians Application Receipt Dates: April 5, August 5, and December 5, 1997 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the American Society of Transplant Physicians (ASTP) invite applications for Individual Postdoctoral Fellowships from racial/ethnic minority individuals, women, and persons with disabilities for research on the etiology, pathogenesis, diagnosis and/or treatment and prevention of transplant rejection. 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), "NIAID/ASTP MINORITY FELLOWSHIPS IN TRANSPLANTATION", is related to the priority area of Immunization and Infectious Diseases. 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 20402-0325 (telephone 202-783-3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Stephen M. Rose, Ph.D. Chief, Genetics and Transplantation Branch Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A14 Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: sr8j@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PAR-97-011 FULL-TEXT ************************************* PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES NIH GUIDE, Volume 25, Number 39, November 15, 1996 PA AVAILABLE: PAR-97-011 P.T. 34; K.W. 0710010, 0785055 National Institute on Aging PURPOSE The National Institute on Aging (NIA) will provide grant support for planning and protocol development of biomedical epidemiologic and intervention studies in research areas supported by the Geriatrics Program (see Research Objectives section of this announcement). The planning grant application and review process is intended to provide a mechanism for peer review of the rationale and basic design of an epidemiologic or intervention study which would require extensive detailed protocols and/or complex organization for proper implementation. The planning grant itself is intended to provide support for the development of a refined study design, organizational plan, detailed protocol, Manual of Procedures, and budget, for implementation of studies whose rationale and basic design are considered sufficiently meritorious. After these are completed, planning grant awardees may submit applications to conduct the full-scale study. These applications will also be peer-reviewed. 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 is related to the priority area of chronic diseases and disabling conditions of older persons. 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 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 FAX: (301) 402-1784 E-mail: EH21f@nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA ES-96-008 - V25(39) 11/15/96 Date: 19 Nov 1996 21:13:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 683 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u41p$emj@net.bio.net> NNTP-Posting-Host: net.bio.net COMMUNITY-BASED PREVENTION/INTERVENTION RESEARCH IN EHS NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA: ES-96-008 P.T. 34; K.W. 0403004, 0745027, 0725005 National Institute of Environmental Health Sciences Office of Behavioral and Social Sciences Research Letter of Intent Receipt Date: December 10, 1996 Application Receipt Date: February 11, 1997 PURPOSE The National Institute of Environmental Health Sciences (NIEHS)and the Office of Behavioral and Social Sciences Research (OBSSR) invite research grant applications addressing development of community-based strategies aimed at prevention and intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. The purpose of awards in this program of Community-Based Prevention/Intervention Research in Environmental Health Sciences is to: o Stimulate further advances in the design and implementation of prevention and intervention methods that are appropriately applied to environmental health. o Develop community-based public health research approaches to diseases and health conditions having an environmentally related etiology and determine the impact of these methods. o Bridge the gaps between basic and clinical research in environmental health science as well as gaps between institutional researchers and community members. The long-range goal of this program is to improve the knowledge and behavior of disadvantaged or underserved community members regarding prevention, detection, and treatment of environmentally related diseases and health conditions, and thereby reduce incidence and mortality rates of such diseases and conditions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, "Community-Based Prevention/Intervention Research in Environmental Health Sciences," is related to the priority area of Environmental 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). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private for-profit and nonprofit domestic organizations, such as universities, colleges, hospitals, laboratories, research institutions, units of state or local governments, tribal governments or organizations, and eligible agencies of the federal government. Collaborative applications are invited. Formation of a consortium involving responsible partnership of a research-intensive health science center and an institution serving an economically disadvantaged community is particularly encouraged. Among collaborators, one must be designated as the lead applicant and assume responsibility for conduct of the project. Because of the community-based nature of this research effort, applicants must describe an existing or proposed involvement with one or more community-based organizations in an area having an underserved population adversely impacted by an environmental contaminant (see Objectives and Scope, below). Applications lacking an existing or proposed link to such a community-based organization will be considered to be nonresponsive to this RFA. The NIEHS has a significant commitment to the support of programs designed to increase participation of individuals from economically disadvantaged communities in biomedical and behavioral research. Therefore, applications from such individuals are encouraged. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program are expected to be $1,500,000 in fiscal year 1997. The actual amount may vary, depending on the response to this announcement and the availability of funds. The anticipated number of awards is four. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress and fulfillment of the Special Requirements (see below) during the preceding year and availability of funds. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory research project grant (R21) mechanism. These grants provide support to develop new research activities in categorical program areas, e.g., prevention/intervention research. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Because the nature and scope of research activities proposed in response to this RFA may vary, it is anticipated that the size of an award will also vary. The maximum allowable award is $250,000 in direct costs per year. Indirect costs will be paid at the approved indirect cost rate for the applicant organization less appropriate exclusions. The total project period for an application may not exceed four years. This RFA is a one-time solicitation. REANNOUNCEMENT AND REVISED APPLICATIONS This RFA, ES-96-008, is a reannouncement of RFA ES-96-005. An applicant who responded to the original RFA but did not receive an award may submit a revised application based on criticisms contained in the summary statement. Applicants interested in submitting such a revised application are urged to read the appropriate instructions on page IV-5 of the PHS 398 and to contact program staff listed under INQUIRIES. RESEARCH OBJECTIVES Background The mission of the NIEHS is to define: how environmental exposures affect our health; how individuals differ in their susceptibility to these effects; and how these susceptibilities change with time. The OBSSR provides leadership and direction in increasing the scope and support of research on the role of human behavior and social processes in the promotion of health and prevention of disease. To help reduce the burden of environmentally associated diseases and health conditions, both agencies must: 1) provide the scientific basis and foundation that is necessary for understanding the impact of the environment on human health; 2) translate this information into prevention and intervention strategies; and 3) communicate this information to the public. The current initiative spans all three of these elements within the missions of the NIEHS and the OBSSR. Environmental health policy is only as good as the scientific foundation upon which it rests. Recent advances are enabling scientists to develop more detailed and meaningful insights into the effects of environmental agents on basic cellular processes. This knowledge in turn can be used to cultivate intervention schemes based on an enhanced understanding of molecular mechanisms. In 1992 the NIEHS issued an RFA to develop interventions at the molecular level for diseases with an environmental etiology. That announcement focused on generation and use of molecular biomarkers to assess the effectiveness of intervention strategies. An understanding of the environmental components and basic biology of disorders can lead to prevention and intervention strategies to circumvent adverse health effects. Such strategies can be classified as primary, secondary, or tertiary prevention. Traditionally, most approaches have focused on primary prevention techniques aimed at intervening before disease arises, such as eliminating or reducing environmental exposures. As our understanding of the molecular and cellular basis of environmentally associated diseases increases, secondary prevention and intervention techniques can be developed to diagnose and treat people exposed to an environmental contaminant. These molecular intervention techniques, such as early detection screening, rely on manipulation of underlying biological mechanisms, e.g., activation/inactivation of particular genes, enzymes, or receptors. These methods may be especially useful in dealing with environmental exposures that are ubiquitous or difficult to eliminate. Tertiary prevention measures seek to limit injury and disability in people already affected by a specific disease process. Prevention and intervention schemes must also take into account the social and cultural lifestyle and behavioral factors that contribute to environmentally associated disorders. It is part of the responsibility of the NIEHS to provide the scientific underpinning that can delineate the contribution of societal and cultural behaviors in development of these disorders. The cultural diversity inherent within various racial/ethnic groups has generally been overlooked by investigators conducting prevention research. Thus, there is a critical need to address diverse, culturally relevant contexts and disease etiologies in environmental health. The present RFA seeks to implement culturally relevant prevention/intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. Research efforts to identify the sources and effects of hazardous environmental exposures among underserved populations have been insufficient. Little is known about the types of environmental agents to which members of such groups are exposed, both at home and at work. Members of economically disadvantaged and/or underserved populations suffer disproportionate levels of morbidity and mortality. Additionally, they are most often the populations with the highest degree of exposure to environmental agents and are frequently the populations with the least information available as to the health consequences of such exposure. Factors such as malnutrition, health status, and socioeconomic status, in combination with behaviors such as smoking, alcohol consumption, and drug use may significantly influence the dose response, metabolism, and health effects of hazardous substances. Geographic location may also play a role in determining the degree and effect of environmental exposure among socioeconomically disadvantaged populations. For example, inner city residents often live in homes with high lead levels and are exposed to higher levels of air pollution. Toxic waste sites, nuclear facilities, and chemical plants are often located in rural areas. More effort must be devoted to identifying disadvantaged populations having high levels of exposure to environmental hazards and to generating prevention and intervention strategies to mitigate the health effects of these hazards. The current announcement is intended not only to foster additional refinement of intervention methods but also to strengthen the participation of affected communities in this effort. Given the complexity and magnitude of environmental health problems, research endeavors aimed at improving our knowledge of and ability to resolve these issues can benefit from establishing collaborative relationships with the communities experiencing these problems. Such community-research partnerships have benefits for both the researcher and the community. These partnerships can, for example, facilitate the definition of important environmental issues and concerns, the development of measurement instruments that are culturally appropriate, and the establishment of trust that will enrich the value of data collected. This scheme emphasizes the involvement of community members throughout the research process, from development of research questions to interpretation, application, and dissemination of results. Only through realization of this final leg of the NIEHS mission, i.e., communication and partnership formation, can we ensure that research findings reach and are made relevant to affected individuals and communities. Objectives and Scope This RFA will support research activities that develop and implement improved prevention and intervention strategies related to environmental health that are designed to include community-based, culturally appropriate approaches applicable to underserved populations. Community-based prevention/intervention research seeks to expand our knowledge and understanding of the potential causes and remedies of environmentally related disorders, while at the same time enhancing the capacity of communities to participate in the processes that shape research approaches and intervention strategies. Community- based research is thus more than just a community-placed outreach activity. These research projects are community-driven and - responsive so as to maximize the potential for change in knowledge, attitudes, and behavior. They are conducted in a manner that reinforces collaboration between community members and research institutions. Relevant results from these projects are disseminated to the community in clear, useful terms. Moreover, these studies are designed to be culturally appropriate, i.e., due consideration is given to the social, economic, and cultural conditions that influence health status. Identifying and incorporating unique cultural factors into intervention strategies may result in increased acceptability, use, and adherence. Each application should develop a comprehensive, strategic plan with time schedules and milestones to address all key aspects. This plan should include: o Identification of target community. Population(s) should be clearly identified, community boundaries described, and known environmental health hazards delineated. o Community collaboration. How will communication and regular exchange of information and ideas between community members and institutional researchers be initiated and enhanced? How are productive relationships with local representatives established and maintained? How are local organizations and leaders recruited? What are the mechanisms for communities to identify their environmental health needs? How will activities be designed to meet these needs? How will findings be disseminated within the community? o Research program definition and implementation. A variety of research designs may be proposed (see below). Primary, secondary, or tertiary prevention strategies may be included. Interventions should be based on appropriate behavioral and scientific theories. They should also be built on the results of previous methods shown to be efficacious in changing risk factors related to knowledge, attitudes, and behaviors. Interventions should use multiple, culturally sensitive, community-based approaches and be adapted to the special needs of underserved populations. o Evaluation. Both outcome and process evaluations should take place. Only projects having well developed, comprehensive evaluation plans will be supported. The application must include detailed descriptions of process and outcome evaluation, specify the measures and instruments for data collection, and indicate a time frame for conducting all evaluation activities. Research designs should focus on an integrated approach employing various culturally appropriate factors that have been previously shown to be effective. It is important that the study population be clearly identified and that community involvement in developing the design be demonstrated. An experimental design with a defined hypothesis is the preferred approach. A randomized design, comparing specially constructed interventions in an experimental cohort against usual and customary conditions in a control cohort, would be an appropriate study design to test intervention models. Other designs may also be considered responsive. Elements that should be considered in assembling such a research design include: o Conceptual framework. o Sampling procedures. o Instrumentation and measurement. o Data collection. o Quality control and process evaluation. o Recruitment, retention, tracking, and follow-up. o Data analysis, statistical methods, and power considerations. State-of-the-art econometric techniques for measuring cost-effectiveness of prevention efforts may also be included. Applicants are encouraged to test and compare multiple innovative strategies and to assess their relative effectiveness. In community-based research, active cooperation and participation of organizations within the community(ies) that is (are) the focus of the study are essential components of the research. Hence, applicants must describe an existing or proposed involvement with one or more community-based organizations in an area having an underserved population adversely impacted by an environmental contaminant. This connection is essential to the development of community-based approaches and should also enhance the potential for long-term impact of the project. Strengths of this approach are its incorporation of local knowledge and beliefs and the possibility of positioning local people as owners and implementors of the intervention. The result should be an intervention tailored to the specific concerns, needs, and interests of the local community. Community input is most meaningful and best utilized if it is built into the research process from the outset. Community representatives should be given a voice in choosing research topics, developing the application, collecting data, and interpreting results. For this reason, applications lacking an existing or proposed link to a community-based organization will be considered to be nonresponsive to this RFA. SPECIAL REQUIREMENTS Annual meetings, to be held in Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs associated with these meetings in their applications. Since projects may include behavioral based prevention/intervention strategies as part of their methodology, the Office of Behavioral and Social Sciences Research will contribute to this initiative by co-sponsoring these conferences. In addition, since these projects are community-based, applicants are expected to maximize opportunities for information exchange between institutional researchers and community members. As part of this program, applicants must generate a report that describes community input, program implementation, and relevant findings. This report must be produced at least annually and distributed among community members in such a way that it can be easily comprehended by the public. Applicants must budget for production and dissemination of such reports. This requirement is intended to establish a minimal level of communication among project participants; additional, more frequent dissemination efforts may be appropriate. RELATIONSHIP TO ENVIRONMENTAL JUSTICE Activities conducted under this announcement should be consistent with Federal Executive Order No. 12898 entitled, ~Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations.~ To the extent practicable and permitted by law, grantees shall make achieving environmental justice part of their project~s mission by identifying and addressing, as appropriate, disproportionately high and adverse human health effects of environmental contaminants on minority and low-income populations. The current RFA builds upon the framework established by the separate NIEHS grant program entitled ~Environmental Justice: Partnerships for Communication.~ That program, initiated in 1993, supports outreach, training, and education efforts that will become the catalyst for reducing exposure to environmental pollutants in socioeconomically disadvantaged or underserved populations. Its main objective is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with environmental health researchers and health care providers. This endeavor will help to ensure that the community is aware of basic environmental health concepts and that they have a role in defining problems and shaping approaches to their solution. The present RFA differs from the ~Environmental Justice~ grant program in that the former is a scientific research project, whereas the latter is an education project. Thus, this RFA is intended to support specific, rigorous, scientific research projects that develop and implement community-based, culturally appropriate prevention/intervention strategies in underserved communities. The ~Environmental Justice~ program supports education projects that enhance the flow of information and communication among scientists, health care providers, and community members. Although these programs are complementary, it is important to differentiate the substantial research orientation of this RFA from the educational goal of the ~Environmental Justice~ program. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 58 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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 A-D of the Research Plan and summarized in Section E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. 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, it will be returned to the applicant. 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. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are requested to submit, by December 10, 1996, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent influences neither review nor funding decisions, but it is helpful to NIEHS staff in planning the review process, e.g., in estimating workload and avoiding conflict of interest. Letters of intent should be directed to: Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-04 111 T.W. Alexander Drive Research Triangle Park, NC 27709 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained >From the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the 5/95 revision of the PHS 398 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 two 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 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Ethel Jackson, D.D.S. Chief, Scientific Review Branch Division of Extramural Research & Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 17-09 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Applications must be received by February 11, 1997. 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 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 (see REANNOUNCEMENT AND REVISED APPLICATIONS above). All human and animal welfare as well as misconduct assurances must be complete for a proposal to be reviewed. All follow-up assurances and approvals submitted as pending must be received within 30 days of the application receipt deadline or the application will not be reviewed. The following is the schedule planned for this initiative. It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of the announcement. Please contact the program official listed below regarding any changes in the schedule. RFA Announcement: November 8, 1996 Receipt of Letters of Intent: December 10, 1996 Application Receipt Deadline: February 11, 1997 Initial Scientific Review: March, 1997 Advisory Council Review: May, 1997 Funding: July, 1997 REVIEW CONSIDERATIONS Review will be carried out by the Scientific Review Branch, Division of Extramural Research and Training. Upon receipt, applications will be screened for completeness by staff of the DRG and for responsiveness to the RFA by staff of the NIEHS. Those that are incomplete or nonresponsive will be returned to the applicant without review. Complete and responsive applications will be reviewed by either the Environmental Health Sciences Review Committee or a special review committee impaneled by the Scientific Review Branch. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Environmental Health Sciences Council and/or the National Advisory Council for Nursing Research. The major review factors listed below will be used in evaluation of applications for this RFA: o Scientific, technical, or clinical significance, merit, and originality of the proposed research. o Appropriateness, adequacy, and feasibility of the proposed approach and methodology. If applicable, sample size, recruitment, and retention plans should be discussed. Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community. o Extent of community sanction/liaison. Rationale for selection of the targeted population and documentation of environmental health needs and risk factors. Evidence of access to, interaction with, and participation of community members and community leaders in development and conduct of the project. Establishment of collaborative interactions among all project participants. Demonstration of effective communication channels between researchers and community members. Plans for useful and practical dissemination of project activities and findings within the affected community(ies). Active involvement of at least one community-based organization is a minimal requirement for responsiveness to this RFA. o Qualifications and experience of the principal investigator and staff. Personnel should demonstrate knowledge of the needs of their target audience. o Strength of institutional commitment as evidenced by provision of resources, services, technical support, and allocation of space necessary to perform the research. o Appropriateness of proposed budget and duration in relation to the project's objectives. o Adequacy, appropriateness, feasibility, and comprehensiveness of the evaluation plan, including sufficient allocation of resources. o Feasibility of plans for independently continuing the program. Evidence of continuing commitment on the part of the proposing institution(s). The potential long-term impact of the proposed project is especially important. o The initial review group will also examine provisions for protection of human subjects. AWARD CRITERIA The following will be considered in making funding decisions: o Merit of the application as determined by peer review. o Availability of funds. o Program balance among research areas of the NIEHS. INQUIRIES NIEHS staff welcome the opportunity to clarify any issues or questions from potential applicants. Written or telephone inquiries concerning the objectives, scope, application procedures, and submission of revised applications for this RFA or inquiries about whether or not specific proposals would be responsive are encouraged and should be directed to the following: Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences Division of Extramural Research and Training P.O. Box 12233, MD 3-04 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-4937 or (919) 541-2843 E-mail: DEARRY@NIEHS.NIH.GOV Questions of an administrative or fiscal nature not directly related to the programmatic aspects of this RFA should be directed to the Grants Management Branch official listed below: Ms. Carolyn Winters Grants Management Specialist Grants Management Branch National Institute of Environmental Health Sciences Division of Extramural Research and Training P.O. Box 12233, MD 2-01 Research Triangle Park, NC 27709 Telephone: (919) 541-7823 FAX: (919) 541-2860 E-mail: WINTERS@NIEHS.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.113, 93.114 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100-607) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-005 - V25(39) 11/15/96 Date: 19 Nov 1996 21:14:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 497 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u43c$eov@net.bio.net> NNTP-Posting-Host: net.bio.net DIABETES RESEARCH AND TRAINING CENTER NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA: DK-97-005 P.T. 04, 44; K.W. 0715075 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 12, 1997 Application Receipt Date: March 12, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports six Diabetes Research and Training Centers (DRTCs). These Centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers provide a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. The NIDDK invites applications for funding of five DRTC grants to be competitively awarded in Fiscal Year 1998. 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), Diabetes Research and Training Centers, is related to the priority area of diabetes mellitus. 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) 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Any institution with an existing, outstanding program of biomedical research in the area of diabetes may apply for a DRTC. In addition, existing Diabetes Endocrinology Research Centers (DERCs) may submit competing applications for conversion to DRTCs. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT This RFA is a one-time solicitation. Support of this program will be through the National Institutes of Health (NIH) comprehensive center (P60) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement FUNDS AVAILABLE The NIDDK anticipates awarding five DRTC grants in Fiscal Year 1998 on a competitive basis. The receipt of five competing continuation applications, which will be in competition together with the other applications received in response to this RFA, is anticipated. The anticipated award will be contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $1,250,000 in direct costs per year. Of this request at least 30 percent must be for the Demonstration and Education (D&E)component. Requests for support for Demonstration and Education (D&E) supplements to convert an existing DERC to a DRTC must be limited to $300,000 in direct costs. If awarded, the D&E supplement funding would be added to the level of the existing DERC budget. The $1,250,000 direct cost application limit would then apply to future DRTC competing renewals. Any application exceeding the direct cost amounts indicated will be returned to the applicant without review. The NIDDK has allocated $8,779,000 in total costs to support this RFA in Fiscal Year 1998 with an anticipated award date of December 1, 1997. RESEARCH OBJECTIVES The NIDDK-supported Diabetes Centers program is comprised of DERCs (P30) and DRTCs (P60). The objective of the Diabetes Research Center is to bring together investigators from relevant disciplines in a manner which will enhance and extend the effectiveness of research and training being conducted in the field of diabetes and its complications. These Centers have provided a focus for increasing collaboration and cost effectiveness among groups of successful investigators at institutions with established comprehensive diabetes research bases. Both types of centers are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the Center. These centers also support a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for new initiatives or feasibility research studies for new investigators or for established investigators in other research disciplines when their expertise may be applied to diabetes research. These include biomedical, epidemiologic, behavioral, and health care research. The Center grant may also include limited funds for program enrichment such as seminars, visiting scientists, consultants, workshops, etc. While the above components are common to DERCs and DRTCs, DRTCs also include a substantial additional component, the Demonstration and Education Division. The D&E Division, which must be supported by at least 30% of the DRTC budget, is composed of cores and projects: (1) engaged in research in the translation of the outcomes of biomedical and behavioral science research into clinical care; and (2) development, testing, and evaluation of innovative methods and programs for translation activities. The D&E Division must include a Model Demonstration Unit (MDU), which is a required component of a DRTC. The MDU should serve as a core facility for the conduct of translation research and include as a central mission the development, testing, and demonstration of model diabetes care. Although located in the D&E Division it can span all Center activities. A DRTC must be an identifiable unit within a single university, medical center, or a consortium of cooperating institutions, including an affiliated university. The overall goal of the DRTC is to bring together, on a cooperative basis, clinical and basic science investigators and those involved in diabetes education and translation. As indicated above, the DRTCs are expected to encompass the following: (1) facilitate and strengthen basic and clinical research related to diabetes and its complications; and (2) train health professionals about diabetes and its management. In addition, the D&E Division of the DRTC: (3) must develop a model demonstration facility to contribute to the above endeavors that ideally spans all of the Center's activities, including basic and clinical research, research training, development of model diabetes care and provision of a core facility for translation research; and (4) translate advances in the field of diabetes into improved care, such as the translation of the intensive management shown to be effective by the Diabetes Control and Complications Trial (DCCT). The latter element should focus on research to identify and overcome barriers to intensive diabetes management and treatment. All of these areas need not be developed to the same degree, acknowledging the variety of strengths present at diverse institutions. A strong base of biomedical research is an essential prerequisite of a Center. Accordingly, a program of excellence in biomedical research in the area of diabetes and related metabolic and endocrine disorders in the form of NIH-funded research projects, program projects, or other peer-reviewed research must be in existence at the time of submission of a Center application. Close cooperation, communication, and collaboration among all involved personnel of the professional disciplines to enhance research progress are ultimate objectives. Applicants should request a copy of the DRTC guidelines and consult with NIDDK staff concerning plans for the development of the Center. D&E projects for existing DRTCs submitting competing renewal applications in response to this RFA must include an in-depth progress report for projects that have ended, with a brief summary progress report for projects that will be continued. Indicate that for the latter a complete report is presented under the related project description section. The D&E project descriptions should not include a project budget. Instead, each proposed D&E project should indicate the percentage use of the appropriate D&E Cores. The Budgets for conducting the proposed work should be included with the associated cores. These features are described briefly in this RFA and in detail in the DRTC Guidelines (which can be obtained from the program official listed under INQUIRIES below). Each project or core description within the D&E Division may not exceed 25 pages. A DERC is eligible to apply for conversion to the DRTC program. An existing DERC that elects to apply for such conversion in response to this RFA must follow the following procedures: (1) if the DERC will have at least one year of support remaining as of December 1, 1997 (the earliest funding date for applications submitted in response to this RFA), a competing supplement to the existing DERC may be submitted which includes only the components of a D&E Division. In addition, information (limited to five pages) should be included describing how this D&E supplement will interact with the existing DERC elements and enhance the comprehensive nature of the Center. A successful competition would result in the DERC being converted to a DRTC for the duration of that Center's current award. It would then be eligible to submit a standard five year DRTC proposal for its competing renewal. (2) If the DERC will have less than one year of support remaining after December 1, 1997, it must submit a full DRTC application. If funded the DRTC would have a five-year award period. 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 agreement from either the GCRC program director or principal investigator should be included with the application. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 12, 1997, a letter of intent that includes a descriptive title of the proposed research; the name; address; and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interests in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES Applicants are strongly encouraged to request a copy of "Guidelines for Diabetes Research and Training Centers." These guidelines contain important suggestions and information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from the program official listed under INQUIRIES. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research, or may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, email: asknih@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 9/95) 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 2 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, plus three signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Room 6AS-37F 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Applications must be received by March 12, 1997. If an application is received after that date, it will be returned to the applicant. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the national advisory council. The initial review group will review each application using the criteria stated below and detailed in the DRTC Guidelines for new and competing DRTC applications. 