From owner-sci-resources@net.bio.net Sun Oct 06 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 5 October 1996 Date: 7 Oct 1996 14:47:02 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 107 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <53btom$sqs@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 October 5, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-35 TRM 96-25 Outline of JFY 1997 Government Budget Requested for Science and Technology File size (bytes): 4882 STIS Filename: int9635.txt Title: INT 96-36 Development of Control Systems for High Speed, High Accuracy Direct-Drive Electronic Motors File size (bytes): 6384 STIS Filename: int9636.txt Document Type: Program Guideline Title: (NSF 96-145) NSF CONACyT Collaborative Research Opportunities. File size (bytes): 9973 STIS Filename: nsf96145.txt Title: NSF 96-153 --GRANTS FOR SCIENTIFIC COMPUTING RESEARCH ENVIRONMENTS FOR THE MATHEMATICAL SCIENCES File size (bytes): 19315 STIS Filename: nsf96153.txt Document Type: Recruit Title: Office Automation Clerk File size (bytes): 8976 STIS Filename: vgs972.txt Title: Program Assistant (Office Automation) File size (bytes): 9263 STIS Filename: vgs973.txt Title: Property Disposal Specialist File size (bytes): 7296 STIS Filename: vgs975.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 12097 STIS Filename: cmmtg.txt Title: NSF Advisory Committee Meetings File size (bytes): 12097 STIS Filename: cmmtg.txt Document Type: Program Guideline Title: NSF 95-155 - Research Opportunity File size (bytes): Cooperative Studies Of The Earth's Deep Interior (CSEDI) STIS Filename: nsf95155.txt (NSF) Document Type: Report Title: NSF 96-139 -- SHAPING THE FUTURE File size (bytes): New Expectations for Undergraduate Education in Science, Mathematics, Engineering, and Technology STIS Filename: nsf96139.txt (NSF) ------------------------------------------------------------------------ ** 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 nsf96139.txt, the text of your message should be as follows: get nsf96139.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf96139.txt, you would enter: ftp> get nsf96139.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 Mon Oct 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 33, pt. 1of1, 4 October 1996 Date: 8 Oct 1996 12:32:03 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 913 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <53ea7j$6b8@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: PA-96-076, PA-96-078, PA-96-079 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.10.04 NIH GUIDE - Vol. 25, No. 33 - October 4, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** MODIFIED COMPETING AND NONCOMPETING APPLICATION INSTRUCTION - ADDENDUM National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N2 ********************************************************** IMPLEMENTATION OF POLICIES FOR HUMAN INTERVENTION STUDIES National Institute on Aging INDEX: AGING $$INDEX N3 ********************************************************** NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM SPECIAL EMPHASIS AREAS National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX P1 ********************************************************** ANABOLIC HORMONES IN BONE: BASIC RESEARCH AND THERAPEUTIC POTENTIAL (PA-96-076) National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Dental Research National Institute on Aging INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; DENTAL RESEARCH; AGING $$INDEX P2 ********************************************************** NOVEL HIV VACCINE DESIGN (PA-96-078) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX P3 ********************************************************** ONTOGENY AND DIFFERENTIATION OF THE LIVER AND BILIARY TREE (PA-96-079) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES ERRATA $$INDEX E1 ********************************************************** TUBERCULOSIS ACADEMIC AWARD (RFA HL-96-022) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD 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 ********************************************************** MODIFIED COMPETING AND NONCOMPETING APPLICATION INSTRUCTIONS - ADDENDUM NIH GUIDE, Volume 25, Number 33, October 4, 1996 P.T. 34; K.W. 1014006 National Institutes of Health The following clarification is provided for the notice, which appeared in the NIH Guide, Vol. 25, No. 32, September 27, 1996. Applicants are strongly encouraged, to the extent possible, to follow the new procedures for the October 1 submission date. Applications not following the new procedures will be accepted for the October, 1996, submission. The Referral Office Division of Research Grants will take the necessary steps to remove the SSN from the application face page. However, applicants must follow the new procedures for receipt dates beyond October 1. INQUIRIES Questions regarding these procedures may be directed to the Referral Office, Division of Research Grants at 301/435-0715 for issues relating to receipt of competing applications, or to Institute or Center grants management offices for issues relating to noncompeting applications. $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** IMPLEMENTATION OF POLICIES FOR HUMAN INTERVENTION STUDIES NIH GUIDE, Volume 25, Number 33, October 4, 1996 P.T. 34; K.W. 0785035, 0783005, 0715175 National Institute on Aging INTRODUCTION The following policies are based on two goals: Protecting the safety of participants in intervention studies. This goal applies to any study including an intervention that could have harmful effects, whether or not the study is a Phase III trial or a more limited intervention study. Policies to achieve it are described in the "Safety Policies" section. Assuring that trials likely to affect clinical or public health practice (Phase III trials) are soundly conducted and analyzed. This goal serves to prevent inappropriate implementation of non-efficacious or harmful interventions (or inappropriate failure to implement efficacious interventions) in practice, based on the results of a trial. Policies to achieve it are in the "Data Integrity/Quality Control Policies for Phase III Trials" section. These policies describe NIA requirements for extramurally supported projects. They apply to all new projects to be submitted for the June 1, 1996 receipt deadline and all subsequent deadlines. They do not replace existing NIH regulations on protection of human subjects, policies and guidelines for conduct of clinical research, inclusion of women and minorities, research project administration, reporting, and financial management, or requirements of local Institutional Review Boards. DHHS regulations for the protection of human subjects are described in 45 CFR46. The implementation of these regulations for PHS research grants involving human subjects is found in the PHS 398 form (rev. 5/95), available on the NIH home page (HTTP://www.nih.gov). This NIA policy document describes further steps to be taken to ensure the protection of human subjects when the study involves a potentially harmful intervention, and for other Phase III studies to ensure that participants receive an appropriate share of the benefits. In individual cases, the NIA may find it beneficial to have additional levels of involvement or oversight beyond those described in these policies. SAFETY POLICIES Applications for any intervention study should state (per the instructions for the "Human Subjects" section of the PHS-398 form) whether or not the proposed study intervention could have harmful effects, and the basis for that opinion. After review of the application by an Initial Review Group (IRG), the Program Administrator will review the risks of the intervention. If the proposal for a study with a potentially hazardous intervention does not include the required information for such studies (described below) NIA will not fund the project until this information is received and reviewed by the Program Administrator. The Program Administrator may obtain additional consultation from IRG members (acting through the appropriate Scientific Review Administrator [SRA]), NIH staff or members of the National Advisory Council on Aging (NACA). The following requirements apply to studies employing interventions that could have significant harmful effects: Requirements for Investigators (design and plans for implementation must be included in application): All studies should have a structured adverse event determination, monitoring and reporting system, including standardized forms and protocols for referring and/or treating subjects experiencing adverse events. The proposed schedule for reporting adverse events to the Safety Monitoring Board (if one is established), the Program Administrator and/or the FDA should be described. The proposed human subjects consent form should be included in the application. All masked studies should describe randomization scheme, and specific criteria and procedures for unmasking. If a Safety Monitoring Board (SMB) is not proposed, the application should also designate individuals for access to unmasked data. If the applicants believe that an independent Safety Monitoring Board is required for adequate subject safety, the application should indicate the proposed frequency of meetings for the SMB, and include a proposed list of data items to be provided to the SMB and estimates for SMB-related expenses in the proposed project budget. Applicants should NOT nominate specific individuals for the SMB in the application. If notified by the Program Administrator that the project is likely to be funded, the investigators should then nominate prospective SMB members, subject to approval by the Director of the NIA. If applicants have not proposed an SMB, but prior to funding of the proposed project, the Program Administrator believes an independent SMB is required, applicants will make arrangements for an SMB as described on page 3 (Requirements for Program Administrators). Responsibilities of Safety Monitoring Boards (SMBs). If an SMB is established, its initial tasks are to review the protocol with regard to subject safety (including identification and formatting of data to be regularly reported to the SMB); identify needs for protocol modification; and, after receipt of a satisfactory protocol, recommend to the NIA initiation of expenditure of project funds. Subsequently, it must meet on a regular schedule (not less than twice a year) over the course of study (with additional meetings as needed) to: o Review data (including masked data) relating to recruitment, randomization, compliance, retention, protocol adherence, trials operating procedures, form completion, intervention effects, and subject safety. o Identify problems relating to safety over the course of the study. o Identify needs for additional data relevant to safety issues and request these