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 i