1. Biomedical Research There must be scientific excellence of the Center's research base as indicated by peer reviewed extramural funding and this research base must have a broad and central focus in diabetes which may extend to related research in metabolism and endocrinology. Also, the relevance of the separately funded research to the DRTC objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. The potential of the cores to contribute to ongoing research, the appropriateness and relevance of the cores, their modes of operation, and the suitability of facilities will be assessed. Renewal applications must include the use, utility, quality control, cost effectiveness, and demonstrated progress of any developmental research in the shared resources. For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. In competitive renewal applications, emphasis is placed on the program as a whole, including past track record and management of the program. The adequacy of plans to include both genders and minorities in meeting the scientific goals of the research must be shown. Plans for the recruitment and retention of subjects will also be evaluated. 2. Research Training Although the Center does not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in diabetes and related metabolic and endocrine disorders will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities, is of particular importance. 3. Demonstration and Education The applicant's existing or planned activities to overcome barriers to translating research knowledge into improved diabetes health care will be evaluated on the basis of: The novelty, feasibility, and quality of programs, materials, and publications that address overcoming barriers to translation of scientific advances into clinical practice. This should include program and/or curriculum development in the education of health care professionals (including students) both within and outside the DRTC. Completed programs and materials should be translatable to other settings. Evaluation activities assessing the success of these programs should be reported. Organization and use of the Model Demonstration Unit which is a required component of the DRTC. For existing Centers, future plans for continuing ongoing activities and initiating new activities and their evaluation. The approach, results, and general utility of any outreach projects, including transferability to other settings, demonstrated effectiveness, and plans for take over by local groups and/or funding >From other sources should be indicated. Overall coordination and cooperation within the D&E component among the cores of the DRTC and with other groups (voluntary health organizations, Federal agencies, and other diabetes-related efforts, etc.) should be indicated. Consideration should be given to the potential impact of proposed activities on the national diabetes effort. 4. Supplemental Demonstration and Education Unit Applications (only for DERCs proposing conversion to DRTCs: The supplement will be evaluated on the basis of the D&E criteria presented above. The D&E supplement should carefully present the rationale for extending the currently funded DERC to include this new element. How interfacing the additional D&E element to the existing DERC will impact on the overall activities of the Center. The overall rating of the DERC plus the D&E supplement for conversion to a DRTC will be based on the above stated D&E criteria in addition to the existing DERC framework. The latter will take into consideration the previous DERC Summary Statement. The DERC elements will not be re-reviewed. 5. Administration The scientific and administrative leadership abilities of the DRTC Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the DRTC program will be assessed. The appropriateness of the DERC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program will be evaluated. Efficiency and effectiveness of use and/or planned use of enrichment funds should be clear. There should be significant institutional commitment to the program, including lines of accountability regarding management of the DRTC grant. AWARD CRITERIA The anticipated date of the award is December 1, 1997. Applications will compete for available funds with all other applications submitted in response to this RFA and as recommended by peer review. The following will be considered in making funding decisions: o Quality of the proposed Center as determined by peer review o Availability of funds o Program priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Sanford A. Garfield Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DRIVE, Room 5AN 24-B, MSC-6600 BETHESDA MD 20892-6600 Telephone: (301) 594-8803 FAX: (301) 480-3503 E-mail: GarfieldS@ep.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Linda Stecklein Grants Management Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DR MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8847 E-mail: SteckleinL@ep.niddk.nih.gov Schedule Letter of Intent Receipt Date: February 12, 1997 Application Receipt Date: March 12, 1997 Initial Review Dates: June-July 1997 Second Level Review Dates: September-October 1997 Anticipated Award Date: December 1, 1997 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-009 - V25(39) 11/15/96 Date: 19 Nov 1996 21:14:54 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 386 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u44e$ept@net.bio.net> NNTP-Posting-Host: net.bio.net OSTEOPOROSIS AND FRACTURES IN MEN NIH GUIDE, Volume 25, Number 39, November 15, 1996 PA NUMBER: PA-96-009 P.T. 34; K.W. 0715031 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental Research National Institute of Environmental Health Sciences National Institute of Nursing Research PURPOSE This initiative invites applications directed to the study of the basic biology, epidemiology, prevention and treatment of osteoporosis and osteoporosis-related fractures in 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 PA, Osteoporosis and Fractures in Men, is related to the priority areas of diabetes and chronic disabling conditions and special population objectives. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Foreign institutions or organizations in foreign countries are not eligible for First Independent Research Support Transitions (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the individual investigator-initiated research project grant (R01) and the First Independent Research Support and Transition (FIRST) (R29) Award. Applicants or collaborators from institutions that have a General Clinical Research Center (GCRC) funded by the National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director should be included with the application. RESEARCH OBJECTIVES Background This Program Announcement is intended to address the under-representation of men in studies of osteoporosis. Although 50 year old white males have about a 13 percent lifetime risk of fractures of the hip, spine or wrist, the etiology and pathogenesis of osteoporosis in males has received little research attention. Men are now much more likely to live into their eighth and ninth decade than 20 years ago. As other causes of early mortality in men are reduced, there is a need to focus on the chronic disabling conditions that will limit independent life in elderly men. Males are about a decade behind females in the manifestation of osteoporosis and osteoporotic fractures. This has been attributed to a higher peak bone mass at maturity and a more gradual diminution in sex steroid influence in aging males. At each age the rate of hip fracture in men is about 50 percent that in women. While this is true in the United States and Northern Europe, in other parts of the world the hip fracture rates are similar or even greater in men. It has been estimated that 1/3 of hip fractures world wide are in men. Therefore hip fractures in men are an important and underscrutinized area of public health. With the decline in premature cardiovascular mortality in males, fractures later in life are becoming an increasingly important cause of morbidity and mortality in older men. An Annotated Bibliography on Osteoporosis in Men is available from the National Osteoporosis and Related Bone Diseases National Resource Center (phone 202-223- 0344) Scope The objective of this PA is to encourage and promote new and innovative research and approaches to elucidate the basic biology, epidemiology, prevention and treatment of osteoporosis and osteoporosis-related fractures in men. For the purposes of this PA skeletal includes craniofacial bone. The following are examples of research topics that are appropriate for this PA; however, they are not to be considered as exclusive or limiting: o Examine skeletal developmental differences in males and females o Investigate biomechanical and structural differences in males and females of different races and ethnic groups that may illuminate the etiology of fracture risk o Determine the risk factors for osteoporosis and fractures in men o Elucidate the etiologic factors in osteoporosis in men o Determine the calcium and vitamin requirements for optimal bone growth, development and maintenance in men o Characterize the differences in the non-gonadal endocrine skeletal regulatory mechanisms in men and women o Determine the prevalence of hypogonadism in men and its role in the etiology of osteoporosis o Develop population based data sources for the prevalence of low bone mass in males The areas of interest listed above include bone are not in any order of priority. They are only suggested examples of areas of research to consider. Applicants are encouraged to propose other areas that are related to the objectives and scope of this PA. INCLUSION OF MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS The inclusion of women is usually standard terminology for all grants and contracts: however, due to the specific subject of this program announcement, osteoporosis and fractures in men, the inclusion of women is not applicable. However, the inclusion of minorities remains relevant. It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. Applications for the FIRST Award (R29) 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. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG. Incomplete applications will be returned to the applicant without further consideration. Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of all applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria 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 the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The Initial review group will also examine the provisions for the protection of human subjects and animal welfare and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIAMS, NIA, NIDDK, NIDR, NIEHS, or NINR. 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 relevance and 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. For scientific programmatic inquiries contact: Joan A. McGowan, Ph.D. Bone Diseases Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-43E 45 Center Drive, MSC 4500 Bethesda, Maryland 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 E-mail: joan_mcgowan@nih.gov Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1033 FAX: (301) 402-1784 Email: ShermanS@gw.nia.nih.gov Ronald N. Margolis, Ph.D. Chief, Endocrinology Section Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12J 45 CENTER DR Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov Linda A. Thomas, Ph.D. Director, Craniofacial Development and Disorders Program National Institute of Dental Research 45 Center Drive, Room 4AN24J Bethesda, MD 10892-6402 Telephone: (301) 594-2425 FAX: (301) 480-8138 E-mail: THOMASL@DE45.NIDR.NIH.GOV Annette Kirshner, Ph.D. Bone Metabolism Program National Institute of Environmental Health Sciences Box 12233, MD 3-03 Research Triangle Park, North Carolina 27709 Office (919) 541-0488 Fax (919) 541-2843 e-mail: kirshner@niehs.nih.gov Laura James, PhD, RN Division of Extramural Activities National Institute of Nursing Research Building 45, 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5959 FAX: (3010 480-8260 Email: Ljames@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Vicki Maurer Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49A 45 Center Drive, MSC 4500 Bethesda, Maryland 20892-6500 Telephone: (301) 594-3504 FAX: (301) 480-4543 E-mail:vicki_maurer@nih.gov Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: EllisJ@gw.nia.nih.gov Kim Law Grants Management Specialist Building 45, Room 6AS-49A National Institute of Diabetes and Digestive and Kidney Diseases 45 CENTER DR BETHESDA, MD 20892-6600 Telephone: (301) 594-8869 Martin R. Rubinstein National Institute of Dental Research 45 Center Drive, Room 4AN44A Bethesda, MD 20892-6402 Telephone (301)594-4800 FAX: (301) 480-480-8301 E-mail: Martin.Rubinstein@NIH.GOV David Mineo Chief, Grants Management Branch National Institute of Environmental Health Sciences Box 12233, MD 2-01 Research Triangle Park, North Carolina 27709 Office (919) 541-7628 Fax (919) 541-2860 e-mail: mineo@niehs.nih.gov Jeff Carow Grants and Contracts Management Branch National Institute of Nursing Research Building 45, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-5074 FAX: (301) 480-8256 Email: JCAROW@ep.ninr.nih.gov AUTHORITY AND REGULATIONS Awards made in this program are described in the Catalog of Federal Domestic Assistance No. 93.846, 93.847, 93.866, 93.121, 93.113, 93.361. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 and Title IV, Part A (Public Law 410, 78th Congress, as amended, 42 USC 241) and administered under PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 18 November 1996 Date: 19 Nov 1996 21:57:26 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 126 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u6k6$iv1@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending November 18, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Program Guideline Title: NSF 97-2 --CHEMISTRY RESEARCH INSTRUMENTATION AND FACILITIES File size (bytes): 41876 STIS Filename: nsf972.txt Also available: nsf972.doc Document Type: Recruit Title: Astronomer (Program Director for Extragalactic Astronomy and Cosmology) File size (bytes): 5510 STIS Filename: vex971.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 90042 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112861 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Alphabetical Telephone Directory File size (bytes): 112861 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 128990 STIS Filename: phnorg.txt Title: NSF Organization Telephone Directory File size (bytes): 128990 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 95-150 ELEMENTARY, SECONDARY, AND INFORMAL EDUCATION Program Announcement and Guidelines File size (bytes): 249484 STIS Filename: nsf95150.txt Document Type: Recruit Title: Astronomer (Program Director for Extragalactic Astronomy and Cosmology) File size (bytes): 5510 STIS Filename: vex971.txt Title: Librarian, GS-1410-13 File size (bytes): 9680 STIS Filename: vgs9712.txt Title: Secretary (Office Automation) File size (bytes): 9685 STIS Filename: vgs9714.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vgs9714.txt, the text of your message should be as follows: get vgs9714.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs9714.txt, you would enter: ftp> get vgs9714.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". ------------------------------------------------------------------------ HOW TO GET OFF THIS LIST This message was mailed to the STIS Summary List STSSUM-L. To get off the list, send the following message to "stislists@nsf.gov". unsubscribe STSSUM-L If you receive an error message, send the following command: help unsubscribe You will receive additional instructions. If, after 24 hours, you haven't received *any* response your message, send a message to "stis@nsf.gov". A human will respond. From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-011 - V25(39) 11/15/96 Date: 19 Nov 1996 21:15:30 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 346 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u45i$esb@net.bio.net> NNTP-Posting-Host: net.bio.net PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES NIH GUIDE PA NUMBER: PAR-97-011 P.T. 34; K.W. 0710010, 0785055 National Institute on Aging PURPOSE The National Institute on Aging (NIA) will provide grant support for planning and protocol development of biomedical epidemiologic and intervention studies in research areas supported by the Geriatrics Program (see Research Objectives section of this program announcement). The planning grant application and review process is intended to provide a mechanism for peer review of the rationale and basic design of an epidemiologic or intervention study which would require extensive detailed protocols and/or complex organization for proper implementation. The planning grant itself is intended to provide support for the development of a refined study design, organizational plan, detailed protocol, Manual of Procedures, and budget, for implementation of studies whose rationale and basic design are considered sufficiently meritorious. After these are completed, planning grant awardees may submit applications to conduct the full-scale study. These applications will also be peer-reviewed. Thus, the planning grant mechanism is intended to facilitate careful and detailed protocol development and peer review of proposed complex intervention and epidemiologic studies through a two-stage process (rationale and basic design first, detailed protocol and organization second), in order to minimize unnecessary effort by applicants and reviewers, and allow careful scrutiny of the methods proposed for projects whose basic rationale and design have been judged to be of high quality. 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 is related to the priority area of chronic diseases and disabling conditions of older persons. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applicant 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 agreement from either the GCRC Program Director or Principal Investigator should be included with the application. MECHANISM OF SUPPORT The mechanism of support will be the NIA Planning Grant (R21), which will provide up to $100,000 in direct costs for one year. The award cannot be renewed. Applicants should note that NIA funding of a planning grant does not imply a commitment by NIA to fund the proposed full-scale study, nor even to accept a subsequent application for such a study. NIA decisions on acceptance of applications for projects whose proposed direct costs are $500,000 or more per year are determined by availability of funds and other programmatic considerations. Persons considering submitting an application for a planning grant to develop a project whose annual direct costs are likely to equal or exceed $500,000 per year are strongly encouraged to contact Geriatrics Program staff (see the "Research Objectives" section of this announcement) before writing the planning grant application, in order to obtain information on current program priorities and projected availability of funds. RESEARCH OBJECTIVES The NIA Geriatrics Program supports biomedical research on clinically-oriented aging topics. More detailed information on the range of research topics for which the Geriatrics Program provides support is available on the Geriatrics Program's section of the NIA Home Page http://www.nih.gov/nia/. Additional information regarding specific topics may be obtained from the staff contacts listed for specific research areas on the Home Page. Persons without access to the NIA Home Page may obtain the information from: Ms. Wanda Solomon Geriatrics Program, NIA Gateway Building, Suite 3E327 7201 Wisconsin Avenue Bethesda MD 20892-9205 Phone: (301) 435-3047 Fax: (301 402-1784 E-Mail: SolomonW@gw.nia.nih.gov Applicants for planning grants may request funds for activities such as: o Preparation of detailed protocols and a Manual of Procedures. These protocols and the Manual must be included in the Final Report for this award. o Analyses of existing data needed for refinement of study design and protocols (e.g., power calculations, dosage or intensity of intervention, budget estimates). o Preliminary studies to guide selection of, and/or refine, study procedures and instruments, and estimate recruitment and retention potential. o Travel expenses of individuals from multiple sites to planning meetings for the project. The planning grant proposal should describe: o The principal hypotheses to be tested, and the rationale for doing so. o Basic study design, estimated sample size, and time course. o The intervention(s) (if any), populations (including general eligibility and exclusion criteria), and outcomes to be studied, and the rationale for their selection. o Outline of strategies for recruitment, retention, and maintenance of subjects' adherence to study protocols. o Outline of methods for outcome measures and other measurements. o Outline of methods for data management and analysis. o The study elements to be planned or refined if the planning grant is awarded. These must be included in the protocol and draft Manual of Procedures to be produced by the awardees upon or before the end of the planning grant award period: e.g., number and identity of sites; power and sample size calculations; protocol elements; external data and safety monitoring procedures; quality assurance of data and study protocols; external data and safety monitoring; liaisons with industry (if any); data coordination and standardization; and planned staffing, organization, and budget. Applicants for planning grants for human intervention studies should review the NIA document "Implementation of Policies for Human Intervention Studies" (NIH Guide to Grants and Contracts: Volume 25, No. 33; October 4, 1996). This is available in the "Grants and Contracts" section of the NIH Home Page (http://www.nih.gov). Persons without access to the NIH Home Page may obtain copies of the policy from: Office of Extramural Affairs, National Institute on Aging; Gateway Building, Suite 2C218; Bethesda, MD 20892-9205. Phone (301) 496-9322) o Proposed preliminary analyses of existing data needed for refinement of study design and protocols (e.g., power calculations, dosage or intensity of intervention, budget estimates). o Proposed preliminary studies to guide selection of, and/or refine, study procedures and instruments, and estimate recruitment and retention potential. o The participants in the planning process, their roles in the development of the plan, and their experience in related studies. o The organizational approach and timetable to be followed in developing the protocol and draft Manual of Procedures over the course of the planning grant award. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the February 1, June 1, and October 1 application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: ASKNIH@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application. The completed original application and three legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) At the same time, two additional copies should be sent to: Chief, Scientific Review National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda MD 20892-9205 (20814 for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by study sections of the NIH Division of Research Grants or by the National Institute on Aging, NIH, convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and given a second level review by the appropriate National advisory council or board. Review Criteria In evaluating a Planning Grant application, the initial review group will consider the criteria outlined below. NIA strongly encourages applicants to address these criteria. o Scientific, technical, or medical significance and originality of the proposed research. o Appropriateness and adequacy of the overall approach and methodology proposed to carry out the proposed research o Qualifications and research experience of the Principal Investigator and staff in the area of the proposed research. o Availability of resources necessary to perform the research o Appropriateness of the proposed budget for the planning activities proposed. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. o Validity of rationale for the study, including scientific, public health, and ethical aspects. o Quality and feasibility of basic study design; recognition of possible problems inherent in the design and the adequacy of plans for dealing with them. o Appropriateness of outcomes to be studied, and the methods used to measure them. o Appropriateness of population, sample size, and eligibility and exclusion criteria. o Appropriateness and effectiveness of overall strategies for data management and analyses. o Feasibility and appropriateness of general strategies for recruitment, retention, and maintenance of subjects' adherence to protocol. o Rationale for, and quality of proposed preliminary analyses and studies. AWARD CRITERIA NIA decisions on funding are determined by scientific merit of proposed projects as determined by peer review, availability of funds, and NIA program needs and balance. 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: Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 FAX: (301) 402-1784 E-mail: EH21f@nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: JE14j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866 and 93.846. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Tue Nov 19 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-010 - V25(39) 11/15/96 Date: 19 Nov 1996 21:15:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 292 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <56u452$eqj@net.bio.net> NNTP-Posting-Host: net.bio.net NIAID/ASTP MINORITY FELLOWSHIPS IN TRANSPLANTATION NIH GUIDE, Volume 25, Number 39, November 15, 1996 PA NUMBER: PA-97-010 P.T. 22, FF; K.W. 0710125, 0745065 National Institute of Allergy and Infectious Diseases The American Society of Transplant Physicians Application Receipt Dates: April 5, August 5, and December 5, 1997 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the American Society of Transplant Physicians (ASTP) invite applications for Individual Postdoctoral Fellowships from racial/ethnic minority individuals, women, and persons with disabilities for research on the etiology, pathogenesis, diagnosis and/or treatment and prevention of transplant rejection. 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), "NIAID/ASTP MINORITY FELLOWSHIPS IN TRANSPLANTATION", is related to the priority area of immunization and infectious diseases. 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 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Individuals must be, at time of application, citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They are generally persons born in lands that are not States, but are under United States sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. Individuals must have received, as of the beginning date of the National Research Service Award (NRSA) appointment, a Ph.D., M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr.P.H., or D.N.S., or equivalent degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree granting institution that all degree requirements have been met is also acceptable. This PA is intended to support racial/ethnic minority individuals, women, and persons with disabilities. MECHANISM OF SUPPORT The mechanism of support will be the NRSA for individual postdoctoral fellows (F32). Individuals may receive up to three years of aggregate NRSA support at the postdoctoral level including any combination of support from institutional training grants and individual fellowship awards. FUNDS AVAILABLE In Fiscal Year 1997, the NIAID and the ASTP plan to jointly fund two F32 awards. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. The usual PHS policies governing NRSA administration and management will apply. Although this program is provided for in the financial plans of the NIAID and the ASTP, awards pursuant to this program announcement 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. New applications submitted for the April 5, August 5, and December 5, 1997 receipt dates will be eligible for funding under this announcement. Competing continuation applications for already funded projects will NOT be eligible for award from NIAID and ASTP under this PA. Although NIAID has a continuing interest in the research areas of this PA, the latest anticipated award date under this PA is September 30, 1998. RESEARCH OBJECTIVES Background Research on the immune system and methods to regulate it are part of the mission of the NIAID. Transplantation is a life-saving treatment for tens of thousands of patients and can also provide an extraordinary improvement in their quality of life. However, despite major improvements in surgical techniques, tissue preservation methods and immunosuppressive drugs, 10-50% of transplanted organs and tissues fail within the first year following transplantation. For organs where there is alternative therapy (e.g. kidney), one-year patient survival is 92%. However, for organs such as hearts, lungs and livers, patient survival is approximately the same as graft survival and is as low as 50%. Transplantation is being performed to replace damaged or non-functional organs and tissues, to supplement cells incapable of providing an adequate level of function, and to correct defective genes via gene therapy. Therapeutic transplantation in humans involves every major organ both singly and in combination. In addition, a variety of tissues and cells, including corneas, skin, fetal liver tissue, bone marrow, pancreatic islet cells, adrenal cells, hepatocytes, fetal brain cells and muscle cells have been transplanted. Also, in experimental animal models, promising results have been obtained with transplantation of a wide array of tissues and cells including heart muscle, neural tissue and nerve and bone cells. Graft rejection has replaced problems in organ and tissue preservation and surgical complications as the primary cause of graft loss. Additionally, in bone marrow transplantation and in transplantation of solid organs which have appreciable amounts of lymphoid tissue, graft-versus-host-disease (GVHD; attack of recipient tissues by immunocompetent cells of the donor) remains a significant risk. While powerful immunosuppressive drugs have greatly reduced graft loss due to rejection, these drugs are toxic to one or more organs and increase the risk of infection, the incidence and severity of malignancy, and the occurrence of atherosclerosis. To overcome these problems, it is desirable to eliminate immunosuppressive drug therapy by specifically regulating the immunologic processes involved in the rejection of transplanted tissues. This requires identification of the various antigens recognized on the graft, elucidating the cellular and molecular mechanisms involved in the response to these antigens, and determining the genetic control of these processes. This information can then be used to avoid mismatches of antigens when possible or to prevent the recognition of, or render the recipient non-responsive to, these specific antigens. Research Objectives and Scope The objective of this PA is to encourage postdoctoral training of individuals in state-of-the-art research that focuses on the etiology, pathogenesis, diagnosis and/or treatment and prevention of rejection of transplanted organs or tissues. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications must be submitted on the application for Public Health Service Individual Research Service Award PHS 416-1 (rev. 8/95). Applications may be submitted for the following receipt dates only: April 5, August 5, and December 5, 1997. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. The completed original and two legible, single-sided copies of the application must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) NRSA (F32) applications must include at least three sealed letters of reference attached to the face page of the original application. F32 applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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 Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete and responsive to the Program Announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. Review Criteria The review criteria focus for individual fellowship applications on three main components: o the applicant; o the research proposed (both its scientific merit and training potential); and o the training resources and environment, including the sponsor. It is important to remember that the F32 program is a training mechanism and not a research mechanism. Major considerations in the review are the applicant's potential for a productive scientific career, the applicant's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will meet the needed training. For more details, see Review Criteria on page 4 of the instructions for application form PHS 416-1. AWARD CRITERIA Applications assigned to the NIAID will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: o quality of the proposed project as determined by peer review, o program balance among research areas of the announcement, o availability of funds, and o whether the applicant is a racial/ethnic minority, a woman, or disabled. 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: Stephen M. Rose, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A14 Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: sr8j@nih.gov Direct inquiries regarding fiscal matters to: Leslie Boggs Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B28 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: lb114t@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 - Immunology, Allergy and Transplantation 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Wed Nov 20 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 21 Nov 1996 14:50:56 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 240 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199611201000.CAA10494@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Mon Nov 25 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-001 - V25(40) 11/22/96 Date: 26 Nov 1996 14:42:46 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1107 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <57frp6$2o8@net.bio.net> NNTP-Posting-Host: net.bio.net PHASE I TRIALS OF ANTI-CANCER AGENTS NIH GUIDE, Volume 25, Number 40, November 22, 1996 RFA: CA-97-001 P.T. 34; K.W. 0715015, 0755015, 0740020 National Cancer Institute Letter of Intent Receipt Date: January 17, 1997 Application Receipt Date: March 12, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to provide continued funding for a Phase I Clinical Trials Program to support scientifically directed Phase I trials of promising anti-cancer agents available through the National Cancer Institute (NCI) from the NCI's drug screening program or referred to NCI from other sources, (e.g., the pharmaceutical and biotechnology industry and academia); and to conduct pharmacokinetic and 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 Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC), NCI invites cooperative agreement (U01) applications >From institutions wishing to study these anti-cancer agents in Phase I Clinical Trials. Single Institution Phase I studies are preferred, although laboratory studies may be conducted by collaborators at other institutions. Strong justification and evidence of well established collaborations must be supplied for multi-institutional applications. Studies begun under a predecessor cooperative agreement may be completed under this cooperative agreement pending agreement from the NCI Program Director. The increasing number of promising new agents with diverse and novel mechanisms of action makes it desirable to continue NCI support in this area. Institutions responding to this Request for Applications (RFA) should be able to perform Phase I trials and establish the pharmacological characteristics, in parallel with biochemical and other appropriate biological studies, of the effects of these agents on cancer cells and normal tissues. It is expected that pharmacokinetics and, where possible, other laboratory correlative studies will be conducted in real-time, throughout the course of the clinical trial to facilitate optimal utilization of the data in the design and coordination of clinical trials with the agent. Applications from any one institution may focus on studies of one or more classes of agents or therapeutic approaches, reflecting the interest, expertise, and experience of the applicant investigators or a more general approach to the pharmacokinetic/pharmacodynamic evaluation of new agents may be developed. 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 I Trials of 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 Summary Report: Stock No. 017-001-00473-1 through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations such as universities, colleges and hospitals, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. 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 and Conditions of Award, NCI Staff Responsibilities. 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 - see INQUIRIES) in all aspects of scientific and technical management of the project in accordance with the Terms and Conditions of Award. 