data from the study investigators. o Propose appropriate analyses and periodically review developing data on safety and endpoints o Make recommendations on continuation of the study, in regard to recruitment, retention, compliance and safety issues. o Send the Program Administrator written reports following each SMB meeting, and additionally as needed, on all issues reviewed by the SMB. Requirements for Program Administrator. For applications receiving a peer review rating that is potentially in the fundable range, the Program Administrator will review the risks of the intervention. If the information required in applications for studies having potentially hazardous interventions (described above) is not included in the application, the Program Administrator will notify the applicant of what items are missing and indicate that NIA will not fund the project until this information is received, reviewed and approved by the Program Administrator. The Program Administrator may obtain additional consultation from IRG members (acting through the appropriate SRA), NIH staff or members of the National Advisory Council on Aging (NACA). If the NIA plans to fund the proposed project, and the applicant has not proposed a SMB, the Program Administrator will determine whether or not an SMB is required for adequate subject safety. If an SMB is required, the Program Administrator will request the applicant to indicate the proposed frequency of meetings for an SMB; to submit a proposed list of data items to be provided to the SMB; to nominate an SMB of no less than three persons subject to approval by the Director of NIA; and to submit a proposed supplemental budget for travel and administrative expenses for the SMB. The NIA will reserve the right to appoint additional members to the SMB to include scientific expertise in topic areas relevant to the trial such as biostatistics, ethics, or patient advocacy. For funded awards, the Program Administrator will: o Institute any appropriate terms in the award needed for subject safety (e.g. data reporting formats and schedules, restrictions on expenditure of funds pending completion of particular activities, etc.). o Review regular reports of data (including masked data if needed) on adverse events. o Request additional data from investigators as needed on safety issues arising over the course of the study. o Upon receipt of noncompeting renewal applications (and more frequently if necessary), review rationale for continuation of study, and terminate award if recommended by the SMB and/or the Director of NIA (e.g., inadequate recruitment, retention or compliance, or excessive adverse events). For studies with SMBs, the Program Administrator will also: o Review proposed membership of SMB before approving initiation of expenditure of award funds. o Review SMB reports. o Request advice of SMB as needed on study protocol and safety issues arising over course of study, and advisability of terminating the study. o Facilitate implementation of SMB recommendations by the Institute DATA INTEGRITY/QUALITY CONTROL POLICIES FOR PHASE III STUDIES A Phase III Clinical Trial, as defined on page 29 of the PHS 398 form (rev. 5/95), is any broadly based prospective study evaluating an experimental intervention with a control or standard, or comparing two or more existing treatments or interventions where the outcome of the study is likely to contribute to change in either standard of care or public health policy. Applications for any intervention study should state in the "Research Plan section" of the PHS-398 form whether or not the proposed study meets NIH's criteria for a Phase III trial and the basis for that opinion. After review of the application by an IRG, the NIA Program Administrator will review this information. If the proposal for a study deemed by NIA to be a Phase III trial does not include the required information for such studies (described below) NIA will not fund the project until this information is received and reviewed by the Program Administrator. The Program Administrator may obtain additional consultation from IRG members (acting through the appropriate SRA), NIH staff, or members of the National Advisory Council on Aging (NACA). The following requirements apply to Phase III trials: Requirements for Investigators (design and plans for implementation must be included in the application). The proposed trial must include: o Explicit criteria and procedures for defining, determining, and reporting intervention-related outcomes. o A data processing and analysis unit or function administered by a designated individual other than the Principal Investigator(s)of the trial. (In the case of multiple-award studies, the designated individual may be the Principal Investigator of an administratively separate award). This individual may report to the Principal Investigator, or, in multiple-award studies, may report to the steering committee, of which the Program Administrator is a member. In all cases, all data from this unit must be directly available to the Program Administrator and the DSMB upon request. o An independent Data and Safety Monitoring Board (DSMB). The application should indicate the proposed frequency of meetings for the DSMB, and include a proposed list of data items to be provided to the DSMB and estimates for DSMB-related expenses in the proposed project budget. Applicants should NOT nominate specific individuals for the DSMB in the application. If notified by the Program Administrator that the project is likely to be funded, the investigators should then nominate prospective DSMB members, subject to approval by the Director of NIA. o The proposed human subjects consent form. o Protocols for quality assurance/quality control, data management, and analysis. o A structured adverse event determination, monitoring and reporting system, including standardized forms and protocols for referring and/or treating subjects experiencing adverse events. The proposed schedule for reporting adverse events to the Data and Safety Monitoring Board and Program Administrator should be described. o Specific criteria and procedures for unmasking (if the study is masked). o Plans for independent auditing of primary subject records over the course of the trial to verify conformance with eligibility criteria, recruitment and outcome data, adverse events, etc., and reporting discrepancies to the Principal Investigator, the DSMB, and the Program Administrator. These plans should provide for reporting serious discrepancies within two weeks of their discovery. o A detailed Manual of Procedures. This is not required in the application submitted to peer review. If an award is made, the applicant should prepare the Manual of Procedures for review by the Data and Safety Monitoring Board and Program Administrator, prior to implementation of the trial. o Plans for notifying subjects of trial results after the conclusion of the trial. Responsibilities of the Data and Safety Monitoring Board (DSMB). The DSMB will report to the Director of the NIA. The initial task of the DSMB is to review the entire study protocol, the Manual of Procedures, and the informed consent form with regard to recruitment, randomization, intervention, subject safety, data management, plans for auditing of primary subject records, quality control and analysis, and to identify needed modifications. The DSMB shall then identify the relevant data parameters and the format of the information to be regularly reported. If the need for modifications to the protocol, Manual of Procedures, consent form, etc., are indicated by the DSMB and/or the program administrator, the DSMB shall postpone its recommendation (to the NIA and the grantee) for the initiation of expenditure of project funds until after the receipt of satisfactory revised protocol(s), etc. DSMB meetings will be open only to NIA staff and designated individuals who have been approved to have access to unmasked data. The DSMB shall meet on a regular schedule over the course of study (at least twice a year), with additional meetings as needed, to: o Review data (including masked data) over the course of the trial relating to recruitment, randomization, compliance, retention, protocol adherence, intervention effects, data management and quality assurance/quality control, and subject safety. o Identify any problems relating to the above issues. o Identify needs for additional data, and request these data from the study investigators. o Review unmasked outcome data as needed and appropriate over the course of the trial. o At each meeting, consider the rationale for continuation of the study, with respect to progress of randomization, retention, protocol adherence, data management, safety issues, and outcome data, if relevant, and make recommendation for or against continuation of the trial. o Provide advice on issues regarding data discrepancies found by the data auditing system or other sources. If this advice is requested by the Project Office/Program Administrator, it should be provided in writing within two weeks of the date of this request. o Send written reports following each DSMB meeting on all issues reviewed by the DSMB as needed to the Program Administrator and Director of NIA o Review manuscripts of trial results prior to submission for publication (at the request of the program administrator) Requirements for the Program Administrator: After review of the application by an IRG, the Program Administrator will assess whether the study meets NIH criteria for a Phase III trial. If the information required in applications for Phase III trials (described above) is not included in the application, the Program Administrator will notify the applicant of what items are missing and indicate that NIA will not fund the project until this information is reviewed and approved by the Program Administrator. The Program Administrator may obtain additional consultation from IRG members (acting through the appropriate SRA), NIH staff, or members of the National Advisory Council on Aging (NACA). For Phase III trial awards, the Program Administrator may: o Review proposed membership of DSMB and recommend endorsement by the Director of NIA before approving initiation of expenditure of award funds. o Institute any appropriate terms in the award needed for subject safety, satisfactory data management, quality, and analysis; recruitment and protocol adherence (e.g., data reporting formats and schedules, restrictions on expenditure of funds pending completion of particular activities, etc.). o Review regular reports of relevant masked group data on treatment effects. o Review DSMB reports. o Request additional data from investigators as needed on safety issues, data management, quality, and analysis; recruitment, retention and protocol adherence issues arising over course of study. o Request advice of the DSMB as needed on trial