From owner-sci-resources@net.bio.net Thu Jul 07 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 3 June 1994 Date: 8 Jul 1994 16:50:47 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 123 Approved: biosci-moderator@net.bio.net Distribution: bionet Message-ID: <2vkoon$bqb@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT94-007 - Expansion of French Ecole Polytechnique File size (bytes): 2555 STIS Filename: int94007 Title: INT94-008 - French National Science Fair File size (bytes): 1439 STIS Filename: int94008 Title: INT94-009 - Creation of Scientific Axis in Ile de France File size (bytes): 2906 STIS Filename: int94009 Title: INT94-010 - Reform of Swedish R&D File size (bytes): 5238 STIS Filename: int94010 Title: INT94-011 - French Research Minister Comments on the EC File size (bytes): 2657 STIS Filename: int94011 Title: INT94-012 - Trouble for French R&D Budget File size (bytes): 4101 STIS Filename: int94012 Title: INT94-013 - French PhD's Face a Shrinking Job Market File size (bytes): 2370 STIS Filename: int94013 Document Type: Letter Title: NSF 94-85 Faculty Early Career Development (Career) File size (bytes): 6654 STIS Filename: nsf9485 Document Type: Program Guideline Title: NSF 94-84 Directorate for Biological Sciences File size (bytes): 10337 STIS Filename: nsf9484 Document Type: Recruit Title: Physical Scientist/Biologist (Associate Program Director) File size (bytes): 7400 STIS Filename: vex9431 Title: Computer Science Education Administrator (Program Director) File size (bytes): 7093 STIS Filename: vex9432 Title: Physical Scientist File size (bytes): 8159 STIS Filename: vgs9487 Title: Biologist File size (bytes): 7986 STIS Filename: vgs9488 Title: Secretary (Office Automation) File size (bytes): 6149 STIS Filename: vgs9490 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 101025 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 118983 STIS Filename: phnorg ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve phnorg, the text of your message should be as follows: get phnorg Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg, you would enter: ftp> get phnorg WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Mon Jul 11 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 10 July 1994 Date: 11 Jul 1994 17:10:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 119 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <2vsn28$35e@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: News Title: Media Tipsheet June 3, 1994 File size (bytes): 4209 STIS Filename: tip40603 Title: Media Tipsheet June 17, 1994 File size (bytes): 4889 STIS Filename: tip40617 Title: Media Tipsheet July 1, 1994 File size (bytes): 5779 STIS Filename: tip40701 Document Type: Program Guideline Title: NSF 94-82 Postdoctoral Research Fellowships in Chemistry File size (bytes): 30091 STIS Filename: nsf9482 Title: NSF 94-89 -- Basic Research in Conservation and Restoration Biology File size (bytes): 8291 STIS Filename: nsf9489 Title: Collaborative Research at Undergraduate Institutions Program (NSF 94-90) File size (bytes): 23057 STIS Filename: nsf9490 Document Type: Recruit Title: Computer Scientist (Program Director) File size (bytes): 4248 STIS Filename: vex9434 Title: Secretary (Office Automation) File size (bytes): 5656 STIS Filename: vgs9496 Title: Program Assistant (Office Automation) File size (bytes): 5754 STIS Filename: vgs9497 Title: Secretary (Office Automation) File size (bytes): 6117 STIS Filename: vgs9498 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Issuance Title: INNDX - Index of Important Notices File size (bytes): 1822 STIS Filename: inndx Document Type: Phone Book Title: NSF Alpha Telephone Directory File size (bytes): 100905 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 119093 STIS Filename: phnorg Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 54784 STIS Filename: sesvac ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve sesvac, the text of your message should be as follows: get sesvac Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve sesvac, you would enter: ftp> get sesvac WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Fri Jul 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-022 - V23(26) 07/15/94 Date: 15 Jul 1994 18:51:09 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 625 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <307eed$pbn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94022 CA-94-022 P1O1 *************************************** RESEARCH PROGRAM GRANTS IN CHEMOPREVENTION NIH GUIDE, Volume 23, Number 26, July 15, 1994 RFA: CA-94-022 P.T. 34; K.W. 0715035, 0745003, 0710030 National Cancer Institute Letter of Intent Receipt Date: September 1, 1994 Application Receipt Date: October 20, 1994 PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications to support a research and development program of multiple projects directed towards chemoprevention of cancer, requiring a broadly based and multidisciplinary approach. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Research and Development Projects in Chemoprevention, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the cooperative agreement (U19) mechanism. The cooperative agreement is an assistance mechanism in which substantial NIH programmatic involvement with the recipient during performance of the planned activity is anticipated. The nature of the Program Director's involvement is described in the section SPECIAL REQUIREMENTS. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. If it is determined that there is a sufficient continuing need, the NCI will invite recipients of awards made in FY 95 under this RFA to submit competitive continuing applications for review according to procedures described below in the APPLICATION PROCEDURES and REVIEW CONSIDERATIONS sections. As more fully described later in this RFA, the recipients will have primary responsibility for the development and performance of the activity. However, there will be government involvement with regard to: (1) assistance in securing an Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), (2) coordination and assistance in obtaining the chemopreventive agent, (3) monitoring of safety and toxicity, and (4) quality assurance of the clinical chemistry aspects of the study. If an investigator anticipates requiring considerable assistance in obtaining the chemopreventive agent and/or in securing an IND permit from the Food and Drug Administration (FDA), such assistance must be sought in writing to the Program Director, and assistance approved by the Program Director, prior to submitting the application. Awards will not be made until all arrangements for obtaining the IND and the agent are completed. Final awards will consider not only the cost of the clinical trial, but also the cost of the agent and, if necessary, its formulation. FUNDS AVAILABLE Approximately $4.0 million in total costs for the first year for project periods up to five years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that four to six awards will be made. This number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. The earliest feasible start date for the initial awards will be July 1995. Although this program is provided for in the financial plans of the NCI, awards made pursuant to this RFA will be contingent upon the continued availability of funds for this purpose. RESEARCH OBJECTIVES Background The Chemoprevention Branch invites research project cooperative agreement applications (U19) in chemoprevention to encourage and facilitate multidisciplinary collaborations through the coordinated submission of related research projects that share a common research theme in chemoprevention. To be eligible for awards, the application must include a minimum of three scientifically meritorious projects, one of which must involve a clinical trial. The theme might involve a particular agent or class of agents (i.e., anti-initiators or antipromoters: retinoids, non-steroidal anti-inflammatory agents), populations (general, at-risk, subjects with precancer or cancer patients free of disease), sites (breast, prostate, lung, colon), or surrogate markers. Relevant preclinical and clinical ancillary projects might include in vitro and in vivo (animal) efficacy studies, pharmacokinetic and pharmacological evaluations, biomarker studies, and nested case control evaluations. The application should include a sufficient number of scientifically meritorious projects to promote an effective collaborative effort among the participating investigators. This particular type of research project cooperative agreement (U19) builds on the leadership of a key principal investigator and the interaction of the participating investigators in order to integrate the individual projects in a way that accelerates the acquisition of knowledge beyond that expected from the same projects conducted separately, without combined leadership or a common theme. Individual investigators may apply their specialized research capabilities to basic, developmental, and clinical aspects, as they relate to the focused, central theme of the overall project. This grant mechanism also offers a special way to achieve an economy of effort through the sharing of personnel, facilities, equipment, data, ideas, and concepts. The principal investigator of the research program cooperative agreement must be an established scientist with a strong record of accomplishment, who is substantially committed to, and capable of, exercising the responsibility for the scientific leadership, integration and administration of a major effort in cancer prevention. The component projects should be directed by investigators who are experienced in the conduct of independent research and whose backgrounds and interests relate sufficiently to one another in order to allow for integrated group pursuits. Awardees will have primary responsibility for the development and performance of the activities. However, there will be involvement by the NCI Program Director with regard to (1) coordination and assistance in obtaining the chemopreventive agent, (2) securing an IND approval from the FDA, (3) monitoring of safety and toxicity, and (4) quality assurance of clinical chemistry aspects of the study. SPECIAL REQUIREMENTS A. General This RFA represents a single competition, with a specified deadline, October 20, 1994, for receipt of applications. It is expected that each application will describe plans for a mixture of basic, developmental and clinical research from an investigator wanting to focus on a particular study in cancer chemoprevention. Each application should have a general focus on study outcomes, and on the application of basic research and development to human subjects and populations. B. Terms and Conditions of Award Under the cooperative agreement, a partnership will exist between the recipient of the award and NCI, with assistance from NCI in carrying out the planned activity. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of cooperative agreements. The Terms and Conditions of Award described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; DHHS grant administration regulations 45 CRF 74 and 92; other DHHS, PHS, and NIH grant administration policy statements; and other NCI administrative terms of award. 1. Awardee Rights and Responsibilities Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. The awardees will retain custody of and have primary rights to their data. a. Safety and Toxicity Review Each awardee institution and principal investigator agrees to comply with the recommendations of the safety and protocol review to assure that all FDA requirements are satisfied. b. Quality Control and Adverse Reaction Reporting (1) The awardee will be required by the NCI Program Director to set-up mechanisms for quality control. Some or all of the following may be relevant: compliance with protocol requirements for eligibility; treatment and follow-up; laboratory data; dietary data; pathological materials; and operative reports. (2) The awardee agrees to perform the study according to the approved protocol. Any proposed changes in the protocol must receive the advance permission of the NCI Program Director for this award. (3) The awardee is required to conform to NCI guidelines for the use of investigational drugs including investigator registration (FDA Form 1573), maintaining a record of drug receipt and reporting of adverse drug reactions. Life threatening or unexpected toxicity MUST be reported by the investigator IMMEDIATELY by telephone to the NCI Program Director shown on the Notice of Award and confirmed with details in writing within two weeks. The investigator will be responsible for amending protocols and consent forms based on new toxicity information sent to the investigators by NCI staff. c. Data Management and Reporting Requirements Data acquisition and analysis is the responsibility of the investigator. Each awardee institution will retain custody and primary rights to their data developed under these cooperative agreements. Investigators will be required to submit reports to NCI using the following schedule and format as required by FDA Investigational Drug Regulations, Code of Federal Regulations (CFR) 21, par. 312.23. (1) Semi-Annual Reports Semi-annual scientific reports should report on the progress of the project during the previous six months and the cumulative progress of the study. (a) Individual Study Information. The summary is required to include the following information for each study: The title of the study (with any appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient population and the inclusion of women and minorities, and a statement as to whether the study is completed. The total number of subjects initially planned for inclusion in the study, the number entered into the study to date, the number whose participation in the study was completed as planned, and the number who dropped out of the study for any reason. If the study has been completed, or if interim results are known, a brief description of the study results. (b) Summary Information. Information obtained during the previous six months' clinical and non-clinical investigations, including: A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system. A list of subjects who dropped out during the course of the investigation, with the cause of death for each subject. A brief description of what, if anything, was obtained that is pertinent to an understanding of the drug's actions, including, for example, information about dose response, information from controlled trials, and information about bioavailability. A list of the preclinical studies (including animal studies) completed or in progress during the past year and a summary of the major preclinical findings. (c) A description of the general investigational plan for the coming year to replace that submitted one year earlier. (d) A description of any significant pilot trial protocol modifications made during the previous year and not previously reported to the IND in a protocol amendment. (e) A brief summary of significant foreign marketing developments with the drug during the past year, such as approval of marketing in any country or withdrawal or suspension from marketing in any country. The NCI Executive Committee states that there must be gender equality in all NCI funded clinical trials absent scientific justification for gender underrepresentation of a single sex study. An award will not be issued that fails to meet this criterion. Program staff are responsible for reviewing actual accrual reported on non-competing renewal applications. Investigators will be required to initiate corrective plans if studies are not accruing as originally proposed. Each progress report must describe accrual by gender and racial/ethnic group. Grants can be terminated for failure to accrue adequate numbers of both genders. Due Dates for Reports (1) January 1 and July 1 for the semi-annual report. (2) Final Study Report The final report of a completed study shall consist of detailed analyses of results and toxicity, plans for publications, a comprehensive list of all previous publications related to the project, and plans for archiving and storing the study records. 2. NCI Staff Responsibilities a. Study/Protocol Plan The NCI Program Director will assist the awardees in the study and protocol design by providing information regarding (a) the nature of concurrent studies in the area of research, pointing out possible duplication of effort, and (b) availability of necessary drugs. The NCI Program Director will also offer advice regarding the scientific rationale, priority, design, and implementation of the proposed studies. A safety and protocol review will be undertaken by the NCI Program Director on all clinical trials from applications which are ultimately funded. Such a review is legally required by the FDA to ensure that all safety toxicity, monitoring, and reporting issues are in conformance with IND guidelines. The awardee institutions and principal investigator must agree to comply with the recommendations of the review. b. Data Access The NCI Program Director will have access to the data to review toxicity and safety aspects of the project, prepare IND applications and monitor any trial aspects required by other federal agencies. This information is necessary to satisfy FDA regulations with regard to Code of Federal Regulations (CFR) 21. The NCI Program Director may encourage and facilitate sharing of data between investigators when this is in the mutual interest of the investigators and the NCI. c. Investigational New Drug (IND) The NCI will have the option to cross-file or independently file an IND on investigational drugs evaluated in trials supported under the cooperative agreements. The NCI will advise investigators of specific requirements and changes in requirements concerning investigational drug management for compliance with NCI and the FDA guidelines and regulations. Investigators conducting trials under cooperative agreements will be expected, in cooperation with the NCI, to comply with all FDA monitoring and reporting requirements for investigational agents, for reporting adverse reactions, and for maintaining necessary records of drug receipt and distribution. d. Assistance with Obtaining or Purchasing Investigational Drugs If an investigator anticipates requiring considerable assistance in obtaining the chemopreventive agent and/or in securing an IND permit from the FDA, such assistance must be sought in writing from the Program Director, and assistance approved by the Program Director, prior to submitting the application. Awards will not be made until all arrangements for obtaining the agent are complete. Final awards by the NCI will also consider not only the cost of the trial, but also the cost of the agent, including its formulation, encapsulation and packaging, if these costs are to be borne by the Government. e. Protocol Modification No protocol modifications shall be implemented without approval from the NCI Program Director, consistent with FDA requirements. f. Protocol Termination The NCI Program Director may request that a protocol study be terminated. Reasons for this request may be (a) insufficient accrual, (b) further accrual will not add information of scientific value, and/or (c) consideration of patient safety. The NCI will not provide drugs or IND sponsorship for a study after requesting termination. Investigators who wish to challenge protocol termination may do so according to the arbitration process described below. In addition, the NCI may withdraw funding for such a protocol, if the grounds for termination are patient safety and toxicity. The Arbitration Mechanism is described below. g. Clinical Trials Progress Review Progress will be evaluated semi-annually by the NCI Program Director from material presented in the awardee's semi-annual report (as described below). Recommendations of the NCI Program Director will be communicated by letter to the investigator to which he/she is expected to respond. Insufficient numbers of patients accrued to attain the stated delta value (d=difference between treatments to be detected divided by standard deviation), unsatisfactory progress, or non-compliance with terms of award may result in a reduction of the budget, withholding of support, suspension or termination of the award. h. Quality Assurance (1) The NCI has established a clinical chemistry quality assurance program with the National Institutes of Standards and Technology (NIST), Gaithersburg, Maryland, which will provide chemical standards for some of the agents that will be used and assayed for in the clinical trials. These standards will contribute to the quality control of selected laboratory determinations. The awardee will participate in the laboratory quality control activity when so notified. (2) The NCI Program Director will review the mechanism established by each awardee for quality control of clinical studies. These mechanisms must conform with FDA regulations. i. Non-compliance with Terms of Award Non-compliance with Terms of Award may result in a reduction of the budget, withholding of support, and/or suspension or termination of the award. j. Other Terms (1) Patient enrollment in a study may not be initiated without the prior written approval of the NCI Program Director for this cooperative agreement. Such approval is contingent upon submission to and approval by the FDA of an IND application and satisfactory response to the recommendations of the safety and protocol review. 3. Arbitration When mutually acceptable agreements on the safety of research protocols, protocol disapproval or protocol termination cannot be obtained between investigators and the NCI Program Director, as described above, an arbitration panel will be formed composed of one award recipient designee, one NCI designee, and a third designee with appropriate expertise chosen by the other two members of the panel. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Population, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 1, 1994, a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the principal investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to Dr. Marjorie Perloff at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director listed under INQUIRIES. The brochure, Guidelines for the Program Project Grant of the National Cancer Institute, should also be consulted. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, "Research Project Grants in Chemoprevention" and the RFA number, CA-94-022, must be typed in block 2a of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear, and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636A 6130 Executive Boulevard Rockville, MD 20852 (If hand-delivered) Bethesda, MD 20892 (If using U.S. Postal Service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received by the designated receipt date. Revised or additional information may not be submitted after the receipt date unless specifically requested by NCI staff. The general instructions for preparation of the applications contained in the grant application form PHS 398 (rev. 9/91) are to be used in preparing cooperative agreement applications. Because of the award terms and conditions included in the section under SPECIAL REQUIREMENTS, it is important that applicants indicate in the Research Plan how they will meet the requirements stated in the RFA for staff involvement. To ensure that the cooperative agreement remains the appropriate instrument, awardees submitting competing continuation and supplemental applications must describe how they have met the established terms and conditions. REVIEW CONSIDERATIONS A. Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. B. Review Criteria The following factors will be considered in evaluating the scientific merit of each response to the RFA. 1. Scientific merit of the study objective(s), design, and methodology to include considerations of toxicity, safety and quality assurance. 2. Basic and clinical scientific significance as well as originality of the proposed research. 3. Research experience and/or competence of the principal investigator and other key personnel to conduct the proposed studies. 4. Adequacy of time (effort) that the principal investigator and staff would devote to conduct the proposed studies. 5. Relevancy and appropriateness of the specific target population along with assurance as to its accessibility. 6. Identity of sources of data, tissues, fluids, etc., procedures for their collection and analysis, and assurances as to their accessibility. 7. Adequacy of plans for NCI program staff involvement with the proposed studies. 8. Adequacy of plan for inclusion of women and minorities. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each meritorious application. AWARD CRITERIA The earliest feasible start date for the initial awards will be July 1995. In addition to the technical merit of the applications, NCI will consider how well the applicant institutions meet the goals and objectives of the program as described in the RFA, the availability of NCI funds, and the applicability of proposed study populations. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic, requests for the program project guidelines, and address the letter of intent to: Marjorie Perloff, M.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 218 Bethesda, MD 20892-4200 Telephone: (301) 496-4664 FAX: (301) 402-0553 Direct inquiries regarding fiscal matters to: Mr. Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Ext. 213 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.999, Cancer Control. Awards will be made under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410; 42 U.S.C. 241, and Section 412, as amended by Public Law 99-158, 42 U.S.C. 258a-1); and administered under Federal regulations 42 CFR Part 52 and PHS grant policies CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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 Fri Jul 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 26, pt. 2of2, 15 July 1994 Date: 15 Jul 1994 18:51:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1285 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <307ee8$pb9@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940715 V23N26 P2O2 ************************************ Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Small grant applications (R03) assigned to NIDA do not receive a second-level review. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute/Center/Division. At NIDA, special consideration will be given to applications that directly deal with AIDS-related issues. The following will be considered when making funding decisions: o Scientific and technical merit of the proposed project as determined by peer review o Availability of funds o Institute/Center/Division program needs and balance INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Dr. Lisa Onken Clinical and Experimental Therapeutics Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-0107 INTERNET: lonken@aoada.ssw.dhhs.gov Direct inquiries regarding fiscal matters to: Dr. Gary Fleming, Chief Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act (42 USC 241 and 290cc) and administered under PHS grants policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects," Title 45 CFR part 74 & 92, "Administration of Grants," and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2 "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Awards must be administered in accordance with the PHS Grants Policy Statement, (Rev., 4/94), which may be available from the institutional office of sponsored research. $$P1 END ************************************************************ $$P2 BEGIN PA-94-079 ************************************************ DNA DAMAGE, GENOMIC INSTABILITY AND BREAST CANCER NIH GUIDE, Volume 22, Number 26, July 15, 1994 PA NUMBER: PA-94-079 P.T. 34; K.W. 0715036, 0755030, 0760053, 1002019 National Cancer Institute PURPOSE The Division of Cancer Etiology of the National Cancer Institute (NCI) invites grant applications from interested investigators through a Program Announcement (PA) to establish whether or not there is greater genomic instability is associated with individuals in families with hereditary breast cancer than in individuals that do not have a family history of cancer. This initiative is in response to Congressional language that NCI emphasize studies on the etiology of female breast cancer as one of its top priorities. 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, DNA Damage, Genomic Instability and Breast Cancer, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0; Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This PA will be supported through the National Institutes of Health (NIH) traditional research project grant (R01). The applicant will have the sole responsibility for planning, directing and executing the proposed research. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background The generally accepted mutation model of cancer requires a small number of select mutations, all in a single cell, for the development of cancer. An increase in mutation rate would significantly decrease the time of onset. Such a mutation rate increase could result from a mutation in any of the multiple genes that affect genomic stability. Because there are multiple sites on each gene for impairing or inactivating normal function, there is a high probability for the formation of genetically unstable clones or mosaics during normal human development (for a pertinent review see: K.C. Cheng and L.A. Loeb, Adv. Cancer Res. 60:121-156, 1993). The association of karyotypic abnormalities with cancer cells and with normal cells from individuals with various syndromes predisposing to cancer suggests that karyotypic instability as a phenotype can be transmitted through the germline and underlies a substantial fraction of the changes required for cancer expression. It is conservatively estimated that one hundred genes are involved in maintaining genomic fidelity. A functional decline in any one of them would be expected to increase the mutation rate. This suggests that genomic instability phenotypes other than karyotypic instability also may exist. The possibility that genomic instability, originating from the germline and/or somatically acquired, is a significant element in the initiation or progression of a cell to cancer is important to establish. This possibility would provide for additional segregation ratios, less than the dominant ratio of 0.5, which are frequently suggested by investigations of cancer families, and it would strongly suggest that hereditary cancer is associated with a significantly greater fraction of the overall incidence than is presently believed. Objectives The goal of this PA is to encourage research on human breast cancer using molecular, biochemical and cytogenetic techniques to determine whether or not a genomic instability in non-tumorigenic cells is associated with familial breast cancer family members both with and without cancer. Normal individuals with no family history of cancer could serve as controls. Suitable cells for this approach might include circulating lymphocytes, normal breast epithelial cells, normal fibroblasts or other appropriate cell types. The term "genomic instability" is taken broadly to mean a significant difference, presumably a decrease from an established normal base line, in any of various parameters expected to decrease the integrity of the cellular genome or its expression. Study of parameters toward this end could include, but need not be limited to: (1) Determination of the relative capacity of suitable cells from members of breast cancer families to repair DNA damaged by either radiation or chemical carcinogens. Analogous cells from individuals who do not have a family history of cancer would serve as normal controls. (2) Determination of the relative abilities of suitable cells from breast cancer family members to deactivate genotoxic chemicals compared with those from normal (as defined above) controls. (3) Determination of the relative capacity of suitable cells from breast cancer family members to repair chromosome or chromatid damage from radiation or chemicals compared to those from normal (as defined above) controls. (4) Comparison of the sensitivity of appropriate cells from breast cancer family members and those from normal (as defined above) controls to the initial damage of DNA by radiation or chemicals. (5) Comparison of the relative capacities of suitable cells from breast cancer family members and those from normal (as defined above) controls to maintain the primary sequence of DNA, i.e., replication fidelity, proof reading capacity, prevention of DNA damage and recombination fidelity. Because these investigations can involve several disciplines, both interdisciplinary studies and more focused investigations are appropriate. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principle investigator could be included with the application. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the staff listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications must be submitted on form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301-594-7248. The format and instructions applicable to regular research grant applications must be followed in preparing an application in response to this PA. The number and title of the PA must be typed on line 2a of the face page of the application and the YES box must be checked. A signed, typewritten original grant application, including the checklist, and five signed, exact photocopies, must be mailed, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. AWARD CRITERIA Scientific merit, contribution to overall programmatic balance, and availability of funds will be major criteria for making award decisions. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Raymond Gantt, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Suite 530 Bethesda, MD 20892 Telephone: (301) 496-9326 FAX: (301) 496-1224 Inquiries regarding fiscal matters may be directed to: Mr. Earl Bowman Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. 217 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention Research. Awards are made under authorization of 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 grant policies and Federal regulations 42 CFR 52 and 45 CFR Part 74. This program in not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-94-080 ************************************************ GENETIC AND PHENOTYPIC MARKERS FOR IONIZING RADIATION-INDUCED BREAST CANCER IN RODENT AND HUMAN CELLS NIH GUIDE, Volume 22, Number 26, July 15, 1994 PA NUMBER: PA-94-080 P.T. 34; K.W. 0715036, 0755030, 0760053, 1002019, 0765014 National Cancer Institute PURPOSE The Division of Cancer Etiology of the National Cancer Institute (NCI) invites grant applications from interested investigators through a Program Announcement (PA) to study changes of gene expression that are induced by exposure of pluripotent, or partially transformed, rodent and human mammary epithelial cells to ionizing radiations; and to define the role of such gene sequences in the progression to radiogenic breast cancer in rodent models. This initiative is in response to Congressional language that NCI emphasize studies on the etiology of female breast cancer as one of its top priorities. 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, Genetic and Phenotypic Markers for Ionizing Radiation-Induced Breast Cancer in Rodent and Human Cells, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0; Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit institutions, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This PA is a one-time solicitation and will be supported through the National Institutes of Health (NIH) traditional research project grant (R01). The applicant will have the sole responsibility for planning, directing and executing the proposed research. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Young adult women and adolescent females under 20 years of age may be unusually susceptible to ionizing radiation- induced breast cancer (e.g., atomic bomb survivors, young female Hodgkin's lymphoma patients treated by radiotherapy). There also is evidence that young female rodents show increased sensitivity to both chemical-induced and radiation-induced mammary cancer. Several lines of evidence, based partly on the growth characteristics of cultured human breast carcinoma cells and more strongly on experimental work on the induction of mammary tumors in rodents, suggest that populations of precursor or pluripotent stem-like cells that are prevalent during the formation and differentiation of the mammalian female breast tissue are the main targets for ionizing-radiation- induced genetic damage that eventually may give rise to cancer. Objectives This PA encourages research applications to study the etiologic and mechanistic basis for the apparent susceptibility of pluripotent cells implanted into the developing breast tissue of rodents to undergo malignant transformation by ionizing radiation. It will focus on the characterization and analyses of the genes and gene products that may be differentially expressed during the progression of these precursor, or partially transformed, rodent mammary epithelial cells into malignant breast cancers. Particular emphasis will be given to defining the possible etiologic roles of such gene sequences in the early stages of progression prior to malignancy (e.g., mutations that result in increased dysplasia and loss of differentiation capabilities in vivo; acquisition of growth factor and hormonal independence for cellular proliferation in vitro). Where feasible, comparative in vitro or in vitro/in vivo studies of the effects of ionizing radiation on non-malignant human mammary epithelial cells will be encouraged. Because of the scope of the studies, involving both whole animals and molecular and cellular endpoints, multidisciplinary applications are encouraged. The PA includes, but is not limited to: o A determination of the susceptibility and involvement of precursor-like mammary epithelial cells in radiation-induced breast cancer in the developing mammary tissue of young female rodents; o The isolation and subsequent genetic and biochemical analyses of gene sequences and gene products that are differentially over- or under-expressed during progression to radiogenic breast cancer in rodent and, if feasible, in human breast epithelial cells; o The assessment, following radiation exposure, of differentially expressed genes, proteins or mutations in breast epithelial precursor cells to serve as biomarkers of preneoplastic lesions for radiation-induced breast carcinomas in rodents and humans. STUDY POPULATIONS Special instructions to applicants regarding implementation of NIH policies concerning inclusion of females and minorities in research involving human subjects are not applicable to this PA. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded from the usual NIH policies on gender and minority representation in human subjects. However, every effort should be made to include tissues from racial/ethnic minority women when it is important to apply the results of the study broadly to human populations, and this issue should be addressed by the applicants. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone, (301) 594-7248. The format and instructions applicable to regular research grant applications must be followed in preparing a grant in response to this PA. The number and title of the PA must be typed on line 2a of the face page of the application and YES must be checked. A signed, typewritten original grant application, including the checklist, and five signed, exact photocopies, must be mailed, in one package, to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Division of Research Grants for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Review Criteria 1. The scientific and technical significance of the proposed research; 2. The adequacy of the methodology to carry out the research; 3. The qualifications and experience of the Principal Investigator and staff; 4. Reasonable availability of resources; 5. Reasonableness of the proposed budget and duration; 6. Other factors: e.g., human subjects, animal welfare, and biohazards AWARD CRITERIA Scientific merit and contribution to overall programmatic balance and the availability of funds will be major criteria for making award decisions. INQUIRIES Written and telephone inquiries concerning the scientific objectives and scope of this PA are encouraged and may be directed to: Richard A. Pelroy, Ph.D. Division of Cancer Etiology National Cancer Institute Executive Plaza North, Room 530 6130 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-9326 FAX: (301) 496-1224 Direct inquiries regarding administrative and fiscal matters to: Ms. Lauren Neumann Grants Administration Branch National Cancer Institute Executive Plaza South, Room 242 6120 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 264 FAX: (301) 496-8601 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393, Cancer Cause and Prevention Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. $$P3 END ************************************************************ $$P4 BEGIN PAR-94-081 *********************************************** MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM NIH GUIDE, Volume 22, Number 26, July 15, 1994 PA NUMBER: PAR-94-081 P.T. 44; K.W. 0720005, 0502000 National Center for Research Resources Application Receipt Date: October 18, 1994 PURPOSE The National Center for Research Resources (NCRR), National Institutes of Health (NIH), plans to continue the Minority High School Student Research Apprentice Program (MHSSRAP) in 1995 during the phase in of the new "NCRR Minority Initiative: K-12 Teachers and High School Students." The purpose of the MHSSRAP program is to provide minority high school students with a meaningful experience in various aspects of health-related research in order to stimulate their interest in careers in science. The program also includes in-service elementary, middle, junior, and senior high school teachers, and potential K-12 science teachers in pre-service education programs. Eligible teachers will still be those who are members of a minority group or who teach a significant number of minority students. Teachers may participate in the program for a second year. The hands-on summer research project must be structured to update the teachers' knowledge and skills in modern research tools and techniques as well as to strengthen their teaching skills. The experience should provide teachers the opportunity to bring back to the classroom a sense of the excitement of research that would stimulate students to pursue scientific careers. A longer range goal is to establish year round linkages between pre-service and in-service science teachers, elementary and secondary school students, and biomedical researchers. Awards are contingent on the availability of appropriated funds. Thus, allocations may be reduced below the amount requested in the application. Upon recommendation of the National Advisory Research Resources Council, the NCRR will give preference in making awards to those institutions that can support a summer program having a "critical mass" of at least five or six students. ELIGIBILITY REQUIREMENTS Eligible organizations or organizational components are those domestic, non-profit organizations that (1) at the time of application, received at least three NIH research grants in the research grants base (defined below) totaling $200,000 in FY 1994; (2) have this minimum threshold of active NIH research grant support, excluding no cost extensions, at time of award; and (3) did not receive a FY 1994 award under the NCRR Minority Initiative K-12 Teachers and High School Students. (For purposes of this program, the "research grants base" is defined as those grants awarded with the following activity codes: K01, K02, K04, K05, K06, K08, K11, K12, K14, K15, K16, K20, K21, P01, P40, P41, P42, P50, P60, R01, R03, R10, R21, R24, R29, R35, R37, R55, S06, S14, U01, U10, U24, U42, and U54.) Recipients of an active Minority Biomedical Research Support (MBRS) Grant are also eligible. Under-represented minority students and teachers are defined as individuals who identify themselves as Black, Hispanic, Native American, Pacific Islander, or any particular ethnic or racial group that has been determined by the grantee institution to be under-represented in biomedical or behavioral research. Participants eligible for support must be U.S. citizens or have a permanent visa. Eligible students are those who are enrolled in high school during the 1994-1995 academic year. (Students who will graduate from high school in 1995 are eligible, as is a student who participated in a previous year provided he/she is still enrolled at the high school level.) MECHANISM OF SUPPORT The mechanism of support for this program will be the NIH supplement (S03). Awards will be for one year beginning March 1, 1995, contingent upon availability of appropriated funds. Support will be provided at a level of $2,000 for each student apprentice, $3,000 for each pre-service teacher, and $5,000 for each in-service science teacher. Applications may request both students and teachers or students only. No indirect costs will be paid. Direct support must be as salary; stipends are not allowed. Funds allocated may also be utilized for supplies, extending the research experience, or if adequate funds exist, for the addition of a student apprentice. However, funds from these grants may only be used for the costs of the apprentice program. The Program Director is responsible for the recruitment and selection of the apprentices and science teachers and assignment of each to an appropriate investigator. Because the nature and scope of the proposed activities submitted in response to this program announcement may vary, it is anticipated that the size of an award will vary also. Students. Recruitment and selection of students must emphasize factors including the student's motivation, ability, scholastic aptitude, and accomplishments. In addition, consideration must be given to science teachers' recommendations and, whenever possible, the degree of parental commitment. Assignments must be made to investigators involved in health-related research who are committed to increasing the high school student's understanding of research and the technical skills needed. Teachers. Recruitment and selection criteria for in-service teachers must include: experience and teaching responsibilities, level of interest in participating in a research program, expected impact on their teaching programs, ability to stimulate minority students to pursue scientific careers, and future plans for continued interaction with the research institution. Potential teachers should be enrolled in pre-service programs and have an expressed interest in teaching life sciences at the K-12 level. APPLICATION PROCEDURES The application consists of (a) a letter stating the justification for the number of student and teacher positions requested (preference will be given to those institutions with a demonstrated commitment and a documented history of encouraging students to pursue scientific careers) and (b) the original and one signed and completed copy of the face page, page 4 "Detailed Budget for First 12-Month Budget Period Direct Costs Only," and checklist pages of the grant application form PHS 398 (rev. 9/91). The required pages of the PHS 398 application form must be completed according to instructions provided in the PHS 398 (rev. 9/91) kit except for the following: Face Page Item 1 - Leave blank. Items 2a and 2b - Check the box marked "YES" and type in the number and title of this Program Announcement. Items 4 and 5 - Not applicable; do not complete. Item 6, Dates of entire proposed project period - Enter 03-01-95 through 02-29-96. Item 7 and 8 - Insert the total dollar amount of the request, which is the sum, from application page 4, of the number of student positions requested times $2,000 per student; the number of pre-service teachers requested times $3,000; and the number of in-service teachers times $5,000. No indirect costs will be provided; thus the direct and total costs will be the same. Item 14 - Enter the appropriate organizational code (see descriptive information provided on page 15 of the PHS-398 form). Note that no credit will be given for the S03 application. Page 4, "Detailed Budget for First 12-Month Budget Period Direct Costs Only" - Using ONLY the Other Expenses category, enter on separate lines the number of students requested at $2,000 per student; the number of pre-service teachers requested at $3,000 per teacher; and the number of in-service science teachers requested at $5,000 per teacher. Enter the sum of the amounts requested for each under the "TOTALS" column for the Other Expenses category and under "Total Direct Costs for First 12-Month Budget Period" at the bottom of the page. The original and one copy of the student and teacher report(s), signed by the Program Director, must be submitted with the renewal application by October 15, 1994 so that the data contained in these reports can be used by NCRR to decide about policies and future funding for the MHSSRAP. These reports should also be submitted at the same time even if renewal support is not requested. All reports, including the Financial Status Report, must be submitted to the NIH by the grantee institution no later than May 31, 1995, unless an extension of the budget period end date has been authorized in writing. Applications must be received by October 18, 1994 by: Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892** DO NOT MAIL THE APPLICATION TO THE DIVISION OF RESEARCH GRANTS, NIH. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Marjorie A. Tingle, Ph.D. Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 10A-11 Bethesda, MD 20982 Telephone: (301) 594-7947 Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20982 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.337, Biomedical Research Support. Grants will be awarded under the authority of the Public Health Service Act, Section 301 (a)(3); Public Law 78-410 (42 USC 241) as amended, and administered under PHS grants policies and Federal Regulations 45 CFR 74 and the Guidelines for Minority High School Student Research Apprentice Program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P4 END ************************************************************ $$P5 BEGIN PAR-94-082 *********************************************** NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS NIH GUIDE, Volume 22, Number 26, July 15, 1994 PA NUMBER: PAR-94-082 P.T. 44; K.W. 0720005, 0502000 National Center for Research Resources Application Receipt Date: September 12, 1994 PURPOSE As part of its continuing commitment to strengthen the quality of precollege health science education, the National Center for Research Resources (NCRR) encourages the submission of applications for a program aimed at increasing the pool of underrepresented minority high school students who are interested in pursuing and academically prepared to pursue careers in biomedical/behavioral research and the health professions. The program will include both K-12 inservice and preservice teachers and minority high school students. This program, the "NCRR Minority Initiative: K-12 Teachers and High School Students," was first announced in FY 1994 to replace the S03 "Minority High School Student Research Apprentice Program" (MHSSRAP), which is being phased down. This program announcement represents the second phase of this transition. During this continued transition, applicants for this program may also submit an application for October 15, 1994 deadline for the FY 1995 MHSSRAP. However, it is not expected that the MHSSRAP will be available for FY 1996. The main component of this program is to provide structured summer science research experiences under the direction of active biomedical/behavioral researchers for both teachers and minority high school students. The individualized research experiences and other activities are intended to: (1) allow teachers to keep pace with the explosive growth of scientific knowledge in health-related areas, enable them to develop new discovery-oriented educational strategies, and transfer this new knowledge to their students; and (2) provide students with a personalized, hands-on exposure to health-related research that stimulates their research interest and encourages decisions towards careers in the health sciences. A long-range goal of the program is to establish and/or strengthen partnerships between biomedical research institutions and K-12 schools by developing mentoring ties among teachers, minority students, and biomedical/behavioral researchers that will result in creating more pathways for minority students to establish careers in the health sciences. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. High schools may not apply. Underrepresented minorities are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Individuals who have been found to be underrepresented in biomedical or behavioral research nationally include Black Americans, Hispanic Americans, Native Americans, and Pacific Islanders. Students are defined as those who are enrolled in high school during the current academic year, or who have just graduated from high school. Participants must be U.S. citizens or have a permanent visa. Inservice teachers include elementary, middle, junior, and senior high school science teachers. In order to maximize the program's impact on minority students, teachers must be members of a minority group or teach a significant number of minority students. Preservice teachers are those teachers in training and enrolled in preservice education programs and who have expressed an interest in teaching life sciences at the K-12 level with a focus on minority students. MECHANISM OF SUPPORT Awards under this Program Announcement will use the education project (R25) grant mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to this Program Announcement may not exceed three years. Because of the wide range in the size and type of institutions that may apply, it is anticipated that the sizes of the awards may also vary. The anticipated award date is April 1, 1995. Applications must request support for both students and teachers, with a minimum of eight students per year unless exceptional justification is provided. Indirect costs, other than those awarded to State or local government agencies, will be reimbursed at eight percent of total allowable direct costs. State and local government agencies will receive reimbursement at their full indirect cost rate. Allowable costs Funds for personnel costs may only be requested for eligible students and teachers and must be paid as salaries and wages; stipends are not allowable costs under this program. While grantee institutions must establish the rate of compensation to be paid to teachers, it is expected that the amounts will be based on their actual monthly salary and fringe benefits and prorated accordingly. Students' salaries should be based on the prevailing scale for comparable type work, but should not be less than the Federal minimum hourly wage. Funds to defray other costs such as supplies can be requested as a lump sum of up to $250 per participant per year. RESEARCH OBJECTIVES Background Relative to their representation in the general population, minority Americans are severely underrepresented in scientific and health fields at every level, from the professional work force - physicians, dentists, research scientists - through all levels of the educational system. Although there are a number of factors for this underrepresentation, it is generally agreed that the long-term resolution of this problem centers at improving science education of minority youths at the early stages of the educational process. With the rapid pace of technological innovations and the increasing number of occupations that require a knowledge of scientific principles, as well as the predicted increase in the minority population, it is imperative that precollege education further enhance the capacity and capability of minority youth to become more productive and competitive in tomorrow's work force. The primary objectives of this program are to improve the quality of precollege science education and to increase the pool of minorities interested and prepared to enter college and pursue a career in the biomedical/behavioral sciences. Program Characteristics The Program Director will be responsible for the selection and recruitment of students, teachers, and mentors, as well as for the overall direction of the program. The program director must be a biomedical/behavioral scientist or an experienced science educator employed by the applicant organization. The program has two major activities. The first is for minority high school students; the second is for K-12 inservice and preservice teachers. While the proposed program should be best suited to an institution's own strengths and characteristics, at a minimum, each program should include: o a description of the proposed overall program plan (specific research projects should not be described); o a description of the research environment (ongoing research activity, availability of equipment, facilities, resources); o methods and criteria for student, teacher, and mentor recruitment and selection; o methods to assign students and teachers to mentors; o the length of the research experiences; o other special enrichment activities available to students and teachers; o plans to evaluate program progress; o prior accomplishments of the institution in precollege education; o the impact of other precollege programs, if any, for the proposed program; and o the level of institutional commitment to precollege programs and partnerships. Criteria for selection of mentors must include: commitment to improving the quality of precollege science education, the ability and time to work with high school students and teachers to instill an understanding of research and the technical skills needed. Mentors must have active biomedical or behavioral research support and/or a recent publication history in biomedical/behavioral research. Research support can include NIH or other Federal agency support or private or institutional grants. An evaluation component must be included as part of the application. Methods, formative in nature, should be devised to evaluate whether or not the program is making progress in meeting the program goals. For example, information should be collected to learn if the program is helping teachers integrate new concepts in health sciences into the classrooms. Student participants should be assessed to determine if it has increased their awareness and/or interest in the health sciences. To the extent possible, students should be followed to determine if they attended and/or graduated from college and, if so, their major academic area of concentration. Specific characteristics regarding the student and teachers activities are as follows. Student Activities The most important aspect of this program is the research laboratory experience. The program provides for matching high school students for approximately six to eight weeks in the summer, with a ratio of not more than two students to one mentor, in an active research laboratory. It is expected that the applicant will describe a research program that will provide: o an independent, hands-on, mentored laboratory experience with attainable goals which introduces the students to some of the latest concepts in biomedical science; o mentoring and career guidance by biomedical/behavioral scientists; o an opportunity for students to participate in various laboratory activities and acquaint them with the environment and resources of the institution. A program of special summer scientific enrichment activities must be proposed. Such activities may include, but are not limited to: programs on research opportunities and careers within the health sciences, bioethical issues in biomedical/behavioral research or implications of the human genome effort. A final forum should be held where students present their research results. In order to maximize the long-term effects of the summer experience, follow-up activities such as seminars, workshops or Saturday study groups may occur during the academic year if the students are located within reasonable distance of the research institution. Mentors should also try to visit students' schools to meet with teachers, recruit future candidates for the program and help build effective partnerships between the research institutions and secondary schools. Recruitment and selection criteria for students should include: the student's motivation, ability, scholastic aptitude, and accomplishments. In addition, consideration should be given to science teachers' recommendations. Teacher Activities K-12 teachers are the key individuals in increasing the pool of scientifically skilled minority high school students. However, most preservice teaching programs do not require a hands-on laboratory experience; most elementary school teachers have had no opportunity for training in science; and most middle, junior, and senior high school teachers need retraining in the latest scientific concepts. To address these deficiencies, the proposed program should provide inservice and preservice teachers with an intensive hands-on mentored laboratory research experience of four weeks or more that: o exposes them to contemporary concepts in the health sciences o introduces them to modern laboratory techniques, including computers; o enables them, in collaboration with their research mentor, to prepare new discovery-based lesson plans. Unless the teachers' schools are geographically remote, the teacher programs must include follow-up components in which the participants discuss their experiences in implementing new scientific activities into the classroom. An important aspect of the program is to develop continuing partnership relationships between teachers and mentors to improve the teaching of life sciences at the precollege level and to stimulate students interest in health science careers. Recruitment and selection criteria for inservice teachers should include: experience and teaching responsibilities, level of interest in participating in a research program, expected impact on their teaching programs, ability to stimulate minority students to pursue scientific careers, and future plans for continued interaction with the research institution. Recruitment and selection criteria for preservice teachers should include the commitment to participate in a research program and the expressed interest to teach life sciences at the K-12 level with a focus on minority students. APPLICATION PROCEDURES Applications are to be submitted using form PHS 398 (rev. 9/91). These forms are available in most institutional offices of sponsored research and may be requested from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. Applications must follow the instructions provided in the PHS 398 form except for the following: Form Page 1 Item 2a. - Identify the number and title of this program announcement and check the box marked "YES." Item 2b. - Type "R25" in 2b. Item 4. Human Subjects - Not relevant (no project description). Item 5. Vertebrate Animals - Not relevant (no project description). Item 6. The project period start date should be 04-01-95. The length of the project period may not exceed three years. Form Page 4 - Detailed Budget for Initial Budget Period. Personnel Category - Follow the instructions provided in the PHS 398 regarding the Principal Investigator/Program Director. Using successive lines in the Personnel Category, indicate the number of positions being requested for students, preservice, and inservice teachers. For each of these classifications, provide requested information regarding type of appointment/months, percent of effort on project, and institutional base salary, as well as the dollar amounts being requested. Salary and fringe benefit support may be requested only for the students and teachers. Other Expenses - Up to $250 per student and teacher participant may be requested as a lump sum to defray costs such as supplies required for their research experiences. Form Page 5 - Budget for the Entire Proposed Project Period - Follow instructions provided on page 19 of the PHS 398 kit. Justification - Applicants should provide sufficient information regarding the support requested for students, preservice, and inservice teachers to permit the reviewers to evaluate the requested costs compared to the proposed length of the research experience. If the proposed program includes academic year as well as summer involvement, provide separate budgetary justification regarding each. Applicants should also explain any increases or decreases over the initial budget period, e.g., if students and/or teachers are expected to return for a portion of a succeeding period and will require salary and other support during this period. Additional Form Pages Biographical Sketch Page - Provide a biographical sketch for the Program Director and each proposed mentor, strictly adhering to the 2 page limitation for each. Other Support Page - Provide the information requested for the Program Director and each proposed mentor. Resources and Environment Page - Follow the PHS 398 instructions. Specific Instructions - Research Plan The following instructions should be used in lieu of the PHS 398 instructions for this section of the application. The Research Plan section of the application must strictly adhere to a limit of 15 pages, excluding a maximum of three letters of institutional support. Include sufficient information to facilitate an effective review; be specific, informative, and avoid redundancies. The outline suggested below should be followed in describing the program. A. Background If the applicant institution has held a MHSSRAP grant in the past, describe the history of the program, the type and size of the program (number of students and teachers) and any program accomplishments including tracking data for the students, if available. Information may be provided in tabular form. Prior accomplishments of the institution in other precollege science activities may also be included. B. Proposed Program At a minimum, provide information regarding: 1. A description of the proposed program; 2. A description of the research environment and how it relates to the proposed program (e.g., ongoing research activity, availability of equipment, facilities, and resources); 3. Methods and criteria for student, teacher, and mentor recruitment and selection; 4. Methods to assign students and teachers to mentors (specific research projects should not be described) but a description of the general scientific skills to be learned should be included; 5. The length of the student, preservice, and inservice teacher research programs; 6. Other special enrichment activities available to the students and teachers; 7. Plans for formative evaluation of the program. C. Institutional Supporting Data Include a minimum of one and a maximum of three letters of institutional support. The letter(s) should be from a highly placed institutional official, at the level of Dean or above, who is in a position to commit the institutional resources necessary to assure effective conduct of the program. Appendix - No appendix material will be allowed. The signed, typewritten original of the application, including the Checklist, and three exact photocopies of the signed application must be submitted to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent to: Dr. Marjorie A. Tingle Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Applications must be submitted by September 12, 1994. Applications submitted after this date will be returned to the applicant. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCRR. Incomplete applications will be returned to the applicant without further consideration. If staff find that the application is not responsive to this program, it will be returned without further consideration. Applications that are complete and responsive to this program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to this program announcement. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Criteria for review of applications include the following: o quality of the overall scientific and educational content of the proposed program including research laboratory and special enrichment activities; o appropriateness of the plans considering the size, strengths, and characteristics of the institution; o the qualifications of the Program Director and the proposed mentors; o the quality of the method of recruitment, selection and assignment of students, teachers, and mentors; o the quality of the institution's plans for a formative evaluation of the program; o the extent of the institutional commitment to providing a quality research experience and to precollege education partnerships; and o the extent of prior accomplishments in precollege education. The second level of review will be provided by the National Advisory Research Resources Council in February 1995. AWARD CRITERIA The following will be considered when making funding decisions: the quality of the proposed application as determined by peer review, availability of funds, program balance among the types of institutions and geographic distribution of the awards. INQUIRIES Written and telephone inquiries concerning this PAR are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Marjorie A. Tingle or Dr. Abraham Levy Biomedical Research Support Program National Center for Research Resources Westwood Building, Room 848 Bethesda, MD 20892 Telephone: (301) 594-7947 Direct inquiries regarding fiscal matters to: Ms. Mary V. Niemiec Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) 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 for Executive Order 12372 or Health Systems Agency review. $$P5 END ************************************************************ ERRATA $$E1 BEGIN R5 19940520 APPEND RFA DK-94-020 BOTH *********************** OBESITY/NUTRITION RESEARCH CENTERS NIH GUIDE, Volume 23, Number 26, July 15, 1994 RFA: DK-94-020 P.T. 04; K.W. 0710095, 0715145, 0710030, 1002004, 0765020 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 1994 The following change is made to RFA DK-94-020, which was published in the NIH Guide for Grants and Contracts, Vol. 23, No. 19, May 20, 1994: On May 20, 1994, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) published RFA DK-94-020 which invited applications for Obesity/Nutrition Research Centers (ONRCs) to conduct basic and clinical research on obesity, and the related fields of energy metabolism, body composition, satiety, adipocyte metabolism, eating disorders and weight management. RFA DK-94-020 stated that the NIDDK anticipated making one award as a result of that RFA. The NIDDK now anticipates awarding two ONRC grants instead of one, assuming that applications with sufficient merit are received. INQUIRIES Applicants may obtain additional information from: Van S. Hubbard, M.D., Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A18B Bethesda, MD 20892 Telephone: (301) 594-7573 FAX: (301) 594-7504 $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Fri Jul 15 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 26, pt. 1of2, 15 July 1994 Date: 15 Jul 1994 18:50:59 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <307ee3$pb4@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940715 V23N26 P1O2 ************************************ X-comment: RFAs described: CA-94-026, CA-94-022 NIH GUIDE - Vol. 23, No. 26 - July 15, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUE RESEARCH RESOURCES PRODUCED WITH PHS FUNDING Public Health Service INDEX: PUBLIC HEALTH SERVICE $$INDEX N2 ********************************************************** NIH MIDWEST REGIONAL SEMINAR IN PROGRAM FUNDING AND GRANTS ADMINISTRATION National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOP National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** NICHD TRANSGENIC MOUSE DEVELOPMENT FACILITY (RFP NICHD-CRMC-95-01) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R2 ********************************************************** ANIMAL CARE AND HOUSING SUPPORT SERVICES FOR STUDY OF SLOW, LATENT AND TEMPERATE INFECTIONS OF THE NERVOUS SYSTEM CAUSED BY CONVENTIONAL AND UNCONVENTIONAL VIRUSES (RFP NIH-NINDS-94-08) National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE $$INDEX R3 10/13/94 ************************************************* PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS (RFA CA-94-026) National Cancer Institute INDEX: CANCER $$INDEX R4 10/20/94 ************************************************* RESEARCH PROGRAM GRANTS IN CHEMOPREVENTION (RFA CA-94-022) National Cancer Institute INDEX: CANCER ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM (PA-94-078) National Institute on Drug Abuse INDEX: DRUG ABUSE $$INDEX P2 ********************************************************** DNA DAMAGE, GENOMIC INSTABILITY AND BREAST CANCER (PA-94-079) National Cancer Institute INDEX: CANCER $$INDEX P3 ********************************************************** GENETIC AND PHENOTYPIC MARKERS FOR IONIZING RADIATION-INDUCED BREAST CANCER IN RODENT AND HUMAN CELLS (PA-94-080) National Cancer Institute INDEX: CANCER $$INDEX P4 ********************************************************* MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM (PAR-94-081) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P5 ********************************************************** NCRR MINORITY INITIATIVE: K-12 TEACHERS AND HIGH SCHOOL STUDENTS (PAR- 94-082) National Center for Research Resources INDEX: RESEARCH RESOURCES ERRATA $$INDEX E1 ********************************************************** OBESITY/NUTRITION RESEARCH CENTERS (RFA DK-94-020) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUE RESEARCH RESOURCES PRODUCED WITH PHS FUNDING NIH GUIDE, Volume 23, Number 26, July 15, 1994 P.T. 36; K.W. 0780010 Public Health Service This announcement is a republication of the one last appearing in the NIH Guide for Grants and Contracts, Vol. 21, No. 33, September 11, 1992. Investigators conducting biomedical research frequently develop unique research resources. Categories of these resources include: synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well as DNA sequences, mapping information, crystallographic coordinates, and spectroscopic data. Some specific examples are: specialized and/or genetically defined cell lines, including normal and diseased human cells; monoclonal antibodies; hybridoma cell lines; microbial cells and products; viruses and viral products; recombinant nucleic acid molecules; DNA probes; nucleic acid and protein sequences; certain types of animals such as transgenic mice; and intellectual property such as computer programs. The PHS provides the following statement of policy concerning unique research resources developed through PHS awards. A. Policy on Distribution of Research Resources The policy of the PHS is to make available to the public the results and accomplishments of the activities that it funds. Restricted availability of unique resources upon which further studies are dependent can impede the advancement of research and the delivery of medical care. Therefore, when these resources are developed with PHS funds and the associated research findings have been published or after they have been provided to the agencies under contract, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. This policy applies to PHS intramural investigators as well as extramural scientists funded by PHS grants, cooperative agreements, and contracts. Because of concern that some crystallographers are not making their coordinates available promptly (see Science, Vol. 245, p. 1179), one of the national advisory councils of the NIH and the executive committee of another institute recently adopted resolutions affirming the policy of the International Union of Crystallographers (IUCr) (Acta Cryst., A45: 658, 1989). The PHS has now adopted the IUCr policy that includes data from publications based on spectroscopic data such as nuclear magnetic resonance as well as crystallographic coordinates. The PHS encourages investigators who have such resources to consult the appropriate Program Administrators who may be of assistance in determining a suitable distribution mechanism. Such a mechanism should take into consideration all applicable Federal regulations including, but not limited to: those regarding human subjects, animal welfare, and use and handling of hazardous materials, where applicable. Investigators requesting materials should provide evidence of having the proper training, experience, and facilities to make use of the items they request. Program staff of the agencies will be available to assist in verification of credentials of requesters where such concern exists on the part of suppliers. Investigators who believe that they will be unable to implement this policy should promptly contact the appropriate PHS Program Administrator to discuss the circumstances, obtain information that might facilitate compliance with the policy, and reach an understanding in advance of the subsequent award. For research and development contracts, approval should be obtained from the PHS Contracting Officer before distribution of unique resources, unless the terms of the contract permit distribution without prior clearance of the Contracting Officer. In order to facilitate the availability of unique or novel biological materials and resources developed with PHS funds, investigators may distribute the materials through their own laboratory or institution or submit them, if appropriate, to entities such as the American Type Culture Collection or other repositories. In the case of unique biological information, such as DNA sequences or crystallographic coordinates, investigators are expected to submit them to the appropriate data banks because they otherwise are not truly accessible to the scientific community. When distributing unique resources, investigators are to include pertinent information on the nature, quality, or characterization of the materials. Investigators must exercise great care to ensure that resources involving human cells or tissues do not identify original donors or subjects, directly or through identifiers, such as codes linked to the donors or subjects. The goals of some programs, (e.g., the Human Genome Program) are such that applicants for certain projects may be required to provide plans for the sharing of data and materials. These plans will undergo review by program staff and the national advisory council prior to award. B. Distribution Costs Institutions and investigators may charge the requester, if necessary, for the reasonable cost of production of unique biological materials, and for packaging and shipping, Such costs may include labor, supplies, and other directly related expenses. Investigators should note, however, that such a charge accrues as general program income. This should not be an impediment to the distribution of materials, but investigators and institutions are advised that: a) for grants, the income is governed by 45 CFR Part 74 and it must be reported on the Financial Status Report. Questions regarding these policies and the treatment of income should be directed to the Grants Management Officer. b) for contracts, the income is governed by Federal Acquisition Regulations (FAR) 45.610-3. Contracting Officers must be contacted before generating any revenues from the distribution of materials. Any contract under which research resources would be sold require specific contract instructions. Existing contracts may require an amendment and specific approval of the Contracting Officer to render them allowable. C. Inventions and Commercialization Federal policy encourages the commercialization of the products of research developed as a consequence of Federal funding; therefore, the intent of this policy is to not discourage, impede, or prohibit the organization that develops unique research resources or intellectual property from commercializing the products. Investigators may make their materials available to others for commercial purposes with appropriate restrictions and licensing terms as they and their institution deem necessary. Institutions are reminded that some of these products may be inventions subject to the various laws and regulations applicable to patents and must be reported to the Extramural Inventions Reports Office of the NIH. The terms for licensing of unpatented research products, such as cell lines, monoclonal antibodies, and other materials and products, should generally be no more restrictive than would have been the case had they been patented---for example, only if there is full public disclosure of the invention/discovery, availability through a repository, and written agreement to end all fees and constraints after 17 years. When reporting is required, it should occur at the earliest possible time. (See 37 CFR 401 and NIH Guide for Grants and Contracts, Vol. 19, No. 6, February 9, 1990.) $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NIH MIDWEST REGIONAL SEMINAR IN PROGRAM FUNDING AND GRANTS ADMINISTRATION NIH GUIDE, Volume 23, Number 26, July 15, 1994 P.T. 34; K.W. 1014006 National Institutes of Health A regional seminar covering topics related to program funding and grants administration at the National Institutes of Health (NIH) has been scheduled for July 21-22, 1994. The seminar, hosted by Northwestern University and held on its Evanston campus, is intended to attract faculty and research administrators from the midwest region of the United States, although those interested from other regions are also invited and welcome. Staff from small and minority colleges, for-profit research organizations, hospitals, universities, and medical centers are encouraged to attend. This two-day seminar will have a dual focus of interest to both academic researchers, as well as new and senior research administrators. Discussions of current issues that affect NIH funding and grants administration will be featured to give conference participants a comprehensive view of NIH-sponsored research. There will be time available to network with fellow researchers and meet informally with NIH representatives to discuss topics of special interest. Mr. Geoffrey Grant, Acting Director, NIH Office of Policy for Extramural Research Administration, and outstanding representatives from the Grants Policy Office, Division of Research Grants, and several awarding components of the NIH will be featured speakers. SEMINAR LOGISTICS Seminar Leader: Geoffrey Grant, Acting Director Office of Policy for Extramural Research Administration (OPERA) Seminar Coordinator (NIH): Joellen M. Harper, NIH Grants Policy Office, 301/496-5967 Seminar Coordinator (Northwestern): Barbara Siegel, Office of Research and Sponsored Programs, Northwestern University, 708/491-3003 Dates: Thursday and Friday, July 21-22, 1994 Location: Northwestern University, Evanston, Illinois Cost of Workshop: $100 REGISTRATION AND INQUIRIES Advance registration is required by July 12, 1994. You are encouraged to register early, because conference space is limited to the first 300 registrants. For registration materials, send a FAX that provides your name, institution, address, telephone number, and anticipated number of registrants to Ms. Barbara Siegel, 708/491-4800. Individuals who previously asked to be placed on the mailing list for registration materials will receive them automatically. It is not necessary to request them again. FUTURE SEMINARS A SOUTHWEST SEMINAR will be hosted by the University of New Mexico in Albuquerque, New Mexico, November 17-18, 1994. To request registration materials, call 505/277-3942 or send a FAX that provides your name, institution, address, telephone number, and anticipated number of registrants to 505/277-8604. Registration materials will be finalized and mailed two to three months before the seminar. At this time, the dates and locations for regional seminars to be held in 1995 have not been finalized. If you have any questions about hosting a regional seminar, contact Ms. Joellen Harper in the NIH Grants Policy Office on 301/496-5967. $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOP NIH GUIDE, Volume 23, Number 26, July 15, 1994 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health (NIH), Office of Extramural Research (OER), Office for Protection from Research Risks (OPRR) is cosponsoring a National Animal Welfare Education Workshop with The Department of Veterans Affairs. The workshop is open to all persons involved in the management and/or oversight of an institutional animal care and use program including institutional administrators, members of Institution Animal Care and Use Committees, laboratory animal veterinarians, investigators, and technicians. DATES: August 4-5, 1994 TOPIC: Sharing Animal Welfare Responsibilities Between Affiliated Institutions LOCATION Portland Marriott Hotel 1401 SW Front Avenue Portland OR Telephone: (503) 226-7600 or 1-800-228-9290 SPONSOR Department of Veterans Affairs REGISTRATION Ms. Margaret Doherty Department of Veterans Affairs Medical Center Veterinary Medical Unit (151-Z) 3710 SW U.S. Veterans Hospital Road Portland OR 97201 Telephone: (503) 220-8262 Ext. 7610 FAX: (503) 273-5351 FEE: $150 - Regular; $100 - Students and Technicians - Registration fee includes workshop materials, two continental breakfasts, one lunch, one wine and cheese social, and refreshment breaks. DESCRIPTION: The workshop will explore the relationships among Academic, Government, and Industry as they pertain to the care and use of laboratory animals and animal research facilities and programs. The speakers will focus on issues such as assuming responsibility; VA vs. Academia; building shared institutional animal care and use committees; proprietary information; and the regulatory agencies' perspective and oversight. DATES: SEPTEMBER 29-30, 1994 TOPIC: Use of Animals in Research and Alternatives LOCATION: The Monteleone Hotel, New Orleans, LA SPONSORS Louisiana State University Medical Center Xavier University of Louisiana REGISTRATION Ms. Lois Herbez Louisiana State University Medical Center 1542 Tulane Avenue New Orleans, LA 70112 Telephone: (504) 568-4198 FAX: (504) 568-4843 FEE: $150 DESCRIPTION: The theme of the workshop will address various aspects of the use of animals in research and the role of animals and alternatives in research and education. The workshop will address such issues as (1) Adequacy of Computer Searches; (2) NIH, USDA, FDA Alternatives Initiative; (3) Occupational Health - Implementation, Update and Biosafety Concerns; (4) Roles of Animals and Alternatives in Education. DATES: December 1-2, 1994 TOPIC: New Frontiers in Surgery LOCATION Sheraton Charleston 170 Lockwood Drive Charleston, SC 29403 Telephone: (803) 723-3000 FAX: (803) 723-3000 SPONSOR: Medical University of South Carolina REGISTRATION M. Michael Swindle, D.V.M. MUSC/Comparative Medicine 171 Ashley Avenue Charleston, SC 29425-2211 Telephone: (803) 792-3625 FAX: (803) 792-9067 FEE: $150.00 (Before Nov 15, 1994) $175.00 (After Nov 15, 1994) DESCRIPTION: The Workshop will address ethics, protocol review and technical and training aspects related to new surgical and interventional technologies. Topics to be discussed in the program include xenographic procedures, fetal intervention, transgenic technologies, and use of biomaterials in orthopedic surgery. INQUIRIES For further information concerning future NIH/OPRR Animal Welfare Education Workshops, contact Mrs. Roberta Sonneborn Office of Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-7163 FAX: (301) 402-2803 $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 26, July 15, 1994 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: September 22-23, 1994 TOPIC: Human Subject Protections Workshop LOCATION: Hyatt Regency Two Fountain Plaza, Buffalo, NY SPONSORS University at Buffalo National Institute of Mental Health, NIH CONTACT Office of Research University at Buffalo State University of New York 314 Crofts Hall Buffalo, NY 14260-1234 Telephone: (716) 645-3869 DESCRIPTION: Human Institutional Review Boards (IRBs) are charged with the responsibility to protect human subjects undergoing research while at the same time permitting the advancement of the biomedical sciences in alleviating human disease. This workshop will address specific complex issues confronting IRBs today including the issues involving the mentally incapacitated individual, research in AIDS, children, research in the emergency room, medical devices and multicenter FDA monitoring. Discussions of what constitutes an expedited review and the elements of an informed consent are also included. Full audience participation in all presentations is welcomed and encouraged. The faculty consists of outstanding individuals with expertise in the operation and function of IRBs including representatives of the OPRR, the FDA, and local colleagues. The workshop is intended for physicians, nurses, pharmacists, basic scientists, students, legal experts, members of IRBs and all persons with an interest in and concern for human research. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene M. Ross Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B63 Bethesda, MD 20892 Telephone: (301) 496-8101 $$N4 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN NICHD-CRMC-95-01 ***************************************** NICHD TRANSGENIC MOUSE DEVELOPMENT FACILITY NIH GUIDE, Volume 23, Number 26, July 15, 1994 RFP AVAILABLE: NICHD-CRMC-95-01 P.T. 34; K.W. 0780035 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) has a requirement for a facility to produce customized transgenic mice. Responsibilities of the facility will include: (1) receiving donor DNA probes, (2) analyzing DNA for microinjection, (3) microinjecting DNA constructs into fertilized one-cell mouse eggs and reimplanting into pseudopregnant recipient females, (4) testing potential founders for DNA integration, (5) producing at least two integration-positive transgenic mice, (6) maintaining the transgenic for a short period, and (7) distributing the transgenics. The Request For Proposal (RFP) will be available on or about July 11, 1994, and responses are due by September 7, 1994. All responsible sources are encouraged to submit a proposal. INQUIRIES All requests must cite the RFP number above and include two self- addressed mailing labels. All sources who consider themselves qualified are encouraged to submit proposals. Mrs. Dorothy McKelvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 7A07 Bethesda, MD 20892 FAX: (301) 402-3676 $$R1 END ************************************************************ $$R2 BEGIN NIH-NINDS-94-08 ****************************************** ANIMAL CARE AND HOUSING SUPPORT SERVICES FOR STUDY OF SLOW, LATENT AND TEMPERATE INFECTIONS OF THE NERVOUS SYSTEM CAUSED BY CONVENTIONAL AND UNCONVENTIONAL VIRUSES NIH GUIDE, Volume 23, Number 26, July 15, 1994 RFP AVAILABLE: NIH-NINDS-94-08 P.T. 34; K.W. 1002002, 1002045 National Institute of Neurological Disorders and Stroke The Division of Intramural Research of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), is seeking a contract for animal care and housing support services for the study of slow, latent and temperate infections of the nervous system caused by conventional and unconventional viruses. Housing and care of this colony includes providing animal management, veterinary care and treatment, laboratory services, and other technical support and specified on-site facilities--as described in the Request for Proposals (RFP)--in an isolated, scrapie-free environment. The colony includes approximately 770 non-human primates, five equine, three goats, and three domestic cats in support of ongoing, long-term research studies. Offerors must have on-site veterinary care, extensive knowledge of and experience with infectious diseases, and be well versed in prescribed guidelines on the use and care of laboratory animals. This requirement represents the recompetition of a current contract with the University of Southwestern Louisiana and the incumbent is expected to reapply. It is anticipated that one award covering a performance period of five years will be made about February 1995. INQUIRIES This is not an RFP. An RFP will be issued on or about July 28, 1994, with proposals due by September 28, 1994. All responsible sources will be considered by the agency. To receive a copy of the RFP, submit a written request with two self-addressed mailing labels to: Contracting Officer ATTN: RFP No. NIH-NINDS-94-08 Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 $$R2 END ************************************************************ $$R3 BEGIN CA-94-026 FULL-TEXT ************************************** PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 22, Number 26, July 15, 1994 RFA AVAILABLE: CA-94-026 P.T. 34; K.W. 0715035, 0745003, 0740018, 0755015 National Cancer Institute Letter of Intent Receipt Date: August 25, 1994 Application Receipt Date: October 13, 1994 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS ONLY AN ABSTRACT OF THE RFA. POTENTIAL APPLICANTS MUST REQUEST THE COMPLETE RFA, WHICH CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION, FROM THE CONTACT LISTED IN "INQUIRIES," BELOW. FAILURE TO FOLLOW THE INSTRUCTIONS IN THE COMPLETE RFA MAY RESULT IN AN INCOMPLETE APPLICATION, WHICH WILL BE RETURNED TO THE APPLICANT WITHOUT REVIEW. PURPOSE The Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications for cooperative agreements to support clinical trials that are directed toward examining the role of various chemopreventive agents and/or diet in the prevention of cancer. This is a follow-up to earlier RFAs that had requested grants, and then later, cooperative agreement applications in this area. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Prevention Clinical Trials Utilizing Intermediate Endpoints and Their Modulation by Chemopreventive Agents, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative agreement mechanism (U01), for which substantial NIH programmatic involvement is expected. An assistance relationship will exist between NCI and the awardees to accomplish the purpose of the activity. The recipients will have primary responsibility for the development and performance of the activity. However, there will be government involvement with regard to (1) assistance securing an Investigational new Drug (IND) approval from the Food and Drug Administration (FDA), (2) monitoring of safety and toxicity, (3) coordination and assistance in obtaining the chemopreventive agent, and (4) quality assurance with regard to the clinical chemistry aspects of the study. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the present RFA may not exceed five years. This RFA will be issued annually for two years. Future unsolicited continuation applications will compete with all other investigator- initiated (R01) research applications and be peer reviewed by a study section in the DRG. However, should the NCI determine subsequently that there is a sufficient continuing program need, NCI may reissue a new RFA and invite all funded recipients to submit competing continuation applications. In the latter case, competing continuation applications will not compete with new applications for funding. FUNDS AVAILABLE Approximately $1.5 million in total costs for the first year will be committed to fund applications submitted in response to this RFA. The project period cannot exceed five years. It is anticipated that three to five awards will be funded. RESEARCH OBJECTIVES The major objective of this solicitation is to encourage cancer chemoprevention clinical trials that utilize biochemical and/or biological markers to identify populations at risk and/or to provide intermediate endpoints that may predict later reduction in cancer incidence rates. These studies may be developed in phases, including a pilot phase, which could later proceed to a full-scale intervention. The main emphasis should be on small, efficient intervention studies aimed at improving future research designs of chemoprevention trials, providing further biologic understanding of the trial results, or providing better, more quantitative and more efficient endpoints for these trials. After successful completion of the pilot phase (i.e., demonstrated modulation of marker endpoints by the intervention), subsequent studies could include a definitive clinical trial monitoring the test system, a cancer incidence or mortality endpoint, and a designated agent. Investigators may apply at this time for the pilot phase, or submit an application for both the pilot and definitive trial studies. However, if the application is for the pilot phase only, it must include a description of its relevance to a broad clinical application, including the chemopreventive agent, marker test system, and study population which could later be the subject of a full-scale, double-blind, randomized, risk reduction clinical trial. Intermediate marker trials of breast cancer chemoprevention are especially encouraged. STUDY POPULATION INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS Awards for research involving human subjects must follow the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research." See the RFA for details. LETTER OF INTENT Prospective applicants are asked to submit, by August 25, 1994, a letter of intent that includes a descriptive title of the proposed research, the name and address of the principal investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Marjorie Perloff at the address listed under INQUIRIES. APPLICATION PROCEDURES The receipt date for application is October 13, 1994. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these cooperative agreements. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application, "Prevention Clinical Trials Utilizing Intermediate Endpoints and Their Modulation by Chemopreventive Agents," and the RFA number, CA-94-026, must be typed in block 2a of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, clear, and single-sided. photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Rockville, MD 20852 (if hand-delivered or delivery service) Bethesda, MD 20892 (if U.S. Postal Service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. Review Criteria The following factors will be considered in evaluating the scientific merit of each response to the RFA: 1. Scientific merit of the study objective(s), design, and methodology to include considerations of toxicity, safety and quality assurance. 2. Basic and clinical scientific significance as well as originality of the proposed research. 3. Research experience and/or competence of the Principal Investigator and other key personnel to conduct the proposed studies. 4. Adequacy of time (effort) which the Principal Investigator and staff would devote to conduct the proposed studies. 5. Relevancy and appropriateness of the specific target population along with assurance as to