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. FUNDS AVAILABLE Approximately $5,500,000 in total costs per year for five 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 approximately fifteen awards will be made. The earliest feasible start date for the initial awards will be February 1, 1998. Although this program is provided for in the financial plans of the NCI, the award of cooperative agreements pursuant to this RFA is contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. At this time the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. If it is determined that there is a sufficient continuing program need, the NCI will either invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review or re-issue the RFA for re-competition. If the NCI does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. RESEARCH OBJECTIVES A. Background The NCI currently holds over 200 active INDs for anticancer agents. NCI actively supports the primary development of a diverse array of anticancer therapeutic agents which originate from the NCI's preclinical Developmental Therapeutics Program as well as from academia; in these cases NCI often holds the only IND investigational new drug application). In addition, for agents derived from the pharmaceutical/biotechnology arena where NCI feels that co-development is in the best interest of improving the treatment of cancer patients, NCI may file INDs and participate in collaborative clinical development. In the latter case, NCI often promotes the exploration of important scientific questions which may not be the primary focus of market-driven industry development, either because of limited resources in the case of small companies, the need to perform combination studies with other investigational agents for which NCI holds an IND, or because of small commercial markets due to the relatively low frequency of certain human cancers. NCI support facilitates the development of these important agents and indications. The increasing number of promising new agents with diverse and novel mechanisms of action makes it desirable to continue NCI support for the study of these agents. The NCI will accelerate cancer treatment development by supporting research applications whereby clinicians and laboratory investigators can utilize their extensive experience and expertise to study investigational agents in comprehensive Phase I trials with appropriate laboratory and clinical correlations. This RFA provides an opportunity for clinical and laboratory investigators within an institution to develop a program in drug development that utilizes the strengths of pre-existing basic scientific expertise and available clinical resources. Scientific approaches will reflect the scientific interest, creativity and capabilities of participants and the agents available for study. The investigators would bring to the collaboration their specific biological and pharmacological expertise, their ideas concerning clinical investigative strategies unique to each agent, the necessary patient and investigative resources for study of the agent, and their data management and analytical abilities. 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 will sponsor (in accord with Food and Drug Administration requirements) 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, DCTDC and specifically, CTEP, is responsible for ensuring that clinical trials proceed safely and rationally from the initial dose-finding studies 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. An Investigational Drug Branch (IDB) Physician is assigned to each DCTDC IND to assist in the coordination of its development. NCI sponsorship of investigational agents increases the likelihood that agents will be fully developed so that they will ultimately be broadly available for use in cancer treatment and will provide resources to accelerate this process. B. Research Goals and Scope The aims of this initiative are to: (1) provide support for Phase I trials of promising new anti-cancer agents in cancer patients; and (2) provide support for complete pharmacokinetic, pharmacodynamic, and other important laboratory correlative studies in cancer patients receiving these anti-cancer agents. Phase I clinical trials have as their objectives the characterization of drug toxicity, maximally tolerated dose, pharmacokinetics, and biological effects (pharmacodynamics) of drugs. These anti-cancer agents have traditionally been obtained either from the NCI drug development program or through collaborative drug development agreements with the pharmaceutical industry. Recent advances in understanding of the pathobiology of malignancy are leading to the development of a wide range of novel anti-cancer therapeutic agents that require Phase I testing. These agents include, but are not limited to, new classes of cytotoxic agents derived from natural products, as well as rationally designed anti-cancer 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 the mediation of anti-cancer effects not only through classical cytotoxic mechanisms, but also through growth inhibition by interruption of specific oncogene-associated biochemical functions, inhibition of protein synthesis through targeted toxins, induction of differentiation and/or programmed cell death (apoptosis), and through inhibition of tumor angiogenesis and metastasis. In addition, new strategies to overcome resistance to conventional cancer therapeutic approaches are also of interest. 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, differentiation-inducing, targeted and/or other novel anti-cancer agents, including monitoring of metabolites and intracellular products when appropriate, or other relevant pharmacology correlative studies; and the measurement of relevant indicators of pharmacodynamic or biologic response (e.g., changes in signal transduction pathways, induction or suppression of specific gene function, other indications of differentiation induction, or induction of apoptosis). The investigators will define scientific objectives and experimental approaches consistent with the goals of Phase I clinical trials. The investigators will select the specific NCI sponsored agents of interest in accord with their areas of scientific interest and expertise, and will develop a series of appropriate phase I trials with supporting protocol documents. The Government will have access to the data generated, will periodically review the data and may perform special analyses of the data. However, the awardees will retain custody and primary rights to their data developed under these awards. Data will be submitted to the NCI's Clinical Trials Monitoring Service at prescribed intervals. Timely publication of findings will be encouraged. Each Phase I awardee institution must have demonstrated experience in conducting Phase I Clinical Trials. Sufficient numbers of patients at the applicant institution should be available in order to allow completion of the trials in a timely manner. In all categories of diseases, the Principal Investigator must select those patients for trial with the best performance status and with the minimum amount of prior treatment consistent with ethical medical practice. The Principal Investigator will ensure that these Phase I 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 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, data management and analysis, adherence to NCI requirements for investigational agents, adherence to FDA/DHHS regulations, and reporting of data from the Phase I trials. For Phase I 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 of the Phase I investigator data submissions (currently biweekly), and to produce periodic routine reports of the results and special reports as necessary. The awardee institution's source documentation will be reviewed on-site three times per year by the CTMS. SPECIAL REQUIREMENTS Terms of Cooperation These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardee and the NCI Project Scientist. The role of the Cancer Therapy Evaluation Program (CTEP) staff as described throughout these terms and conditions of award is to facilitate and assist 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 DCTDC as a drug sponsor as defined in CFR 21 Part 312. 1. Awardee Rights and Responsibilities It is the responsibility of the Principal Investigator (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. 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 DCTDC investigational agents. a. Protocol Development The PI shall, with CTEP assistance, develop Phase I protocols which define the scientific objectives and experimental approaches for: 1) Anticancer agents identified by the NCI's drug screening program or referred to NCI from other sources, including the pharmaceutical and biotechnology industry; 2) Anticancer agents with novel mechanisms, including but not limited to: inhibitors of angiogenesis and metastasis, differentiating agents, apoptosis-inducing agents, anti-sense oligonucleotides and related gene-specific therapeutic agents, and targeted cytotoxic agents. 3) Existing chemotherapeutic agents which, when administered with colony stimulating factors or other agents to ameliorate dose-limiting toxicities, can be given in doses substantially higher than those previously tested or which on the basis of preclinical studies might have increased anti-tumor effect in combination; and; 4) novel combination pilots of importance to CTEP's drug development program where dose, pharmacokinetic or drug interaction issues must be carefully defined. The protocols shall be conducted in accordance with the instructions in the INVESTIGATOR'S HANDBOOK, A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, National Cancer Institute, Revised 10/93 (available from the NCI Program Director). The INVESTIGATOR'S HANDBOOK describes the procedures for: o Requirements for Protocol Development and Submission o Ordering Investigational Drugs from NCI o Responsibility for Reporting of Results to CTEP o Adverse Event Reactions o Accountability and Storage of Investigational Drugs o Monitoring and Quality Assurance The PI shall submit the Phase I protocols 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. 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 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. b. Protocol Submission Communication at the various stages of protocol development is encouraged as necessary to promote protocol development and implementation. It is recommended that protocols be preceded by a written declaration of interest in conducting a particular study from the PI using the suggested format described in the INVESTIGATOR'S HANDBOOK, Appendix VII, GUIDELINES FOR SUBMITTING LOIs - Letter of Intent/ INVESTIGATIONAL DRUG TRIAL. The LOI shall describe the hypothesis to be investigated with appropriate references or supporting data, the general design of the contemplated trial plus relevant information on accrual capabilities to document feasibility. The LOI should be sent to the CTEP LOI Coordinator who receives, logs in and schedules LOIs for review by the PRC. The PI shall submit the Phase I protocols to the CTEP Protocol and Information Office, the receiving office for all protocols sent to CTEP, for review as appropriate prior to their implementation. c. Study Conduct and Monitoring The awardee institution is responsible for ensuring accurate and timely knowledge of the progress of each study through: 1) establishing data management support capabilities that ensure that data will be submitted via electronic transfer biweekly to NCI's Clinical Trials Monitoring Service (CTMS). This data includes: registration of each patient entered onto a Phase I 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/DCTDC Case Report Form and the individual protocol. 2) establishing procedures for assigning dose level at the time a new patient is entered, and assuring that the required observation period has elapsed before beginning a higher dose level. 3) registration, tracking and reporting of patient accrual and adherence to defined accrual goals; appropriate attempts to accrue patients who fulfill NIH Guidelines for accrual of women and minorities to clinical trials with appropriate documentation and reporting of accrual as specified by NIH Guidelines; 4) ongoing assessment of case eligibility and evaluability; 5) timely medical review and assessment of patient data; 6) rapid reporting of treatment-related morbidity (adverse event reactions) and measures to ensure communication of this information to all parties; 7) interim evaluation and consideration of measures of outcome, as consistent with patient safety and good clinical trials practice; and 8) timely communication of results of studies. d. Data Management and Analysis The awardee will develop procedures to ensure that data collection and management are: a) adequate for quality control and analysis; and b) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense. f. Investigational Drug Management Investigators performing trials under cooperative agreements involving a Division of Cancer Treatment, Diagnosis and Centers (DCTDC) investigational agent must be NCI registered investigators (Form FDA 1572) and will be expected to implement CTEP requirements described in the 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. g. Compliance with Federally Mandated Regulatory Requirements The awardee is responsible for establishing procedures to comply with FDA regulations for studies involving investigational agents and OPRR requirements for the protection of human subjects. These procedures are: 1) methods for ensuring that the awardee institution 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 1572 form on file; and that each patient (or legal representative) gives written informed consent prior to entry on study. 2) a system for ensuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, (IDB), CTEP according to CTEP guidelines (mailed annually to all registered investigators). This may require reporting Adverse Event Reactions (AERs) by telephone to the responsible IDB Physician within 24 hours of the event and requires a written report to follow within 10 working days. (See 2. NCI Staff Responsibilities for definition of responsible IDB Physician.) 3) a system for ensuring that the required data is provided biweekly to the CTMS. h. Reporting Requirements Reporting requirements will be in agreement with FDA regulations and NCI procedures. Annual progress reports will be submitted to the NCI in a non-competing continuation application and will include at a minimum summary data on protocol performance by the awardee institution, interim reports of each activated study including specific data on patient accrual, as well as detailed reports of treatment-associated morbidity and other relevant data. I. Publication of Data Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NCI support. The NCI will have access to all data generated under this cooperative agreement, will periodically review the data and may perform special analyses of the data. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies. 2. NCI Staff Responsibilities The role of the Cancer Therapy Evaluation Program (CTEP) staff as described throughout these terms and conditions of award is to facilitate and assist 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 DCTDC as a drug sponsor as defined in CFR 21 Part 312. a. Provision of NCI-sponsored Investigational Agents and Responsibilities of IND Sponsor CTEP will supply the investigational agents to be studied and will be the Sponsor for these agents. CTEP will submit Investigational New Drug Applications to the FDA permitting DCTDC to act as a drug sponsor. As a sponsor of an investigational drug, DCTDC, and specifically CTEP, is responsible for seeing that clinical trials proceed safely and rationally from the initial dose-finding studies through the definitive evaluation of the new drug in the treatment of one or more specific cancers. b. CTEP as a Scientific Resource for NCI-supported Phase I Clinical Trials Investigations An Investigational Drug Branch (IDB) Physician is assigned to each DCTDC IND agent to assist in the coordination of its development. The NCI Program Director and the responsible IDB physician 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 and/or responsible IDB Physician will advise the PI of potential studies that will be relevant to new avenues of cancer therapy. The NCI Program Director and/or responsible IDB Physician will assist the PI as appropriate in developing information concerning the scientific basis for specific trials and also will advise the PI of the nature and results of relevant trials being carried out under NCI sponsorship. The NCI Program Director and/or responsible IDB Physician 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 DCTDC. c. CTEP Assistance in Protocol Development The CTEP Protocol Review Committee (PRC), must review and approve every protocol involving DCTDC investigational agents. The PRC, which meets weekly, is chaired by the Associate Director, CTEP, and is comprised of professional staff of the DCTDC including the IDB Physicians, Clinical Investigations Branch disease coordinators, regulatory staff, pharmacy staff and ad hoc reviewers external to NCI when deemed appropriate by the PRC chairperson. The PRC will formally review the LOI. Following LOI review, the responsible IDB physician 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; d) the scientific rationale and value of the proposed study, the design, the statistical requirements; e) the projected accrual rate; f) correlative laboratory studies; and g) the implementation of the study, if indicated. The LOI mechanism is designed for preliminary review and is recommended to expedite protocol development and implementation, to avoid duplication and to facilitate agreement on study priority and design (see the DCTDC Investigator's Handbook, pp 32-35, available on request from the NCI Program Director. d. CTEP Review of Proposed Protocols 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. Following the review of the protocol by the PRC, the responsible IDB physician will provide the PI with a consensus review prepared by the IDB Physician. The consensus review summarizes the PRC review and describes required or recommended modifications and other suggestions, as appropriate. (See the INVESTIGATOR'S HANDBOOK, for further information regarding protocol review at CTEP). If a proposed protocol is disapproved, the specific reasons for lack of approval will be communicated to the PI as a consensus review within 30 days of protocol receipt by the NCI. The NCI Program Director and/or responsible IDB Physician 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. An arbitration system, as detailed below, will be available to resolve disagreements between the NCI and the awardee. 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 below. e. Access to Data The NCI will have access to all data generated under this cooperative agreement and will periodically review the data and may perform special data analyses. 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 of and primary rights to the data consistent with current HHS, PHS, and NIH policies. f. CTEP Involvement in Protocol Closure The NCI Program Director and/or responsible IDB Physician and the Head, Quality Assurance and Compliance Section (QACS), Clinical Trials Monitoring Branch (CTMB) will monitor protocol progress. The NCI Program Director or the responsible IDB Physician 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 to resolve disagreements between the NCI and the awardee. g. CTEP involvement in Investigational New Drug Applications 1) The NCI Program Director and/or 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. 2). The NCI Program Director and/or 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). h. CTEP Review of Federally Mandated Regulatory Requirements The Head, QACS, CTMB will review protocols to determine if the awardee's mechanisms for meeting FDA regulatory requirements for studies involving DCTDC-sponsored investigational agents and the Office for Protection from Research Risks (OPRR) requirements for the protection of human subjects are sufficient. These comments are incorporated into the protocol consensus review. (See Awardees Rights and Responsibilities). For Phase I 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 results and special reports as necessary. For these trials, source documentation will be reviewed on-site three times per year by the CTMS. I. 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 semi-annual Phase I meetings, in the continuation application, in the study summary reports submitted via the CTEP Data Update reporting system 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 Special Terms and Conditions of Award, may result in a reduction of budget, withholding of support, suspension or termination of the award. 3. Collaborative Responsibilities a. Phase I strategy meetings The NCI Program Director will sponsor semi-annual Phase I strategy meetings with the PIs 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. The PI will be responsible for making scientific reports at these meetings as requested by Program Staff. b. The PI shall, with CTEP assistance as described in the above terms for the NCI staff responsibilities, develop Phase I protocols. The protocols must be mutually acceptable to the PI and to the CTEP Protocol Review Committee (PRC). 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), excluding patient safety issues or regulatory compliance, between award recipients and the NCI may be brought to arbitration. An arbitration panel composed of one awardee 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, DCTDC. The arbitration procedures in no way affect the awardee's right to appeal an adverse determination under the terms of 42 CFR Part 50, Subpart D, and 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Population, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by January 17, 1997, 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: Michaele C. Christian, M.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard MSC 7432 BETHESDA, MD 20892-7432 ROCKVILLE, MD 20852 (for express/courier service) Telephone: (301) 496-5223 FAX: (301) 480-4663 APPLICATION PROCEDURES A. PREPARATION OF APPLICATION Applications are to be submitted on the grant application form PHS 398 (rev. 9/96). These forms are available at most institutional offices of sponsored research; from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, E-mail ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. 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 as well as how all of the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive continuation and must include a progress report, which at a minimum consists of a summary of prior Phase I activities/accomplishments, including a clear presentation of pharmacokinetic studies, pharmacodynamic correlations and results, conclusions of correlative laboratory studies and annual accrual over the funding period. A summary of accrual by gender and race and/or ethnicity to all Phase I trials (reported by trial) conducted during the project period must be provided. ALL Applicants 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 that 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 at the applicant institution to complete on average two to three Phase I trials annually. b. laboratory support within the institution to perform pharmacokinetic studies of cytotoxic, differentiation-inducing, targeted, and/or other novel anti-cancer agents, including monitoring of metabolites and intracellular products when appropriate, or other relevant pharmacology correlative studies; c. laboratory support within the institution to measure relevant indicators of pharmacodynamic or biologic response (e.g., changes in signal transduction pathways, induction or suppression of specific gene function, other indications of differentiation induction, or induction of apoptosis); d. adequate central data collection and processing capabilities in order to meet FDA requirements for the conduct of research using investigational agents. These specifically include: e. the capability to transmit patient data to the NCI's Clinical Trials Monitoring Service (CTMS) on a biweekly basis. f. the capability of prompt reporting of AERs to CTEP for investigational agents supplied by NCI in accordance with the CTEP guidelines (mailed annually to all registered investigators). g. adequate pathology support for tumor classification and for banking and distribution of tumor tissues for concurrent and future studies. h. 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 Part 46, Protection of Human Subjects, indicating that they are aware of the investigational nature of the studies involved. I. Evidence of a level of supportive care appropriate for the treatment of patients with advanced malignancies; j. Intensive care and blood bank facilities on-site and functioning 24 hours per day. k. Adequate physician and nursing resources to comply with all reporting requirements of NCI-sponsored Phase I trials. l. Appropriate drug accountability procedures as required for utilization of NCI-supplied investigational agents. 3. 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 I studies including costs related to patient accrual, data collection, sample handling, additional staff time, specific supply needs related to required laboratory studies, quality assurance, data management and data analysis, study monitoring, travel, and biweekly electronic data submissions to the NCI's Clinical Trials Monitoring Service as required by the reporting requirements for investigational agents. 4. 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 Clinical Research Associate/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). 5. Travel funds for two meetings per year for two representatives >From the awardee institution should be included in the budget. The RFA label available in the PHS 398 (rev. 5/95) 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package: DIVISION OF RESEARCH GRANTS National INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express mail) 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 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express mail) Applications must be received by March 12, 1997. 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 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 A. Review Procedure Upon receipt, applications will be reviewed by the Division of Research Grants (DRG) for completeness and by the NCI for responsiveness. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. The review group will assess the scientific merit of the studies using the following review criteria: 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 I 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 I clinical trials b. adequacy of plans, equipment and resources to carry out pharmacokinetic and pharmacodynamic analyses in a timely manner. c. adequacy of plans for correlative laboratory studies and evaluation of the data with respect to treatment administration or treatment outcome d. adequacy of statistical approach for correlating research studies with treatment outcomes in Phase I trials. e. adequacy of plans for effective collaboration among laboratory, clinical, and statistical investigators. f. 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 I trials. b. 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. c. 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. d. experience in performance of pharmacokinetic/pharmacodynamic 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 pharmacokinetic/pharmacodynamic 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 I clinical trials and/or to human tissue with the associated pathological data and clinical follow-up. 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 February 1, 1998. In addition to the technical merit of the application, NCI will consider how well the applicant institution meets 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 welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Dr. Michaele C. Christian Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute Executive Plaza North, Room 734 6130 Executive Boulevard, MSC 7432 BETHESDA, MD 20892-7432 Telephone: (301) 496-5223 FAX: (301) 480-4663 Email: christim@DCT.NCI.NIH.GOV Direct inquiries regarding fiscal matters to: Crystal Wolfrey National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 256 FAX: (301) 496-8601 Email: WOLFREYC@GAB.NCI.NIH.GOV 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. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Nov 25 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 40, pt. 1of1, 22 November 1996 Date: 26 Nov 1996 14:42:28 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 554 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <57frok$2np@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 25, No. 40 - November 22, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICES $$INDEX N2 ********************************************************** NIDCD RESEARCH AREAS OF SPECIAL EMPHASIS National Institute on Deafness and Other Communication Disorders INDEX: DEAFNESS, OTHER COMMUNICATION DISORDERS NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/12/97 ************************************************* PHASE I TRIALS OF ANTI-CANCER AGENTS (RFA CA-97-001) National Cancer Institute INDEX: CANCER $$INDEX R2 03/12/97 ************************************************* CONSORTIUM THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVOUS SYSTEM MALIGNANCIES IN ADULTS (RFA CA-97-002) National Cancer Institute INDEX: CANCER $$INDEX R3 05/15/97 ************************************************* SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH (RFA HD-96-008) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT THE NIH GUIDE IS AVAILABLE ELECTRONICALLY VIA BITNET OR INTERNET, BY SUBSCRIPTION, AND IS ALSO ON THE NIH GOPHER (GOPHER.NIH.GOV) AND THE NIH WEBSITE (HTTP://WWW.NIH.GOV). ALTERNATIVE ACCESS IS THROUGH THE NIH GRANT LINE VIA MODEM (DATA LINE 301/402-2221); CONTACT DR. JOHN JAMES AT 301/435-2801 FOR DETAILS ON THE NIH GRANT LINE. THE PHS STRONGLY ENCOURAGES ALL GRANT AND CONTRACT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. IN ADDITION, PUBLIC LAW 103-227, THE PRO-CHILDREN ACT OF 1994, PROHIBITS SMOKING IN CERTAIN FACILITIES (OR IN SOME CASES, ANY PORTION OF A FACILITY) IN WHICH REGULAR OR ROUTINE EDUCATION, LIBRARY, DAY CARE, HEALTH CARE OR EARLY CHILDHOOD DEVELOPMENT SERVICES ARE PROVIDED TO CHILDREN. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. ALL COMPETING GRANT APPLICATIONS SUBMITTED TO THE NATIONAL INSTITUTES OF HEALTH MUST BE SENT TO: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) THE GRANTS INFORMATION OFFICE, DRG, HAS BEEN INCORPORATED INTO THE NEW OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES, OFFICE OF EXTRAMURAL RESEARCH, OFFICE OF THE DIRECTOR, NIH. REQUESTS FOR APPLICATION FORMS, PUBLICATIONS, AND OTHER INFORMATION MAY BE DIRECTED TO THE FOLLOWING: OFFICE OF EXTRAMURAL OUTREACH & INFORMATION RESOURCES NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7910 BETHESDA, MD 20892-7910 TELEPHONE: (301) 435-0714 EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 25, Number 40, November 22, 1996 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Gang Yuan, Fox Chase Cancer Center (FCCC). ORI has entered into a Voluntary Exclusion Agreement with Mr. Gang Yuan, a former laboratory technician at FCCC. The agreement resolved ORI's proposed administrative actions against Mr. Yuan, which were based on allegations concerning research data he generated at FCCC. The data became the subject of an investigation conducted by FCCC and an ORI oversight review. The data at issue were included in a grant application submitted to the National Institute of General Medical Sciences of NIH and in a manuscript submitted to, but not published by, the journal Biochemistry. Mr. Yuan disagreed with the allegations, but to settle the matter he has voluntarily agreed, without admitting to guilt, to voluntarily exclude himself for the two-year period beginning October 25, 1996, from: (1) any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement transactions (e.g., grants and cooperative agreements) of the United States Government as defined in 45 C.F.R. Part 76 (Debarment Regulations); and (2) serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. INQUIRIES For further information, contact: Acting Director, Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIDCD RESEARCH AREAS OF SPECIAL EMPHASIS NIH GUIDE, Volume 25, Number 40, November 22, 1996 P.T. 34; K.W. 0715050, 0715055 National Institute on Deafness and Other Communication Disorders PURPOSE This notice is to inform the scientific community of several areas of research emphasis within the National Institute on Deafness and Other Communication Disorders (NIDCD) and to encourage grant applications seeking support for these areas of research. The NIDCD has primary responsibility for supporting basic, clinical and applied research and research training on normal and disordered mechanisms of hearing, balance, smell, taste, voice, speech and language (i.e., communication disorders). More than 46 million people in the United States suffer from some form of communication disorder. The NIDCD addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders. This notice highlights several of the research areas that have been identified by the Programs Advisory Committee of the NIDCD as opportunities or gap areas in need of research emphasis. Research Goals and Scope I. Application of Emerging Technologies to Human Communication The introduction of new technologies in recent years offers a unique opportunity to apply innovative approaches to basic and clinical investigations of human communication. Areas of research emphasis include, but are not limited to: o Application of advanced imaging technologies - New imaging techniques provide research opportunities for studies of structure and function, diagnostics, treatment and rehabilitation of individuals with communication disorders. Research plans should focus on the development of new imaging techniques and the application of existing imaging techniques to the study of the normal processes of human communication as well as the changes in function that are associated with diseases and disorders of communication. Collaborations among scientific disciplines are encouraged. o Approaches for gene transfer into cells of the inner ear - Advances in gene transfer technology provide the possibility of replacing or enhancing the function of mutated genes in disorders that lead to or predispose the development of inner ear lesions which cause hearing impairment and balance disorders. Initial studies of effective approaches for DNA transfer into cells of the inner ear may include the use of "reporter" genes that produce an easily detectable product. o Application of genetic and molecular approaches to voice, speech and language research - Within this broad area, research topics may include, but are not limited to: cellular and molecular mechanisms underlying critical periods in voice, speech and language development; the role of neurotrophins and growth factors in recovery >From brain injury and wound healing; and the application of molecular genetic techniques such as gene linkage analysis and positional cloning strategies to voice, speech and language disorders. o Molecular regulation of receptor subtypes in chemoreceptors - Continuous renewal of chemosensory receptor cells poses a fundamental question of how these systems maintain stable sensory capabilities in the face of sensory cell turnover and subsequent synaptogenesis. Studies are needed to examine the molecular mechanisms that regulate the expression of individual receptor subtypes and to identify signals from the nervous system and/or chemical environment that may influence these processes. II. Prevention and Treatment of Communication Disorders The NIDCD encourages research on the development and evaluation of new approaches for the prevention and treatment of communication disorders. Results of research in these areas will provide a rational basis for designing interventions to improve the quality of life for all individuals with communication disorders. Within this broad area, research topics of emphasis include, but are not limited to: o Pharmacotherapy for individuals with communication disorders - The application of contemporary techniques of molecular and cellular biology is needed for the rational development of effective pharmacotherapeutic agents for the prevention and treatment of communication disorders. Randomized, controlled clinical trials are also needed to determine the efficacy of a variety of pharmacotherapeutic agents for individuals with communication disorders. o Hearing impairment and other communication disorders associated with cytomegalovirus (CMV) infection, human immunodeficiency virus (HIV) infection, and acquired immunodeficiency syndrome (AIDS) - Additional research on these topics will increase understanding of the etiology and pathophysiology of communication impairments resulting from CMV infection, HIV infection, and AIDS. This information is needed to improve treatment and quality of life for HIV-infected individuals. o Neural control of swallowing and dysphagia - Basic and clinical studies will lead to a better understanding of the oral, pharyngeal and laryngeal components of swallowing and dysphagia. The NIDCD encourages studies on the development of instrumentation and imaging techniques to assess the normal swallowing process and its disorders, and the assessment of treatment efficacy including pharmacotherapy, surgery, prosthetic devices, compensatory strategies and behavioral treatment. III. Integrative Neuroscience Integration of various aspects of molecular and cellular biology with function and behavior and the determination of their relationship to disorders of human communication will provide a rational basis for approaches to therapeutic intervention. Emphasis should be placed on integrating findings across two or more levels of biological organization to answer questions directly; previously, answers could only be inferred by combining data obtained from several sources. Examples of areas of emphasis include, but are not limited to: o Computational neuroscience - Computational neuroscience offers new and powerful tools to develop comprehensive and accurate models of neural and behavioral function. Research areas of interest include, but are not limited to: models of ion channels and receptors; biophysical mechanisms in synapses and neurons; simulations of neural circuits or networks; and models of sensory information processing, sensorimotor integration, plasticity, recovery of function, learning, language and memory. o New approaches to investigate higher cognitive functions - Research is needed on the central processing of sensory information leading to higher cognitive functions in communication, such as perception, discrimination, plasticity, multisensory integration, learning, language and memory. Recent progress on receptor mechanisms and transduction events underscores the importance of integrating these findings with more complex behaviors and functions of the whole organism. The ability of sensory systems to preserve and enhance certain types of information and then to transform that information into other coding schemes that lead to perception and interpretation is currently not well understood. Specific questions of interest include, but are not limited to: (1) the failure of specific cognitive mechanisms in language impairment; and (2) the role of cerebral cortical centers receiving vestibular inputs in spatial cognitive functions, such as the perception of verticality and the direction of "heading" (spatial navigation) during locomotion. IV. Development, Repair and Regeneration Research is needed to understand the molecular, genetic and cellular regulatory factors that underlie normal and abnormal development of communication processes. Studies are encouraged to identify mechanisms that regulate differentiation, cell migration, axonal