protocol and safety issues; data management, quality, and analysis; recruitment, retention and protocol adherence issues arising over the course of the study, and on the advisability of continuing the study. o Convey DSMB recommendations and requests to the Principal Investigator(s) o Acknowledge reports of serious data discrepancies found by the data auditing system, the DSMB, or other sources within two weeks of the receipt of this information by the Project Office/Program Administrator. This acknowledgment should be in writing and include a plan describing the steps that are to be taken next, and should be sent to the Principal Investigator, the Chair of the DSMB and the Director of NIA. In addition, in instances of reported fraud or abuse, standing NIH policies apply. o Upon receipt of noncompeting renewal applications and DSMB recommendations (and more frequently if necessary), review rationale for continuation of study, and terminate award if indicated (e.g., inadequate recruitment, retention or protocol adherence or excessive adverse events). o Prepare clinical alert in the event of a clinically significant finding which should be disseminated immediately. o Reserve the option, at any point in the trial, to obtain an independent audit of a sample of primary subject records for comparison with the trial's regular audit reports. Auditors so engaged will report directly to NIA and be reimbursed directly by NIA, i.e. reimbursement will not be drawn from the award for the trial, and costs of such audits will not be borne by the awardee institution(s). o Reserve the option to obtain prior review by the DSMB of manuscripts reporting major outcomes before submission of such manuscripts for publication The Program Administrator may serve as a non-voting, ex officio member of the DSMB. Peer Review of Applications to NIA for Phase III Trials. Applications will be reviewed by an IRG, which includes several members with expertise in clinical trials methodology (including Phase III trials) as well as several members with expertise in the particular topic(s) of the trial. The review will specifically address the adequacy of plans, budgeting, and staffing to implement the requirements listed under "REQUIREMENTS FOR INVESTIGATORS". INQUIRIES The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries are encouraged and may be directed to: Dr. Robin A. Barr or Dr. Miriam Kelty Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Suite 2C218 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Email: RB42H@NIH.GOV Email: MK46U@NIH.GOV $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM SPECIAL EMPHASIS AREAS NIH GUIDE, Volume 25, Number 33, October 4, 1996 P.T. 34; K.W. 0404003, 1002019, 1002030, 0404000, 0745070 National Institute on Alcohol Abuse and Alcoholism PURPOSE This notice is to inform potential applicants of National Institute on Alcohol Abuse and Alcoholism (NIAAA) special emphasis areas that are of high program relevance for development during the next two fiscal years. Formal identification of areas of high program relevance enables the NIAAA to foster emerging areas of science and to encourage submission of applications on these topics. Given fiscal constraints, establishing and publishing priorities to be used as part of a select pay process helps the NIAAA meet program needs and take advantage of scientific opportunities, while still ensuring that high quality applications are funded. These special emphasis areas will be revised, as necessary, based on future developments in the scientific and legislative areas. The NIAAA wants to emphasize that it will continue to fund those projects that are deemed to be scientifically excellent and innovative within the full scope of its mission as described in "NIAAA Extramural Program Descriptions" dated October 1995. This publication is available on the NIAAA Home Page and from the Office of Scientific Affairs as listed under INQUIRIES. It is anticipated that the use of special emphasis areas will reduce the need to publish Requests for Applications (RFAs) and Program Announcements (PAs). The order in which they are listed does not reflect any added priority for a specific area. Full descriptions of the Special Emphasis Areas are available on the NIAAA Home Page. DIVISION OF BASIC RESEARCH o Genetic Linkage and Association Studies on Alcoholism o Alcohol in Cell Development, Differentiation and Death o Alcohol in Cell Signaling and Behavior o Alcohol and Neural Circuits and Behavior o Use of Invertebrates in Alcohol Research DIVISION OF CLINICAL AND PREVENTION RESEARCH o Adolescent Alcoholism Treatment o Prevention of Alcohol Abuse by College Students o The Effectiveness of Court-Ordered Interventions in Reducing DUI Recidivism o Research on Relationships Between Alcohol and Violence o Managed Care and Alcohol Treatment Services o Preventing Alcohol-Related Birth Defects (ARBD) o Behavioral Research o Medications Development o Alcohol Use and Abuse in Rural America GENERAL EXTRAMURAL PROGRAM PRIORITIES - In addition to the above extramural division specific special areas of emphasis, the NIAAA encourages research in all program areas on: o Alcohol Abuse and Women o Alcohol Abuse and Minority Populations o Alcohol Abuse and AIDS o Moderate Alcohol Consumption: Benefits and Risks STATUTORY LEGISLATIVE PRIORITIES - Applicants should also be aware that the NIAAA's statutory authorizing language [at PHS Act Section 464H(b)(3)] authorizes the Director of the NIAAA to make grants giving special consideration to projects relating to: 1. the relationship between alcohol abuse and domestic violence; 2. the effects of alcohol use during pregnancy; 3. the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of health services; 4. the relationship between the abuse of alcohol and other drugs; 5. the effect on the incidence of alcohol abuse and alcoholism of social pressures, legal requirements respecting the use of alcoholic beverages, the cost of such beverages, and the economic status and education of users of such beverages; 6. the interrelationship between alcohol use and other health problems; 7. the comparison of the cost and effectiveness of various treatment methods for alcoholism and alcohol abuse and the effectiveness of prevention and intervention programs for alcoholism and alcohol abuse; and 8. alcoholism and alcohol abuse among women. Another legislative priority is made apparent in Section 464(d)(2) of the PHS Act, which requires the NIAAA to obligate not less than 15 percent of its fiscal year appropriations for health services research relating to alcohol abuse and alcoholism. INQUIRIES Further information on NIAAA research priorities can be obtained from program announcements on the NIAAA Home Page, http://www.niaaa.nih.gov/grants/grants.html, by contact with the appropriate extramural division, and from: Director, Office of Scientific Affairs 6000 Executive Boulevard, Suite 409, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 Email: gosamail@willco.niaaa.nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$P1 BEGIN PA-96-076 FULL-TEXT ************************************** ANABOLIC HORMONES IN BONE: BASIC RESEARCH AND THERAPEUTIC POTENTIAL NIH GUIDE, Volume 25, Number 33, October 4, 1996 PA AVAILABLE: 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 PURPOSE The objective of this initiative is to elicit grant submissions which focus on the role(s) of systemic hormones, local growth factors, and bone-active cytokines which have specific or generalized anabolic effects on bone. While the primary focus is on basic research, the long-term emphasis is on identifying mechanisms or processes related to hormone action with potential applicability as targets for therapeutic agents for the treatment of diseases that adversely affect bone, including osteoporosis and primary hyperparathyroidism. Support mechanisms for this PA will be research project grants (R01) and First Independent Research Support and Transition (FIRST) (R29) awards. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000, n a PHS-led national activity for getting priority areas. This PA, Anabolic Hormones in Bone: Basic Research and Therapeutic Potential, is related to the priority area of chronic disabling conditions. 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), the NIH Website (http://www.nih.gov), or by mail or email from the program official contact listed below. Ronald N. Margolis, Ph.D. Endocrinology Section National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12J Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PA-96-078 FULL-TEXT ************************************** NOVEL HIV VACCINE DESIGN NIH GUIDE, Volume 25, Number 33, October 4, 1996 PA AVAILABLE: PA-96-078 P.T. 34; K.W. 0715008, 0740075 National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Our Program Announcements identify areas of ongoing research emphasis for the NIAID. The purpose of this Program Announcement (PA) is to solicit investigator-initiated research to study novel "high risk - high impact" HIV vaccine concepts in early stages of development. The mechanisms of support will be the individual research project grant (R01), Interactive Research Project Grants (IRPG), the First Independent Research Support Transition (FIRST; R29) award, and the Small Research Grant (R03). Research support may also be obtained through applications for a competitive supplement to ongoing NIH-funded grants. Multidisciplinary approaches that involve collaborative efforts among investigators in the fields of basic immunology, molecular biology, cell biology, biochemistry, and infectious diseases are strongly encouraged. Examples of novel vaccine strategies responsive to this PA would include live virus vectors, bacterial vector-based vaccines, nucleic acid-based immunogens, adjuvants, and conformational (nonlinear) synthetic peptide vaccine approaches. Some examples of relevant research topics are given below; these examples, however, are not intended to be all-encompassing or limiting. o Incorporation of antigen or antigenic peptides into targeting molecules that will more efficiently deliver them to antigen presenting cells and/or specific lymphoid tissues o Manipulation of antigen processing and presentation pathways to enhance cell-mediated immunity (e.g., cytotoxic T lymphocyte (CTL) responses). o Concomitant administration of appropriate cytokines and antigens to modulate the quality of immune responses to vaccine antigens (e.g., type 1 (Th1) vs. type 2 (Th2) immune responses, immunoglobulin isotypes). Vaccine concepts that are presently being tested in primate models or in clinical trials would not be responsive to this PA. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Novel HIV Vaccine Design, is related to the priority areas of immunization and infectious diseases, HIV infection, sexually transmitted diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). 