guidance, synaptogenesis and neurogenesis. There is a particular need for investigations aimed at determining how connectivity and synaptic specificity are established in the vestibular pathways. Additional areas of emphasis include: neural plasticity and recovery >From injury; critical periods of development; factors that enhance regeneration and repair; and transplantation of neurogenic cell populations. INQUIRIES Applicants that think the topic of an application is within an area of special research emphasis are encouraged to contact the NIDCD. The opportunity to clarify any issues or questions from potential applicants is welcome. All applications will be assigned according to PHS Referral Guidelines and determination of high program priority will be made by NIDCD staff. Direct inquiries regarding programmatic issues to: Dr. Rochelle Small Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: Rochelle_Small@nih.gov $$N2 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN CA-97-001 FULL-TEXT ************************************** PHASE I TRIALS OF ANTI-CANCER AGENTS NIH GUIDE, Volume 25, Number 40, November 22, 1996 RFA AVAILABLE: CA-97-001 P.T. 34; K.W. 0715015, 0755015, 0740020 National Cancer Institute Letter of Intent Receipt Date: January 17, 1997 Application Receipt Date: March 12, 1997 PURPOSE The purpose of this Request For Application (RFA) is to provide continued funding for a Phase I Clinical Trials Program to support scientifically directed Phase I trials of promising anti-cancer agents available through the National Cancer Institute (NCI) from the NCI's drug screening program or referred to NCI from other sources, (e.g., the pharmaceutical and biotechnology industry and academia); and to conduct pharmacokinetic and 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 Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC), NCI invites cooperative agreement (U01) applications >From institutions wishing to study these anti-cancer agents in Phase I Clinical Trials. Single Institution Phase I studies are preferred, although laboratory studies may be conducted by collaborators at other institutions. Strong justification and evidence of well established collaborations must be supplied for multi-institutional applications. Studies begun under a predecessor cooperative agreement may be completed under this cooperative agreement pending agreement from the NCI Program Director. The increasing number of promising new agents with diverse and novel mechanisms of action makes it desirable to continue NCI support in this area. Institutions responding to this RFA should be able to perform Phase I trials and establish the pharmacological characteristics, in parallel with biochemical and other appropriate biological studies, of the effects of these agents on cancer cells and normal tissues. It is expected that pharmacokinetics and, where possible, other laboratory correlative studies will be conducted in real-time, throughout the course of the clinical trial to facilitate optimal utilization of the data in the design and coordination of clinical trials with the agent. Applications from any one institution may focus on studies of one or more classes of agents or therapeutic approaches, reflecting the interest, expertise, and experience of the applicant investigators or a more general approach to the pharmacokinetic/pharmacodynamic evaluation of new agents may be developed. It is anticipated that approximately $5.5 million will be available to fund approximately 15 grants. 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 I Trials of 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 Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant line (data line/301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and E-mail from the program contact listed below. Dr. Michaele C. Christian Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 734 - MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-5223 FAX: (301) 480-4663 Email: christim@DCT.NCI.NIH.GOV $$R1 END ************************************************************ $$R2 BEGIN CA-97-002 FULL-TEXT ************************************** CONSORTIUM THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVOUS SYSTEM MALIGNANCIES IN ADULTS NIH GUIDE, Volume 25, Number 40, November 22, 1996 RFA AVAILABLE: CA-97-002 P.T. 34; K.W. 0705055, 0715035, 0740020 National Cancer Institute Letter of Intent Receipt Date: January 24, 1997 Application Receipt Date: March 13, 1997 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Treatment Diagnosis and Centers (DCTDC) at the National Cancer Institute (NCI) invite applications for cooperative agreements (U01) from consortia of institutions to perform Phase I and II clinical evaluations of promising new therapeutic agents or approaches for the treatment of primary central nervous system (CNS) malignancies in adult patients, especially glioblastoma multiform and other high grade gliomas, and to perform ancillary laboratory studies of aspects of CNS tumor biology with potential clinical implications. The NCI is seeking talented scientists from academic, non-profit and for-profit research organizations who will interact with other members of the consortium, and with NCI, in a concerted way to conceive, create, and evaluate new approaches to the therapy of CNS tumors. Integrated packages of individual applications are encouraged, with the lead institution of a proposed consortium indicating which participating institutions will provide organizational support, scientific leadership, laboratory capabilities, and/or patient resources. Each consortium of institutions will be referred to as a CNS Consortium (CNSC) for the purpose of this RFA. The purpose of the proposed awards is to stimulate cooperative efforts to improve treatment and to develop more effective therapies for brain tumors. Approximately $2,200,000 in total costs per year for five years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that new and/or competing continuation awards will be made to between five and eight individual members of each of two consortia. 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, Consortium Therapeutic Studies of Primary Central Nervous System Malignancies in Adults, 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 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Richard Kaplan Division of Cancer Treatment Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 734 - MSC 7436 Bethesda, MD 20892-7436 Telephone: (301) 496-2522 FAX: (301) 402-0557 Email: KAPLANR@DCT.NCI.NIH.GOV $$R2 END ************************************************************ $$R3 BEGIN HD-96-008 FULL-TEXT ************************************** SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH NIH GUIDE, Volume 25, Number 40, November 22, 1996 RFA AVAILABLE: HD-96-008 P.T. 04; K.W. 0413002, 1002042 National Institute of Child Health and Human Development Letter of Intent Receipt Date: January 8, 1997 Application Receipt Date: May 15, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) through the Reproductive Sciences Branch (RSB) in the Center for Population Research (CPR) provides funding for a limited number of research centers in the reproductive sciences. These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality research programs in the reproductive sciences. Applications for cooperative specialized centers (U54) are sought from investigators willing to participate with the NICHD under a cooperative agreement in a multicenter cooperative research program. Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and between centers. Such a cooperative program will form a national network that fosters communication, innovation and research excellence with the ultimate goal of improving human reproductive health through accelerated transfer of basic science findings into clinical practice. It is anticipated that $3.1 million will be available to support up to four Centers in FY 1998. 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), Specialized Cooperative Centers Program in Reproduction Research, is related to the priority area of family planning. 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 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and e-mail from the program contact listed below. Louis V. DePaolo, Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: depaolol@hd01.nichd.nih.gov $$R3 END ************************************************************ From owner-sci-resources@net.bio.net Mon Nov 25 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 23 November 1996 Date: 25 Nov 1996 17:07:18 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 106 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <57dfs6$s3d@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending November 23, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Recruit Title: Assistant Director of Mathematical and Physical Sciences (MPS) File size (bytes): 5295 STIS Filename: vep970a.txt Title: Astronomer (Program Director for Extragalactic Astronomy and Cosmology) File size (bytes): 5510 STIS Filename: vex971.txt Title: Science Education Analyst File size (bytes): 7498 STIS Filename: vex972.txt Document Type: Report Title: NSF-car96p Fiscal Year 1996 Career Program Awards (by program) File size (bytes): 990 STIS Filename: nsfcar6p.txt Also available: nsfcar6p.xls Title: NSF-car96 Fiscal Year 1996 Career Program Awards (by state/university) File size (bytes): 998 STIS Filename: nsfcar96.txt Also available: nsfcar96.xls Title: OIG 96-3508 -- Cincinnati Inspection Report File size (bytes): 109060 STIS Filename: oig63508.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 90042 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 112861 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 128990 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 96-131--Program for Women and Girls in Science, Engineering, and Mathematics File size (bytes): 69183 STIS Filename: nsf96131.txt Also available: nsf96131.pdf ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. 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From owner-sci-resources@net.bio.net Mon Nov 25 22:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-002 - V25(40) 11/22/96 Date: 26 Nov 1996 14:43:13 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1287 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <57frq1$2pb@net.bio.net> NNTP-Posting-Host: net.bio.net CONSORTIUM THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVOUS SYSTEM MALIGNANCIES IN ADULTS NIH GUIDE, Volume 25, Number 40, November 22, 1996 RFA: CA-97-002 P.T. 34; K.W. 0705055, 0715035, 0740020 National Cancer Institute Letter of Intent Receipt Date: January 24, 1997 Application Receipt Date: March 13, 1997 PURPOSE The Cancer Therapy Evaluation Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Treatment Diagnosis and Centers (DCTDC) at the National Cancer Institute (NCI) invite applications for cooperative agreements (U01) from consortia of institutions to perform Phase I and II clinical evaluations of promising new therapeutic agents or approaches for the treatment of primary central nervous system (CNS) malignancies in adult patients, especially glioblastoma multiform and other high grade gliomas, and to perform ancillary laboratory studies of aspects of CNS tumor biology with potential clinical implications. The NCI is seeking talented scientists from academic, non-profit and for-profit research organizations who will interact with other members of the consortium, and with NCI in a concerted way to conceive, create, and evaluate new approaches to the therapy of CNS tumors. Integrated packages of individual applications are encouraged, with the lead institution of a proposed consortium indicating which participating institutions will provide organizational support, scientific leadership, laboratory capabilities, and/or patient resources. Each consortium of institutions will be referred to as a CNS Consortium (CNSC) for the purpose of this RFA. The purpose of the proposed awards is to stimulate cooperative efforts to improve treatment and to develop more effective therapies for brain tumors. 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, Consortium Therapeutic Studies of Primary Central Nervous System Malignancies in Adults, 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 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by North American non-profit and for-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, women, and persons with disabilities are encouraged. It is essential that applications be submitted as an integrated package from a team or consortium (CNSC) of medical institutions (a minimum of five Participant Member Institutions that agree to work together with a single Project Leader and a single administrative structure, and submit applications that will be reviewed in relation to the consortium. Eligible institutions may apply for any or all of the following types of award: (1) Participant Member Institution; (2) Central Operations Office/Coordinating Center; (3) Pharmacokinetics Laboratory. Participant Member Institution and Central Operations Office/Coordinating Center applications must be submitted separately, but the pharmacokinetics lab activity may be submitted separately or be combined with either of the other types in a single application. Together, the institutions in the consortium would encompass experience in investigational drug clinical trials, access to sufficient numbers of primary CNS tumor (glioma) patients to enter 60 to 80 fully evaluable cases per year and complete three to four Phase I and II protocols, expertise in laboratory investigation of the biology of human gliomas, and access to a Central Operations Office for coordination of research activities and data analysis. Ordinarily, the Central Operations Office/Coordinating Center would be expected to reside at the Project Leader's institution. Detailed requirements are listed below in Terms and Conditions of Award, Awardee Rights and Responsibilities. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an "assistance" mechanism, in which substantial NCI scientific and/or programmatic collaboration with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activity by working jointly with the award recipient in a partner role, but is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreements(s) are discussed later in this document under the section "Terms and Conditions of Award". Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. The total project period for each application submitted in response to the RFA may not exceed five years. The earliest anticipated award date is December 1, 1997. At this time, the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE Approximately $2,200,000 in total costs per year for five years will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that new and/or competing continuation awards will be made to between five and eight individual members of each of two consortia, although larger consortia will be considered with justification. Because of the variation in numbers of patients to be accrued and the type of award, it is anticipated that the size of Participant Member Institution awards will vary. It is anticipated that the Central Operations Office/Coordinating Center will require approximately $250,000-$300,000 direct costs per year (of which $100,000 is reserved for a Discretionary Fund for laboratory studies and the shipping of patient specimens). RESEARCH OBJECTIVES A. Background Primary malignant brain tumors occur in approximately 18,000 adults annually in the US and have been increasing in incidence, especially in the elderly. Meaningful therapeutic improvement has been made for the less common histologic types such as ependymomas, oligodendrogliomas, and CNS lymphomas. However, for the largest category, astrocytomas of various grades, little progress has been made. Aggressive multimodality therapy has been shown to improve short term survival by two- to three-fold, but average survival for patients with high-grade gliomas is only 9-15 months and, despite the fact that these cancers rarely metastasize, they remain essentially 100 percent lethal. Limited therapeutic success is related to many factors, including the unique biology of high grade gliomas and the susceptibility of adjacent normal brain to adverse effects of treatment. There has also been an extremely limited number of identified agents with therapeutic activity, which may well be due to inherent resistance to the classes of agents that have been available. However, in part, it may also reflect the fact that relatively few compounds have received thorough clinical evaluation. In addition, clinical trials have been hampered by the fact that tumor status, the adverse sequelae of therapy, and the effects of ancillary treatments (such as steroids) are very challenging to segregate when assessed either by clinical examination or conventional diagnostic imaging. Optimal response evaluation and management of these patients continues to require complex and well coordinated interdisciplinary management involving neurosurgeons, neurologists, medical and radiation oncologists, neuroradiologists, and neuropathologists, so that relatively few programs have been optimally suited to undertake such trials. Clinical investigations of new strategies to treat such tumors are needed. Collaborative interactions between clinicians and laboratory scientists and between clinicians and diagnostic imagers are essential features of these investigations. The special skills of experienced tumor neurosurgeons, neuro-oncologists, radiation therapists, and neuroradiologists with access to the latest generation of imaging equipment will be required. NCI is therefore seeking multidisciplinary and multi institutional teams of talented scientists from non-profit and for-profit research organizations who will interact with CTEP and RRP in a concerted way to conceive, create, and evaluate new approaches to therapy of CNS malignancies. Scientific approaches should be broad and reflect the creativity and capabilities of team participants, including surgical, medical, radiotherapeutic, diagnostic imaging, laboratory and statistical skills. New clinical research opportunities exist with the development of novel cytotoxic drugs, drug resistance inhibitors, radiation enhancers, radiosurgery techniques, antiangiogenic agents, signal transduction inhibitors, antisense oligonucleotides, differentiating agents, immune modulators, antibody-based approaches, regional delivery techniques, and new approaches to gene therapy. Team objectives and approaches will be investigator-originated but consistent with program aims of improving the survival and quality of life for persons with primary CNS malignancies and providing fundamental insights into the biology of these tumors. B. Definitions COOPERATIVE AGREEMENT - An assistance mechanism in which substantial NCI programmatic involvement with the recipient is anticipated during performance of the planned activity. CENTRAL NERVOUS SYSTEM CONSORTIUM (CNSC) - The consortium of institutions (minimum of five members) who are submitting research grant applications together to conduct Phase I/II clinical trials and ancillary laboratory studies. Each CNSC also contains an application for a Central Operations Office/Coordinating Center. Each consortium will consist of talented and experienced individuals in multiple disciplines (e.g. medical oncology, neurosurgery, neurology, radiotherapy, radiobiology, pharmacology, molecular biology, pathology, biostatistics). CENTRAL OPERATIONS OFFICE/COORDINATING CENTER - An administrative unit that coordinates all CNSC activities. Responsibilities include administrative management, coordination of protocol development and submission, study conduct, quality control and protocol performance monitoring, statistical analyses, adherence to requirements regarding NCI drug accountability and FDA, OPRR and HHS regulations, and protocol and institutional performance reporting. Statistical responsibilities include experimental design, participation in study planning and coordination, collection and analysis of patient and laboratory data, data management and analysis, data monitoring, and reporting of data. The Central Operations Office/Coordinating Center may consist of a consortium with the statistics center located at another institution. PROJECT LEADER - The person who submits the application for the Central Operations Office/Coordinating Center and who is responsible for the CNSC as a whole. The consortium of Participant Member Institutions must agree to work together with the Project Leader. The Project Leader is responsible for coordinating the CNSC activities scientifically and administratively. The Project Leader may also be the principal investigator on a Participant Member Institution application. PARTICIPANT MEMBER INSTITUTION - The individual research grant application from an institution who is participating in the CNSC. The Participant Member Institution may conduct clinical trials and/or laboratory studies. PRINCIPAL INVESTIGATOR - The person who submits the single application for the Participant Member Institution and who is responsible for performance of the key personnel of that application. The Principal Investigator (PI) provides the scientific leadership for the Participant Member Institution. NCI PROGRAM DIRECTOR - The CTEP extramural grants staff member (cited in the INQUIRIES SECTION) who will coordinate DCTDC interactions and provide guidance for the overall program within the NCI. He/she is available for consultation during preparation of applications, as well as throughout the course of the research conducted under these cooperative agreements. He/she also serves in a back-up role for the NCI Scientific Coordinator. NCI SCIENTIFIC COORDINATOR - The Senior Investigator, Clinical Investigations Branch, CTEP, DCTDC, NCI, who interacts scientifically with the Applicant/Awardee Institutions. STEERING COMMITTEE - Each consortium's steering committee will be composed of the Project Leader, PIs, the NCI Scientific Coordinator, and the NCI Program Director, and will be the main oversight body of the consortium. DISCRETIONARY FUND - A fixed portion ($100,000) of the award to the Central Operations Office/Coordinating Center that will be allocated according to the instructions of the Steering Committee. Appropriate uses may include seed funding for laboratory projects, shipment of samples, supplementation of existing budgets for patient accrual or special clinical costs, auditing of clinical trials, or other purposes. C. RESEARCH GOALS AND SCOPE The primary goal of this initiative is to stimulate clinical research in the treatment of primary CNS malignancies in adult patients by providing support for consortia of institutions to take advantage of promising new developments and perform Phase I and II clinical evaluations of innovative approaches or agents. A secondary goal is to utilize the consortia as a mechanism for sharing human brain tumor specimens among investigators conducting laboratory studies relevant to the biology, clinical behavior, or therapy of CNS tumors, particularly malignant gliomas. Each CNSC will be formed for the purpose of: (1) sharing expertise of researchers in multiple disciplines; (2) conducting joint phase I and II clinical trials to provide adequate patient populations and timely completion; and (3) sharing of tumor specimens and data useful in the conduct of clinical pharmacologic and correlative laboratory studies. Participant Member Institutions in the proposed consortium may be involved in clinical trials and/or laboratory studies. It is anticipated that two consortia will be established, comprising a total of 10-16 institutions. Each CNSC will select the specific agents to be tested in accord with their scientific interest and expertise and will develop a series of appropriate Phase I or Phase II trials with supporting protocol documents. Each applicant CNSC should submit as examples one or more draft clinical protocols as supplements to the Central Operations Office/Coordinating Center (Project Leader) and the Participant Member Institution applications. Each CNSC must be able to document access to adequate numbers of patients with CNS tumors and a history of accrual of patients to clinical trials adequate to support three-four phase I or II trials (60-80+ patients) per year. In addition, proposed consortia must have: (1) adequate radiotherapy support for clinical trials utilizing radiation in combination with other modalities; (2) adequate central data collection and processing capabilities as well as biostatistical expertise; (3) adequate pathology support for both institutional tumor classification and central neuropathology review and for banking and distribution of tumor tissues for concurrent and future laboratory studies; (4) mechanisms to collect and store patient specimens for laboratory studies being conducted by institutions in the CNSC; (5) expertise in antineoplastic drug pharmacology/pharmacokinetics. Each CNSC, with the assistance of the NCI Scientific Coordinator and Program Director, will develop a plan for prioritization of investigational trials. The NCI will provide assistance in design of trials and may provide NCI-sponsored IND agents or provide assistance to the awardee(s) by sponsoring or cross-referencing INDs for selected agents. A CNSC may also carry out some of its trials with agents that are not sponsored by NCI. The correlative laboratory research program in a CNSC should have demonstrable capability to address at least one field of research into the biology of human malignant gliomas with some potential for future clinical relevance. Examples of research fields for laboratory studies include: molecular genetics and cytogenetics, gene function and expression, signal transduction pathways, radiobiology, growth regulation, metabolism, differentiation and gene modulation by investigational agents, intracellular metabolism, mechanisms of drug resistance in tumor cells, CNS pharmacokinetics, invasion and spread, cytokine production or interactions, immune function and antigen expression, or other aspects that may have clinical implications or lead to new therapeutic approaches. It is not expected that funding for these clinical consortia will be adequate to support to completion high quality laboratory projects (other than pharmacokinetic projects directly linked to the clinical protocols). Some funding for lab pilot studies will be available through the CNSC Discretionary Fund. However, the expectation is that investigators from within the consortium membership will have in place or will seek other funding for laboratory projects that can draw upon and utilize the substantial tissue and clinical data resources of the CNSCs. The intent is that each CNSC should establish under these cooperative agreements an infrastructure that will promote this type of interaction. Correlative laboratory studies need not be directly related to individual clinical Phase I/II trials but should attempt to utilize the large clinical database that will be generated by the consortium to identify potential correlates of tumor behavior. Laboratory studies should naturally be based on strong and testable hypotheses. Within the CNSC package of applications, there should be an initial plan for developing one or more laboratory programs that can utilize the resources provided by the CNSCs clinical trials. A clear rationale should be given for the experimental design and technological methodologies selected. Preliminary data from appropriate tumor models or analysis of patient specimens should be provided to support the feasibility of each study. The laboratory assays must utilize tumor specimens from patients and there should be an established plan for prioritization of specimen distribution to collaborating laboratories. Participating institutions primarily involved in laboratory studies may accrue patients on CNSC clinical trials if the minimum clinical resources are in place (See Eligibility Requirements). The cooperative approach outlined in this RFA allows for interactions among successful applicants, with the assistance of NCI extramural staff, to perform Phase I and Phase II trials of therapeutic approaches and ancillary laboratory studies. This mechanism retains the decision-making prerogatives of the Principal Investigator and his/her colleagues, but at the same time, permits the active participation of NCI in research activities. (See Terms and Conditions of Award) SPECIAL REQUIREMENTS A. Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI staff. The role of the NCI staff as described throughout these terms and conditions of award is to facilitate and assist 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 NCI staff listed below has very specific and well defined responsibilities in terms of investigational agent development and the role of DCTDC as a drug sponsor as defined in CFR 21 part 312. These Terms and Conditions of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 74, and other HHS, PHS and NIH grant administration policy statements. Awardee Rights and Responsibilities It is the responsibility of the CNSC to develop the details of the clinical and laboratory research design, including definition of objectives and approaches, planning, implementation, analysis, and publication of results, interpretations and conclusions of studies. The CNSC shall, with CTEP assistance, develop Phase I and II protocols for clinical cancer research in accord with the research interests, abilities and goals of the CNSC, and submit them to CTEP for review as appropriate prior to their implementation. 1. Protocol Development It is anticipated that decisions in all CNSC activities will be reached by consensus of the collaborating member institutions under the leadership of the CNSC Project Leader. The Project Leader shall designate a Protocol Chairperson for each proposed study. The Project Leader along with coordinating Central Operations Office/Coordinating Center staff will be responsible for communication with the appropriate CTEP staff. 2. The CNSC Central Operations Office/Coordinating Center The CNSC Central Operations Office/Coordinating Center, under the leadership of the Project Leader and with CTEP assistance, is responsible for coordinating protocol development, protocol submission, study conduct, quality control and study monitoring, drug ordering, data management, statistical analysis, protocol amendments/status changes, adherence to requirements regarding investigational drug management and federally mandated regulations and protocol and performance reporting. All the scientific and administrative decisions related to the CNSC funded activities and made by the CNSC institutions or affiliates will be coordinated by the Project Leader with the assistance of the CNSC Central Operations Office/Coordinating Center. 3. Protocol Submission The CNSC Central Operations Office/Coordinating Center, under the leadership of the Project Leader, will submit CNSC protocols to the CTEP Protocol and Information Office in a timely fashion for review and approval by NCI. It is recommended that protocols involving NCI sponsored agents be preceded by a written Letter of Intent (LOI) from the CNSC 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 will be developed and submitted and studies will be conducted in accordance with the DCTDC "Investigator's Handbook" (available upon request from the Program Director at the address below). The Project Leader, with the assistance of the Central Operations Office/Coordinating Center staff, will communicate the results of the NCI review of protocols to the CNSC Participant Member Institutions. 4. Prioritization of Studies The CNSC Project Leader and the Principal Investigators of the Participant Member Institutions will develop, together with the NCI Scientific Coordinator and Program Director, mutually acceptable plans for prioritization of clinical protocols, laboratory studies, and distribution of clinical specimens and tissues. 5. Quality Control The CNSC 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) Neurosurgery: Assessment of adequacy of protocol-specified surgical procedures (where relevant) through review of operative notes and study-specific surgical forms. e) Diagnostic Imaging: Central review of claimed responses and adequacy of imaging. 6. Study Monitoring The CNSC will establish mechanisms for study monitoring. The CNSC is responsible for assuring accurate and timely knowledge of the progress of each study through: a) establishing procedures for assigning dose level at the time a new patient is entered, and assuring that the required observation period has elapsed before beginning a higher dose level; b) registration, tracking and reporting of patient accrual and adherence to defined accrual goals; appropriate attempts to accrue patients who fulfill NIH Guidelines for accrual of women and minorities to clinical trials with appropriate documentation and reporting of accrual as specified by NIH Guidelines; c) ongoing assessment of case eligibility and evaluability; d) timely medical review and assessment of patient data; e) 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; g) timely communication of results of studies; 7. Data Management and Analysis The CNSC will develop procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) as simple as appropriate in order to encourage maximum participation of physicians entering patients and to avoid unnecessary expense; and (3) coordinated across the participating institutions. 8. Investigational Drug Management Investigators performing trials under cooperative agreements involving DCTDC Investigational Agents must be NCI registered investigators (form 1572) and will be expected to implement CTEP requirements described in the DCTDC 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. 9. CNSC Compliance with Federally Mandated Regulatory Requirements The CNSC 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 each institution where investigators are conducting CNSC 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 each investigator is registered with the Drug Management and Authorization Section (DMAS), CTEP, with a current 1572 form 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 Investigational Drug Branch (IDB), CTEP according to CTEP guidelines (mailed annually to all registered investigators). This requires reporting Adverse Event Reactions (AERs) 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) a system for ensuring that the data required for the conduct and auditing of clinical trials with DCTDC-sponsored investigational agents (see DCTDC Investigator's Handbook) is provided to the Clinical Trials Monitoring Service, an NCI contractor. 10. Progress Review The CNSC will establish a mechanism for assessing performance of its members, with particular attention to accrual of adequate number of eligible patients onto consortium trials, timely submission of required data, conscientious observance of protocol requirements, authorship and participation in group leadership. 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. 11. Attendance at Meetings The CNSC Project Leader and appropriate representative(s) of the CNSC participating member institutions , shall meet twice a year with the NCI Scientific Coordinator and Program Director to review CNSC progress, establish priorities, and plan future activities. Additional meetings between the NCI staff and the Project Leader will be held if necessary. 12. 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, data 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. 13. Publication of Data Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment 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. NCI Staff Responsibilities It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Director and NCI Scientific Coordinator. The NCI Program Director and Scientific Coordinator will be the main contact points for all facets of the scientific interaction with the awardees. Two NCI staff are required for the coordination of activities, to expedite progress, and to provide advice to the awardee on specific scientific and/or analytic issues in addition to programmatic issues. 1. CTEP as a Scientific Resource for NCI-supported Phase I and II Clinical Trials Investigations The NCI Scientific Coordinator will serve as a resource available to the for scientific information with respect to treatment regimens and clinical trial design. The NCI Scientific Coordinator will assist the CNSC as appropriate in developing information concerning the scientific basis for specific trials and also will be responsible for advising the CNSC of the nature and results of relevant trials being carried out nationally or internationally. The NCI Program Director and Scientific Coordinator will sponsor an initial strategy meeting with the awardees to review the research plans proposed 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 NCI Scientific Coordinator and Program Director will also sponsor strategy meetings as needed, to be attended by investigators in the CNSC and other investigators as appropriate. At these meetings relevant information will be reviewed, national research goals discussed, and the outstanding research questions established and prioritized by the CNSC investigators. The NCI Scientific Coordinator will also provide updated information on the efficacy and toxicity of investigational new agents supplied to the CNSC under an Investigational New Drug (IND) Application sponsored by the DCTDC. 2. CTEP Assistance in Protocol Development The protocol must be a detailed written plan of a clinical experiment mutually acceptable to the proposing CNSC and to the CTEP Protocol Review Committee (PRC). Communication at the various stages of protocol development is encouraged as necessary to promote protocol development and implementation. It is recommended that protocols utilizing NCI-sponsored agents be preceded by a written Letter of Intent (LOI) from the CNSC declaring interest in conducting a particular study. The PRC will formally review the LOI. Following review, the NCI Scientific Coordinator will provide a Program response to the CNSC 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; (d) the PRC's assessment of the scientific rationale and value of the proposed study, its design, and 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 DCTDC Investigator's Handbook, pp 32-35, available on request from the NCI Program Director at the address below, for further discussion of these mechanisms). 3. CTEP Review of Proposed Protocols All CNSC protocols, including protocols utilizing agents not sponsored by NCI, will be reviewed by the PRC, which meets weekly and is chaired by the Associate Director, CTEP. Ad hoc reviewers, external t