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. Frederick R. Vogel, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A28A, MSC-7620 Bethesda, MD 20892-7620 Telephone: (301) 402-0121 FAX: (301) 402-3684 Email: fv1v@nih.gov $$P2 END ************************************************************ $$P3 BEGIN PA-96-079 FULL-TEXT ************************************** ONTOGENY AND DIFFERENTIATION OF THE LIVER AND BILIARY TREE NIH GUIDE, Volume 25, Number 33, October 4, 1996 PA AVAILABLE: PA-96-079 P.T. 34; K.W. 1002004, 1002059 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The Division of Digestive Diseases and Nutrition of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) wishes to encourage research applications in the identification and characterization of the cellular lineages of the liver and biliary tree. Substantial evidence has accumulated indicating the existence of stem cells in the liver. In ontogeny, hepatoblasts have the ability to differentiate into hepatocytes and biliary cells. As the organ develops cellular terminal differentiation occurs and there appears to be an inverse relationship between cellular differentiation and cell proliferation. However, the liver is a unique organ in the capacity to regenerate subsequent to specific forms of trauma, such as partial hepatectomy. It is unclear the quantity and form of hepatic progenitor cells which could exhibit unique characteristics promoting novel therapeutic approaches to liver disease such as hepatocyte transplantation, gene therapy and artificial liver assist devices. Thus, the identification and characterization of hepatic progenitor stem cells could have a substantial impact on current experimental therapies for human liver disease. The support for this program announcement will be through the NIH research project grant (R01) award, the First Independent Research Support and Transition (FIRST) (R29) award, and the small grants (R03) award. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Ontogeny and Differentiation of the Liver and Biliary Tree, is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000 (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (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), the NIH Website (http://www.nih.gov), and by mail or email from the program official contact listed below. Thomas F. Kresina, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8871 FAX: (301) 480-8300 Email: tk13v@nih.gov $$P3 END ************************************************************ ERRATA $$E1 BEGIN R1 19960920 APPEND RFA HL-96-022 BOTH *********************** TUBERCULOSIS ACADEMIC AWARD NIH GUIDE, Volume 25, Number 33, October 4, 1996 RFA: HL-96-022 P.T. 34; K.W. 0715165 National Heart, Lung, and Blood Institute The following correction is issued for RFA HL-96-022, which was published in the NIH Guide, Vol. 25, No. 31, September 20, 1996: The application receipt date for this RFA is November 18, 1996. INQUIRIES Direct inquiries to: Melonie Shine Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: Shine@nih.gov $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Oct 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-076 - V25(33) 10/04/96 Date: 8 Oct 1996 12:32:22 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 373 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <53ea86$6c5@net.bio.net> NNTP-Posting-Host: net.bio.net ANABOLIC HORMONES IN BONE: BASIC RESEARCH AND THERAPEUTIC POTENTIAL NIH GUIDE, Volume 25, Number 33, October 4, 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 PURPOSE The objective of this initiative is to elicit grant submissions which focus on systemic hormones, local growth factors, and bone-active cytokines which may have specific or generalized anabolic effects on bone. While the primary focus is on basic research, the long-term emphasis is on identifying mechanisms or processes related to hormone action with potential applicability as targets for therapeutic agents for the treatment of diseases which adversely affect bone, including osteoporosis and primary hyperparathyroidism. 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, Anabolic Hormones in Bone: Basic Research and Therapeutic Potential, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this Program Announcement will be through the NIH research project grant (R01) and FIRST (R29) award mechanisms. Applicants will be responsible for the planning, direction, and execution of the proposed project. Applications submitted in response to this PA will compete for funds with other regular research project grant applications. Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. The award of grants in response to this PA is also contingent upon the availability of funds. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement (rev. 4/94). RESEARCH OBJECTIVES Background Diseases that affect bone, such as osteoporosis and primary hyperparathyroidism, result in gradual loss of bone. This osteopenia, or thinning of the bones, is a leading cause of fractures in the adult, and is particularly prevalent in women. Hormones are major regulators of bone mass and osteopenia may result from alterations in hormone action, such as loss of normal estrogen production in post-menopausal women, excessive production of parathyroid hormone (PTH) as in primary hyperparathyroidism, or glucocorticoid excess as a consequence of chronic steroid use in immunosuppressive therapy. Other imbalances in local growth factors and/or bone-active cytokines resulting from a variety of conditions may also contribute to osteopenia. Limited clinical trials have been initiated to determine whether hormone replacement can mitigate or reverse the osteopenia associated with menopause, hypogonadism or primary hyperparathyroidism. To date therapeutic agents have been restricted to compounds which alter mineral content and/or molecular structure of bone (e.g., bisphosphonates) or alter hormonal balances (e.g., estrogen replacement therapy, calcitonin, vitamin D). Unintended or undesired side effects limit effectiveness of such agents. This initiative stems from an NIDDK Workshop entitled: "Anabolic Hormones in Bone: Basic Research and Therapeutic Potential" which was held May 1-2, 1995 (see Margolis et al., Journal of Clinical Endocrinology and Metabolism 81 (3):872-77, 1996), and co-sponsored by NIAMS and the NIH Office of Research on Women's Health. The workshop focused on hormones, growth factors, and cytokines which express positive, anabolic effects on bone mass, either directly or indirectly. The workshop identified several key issues essential to the development of agents with potential anabolic effects on bone, including: efficacy, mechanism of action, specificity, ease of use, and long-term benefit. This initiative is therefore designed to elicit grant submissions which focus on systemic hormones, local growth factors, and bone-active cytokines which may have specific or generalized anabolic effects on bone. While the primary focus is on basic research, the long-term emphasis should be on identifying mechanisms or processes associated with hormonal regulation of bone cell structure/function with potential applicability as therapeutic agents for the treatment of diseases which adversely affect bone, including osteoporosis and primary hyperparathyroidism. Research Objectives and Scope The major areas of interest and potential that have been identified relevant to this program announcement are the following: o The mechanism(s) of action of sex steroids, including estrogen, estrogen agonists, partial agonists, and agents with estrogen-like activity in bone; androgens and androgen-like agents which express positive, anabolic effects on bone. o Other members of the steroid/thyroid/retinoid superfamily, including vitamin D which may have positive effects on net bone mass. o Parathyroid hormone (PTH) and/or parathyroid hormone-related peptide (PTHrP) and agonists or partial agonists which express PTH- or PTHrP-like anabolic effects in bone. o Insulin-like growth factor I (IGF-I), IGF-I binding proteins, or any other component of the IGF axis which might help to safely express the positive effects of IGFs on bone. o Fibroblast growth factor(s) and their role(s) in bone/cartilage development and/or angiogenesis related to bone. o Members of the Bone Morphogenetic Protein family (e.g., TGFs). o Colony-stimulating factor-1. o Prostaglandins with effects on bone cells. o Interleukins, including those that have positive effects and agents which can oppose putative negative effects on bone. This is by no means a complete listing of potentially important agents. The general focus should be on developing an understanding of the putative mechanism(s) of action of these agents with the goal of defining what aspect(s) of bone metabolism is/are affected and how anabolic actions may be achieved and sustained. The mission of the NIDDK is to provide broad fundamental and clinical research support for a spectrum of chronic and disabling diseases which affect bone, including osteoporosis and primary hyperparathyroidism. Applications for research focusing primarily or solely on craniofacial bone will be assigned to the National Institute of Dental Research. Applications that address changes in the levels of, and biologic responses to, these bone regulatory factors as a consequence of aging may be relevant to the National Institute on Aging. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement 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. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned to initial review groups for review and to Institutes/Centers for possible funding on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; 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, the safety of the research environment. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ronald N. Margolis, Ph.D. Endocrinology Section National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN-12J Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov William Sharrock, Ph.D. Bone Biology Program National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Room 5AS-43E, MSC 4500 Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: william_sharrock@nih.gov Linda A. Thomas, Ph.D. Craniofacial Development and Disorders Program National Institute of Dental Research 45 Center Drive, Room 4AN24J Bethesda, MD 10892-6402 Telephone: (301) 594-2425 FAX: (301) 480-8138 Email: THOMASL@DE45.NIDR.NIH.GOV Sherry Sherman, Ph.D. Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 Bethesda, MD 20892-9205 Telephone: (301) 435-3048 FAX: (301) 402-1784 Email: shermans@gw.nia.nih.gov Direct inquiries regarding fiscal and administrative matters to: Kim Law Grants Management Specialist Building 45, Room 6AS-49A National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive Bethesda, MD 20892-6600 Telephone: (301) 594-8869 Vicki Maurer Grants Management Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49A, MSC 4500 Bethesda, MD 20892-6500 Telephone: (301) 594-3504 FAX: (301) 480-4543 Email: vicki_maurer@nih.gov Mr. Martin R. Rubinstein National Institute of Dental Research 45 Center Drive, Room 4AN44A Bethesda, MD 20892-6402 Telephone (301) 594-4800 FAX: (301) 480-8301 E-mail: Martin.Rubinstein@NIH.GOV Robert Pike Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 28092-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: pikeb@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847 (NIDDK), 93.846 (NIAMS), 93.121 (NIDR), and 93.866 (NIA). Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Oct 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-078 - V25(33) 10/04/96 Date: 8 Oct 1996 12:32:40 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 307 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <53ea8o$6d1@net.bio.net> NNTP-Posting-Host: net.bio.net NOVEL HIV VACCINE DESIGN NIH GUIDE, Volume 25, Number 33, October 4, 1996 PA NUMBER: PA-96-078 P.T. 34; K.W. 0715008, 0740075 National Institute of Allergy and Infectious Diseases PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) gives special consideration for funding to scientifically meritorious applications in response to Program Announcements. Our Program Announcements identify areas of ongoing research emphasis for the NIAID. The purpose of this Program Announcement (PA) is to solicit investigator-initiated research to study novel "high risk - high impact" HIV vaccine concepts in early stages of development. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), "Novel HIV Vaccine Design", is related to the priority area(s) of immunization and infectious diseases; HIV infection; sexually transmitted diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. The total requested project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years of support and will receive no support for indirect costs. Domestic applications may include international components but these components will receive no support for indirect costs. 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) award (R29). MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01), Interactive Research Project Grants (IRPG), the First Independent Research Support Transition (FIRST; R29) award, and the Small Research Grant (R03). Research support may also be obtained through applications for a competitive supplement to ongoing NIH-funded grants. Information on the IRPG mechanism is available in program announcement PA-96-001, published in the NIH Guide, Vol. 24, No. 35, October 6, 1995. NIAID uses R03 grants to support small highly innovative or pilot projects. Applicants for R03 grants must follow application guidelines, SMALL RESEARCH GRANTS - NIAID, which appeared in the NIH Guide, Vol. 25, No. 9, March 22, 1996. Both of these publications are available from NIAID program staff listed under INQUIRIES and on the World Wide Web (http://www.nih.gov/grants/funding/funding.htm). Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal of patient populations. Potential applicants are encouraged to contact the program staff listed under INQUIRIES for guidance concerning both the organization and scope of the proposed work and the preparation of the application itself. RESEARCH OBJECTIVES Background The area of HIV vaccine research and development has been, and continues to be, a major priority for the Division of AIDS NIAID as outlined in the NIAID HIV/AIDS Research Agenda. NIAID continues to be the lead agency within the National Institutes of Health (NIH) for such efforts. Vaccines are probably the best tools ever developed for the prevention of disease, and they are important for both disease control and control of health care costs. The National Cooperative Vaccine Development Groups for AIDS (NCVDG) program is one of the major NIAID efforts to fund investigator-initiated vaccine development. However, vaccine concepts need to be already relatively well-developed to merit funding of these multi-project awards. In contrast, this Program Announcement is designed to encourage and fund the very earliest steps of vaccine development. Major advances in our understanding of the immune system and its response to infectious agents have occurred in recent years. These advances include: characterization of the structure and function of the T lymphocyte receptor for antigen and the numerous accessory molecules involved in the initial signal transduction events; identification and characterization of the numerous cytokines that regulate immune responses; delineation of the steps involved in antigen processing and presentation; definition and characterization of adhesion molecules and their roles in interactions between cells of the immune system; identification of genes that regulate the expression and function of many immune system molecules; and, in several infectious diseases, elucidation of the role (protective vs. pathogenic) played by different arms of the immune response. In addition, advances in the understanding of HIV pathogenesis that may lead new vaccine strategies have recently been made. These include the identification and characterization of HIV coreceptors and the inhibitory effects of chemokines. Research Objectives and Experimental Approaches Examples of novel experimental approaches to HIV immunization that would be responsive to this PA would include live virus vectors, bacterial vector-based vaccines, nucleic acid-based immunogens, adjuvants, and conformational (nonlinear) synthetic peptide vaccine strategies. Vaccination approaches focussing on novel antigen design or vaccine target antigens are also encouraged. Research objectives responsive to this PA would include investigations into the mechanisms of protective immunity required for the development of safe and effective HIV vaccines. Some examples of relevant research objectives are given below; these examples, however, are not intended to be all-encompassing or limiting. o Incorporation of antigen or antigenic peptides into targeting molecules that will more efficiently deliver them to antigen presenting cells or specific lymphoid tissues including mucosal inductive sites o Manipulation of antigen processing and presentation pathways to enhance cell-mediated immunity (e.g.,preferential induction of cytotoxic T lymphocyte (CTL) responses) o Concomitant administration of appropriate cytokines or costimulatory molecules with antigens to enhance specific immune effector functions (e.g., Th1 [type 1] vs. Th2 [type 2] immune responses and immunoglobulin isotypes) or to enhance mucosal responses. Vaccine concepts that are already being tested in primate models or in clinical trials would not be responsive to this PA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714, email: asknih@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application. The completed original and five legible, single-sided copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST 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 Center for AIDS Research (CFAR) or a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the Center Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o Availability of the facilities and 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, the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. The following will be considered when making funding decisions: o quality of the proposed project as determined by peer review o program balance among research areas of the announcement o availability of funds INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic (eligibility and responsiveness) issues to: Frederick R. Vogel, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 2A28A - MSC-7620 Bethesda, MD 20892-7620 Telephone: (301) 402-0121 FAX: (301) 402-3684 Email: FV1V@nih.gov Direct inquiries regarding fiscal matters to: Ms. Lesia Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B34 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: LN5T@nih.gov AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is 93.856, Microbiology and Infectious Diseases Research, No. 93.855 - Immunology, Allergy, and Transplantation Research, or both, as appropriate). Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Oct 07 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-96-079 - V25(33) 10/04/96 Date: 8 Oct 1996 12:33:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 280 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <53ea9g$6dr@net.bio.net> NNTP-Posting-Host: net.bio.net ONTOGENY AND DIFFERENTIATION OF THE LIVER AND BILIARY TREE NIH GUIDE, Volume 25, Number 33, October 4, 1996 PA NUMBER: PA-96-079 P.T. 34; K.W. 1002004, 1002059 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE This initiative encourages research applications in the identification and characterization of the cellular lineages of the liver and biliary tree. Substantial evidence has accumulated indicating the existence of stem cells in the liver. In ontogeny, hepatoblasts have the ability to differentiate into hepatocytes and biliary cells. As the organ develops, cellular terminal differentiation occurs and there appears to be an inverse relationship between cellular differentiation and cell proliferation. However, the liver is a unique organ in the capacity to regenerate subsequent to specific forms of trauma, such as partial hepatectomy. It is unclear the quantity and form of hepatic progenitor cells which could exhibit unique characteristics promoting novel therapeutic approaches in, for example, hepatocyte transplantation, gene therapy and artificial liver assist devices. Thus, the identification and characterization of hepatic progenitor stem cells could have a substantial impact on current experimental therapies for human liver disease. 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, Ontogeny and Differentiation of the Liver and Biliary Tree, is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000 (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The support for this program announcement will be through the NIH research project grant (R01), the FIRST (R29) award, and the small grants (R03) award. First Independent Research Support and Transition (FIRST) (R29) award applicants must adhere to the R29 Administrative Guidelines (revised February, 1994) for eligibility, budget and period of award. Potential R29 applicants should refer to the announcement on "Just-in-Time Procedures for FIRST and Career Awards" (NIH Guide, Vol. 25, No.10, March 29, 1996. The small grants research program (R03) provides limited funds (maximum of $50,000 direct costs per year) for short term (up to two years) research projects. These grants are non-renewable, but continuation of projects developed under this program can be supported by the investigator-initiated research project grant (R01) mechanism. Applicants will be responsible for the planning, direction, and execution of the proposed project. Applications submitted in response to this PA will compete for funds with other regular research project grant applications. Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. The award of grants in response to this PA is also contingent upon the availability of funds. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement (rev. 4/94). RESEARCH OBJECTIVES Summary This initiative encourages research applications in the identification and characterization of the cellular lineages of the liver and biliary tree. Substantial evidence has accumulated indicating the existence of stem cells in the liver. In ontogeny, hepatoblasts have the ability to differentiate into hepatocytes and biliary cells. As the organ develops, cellular terminal differentiation occurs and there appears to be an inverse relationship between cellular differentiation and cell proliferation. However, the liver is a unique organ in the capacity to regenerate subsequent to specific forms of trauma, such as partial hepatectomy. It is unclear the quantity and form of hepatic progenitor cells which could exhibit unique characteristics promoting novel therapeutic approaches in, for example, hepatocyte transplantation, gene therapy and artificial liver assist devices. Thus, the identification and characterization of hepatic progenitor stem cells could have a substantial impact on current experimental therapies for human liver disease. This program announcement specifically requests applications that will advance the current knowledge of hepatocyte cloning, long term cell culture, cellular differentiation and characterization as well as provide novel hypotheses for the elucidation of hepatocyte and biliary cell differentiation in the following areas: o hepatic cell transplantation o hepatic regeneration o hepatic gene therapy o susceptibility of cellular populations to viral infection o artificial liver assist devices o cellular participation in the induction of hepatic pathology o cellular signal transduction and transport o cellular apoptosis INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement 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. Mail the original, single-sided application, along with five exact, single-sided copies and five collated sets of appendix materials (if included) to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; 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. o availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Thomas F. Kresina, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8871 FAX: (301) 480-8300 Email: tk13v@nih.gov Direct inquiries regarding fiscal and administrative matters to: Sharon Bourque Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8846 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Sun Oct 13 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 12 October 1996 Date: 14 Oct 1996 16:19:36 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 127 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <53uhq8$134@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 October 12, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Dir of Awards Title: NSF 96-146 -- TEACHER PREPARATION AWARDS, NSF COLLABORATIVES FOR EXCELLENCE IN TEACHER PREPARATION AWARDS - FISCAL YEAR 1996 File size (bytes): 195529 STIS Filename: nsf96146.txt Document Type: Issuance Title: iin106 - IMPORTANT NOTICE RESPONSIBILITIES OF INSTITUTIONS AND INVESTIGATORS IN THE CONDUCT OF RESEARCH File size (bytes): 4954 STIS Filename: iin106.txt Title: ibndx - IMPORTANT NOTICE NSF Grant Proposal Guide and Proposal Forms Kit File size (bytes): 7133 STIS Filename: iin116.txt Title: iin117 - IMPORTANT NOTICE Investigator Financial Disclosure Policy File size (bytes): 13133 STIS Filename: iin117.txt Title: iin118 - IMPORTANT NOTICE Investigator Financial Disclosure Policy File size (bytes): 5755 STIS Filename: iin118.txt Title: iin119 - IMPORTANT NOTICE Impact of partial government shutdowns and short-term continuing resolutions on NSF operations File size (bytes): 8842 STIS Filename: iin119.txt Document Type: Program Guideline Title: NSF 96-152 -- ENVIRONMENTAL GEOCHEMISTRY AND BIOGEOCHEMISTRY File size (bytes): 18275 STIS Filename: nsf96152.txt Also available: nsf96152.pdf Document Type: Report Title: IG 96-3502 -- Emory University Inspection Report File size (bytes): 71580 STIS Filename: ig963502.txt Title: IG 96-3505 -- University of New Hampshire Inspection Report File size (bytes): 95541 STIS Filename: ig963505.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Dir of Awards Title: NSF 96-146 -- TEACHER PREPARATION AWARDS, NSF COLLABORATIVES FOR EXCELLENCE IN TEACHER PREPARATION AWARDS - FISCAL YEAR 1996 File size (bytes): 195529 STIS Filename: nsf96146.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 113272 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 128300 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 96-152 -- ENVIRONMENTAL GEOCHEMISTRY AND BIOGEOCHEMISTRY File size (bytes): 18275 STIS Filename: nsf96152.txt Also available: nsf96152.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 nsf96152.txt, the text of your message should be as follows: get nsf96152.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf96152.txt, you would enter: ftp> get nsf96152.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 Oct 16 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 25, no. 34, pt. 1of1, 11 October 1996 Date: 16 Oct 1996 23:30:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 601 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <544jqr$44g@net.bio.net> NNTP-Posting-Host: net.bio.net X-comment: RFAs described: GM-97-001, GM-97-002, PA-97-001 X-URL: gopher://gopher.nih.gov:70/11/res/nih-guide/guide-files/96.10.11 NIH GUIDE - Vol. 25, No. 34 - October 11, 1996 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH - ADDENDUM Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** THE STREPTOCOCCAL INITIATIVE (RFP NIH-NIAID-DMID-97-08) National Institutes of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS FOR CLINICAL STUDIES (RFP NCI-CM-77020-10) National Cancer Institute INDEX: CANCER $$INDEX R3 ********************************************************** PATHOLOGY AND VETERINARY SUPPORT SERVICES (RFP NCI-CM-77027-30) National Cancer Institute INDEX: CANCER $$INDEX R4 ********************************************************** PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS DEVELOPED FOR CANCER, AIDS AND AIDS-RELATED ILLNESSES (RFP NCI-CM-77028-30) National Cancer Institute INDEX: CANCER $$INDEX R5 01/17/97 ************************************************* INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE (RFA GM-97-001) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX R6 01/17/97 ************************************************* INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORAL DEGREE (RFA GM-97-002) National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES $$INDEX P1 ********************************************************** STEROID RECEPTOR STRUCTURE: FUNCTIONAL CONSIDERATIONS (PA-97-001) National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; 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 ********************************************************** GRANTS FOR HEALTH SERVICES DISSERTATION RESEARCH - ADDENDUM NIH GUIDE, Volume 25, Number 34, October 11, 1996 P.T. 34; K.W. 0730050 Agency for Health Care Policy and Research The purpose of this addendum is to inform potential applicants of clarification to the review process and changes in submission location and 1997 receipt dates for PAR-96-016, "Grants for Health Services Dissertation Research," administered by the Agency for Health Care Policy and Research (AHCPR). This small grant (R03) program was announced in the NIH Guide for Grants and Contracts, Vol. 25, No. 1, January 26, 1996 (PAR-96-016) and supports research undertaken as part of an academic program to qualify for a doctorate. Through this support AHCPR seeks to increase the number of researchers who study health care systems and the cost, quality, and effectiveness of health care services. With respect to review considerations, AHCPR dissertation applications typically will be evaluated for scientific and technical merit in accordance with AHCPR small grant peer review procedures. Reviewers are selected on the basis of knowledge and expertise in areas germane to the application. The review may be by field reader review or through a special emphasis panel convened in accordance with AHCPR peer review procedures. All other review considerations specified in the January 26, 1996 announcement remain in effect. Effective with the publication of this addendum all applications for AHCPR dissertation support must be submitted 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) Dates for receipt of AHCPR dissertation grant applications at the Division of Research Grants are: November 15, 1996 May 8, 1997 November 14, 1997 INQUIRIES Applicants should obtain copies of the grant application kit, program announcement, and this addendum from: Global Exchange, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Direct inquiries regarding programmatic issues, including suitability of research topics and information on the policy of inclusion of women and minorities in study populations to: Dissertation Program Coordinator Office of Scientific Affairs Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 400 Rockville, MD 20852-5908 Telephone: (301) 594-1449 FAX: (301) 594-0154 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-NIAID-DMID-97-08 ************************************* THE STREPTOCOCCAL INITIATIVE NIH GUIDE, Volume 25, Number 34, October 11, 1996 P.T. 34; K.W. 0715125 RFP AVAILABLE: NIH-NIAID-DMID-97-08 National Institutes of Allergy and Infectious Diseases The Respiratory Diseases Branch (RDB), Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for a collaborative, multifaceted, prevention-focused, clinical and basic research effort on Group B Streptococcal (GBS) and associated infections in infants. The program is aimed at understanding disease pathogenesis and prevention of infection. A link will be made to the Group A streptococcal (GAS) program by supporting a basic biology program in both GBS and GAS that focuses on the pathogenesis of invasive infections. The Contractor must have demonstrated experience in clinical and basic research associated with both Group B Streptococci and Group A Streptococci. It is anticipated that one cost reimbursement, level-of-effort type contract will be awarded for a period of five years. RFP NIH-NIAID-DMID-97-08 will be available electronically on or about October 22, 1996, and may be accessed through the NIH Gopher and/or the Internet by using the following electronic mail addresses and instructions: 1. NIH Gopher: Point your Gopher client to GOPHER.NIH.GOV Port 70 (you should now be in the NIH Gopher). Select "Grant and Research Information"; select "R&D Request for Proposals (RFP)"; select "RFPs Available"; select "NIAID"; and select "RFP NIH-NIAID-DMID-97-08". 2. Internet: The URL is: gopher://gopher.nih.gov:70/11/res/rd-rfp The RFP for this acquisition includes only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, if any, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer is contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses will be due on January 21, 1997. Any responsible offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Cyndie Cotter Contracting Officer National Institute of Allergy and Infectious Diseases Telephone: (301) 402-0641 FAX: (301) 402-0972 Email: cc41w@nih.gov $$R1 END ************************************************************ $$R2 BEGIN NCI-CM-77020-10 ****************************************** DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS FOR CLINICAL STUDIES NIH GUIDE, Volume 25, Number 34, October 11, 1996 RFP AVAILABLE: NCI-CM-77020-10 P.T. 34; K.W. 0740021, 0715135, 0715008 National Cancer Institute Develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer or the HIV virus. Certain agents selected by the NCI, DCTDC, Cancer and AIDS operating committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes will range from small development batches (less than 100) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch size (10-30,000 or more) for Phase III/IV trials and Group C distribution is possible. It is estimated that the successful offerors must be prepared to supply more than five-hundred thousand parenteral dosage units each year. The capability to develop and manufacture other pharmaceutical dosage form (i.e., large volumes parenteral, sterile emulsions, micro-dispersions, etc.) is desirable but not essential. Data obtained from the contract will: 1) be used to support IND applications submitted by the NCI to the U.S. Food and Drug Administration, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, and nurses and other medical personnel handling these products in a clinical setting. It is anticipated that two cost reimbursement, completion type contracts will be awarded for a base period of three years with two one-year options for each contract. The offeror must be registered with the FDA as a pharmaceutical manufacturing facility for sterile products at the time of proposal submission. INQUIRIES Therese Dick Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Room 603 - MSC 7220 Bethesda, MD 20892-7220 Telephone: (301) 496-8620 No collect calls accepted. $$R2 END ************************************************************ $$R3 BEGIN NCI-CM-77027-30 ****************************************** PATHOLOGY AND VETERINARY SUPPORT SERVICES NIH GUIDE, Volume 25, Number 34, October 11, 1996 RFP AVAILABLE: NCI-CM-77027-30 P.T. 34; K.W. 0785165, 0201058 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), Development Therapeutics Program (DTP) anticipates the award of one cost-reimbursement contract, for a five year period, beginning on or about July 30, 1997. As a minimum requirement, the contractors must comply with the FDA's current Good Laboratory Practice Regulations (GLPs). The proposed awarded contract will be administrated on a work assignment managed basis. Work assignments will be issued under the proposed, level of effort, contract resulting from this solicitation. DTP is seeking organizations to perform a variety of pathology and veterinary services to support the DTP preclinical toxicology and pharmacology program for anticancer and anti-AIDS drug development. The organization should have the facilities and staff to carry out the requested efforts and the management expertise to respond to the diverse and changing needs of this project. Specifically, the work assignments to be issued will involve the following: operation of an repository to hold the pathology materials and raw data generated in past and future toxicology studies; storage of data on optical medium; performance of an independent verification (peer review) of the pathological findings by the study pathologist especially with respect to individual diagnoses, drug-relatedness, nomenclature and slide quality; provide a pathology support program to prepare blocks and slides and conduct histopathological evaluation of tissues; perform the site visits to conduct necropsies, slide preparation or to assist the Project Officer in project evaluation. This includes providing expertise in special techniques to assess cardiotoxicity, neurotoxicity, nephrotoxicity, etc.; storage, maintenance and shipment of Government infusion equipment to other DTP contractors; development and implementation of a new surgical or other procedures for drug administration or sampling; instruction in these procedures; or performance of these procedures in actual animal studies; conduct site visits to the DTP toxicology contractor laboratories to evaluate pathology laboratories, animal care programs or to investigate pathology or animal care problems; and to support the Toxicology and Pharmacology Branch toxicology efforts required through the preparation of study protocols, study monitoring and report evaluation. The Principal Investigator should be a board certified veterinary pathologist or veterinarian with at least three years experience with similar programs. This is recompetition of a contract performing these activities. INQUIRIES The Request for Proposal will be available on or about October 3, 1996. No collect calls will be accepted. Requests for the RFP may be directed to: Elsa B. Carlton Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Room 603 - MSC 7220 Bethesda, MD 20892-7220 Telephone: (301) 496-8620 $$R3 END ************************************************************ $$R4 BEGIN NCI-CM-77028-30 ****************************************** PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS DEVELOPED FOR CANCER, AIDS AND AIDS-RELATED ILLNESSES NIH GUIDE, Volume 25, Number 34, October 11, 1996 RFP AVAILABLE: NCI-CM-77028-30 P.T. 34; K.W. 0715035, 0715008, 1007009, 0710100 National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), Development Therapeutics Program (DTP) anticipates the award of five cost-reimbursement contracts, for a five year period beginning August 30, 1997. As a minimum requirement, the contractors must perform all toxicology studies in accordance with the FDA's current Good Laboratory Practice (GLP). Contractors must also indicate their willingness to sign a confidentiality of information statement. The proposed awarded contracts will be administered on a work assignment managed basis. Offerors are required to proposed levels of effort for both levels: Level A: 46,875 labor hours, and Level B: 93,750 labor hours over a five year period. DTP is seeking organizations to carry out pharmacology and toxicology studies, the data from which must be suitable for filing with the FDA as part of Investigational New Drug Applications Offerors should have the facilities and staff to carry out such studies and the management expertise to analyze and evaluate the data. Work assignments are estimated to involve two or three chemical agents annually per contract. The objectives of the assignments in relative order of importance are: (1) assessment or acute and subacute toxicity in rodents and dogs including determination of a maximum tolerated dose (MTD), of dose limiting toxicities (DLT), schedule-dependent toxicity, of the reversibility of adverse effects and of a safe clinical starting dose; (2) validation of analytical methodology to quantitate plasma drug levels in preclinical animal models and to measure plasma drug levels in rodents, dogs, and/or non-human primates treated with the agents under study, (3) determination of bioavailability of drug after parenteral and/or oral administration if efficacious drug levels can be attained in plasma in vivo and is the drug crosses the blood-brain barrier, (4) the use of pharmacokinetic information to permit extrapolation of toxic effects across species by relating plasma drug levels to the time of appearance and severity of toxicity, and to establish the safety of potentially efficacious doses. The Principal Investigator should have a doctoral degree in pharmacology/toxicology plus at least five years experience in directing, implementing and evaluating drug toxicity studies in experimental animals. The pathologist, pharmacokinetics and analytical chemist should likewise have credentials which illustrate their competence and accomplishment in service as critical team members in the conduct of such studies. This is a recompetition of a group of 5 contractors currently performing these activities. The Request for Proposal will be available on or about October 18, 1996. No collect calls accepted. Requests for the RFP may be directed to: Elsa B. Carlton Research Contracts Branch National Cancer Institute 6120 Executive Boulevard, Room 603 - MSC 7220 Bethesda, MD 20892-7220 Telephone: (301) 496-8620 $$R4 END ************************************************************ $$R5 BEGIN GM-97-001 FULL-TEXT ************************************** INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE BACCALAUREATE DEGREE NIH GUIDE, Volume 25, Number 34, October 11, 1996 RFA AVAILABLE: GM-97-001 P.T. 44, FF; K.W. 0720005 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 15, 1996 Application Receipt Date: January 17, 1997 PURPOSE The National Institute of General Medical Sciences (NIGMS) and the Office of Research on Minority Health (ORMH), National Institutes of Health (NIH), re-announce two research initiatives directed at increasing the number of underrepresented minorities entering careers in biomedical research. This is the sixth year of this program which seek to encourage the development of new and innovative programs and the expansion of existing programs to improve the academic competitiveness of underrepresented minority students and facilitate their transition into the next stage towards careers in biomedical research. This Request for Applications (RFA) solicits new applications for a partnership program involving two-year colleges awarding the Associate's degree and institutions awarding the Baccalaureate degree. A separate RFA (GM-97-002) describes a program targeting the transition from the Master's degree granting institutions to universities awarding the Doctoral degree. 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. Americo Rivera, Jr., Ph.D. National Institute of General Medical Sciences 45 Center Drive, Room 2AS-13H - MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0533 FAX: (301) 480-2004 Email: RiveraA@GM1.NIGMS.NIH.GOV $$R5 END ************************************************************ $$R6 BEGIN GM-97-002 FULL-TEXT ************************************** INITIATIVE FOR MINORITY STUDENTS: BRIDGES TO THE DOCTORAL DEGREE NIH GUIDE, Volume 25, Number 34, October 11, 1996 RFA AVAILABLE: GM-97-002 P.T. 44, FF; K.W. 0720005 National Institute of General Medical Sciences Letter of Intent Receipt Date: November 15, 1996 Application Receipt Date: January 17, 1997 PURPOSE The National Institute of General Medical Sciences (NIGMS) and the Office of Research on Minority Health (ORMH), National Institutes of Health (NIH), re-announce two research initiatives directed at increasing the number of underrepresented minorities entering careers in biomedical research. This is the sixth year of this program which seek to encourage the development of new and innovative programs and the expansion of existing programs to improve the academic competitiveness of underrepresented minority students and facilitate their transition into the next stage towards careers in biomedical research. This Request for Applications (RFA) solicits new applications for a partnership program involving institutions awarding the M.S. degree to universities awarding the Ph.D. degree. A separate RFA (GM-97-001) describes a program targeting the transition from the Associate's degree to institutions awarding the Baccalaureate degree. 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. Americo Rivera, Jr., Ph.D. National Institute of General Medical Sciences 45 Center Drive, Room 2AS-13H - MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0533 FAX: (301) 480-2004 Email: RiveraA@GM1.NIGMS.NIH.GOV $$R6 END ************************************************************ $$P1 BEGIN PA-97-001 FULL-TEXT ************************************** STEROID RECEPTOR STRUCTURE: FUNCTIONAL CONSIDERATIONS NIH GUIDE, Volume 25, Number 34, October 11, 1996 PA AVAILABLE: PA-97-001 P.T. 34; K.W. 0760075, 0760085 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging Application Receipt Date: February 1, June 1, October 1 PURPOSE The objective of this initiative is to elicit grant submissions which focus on integrating structural with functional information about the receptors in the steroid/thyroid/retinoid superfamily, including the orphan receptors for which no known ligands have been identified. Also referred to as nuclear receptors, the identification and characterization of the receptors for many of these hormones has revealed several examples of mutations in key domains or alterations in function which have been linked to human diseases, including vitamin D-dependent rickets, thyroid hormone resistance, and androgen resistance syndrome. In addition, hormones and their receptors in this large superfamily have been linked to breast, prostate (and other) cancers, osteoporosis, obesity, diabetes, and other diseases or disorders. Finally, agonists and/or antagonists of steroid/thyroid/retinoid hormones may have clinical utility for the prevention or treatment of diseases with significant health relevance to women, including breast cancer and osteoporosis. HEALTHY PEOPLE 2000 The PHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000, a PHS-led national activity for getting priority areas. This PA, STEROID RECEPTOR STRUCTURE: FUNCTIONAL CONSIDERATIONS, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000 (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783 -3238). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and by mail or email from the program official contact listed below. Ronald N. Margolis, Ph.D. Endocrinology Section National Institute of Diabetes and Digestive and Kidney Diseases Building 45, Room 5AN-12J Bethesda, MD 20892-6600 Telephone: (301) 594-8819 FAX: (301) 480-3503 Email: rm76f@nih.gov $$P1 END ************************************************************ From owner-sci-resources@net.bio.net Wed Oct 16 23:00:00 1996 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-001 - V25(34) 10/11/96 Date: 16 Oct 1996 23:31:44 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 357 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <544jsg$4ap@net.bio.net> NNTP-Posting-Host: net.bio.net STEROID RECEPTOR STRUCTURE: FUNCTIONAL CONSIDERATIONS NIH GUIDE, Volume 25, Number 34, October 11, 1996 PA NUMBER: PA-97-001 P.T. 34; K.W. 0760075, 0760085 National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute on Aging PURPOSE The objective of this initiative is to elicit grant submissions that focus on integrating structural with functional information about the receptors in the steroid/thyroid/retinoid superfamily, including the orphan receptors for which no known ligands have been identified. Also referred to as nuclear receptors, the identification and characterization of the receptors for many of these hormones has revealed several examples of mutations in key domains or alterations in function which have been linked to human diseases, including vitamin D-dependent rickets, thyroid hormone resistance, and androgen resistance syndrome. In addition, hormones and their receptors in this large superfamily have been linked to breast, prostate (and other) cancers, osteoporosis, obesity, diabetes, and other diseases or disorders. Finally, agonists and/or antagonists of steroid/thyroid/retinoid hormones may have clinical utility for the prevention or treatment of diseases with significant health relevance to women, including breast cancer and osteoporosis. 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, Steroid Receptor Structure: Functional Considerations, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this Program Announcement will be through the NIH research project grant (R01) and FIRST (R29) award. Applicants will be responsible for the planning, direction, and execution of the proposed project. The award of grants in response to this PA is also contingent upon the availability of funds. Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement (rev. 4/94). Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. RESEARCH OBJECTIVES Background The receptors for hormones in the steroid/thyroid/retinoid supergene family are transcription factors which bind to target sequences in the regulatory regions of hormone-sensitive genes to enhance or suppress their transcription. These receptors have evolutionarily conserved similarities in a series of discrete structural domains, including a ligand binding domain (LBD), a DNA binding domain (DBD), a dimerization domain, and one or more trans-activation domain(s) (AF-1/AF-2). While most members of this family have well characterized ligands, others have no known ligand(s). These "orphan" receptors often have domains with sequences that resemble LBDs suggesting that ligands do exist. In other instances, the absence of consensus LBDs suggests that ligand binding is not a requisite of function. Upon ligand binding most of the receptors in this supergene family form either homo- or hetero-dimers, which bind to discrete regulatory regions of the promoters of target genes called hormone response elements (HRE). There is also a subset of members of the family which bind DNA as monomers. Binding to DNA may occur with or without ligand and may result in repression or enhancement of gene expression in a cell/promoter context. More recently it has become evident that additional nuclear accessory proteins are required to effect receptor-dependent repression or activation of gene expression. The structure of the receptor, the HRE, and the presence/absence of accessory proteins all represent key determinants of the final effect on expression of target genes. New information is developing at a rapid pace delineating the three-dimensional structure of these receptors. To date, the x-ray crystallographic structure has been solved for the LBD of the thyroid receptor, the retinoic X receptor (RXR)gamma, and the peroxisome proliferator-activated receptor (PPAR)gamma. Similarities in conserved regions of other receptors, including the estrogen receptor and the vitamin D receptor, have allowed models to be created which putatively assign key amino acid residues roles in ligand binding and regulation of transcription activation domains. Such information is increasingly important as a guide for the development of compounds which can act as full or partial agonists, or antagonists in a therapeutic context. Therefore, it is important to integrate emerging and developing information about receptor structure with function of these receptors in cell and promoter-specific contexts. The long-term goal of this initiative is to increase basic understanding of the receptors in this hormone superfamily to allow for development of specific analogs, partial agonists, or antagonists with clinical significance in the treatment of disease (e.g., osteoporosis, obesity, breast or prostate cancer). This initiative is therefore designed to elicit grant submissions which focus on the structure of steroid/thyroid/retinoid (nuclear) receptors, including the orphan receptors for which no known ligand has been identified, and the implications of this structural information for understanding function. Research Objectives and Scope The major areas of interest and potential that have been identified relevant to this program announcement are the following: o Effects of binding of agonists/antagonists to steroid receptors on structure/function of the receptor o Role(s) of cytosolic accessory proteins in three-dimensional folding, subcellular processing, activation/inactivation of steroid receptors o Role(s) of nuclear accessory proteins in mediating proper interaction(s) of liganded or unliganded nuclear receptors with hormone response elements and/or components of the transcriptional apparatus o Effects of structural or mutational alterations in receptor structure on cell/promoter specificity of the receptor: effects of homo- or hetero-dimerization and/or HRE spacing and DNA bending on transactivation o Components of the structure of steroid receptors and/or the HRE which have a role in determining the cell, tissue, or promoter specificity of function While these areas of interest are representative of the intended scope, the general focus should be on developing an understanding and integration of structure and function of steroid/thyroid/retinoid receptors. Applications addressing changes in the structure and function of these receptors as a direct consequence of aging may be relevant to the National Institute on Aging. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research, or may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov. The program announcement 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. The completed original application and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and 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. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation