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 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. INQUIRIES Written and telephone inquiries requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, 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 No. 93.399, 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 and Federal regulations 42 CFR Part 52 and PHS grant policies 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ $$R4 BEGIN CA-94-022 FULL-TEXT ************************************** RESEARCH PROGRAM GRANTS IN CHEMOPREVENTION NIH GUIDE, Volume 22, Number 26, July 15, 1994 RFA AVAILABLE: 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 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 cooperative agreements 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 RFA, Research Program Grants 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 or 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 Program Director's involvement is described in the RFA. 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. As more fully described in the 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. 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 which 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 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. SPECIAL REQUIREMENTS 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. All PHS and NIH grant policies will apply to applications received in response to this announcement. STUDY POPULATIONS 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 September 1, 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 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 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 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 or delivery service) Bethesda, MD 20892 (if U.S. Postal Service) REVIEW CONSIDERATIONS Upon receipt, applications will be administratively reviewed (initially) by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the RFA is an NCI program staff function. Applications will be judged to determine if they meet the goals and objectives of the program as described in the RFA. Applications that are judged non-responsive will be returned. Questions concerning the relevance of proposed research to the RFA may be directed to the NCI Program Director. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to identify those which are clearly not competitive for awards. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, 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 93.399, 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 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R4 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-078 ************************************************ BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM NIH GUIDE, Volume 22, Number 26, July 15, 1994 PA NUMBER: PA-94-078 P.T. 34; K.W. 0404009, 0404000, 0415001, 0745007, 0745060 National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to firmly establish the ongoing commitment of the NIDA to a major program of research on behavioral therapies for drug abuse and dependence. The term "behavioral therapy" is used here in a broad sense and includes various forms of psychotherapy, behavior therapy, cognitive therapy, skills training, counseling, and other rehabilitative therapies. Behavioral therapy research has been conceptualized, for the purposes of this initiative, to consist of three stages: (1) Stage I research (including the development, refinement, and pilot efficacy testing of behavioral interventions); (2) Stage II research (efficacy testing and replication of promising piloted behavioral therapies); and (3) Stage III research (studies to test the transferability to the community of behavioral therapies proven efficacious in Stage II studies). 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, Behavioral Therapies Development Program, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" Full Report: Stock No. 017-001-00474-0 or Summary report: Stock No. 017-001-00473-1 through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organization, 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). MECHANISM OF SUPPORT Support mechanisms include: research project grants (R01), small grants (R03), cooperative clinical research grants (R10) and FIRST Awards (R29). Investigators may also respond to this program announcement under the Interactive Research Project Grant (IRPG) Program. If an investigator wishes to respond under an IRPG, additional requirements must be met as described in PA-93-078. Research grants are awarded to institutions on behalf of Principal Investigators who have designed and will direct a specific project or set of projects. In fiscal year 1995, it is estimated that NIDA will have approximately $10 million to support approximately 30 new grants under this announcement. RESEARCH OBJECTIVES Background and Rationale. Behavioral therapies are frequently the only treatments available to drug dependent individuals. Even where medications are available, behavioral therapies are an integral component of treatment. Recognizing the importance of this area, the NIDA has launched a Behavioral Therapies Development Program. It is intended to: (1) complement and dramatically expand work underway within the Clinical and Experimental Therapeutics Research Branch, Division of Clinical Research, NIDA; and (2) parallel NIDA's Medications Development Program. It is NIDA's intention to support scientifically sound and clinically relevant behavioral therapy research that will potentially have a meaningful impact on the efficacy of drug abuse/ dependence treatment. Due to the growing AIDS problem in this country, special consideration will be given to grants that address AIDS- related issues in their therapies and include measures of the effect of the therapies on AIDS risk behaviors. Through the Behavioral Therapies Development Program, support may be sought to identify, evaluate, and standardize behavioral therapies for the treatment of drug abuse and dependence. Ultimately, therapies found to be efficacious through rigorous testing will be disseminated to clinicians. Although substantial work has already been done, this initiative will target for funding, in a systematic way, essential research on behavioral therapies for drug abuse and dependence. This will include, in particular, critical areas of research that have been overlooked in the past. Recent results from research studies indicate great promise for the efficacy of behavioral therapies for drug dependence. While considerable progress has been made, engagement and retention in treatment and relapse following treatment remain concerns. NIDA has undertaken the Behavioral Therapies Development Program with the goal of addressing these concerns and substantially improving the efficacy of behavioral treatments for drug abuse. The NIDA's Behavioral Therapies Development Program delineates three stages of behavioral therapy research. Stage I, the earliest stage of behavioral therapy research, therapy development, is viewed as a process involving identifying promising clinical and research findings relevant to drug abuse treatment, generating and formulating new behavioral therapies, operationally defining the therapies in manuals, and pilot testing and refining the therapies. Stage II research consists of small-scale efficacy testing of promising therapies identified in Stage I, as well as studies examining the efficacy of components of therapies. Most of the behavioral treatment research that NIDA has supported in the past has been of this type. Stage II also involves the replication, at other sites, of efficacy studies with positive results. Stage III entails the testing of the transferability to the community of therapies that have been shown to be efficacious in more than one controlled Stage II clinical trial. That is, Stage III, as defined in this program announcement, involves the determination of the usefulness of a therapy within community- based treatment programs. In order to meet the goals of Stage III research, investigators may wish to propose the development of training materials for the community drug abuse treatment provider. It is NIDA's objective to ensure sufficient emphasis and support for all stages of behavioral therapy research. Through the Behavioral Therapies Development Program, NIDA will greatly increase its support of the early stages of behavioral therapy development, small-scale controlled clinical trials of fully- developed therapies (including replications), and studies in community-based treatment programs of the most promising therapies identified in the Stage II clinical trials. This PA is intended to introduce this initiative by encouraging research grant applications in any one of the three stages of behavioral therapy research. Specific Areas of Interest Stage I Research. Investigators are encouraged to submit applications to develop and pilot test new or to modify and pilot test existing individual, group or family behavioral therapies that (1) appear promising for the treatment of drug dependent and abusing individuals and (2) have a theoretical basis and/or logical rationale. For drug abusers/addicts at high risk for AIDS, investigators are encouraged to include AIDS risk reduction interventions as an integral component of the therapy. Wherever appropriate, applicants are strongly encouraged to address how they will incorporate AIDS risk reduction strategies into the therapies they are proposing to develop. Of particular interest for development are: (1) discrete therapy modules, such as HIV risk reduction modules or modules to engage ambivalent drug dependent individuals in treatment, that can be implemented in conjunction with other therapeutic services; (2) therapies to treat populations with co-occurring drug abuse and mental problems; (3) therapies that address the unique needs and perspectives of women, minorities, adolescents, families, or specific cultural groups; (4) group therapies; and (5) therapies for HIV- positive drug abusers/addicts. Applicants proposing to develop a therapy are encouraged to explicitly describe the theoretical basis for the proposed therapy, and the population for whom it is intended. Although, of course, a manual for a therapy will not exist prior to an application to develop such a manual, applicants are encouraged to describe in as much detail as possible the nature of the therapy to be developed. Where appropriate, applicants may seek support under this program announcement to develop theoretically-based and psychometrically- sound client assessment scales tailored to assess the specific effects of the proposed therapy. If one theorizes, for example, that certain heroin addicts either began or maintained heroin use due to interpersonal conflicts, and that the resolution of these conflicts will decrease drug use, a measure of interpersonal conflicts may be required to ascertain the impact of the therapy under development. Applicants are encouraged to address the issue of therapy process measurement. Where appropriate, applicants may propose to develop measures of therapist competence and adherence, process measures, and instruments measuring the integrity and fidelity of the therapy. In the development of a new therapy for drug dependence, a broad range of issues relevant to efficacy and safety are raised. Pilot efficacy testing of newly developed/modified therapies is an integral part of any therapy development process. Therefore, applicants are encouraged to describe, in detail, the nature of any pilot testing intended. Wherever appropriate, applicants are encouraged to collect pilot data on the impact of the therapy on AIDS risk behavior, including data on the route of drug administration, and sexual behavior that may place individuals at risk for AIDS. Stage II Research. According to the model described in this program announcement, Stage II research establishes the efficacy of behavioral therapies or therapy components shown to be promising in Stage I. Therefore, it is strongly suggested that Stage I pilot data showing that a behavioral therapy is promising (in terms of a reduction in drug use, dropout rate, or psychiatric symptoms) be provided when proposing a Stage II controlled clinical trial. In Stage II research, control and comparison conditions are operationally defined, standardized, and manualized. However, early in Stage II, it may be appropriate to compare a therapy with "treatment as usual." Of course, control/comparison conditions are determined by clearly delineated research questions. It is appropriate, but not required, that investigators design studies to answer not only if their therapy works, but why it works. Where investigators are studying populations that are at risk for HIV, they are encouraged to explicitly address AIDS-related issues in their applications. Controlled clinical trials that examine the relative efficacy of individual, group, or family behavioral therapies and attempt to determine which therapies are best for which individuals, and under what conditions, are considered Stage II research. Where effective pharmacotherapies are available, research projects that attempt to maximize the efficacy of that pharmacotherapy through integration with behavioral therapy, or vice versa, are encouraged. Knowing the effective components of treatment can greatly aid in improving the quality of treatment. Theoretically based research that attempts to determine the effective components or combination of components in drug dependence psychotherapies, behavior therapies, or counseling strategies is encouraged. Where positive Stage II findings exist, replications are strongly encouraged. Applications that propose to generalize the efficacy of a promising therapy in another population are also encouraged. Where the investigator believes that significant modification of the therapy is needed before it can be tested in another population, investigators are referred to the section of this PA entitled, "Stage I Research." Investigators proposing a Stage II controlled clinical trial are encouraged to address pertinent methodological/design issues in their applications, such as attrition, selection bias, therapist/counselor training, assessment and control for patient psychiatric diagnosis and problem severity level, the use of manuals to guide the therapy, measurement of the treatment process, adequate follow-up assessments, and potential replication of the research proposed. It is recognized that for many research questions asked in the field of psychotherapy, behavior therapy, and counseling, no perfect research design may exist. Where there is more than one way to answer a proposed research question, investigators are urged to state their theoretical, ethical, and practical reasons for choosing one control group or one research design over another. Stage III Research. Where a behavioral therapy has been shown to be efficacious in a clinical trial, and where replication by a different investigator has borne out the contention that the therapy is, indeed, efficacious, investigators may propose to carry out a study to address the therapy's transferability to a community setting. A therapy that has been shown to be efficacious in a Stage II clinical trial and a replication is a possible candidate for a Stage III study. An investigator may propose to do a Stage III study on a therapy that was determined to be efficacious in Stage II by themselves or other investigators. Stage III may include packaging a therapy for use by a community drug abuse treatment provider and developing training manuals and other training materials. The investigator might then pilot the therapy in the community clinic, refine the therapy package, and ultimately test the usefulness of the packaged therapy in the community setting. Applicants are strongly encouraged to develop applications that are focused on one stage. That is, investigators may choose to focus on either Stage I, Stage II or Stage III research. However, where necessary, investigators may develop applications to include a research component consistent with the another stage (e.g., a Stage II research application may include a small Stage I component). If a subject is identified as being at risk for HIV acquisition and/or transmission, HIV testing and counseling must be offered to the subject in accordance with current guidelines. Wherever appropriate, investigators are encouraged to collect data on the effect of their behavioral therapy on AIDS risk behaviors and the effect of their therapy on the acquisition/transmission of associated infectious disease, including HIV. 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 For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 11146-11151), 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are 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 240, Bethesda, MD 20892, telephone (301) 594-7248. The title and number of the program announcement must be typed in Section 2a on the face page of the application. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: 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-94-026 - V23(26) 07/15/94 Date: 15 Jul 1994 18:51:13 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 786 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <307eeh$pc0@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94026 CA-94-026 P1O1 *************************************** PREVENTION CLINICAL TRIALS UTILIZING INTERMEDIATE ENDPOINTS AND THEIR MODULATION BY CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 23, Number 26, July 15, 1994 RFA: 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 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 Request for Application (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 cooperative agreement mechanism (U01). 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 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. This RFA will be issued annually for two years. Future unsolicited competing 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. 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 Investigational New Drug (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 award decisions 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 $1.5 million in total costs for the first year will be committed to specifically fund applications submitted in response to this RFA. It is anticipated that three to five awards will be made annually. This number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest feasible start date for the initial awards will be July 1, 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 primary objective of this RFA is to encourage cancer chemoprevention clinical trials that utilize biochemical and 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 would be the subject of a full scale, randomized, cancer risk reduction clinical trial. Applications should be prepared and submitted in accordance with the aims and requirements described in the following sections: A number of compounds and/or dietary components have been associated with the inhibition of carcinogenesis in animal models, in vitro systems, and/or epidemiologic investigations. Results from these studies suggest that chemopreventive agents, including dietary components, affect the later stages of carcinogenesis. The best approach to confidently address the efficacy and safety as well as the applicability and effectiveness for these agents is through the conduct of clinical trials. A variety of parameters have become available and may be used to identify or evaluate risk modulation in selected target populations by chemopreventive agents. Examples include reversal of abnormal cytology, prevention or reversal of nuclear aberrations (micronuclei), ornithine decarboxylase and/or prostaglandin synthetase inhibition, DNA ploidy alterations, changes in colonic mucosal proliferation (histology, tritiated thymidine labelling indices), decreases in fecal mutagens, and oncogene suppression tests. Markers of precancerous lesions may also be useful to define populations that may benefit from chemoprevention trials; however, more information is required concerning the ability of such markers to predict and/or modulate cancer incidence. The development of sensitive and accurate intermediate endpoints should greatly enhance the ability to design effective cancer risk reduction trials. Chemoprevention clinical trials involve a spectrum of subjects in various categories of risk. These might involve normal human subjects, subjects at high risk due to prior exposure to carcinogens, subjects with precancerous lesions, patients having been treated for a primary cancer now free of disease, and patients treated for primary cancer with alkylating agents or radiation who are at high risk for developing second cancers. Methods for identification of populations at risk and assessment of their risk of developing cancer is therefore a major goal of the chemoprevention program. These studies are expected to augment the efficient experimental design of clinical trials leading to lesser number of subjects required to achieve adequate statistical power. The tests used for risk identification are also of value because of the multi-step nature of cancer induction and the different mechanisms by which chemopreventive agents are known to inhibit the carcinogenic process. Thus, it is useful to have tests that measure genotoxic exposure as well as tests which indicate that subjects are in the later (e.g. promotional, progressional) phase of the carcinogenic process. It should be emphasized that protocols that propose use of assays/methods for risk identification must also include assays that measure biochemical or biological intermediate markers of cancer endpoints (in the pilot phase) or measurement of the intermediate endpoints themselves (in the later definitive trials). Studies of Special Interest Short term chemoprevention clinical trials that evaluate the effect of innovative biomedical monitoring tests in high risk populations are sought. These tests might be useful to determine an intermediate endpoint, serve as a basis to assess cancer risk status or to assess response to a chemopreventive agent. The modulation of effects by a chemopreventive agent on tests which are indicative of neoplastic progression may be an early indicator of its efficacy. Examples of such tests might include classical cytological techniques, suppression of oncogene protein products, etc. Modulation of a biological marker by a chemopreventive agent might be highly significant in relation to ultimate cancer prevention. A series of one or more tests would be included in the chemoprevention intervention clinical trial, initially to determine baseline parameters and later as a follow-up after administration of the chemopreventive agent. Biological fluids including urine, blood, sputum, etc. would have to be obtained from participants for analysis. Priority would be given for studies with biological monitoring procedures which do not overlap or duplicate currently funded projects. The pilot phase should attempt to detect the clinical activity of the chemopreventive agent rapidly, efficiently, and in reasonably accurate fashion with a relatively small number of subjects. In vivo or in vitro assays are acceptable if of particular and direct relevance to clinical trials. The pilot phase is not expected to give a definite answer to the ultimate value of the chemopreventive agent, which is the purpose of a larger Phase III study. It is expected, however, that upon completion of a pilot study, it should be possible to make a judgement regarding the effectiveness of the agent to modulate the marker test system (which will be correlated with modulation of the cancer endpoint in the definitive trials). Additionally, the pilot phase is expected to give an indication of the nature of any short term adverse effects related to the particular dose schedule, information on patient compliance, ability to measure the agent in body fluids and any other factors related to the subsequent clinical trial. These factors may provide further clarification on the need for a large, full scale study. Intervention populations of interest might include: individuals at high risk at selected cancer sites, individuals with precancerous lesions, or individuals presently free of cancer but at risk for second cancers. Intermediate marker studies of breast cancer chemoprevention are especially encouraged. SPECIAL REQUIREMENTS A. 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 a. Safety and Toxicity Review Each awardee institution and principal investigator agree 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. Informed Consent; IRB Approval Approval by the Institutional Review Board (IRB) must be obtained by awardees on all protocols because of the involvement of human subjects. d. Data Management and Reporting Requirements Data acquisition and analysis is the responsibility of the investigator. Investigators will be required to submit reports to NCI using the following schedule and format: (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 nonclinical investigations, including: A narrative or tabular summary showing the most frequent and most serious adverse experiences by body system. A list of subjects who died during participation in the investigation, with the cause of death for each subject. A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related. 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 that fails to meet this criterion will not be issued. 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 January 1 and July 1 for the semiannual 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 awardee 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, b) safety and toxicity of proposed regimens, and c)availability of necessary drugs. The NCI Program Director may 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 proposals which are ultimately funded. Such a review is legally required by the Food and Drug Administration to assure that all safety, toxicity, monitoring, and reporting issues are in conformance with Investigational New Drug guidelines. The awardee institution 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 Investigational New Drug (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 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 may be implemented without approval from the NCI Program Director, and also from the FDA, if indicated. 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. h. Clinical Trials Progress Review Progress will be evaluated semi-annually by the Program Director from material presented in the awardee's semi-annual report (as described above). Recommendations of the 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, and/or suspension or termination of the award. i. Quality Assurance (1) The NCI has established a clinical chemistry quality assurance program with the National Institutes of Standards and Technology, 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) Periodically, the NCI Program Director will review the mechanisms established by each awardee for quality control of clinical studies. These mechanism must conform with Food and Drug Administration (FDA) regulations. j. The awardees will retain custody of and primary rights to their data. k. Other Terms Patient enrollment may not begin without the prior written approval of the NCI Program Director for this cooperative agreement including 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 Mechanism 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 involvinghuman 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 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 and telephone numbers 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 researcher; 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 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, "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 Referral Officer 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 using U.S. Postal Service) If the application submitted in response to this RFA is substantially similar to a research grant application already submitted to the NIH for review, and has been or has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Preparation of the Application The general instructions providing for the 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 who are invited by the NCI to submit competing continuation and supplemental applications must describe how they have met the established terms and conditions. The following items apply to new as well as to competing continuation applications: 1. The study must clearly address a pilot trial, and optionally a definitive trial. The pilot trial must involve the application of a biological and/or biochemical marker and its modulation by the study agent. The definitive trial involves the implementation of a full scale randomized, double-blind, risk reduction, prevention clinical trial. For applicants seeking to conduct only a pilot trial, the study must describe relevance to a clinical trial application including a marker, agent and target group that might be appropriate for a full scale intervention after completion of the pilot study. 2. The applicant must provide a rationale for selection of the biological or biochemical marker, its relevance to risk identification or modulation, and its relevance to the intervention agent and the target population. 3. The applicant must provide the rationale for selection of the proposed intervention agent. This should include relevant epidemiologic and laboratory data. Preclinical and clinical data on any potential untoward effects of the intervention agent should also be presented. In circumstances where there might be some doubt as to the availability or the safety of the agent, the applicant may wish to consult with the pharmaceutical company and the NCI Program Director prior to preparing the application. The applicant should thus present a reasonable case for the "readiness" of the proposed intervention agent for a clinical trial. 4. The applicant must provide a rationale for selection of a specific target group and provide an estimate of the number of participants required for the completion of the study. Criteria and calculations used to estimate sample size must be included. The applicant must provide a description of the target population or group chosen and must justify the selection of this group. The group should be defined, as appropriate, by age, sex, race, dietary customs, education, geographic location, occupational or life style risk factors, and relevancy to a specific cancer problem or to its possible prevention by the designated inhibitor(s). The accrual rate should be estimated. If multiple institutions are involved, the application must include verification of the coinvestigators' willingness to participate, and pertinent additional information regarding the cooperating institutions' staff qualifications, resources, research plans, including patient availability and data flow, as well as corresponding budget requirements. Each project in a multiproject application must have individual budgets for the first budget period and a summary budget for all years. 5. The applicant must clearly indicate the clinical chemistry and biologic aspects of the study to include collection, storage, handling, analysis, and quality control of biological or biochemical samples. The methods and equipment to be used and the technical qualifications and experience of the personnel involved must be addressed. If these aspects of the study are to be conducted by groups other than at the applicant's institution, a letter from the cooperating institutions indicating their willingness to participate should be included. 6. The applicant must elucidate any known or potential safety or toxicity considerations, the techniques and procedures to monitor and report any adverse health effects and appropriate dose modifications based on toxicity monitoring. 7. The applicant must specify the methods to be used to document nutrient intake, if indicated, and adherence to the prescribed intervention during the course of the trial. 8. The applicant must indicate a willingness to work cooperatively with the assistance of the Program Director in the implementation and conduct of the study. 9. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. 10. The applicant should indicate the availability of the chemopreventive agents or dietary factors. REVIEW CONSIDERATIONS A. Review Procedure Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. 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 an award will be July, 1995. Funding discussions will also consider not only the cost of the clinical trial but also the cost of the agent and, if necessary, its formulation. Funding priority will be given for studies with biological monitoring procedures that do not overlap or duplicate projects currently funded by the NCI. Awards will not be made until all arrangements for obtaining the agent are complete. In setting funding priorities, the NCI will 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. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues 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 93.399, 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 and Federal regulations 42 CFR Part 52 and PHS grant policies 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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 Mon Jul 18 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 - 17 July 1994 Date: 18 Jul 1994 19:06:45 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 68 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30fcfl$l97@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: General Publication Title: NSF 88-16 A Brief History File size (bytes): 88754 STIS Filename: nsf8816 Document Type: Recruit Title: Senior Program Assistant (Office Automation) File size (bytes): 4913 STIS Filename: vgs9499 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Organizational Directory File size (bytes): 233270 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 Fri Jul 22 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 27, pt. 1of2, 22 July 1994 Date: 22 Jul 1994 17:50:04 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30ppfs$bih@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940722 V23N27 P1O2 ************************************ X-comment: RFAs described: DE-94-008, CA-94-013, HD-94-021 NIH GUIDE - Vol. 23, No. 27 - July 22, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** EXTENSION OF PROGRAM ANNOUNCEMENT EXPIRATION DATES Agency for Health Care Policy and Research INDEX: HEALTH CARE POLICY, RESEARCH NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 11/22/94 ************************************************* RESEARCH ON PERIODONTAL COMPLICATIONS OF DIABETES MELLITUS (RFA DE- 94-008) National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R2 11/23/94 ************************************************* CHEMOPREVENTION CLINICAL TRIALS INVOLVING MODULATION/FUNCTION OF GENES AND/OR GENE PRODUCTS (RFA CA-94-013) National Cancer Institute INDEX: CANCER $$INDEX R3 01/18/95 ************************************************* CHILD HEALTH RESEARCH CENTERS (RFA HD-94-021) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES (PAR-94-083) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P2 ********************************************************** ANIMAL FACILITY IMPROVEMENT FOR SMALL RESEARCH PROGRAMS (PAR-94-084) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX P3 ********************************************************** NATIONAL RESEARCH SERVICE AWARDS INSTITUTIONAL TRAINING GRANTS IN GENOMIC SCIENCE (PA-94-085) National Center for Human Genome Research INDEX: HUMAN GENOME RESEARCH This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** EXTENSION OF PROGRAM ANNOUNCEMENT EXPIRATION DATES NIH GUIDE, Volume 23, Number 27, July 22, 1994 P.T. 34; K.W. 0408006, 0730050, 0730020 Agency for Health Care Policy and Research PURPOSE The Agency for Health Care Policy and Research (AHCPR) announces the extension of the expiration dates to: (1) July 1, 1995 for the "Cost and Financing Issues in Health Care Reform" program announcement (PA-93-045), printed in the NIH GUIDE, Volume 22, Number 4, January 29, 1993; and (2) July 1, 1996 for the "Primary Care and Health Care Reform" program announcement (PA-93-063), printed in the NIH GUIDE, Volume 22, Number 10, March 12, 1993. Copies of these updated PAs and other AHCPR announcements are available from Global Exchange Inc., 7910 Woodmont Ave Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). INQUIRIES For programmatic information on the "Cost and Financing Issues in Health Care Reform" PA, contact: Michael Hagan Division of Cost and Financing Agency for Health Care Policy and Research Executive Office Center, Suite 502 2101 East Jefferson Street Rockville, MD 20852-4908 Telephone: (301) 594-1354 ext. 124 For programmatic information on the "Primary Care and Health Care Reform" PA, contact: Carolyn Clancy, M.D., Director Division of Primary Care Agency for Health Care Policy and Research Executive Office Center, Suite 502 2101 East Jefferson Street Rockville, MD 20852-4908 Telephone: (301) 594-1357 ext. 133 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN DE-94-008 FULL-TEXT ************************************** RESEARCH ON PERIODONTAL COMPLICATIONS OF DIABETES MELLITUS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA AVAILABLE: DE-94-008 P.T. 34; K.W. 0715075, 0715157, 0765033, 0755030 National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 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 National Institute of Dental Research (NIDR) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated grant applications to conduct multidisciplinary basic and clinical research on the periodontal complications of diabetes mellitus (DM). One purpose of this initiative is to further our understanding of the pathogenesis of periodontal diseases associated with DM. Another purpose is to increase research on the effects of periodontal diseases on glucose metabolism in diabetics. Investigators who are well-trained in the modern techniques of cellular and molecular biology are encouraged to focus their expertise and work closely with oral clinicians on issues directly related to the diagnosis, etiology, pathogenesis, and treatment of periodontal diseases associated with DM. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Research on Periodontal Complications of Diabetes, is related to the priority areas of oral health and diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, non-profit, and for-profit, public and private organizations, such as dental or medical schools, universities and research institutions. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms available for the support of research in response to this RFA are the traditional research project grant (R01), and the FIRST (R29) Award. The project period for applications submitted in response to this RFA may not exceed five years for R29 grants and four years for R01 grants. A maximum of three years may be requested for foreign awards. R01 applicants must limit their request to not more than $160,000 direct costs for the initial budget period. FUNDS AVAILABLE For Fiscal Year 1995, $1.2 million total costs will be committed by the NIDR and NIDDK to fund applications submitted in response to this RFA. Approximately five awards will be made depending on the receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES Background Diabetes may affect the progression and treatment of periodontal diseases. In particular, the incidence of aggressive and difficult to treat forms of periodontitis is well-documented in patients with DM. Epidemiological studies have clearly shown that periodontal diseases tend to be more prevalent, more severe, and progress more rapidly in persons with diabetes than in non-diabetic subjects. Periodontitis is now recognized as one of the six major complications of diabetes. It appears that although all diabetics may be at a higher risk for periodontal diseases than the general population, certain subgroups are at particularly high risk, including individuals who do not maintain good oral hygiene, individuals with other complications of diabetes such as retinopathy, neuropathy, or individuals with a history of poorly controlled diabetes, and teenagers and pregnant women undergoing fluctuations in hormonal levels. A detailed epidemiological analysis of periodontitis and tooth loss in the Pima Indians showed that the incidence of diabetes-specific complications, poor glycemic control, and severity of Type 2, non-insulin dependent diabetes mellitus (NIDDM) are associated with increased risk of periodontitis. The prevalence of periodontal diseases in well-controlled diabetics is reportedly no higher than that found in healthy control subjects. The molecular and cellular basis for the pathogenesis of periodontal diseases in uncontrolled DM patients remains to be investigated. Oral infections associated with periodontitis may destabilize the metabolic balance of the diabetic. Diabetics with infections tend to have difficulty in maintaining normal blood glucose/insulin levels, and often experience hyperglycemia. Understanding the association between infections in the oral cavity and impaired metabolic control is central to attaining effective therapy for the diabetic patient. Scope Applications may address any objective that would advance the diagnosis, etiology, pathogenesis or treatment of periodontal complications of diabetes. Applications may also address the role of periodontitis in metabolic control of the diabetic. Because research in this area can involve several scientific specialties, including microbiology, immunology, physiology, endocrinology, cell biology, and clinical medicine and dentistry, collaboration of investigators having expertise in these and other appropriate disciplines is encouraged. Large-scale epidemiological studies and clinical trials are specifically excluded from this RFA. Because Type 1, insulin-dependent diabetes mellitus (IDDM) and NIDDM are pathologically and genetically different, studies that examine the molecular and cellular basis of periodontal complications of both types of diabetes are encouraged. STUDY POPULATIONS 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 October 21, 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 identities of other key personnel and participating institutions, and the number and title of this RFA. The letter of intent is to be sent to Dr. Dennis Mangan 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 grants. These forms are available at most institutional offices of sponsored research, as well as from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, Westbard Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. See the RFA for further information. Submit a signed, original copy of the application, and three signed photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Also send two copies of the completed application to: H. George Hausch, Ph.D. National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 594-7632 FAX: (301) 594-7601 Applications must be received by November 22, 1994. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated by an appropriate peer review group convened by the NIDR in accordance with the usual NIH peer review procedures. Following review, the applications will be given a secondary review by the NIDR and NIDDK Advisory Councils unless not recommended for further consideration by the initial review group. Applications that are incomplete or unresponsive to the RFA will be returned to the applicant. AWARD CRITERIA The anticipated award date is September 1, 1995. In addition to the technical merit of the application, the NIDR and NIDDK will consider support of applications based on availability of funds and program priorities of the funding ICD. INQUIRIES The RFA may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER via Internet, and in print form from the program contact listed below. Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues, requests for the RFA, and the letter of intent to: Dennis F. Mangan, Ph.D. National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7641 FAX: (301) 594-9720 Email: UFD@CU.NIH.GOV Dr. Charles A. Wells National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 594-7505 FAX: (301) 594-9011 Direct inquiries regarding fiscal matters to: Ms. Theresa Ringler Extramural Program National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 FAX: (301) 594-7600 Ms. Betty E. Bailey Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158,(42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R1 END ************************************************************ $$R2 BEGIN CA-94-013 FULL-TEXT ************************************** CHEMOPREVENTION CLINICAL TRIALS INVOLVING MODULATION/FUNCTION OF GENES AND/OR GENE PRODUCTS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA AVAILABLE: CA-94-013 P.T. 34; K.W. 0745003, 0765014, 0760020, 0740020 National Cancer Institute Letter of Intent Receipt Date: October 15, 1994 Application Receipt Date: November 23, 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 stimulate and facilitate investigator initiated chemoprevention research involving agents that may effect gene expression and cellular growth and to encourage development of short-term clinical trials that evaluate the modulation/function of gene products by chemoprevention agents. 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, Chemoprevention Clinical Trials Involving Modulation/Function of Genes and/or Gene Products, is related to the priority area of chemoprevention. 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 or local governments, and eligible agencies of the Federal government. Applications from minority individuals and women investigators are encouraged. Each application will be considered on its own merit as an individual research project. Applicants for "Chemoprevention Clinical Trials Involving Modulation/Function of Genes and Gene Products" MAY NOT concurrently submit R01 applications that represent significant duplication of the efforts. MECHANISM OF SUPPORT This RFA will use the cooperative agreement (U01) 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. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed in the RFA. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. This RFA is a one-time solicitation. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research applications and be peer reviewed by a study section in the Division of Research Grants (DRG), NIH. However, 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. Applicants funded under this RFA will be supported through the cooperative agreement mechanism. 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 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 agents or in securing the Investigational New Drug (IND) permit, from the Food and Drug Administration, such assistance must be sought in writing from 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 also consider not only the cost of the clinical trial, but also the cost of the agent and its formulation. FUNDS AVAILABLE Approximately $2.0 million in total costs per year for five years will be committed to specifically funded applications that are submitted in response to the RFA. It is anticipated that three to six awards will be made. The number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for an application submitted in response to the present RFA may not exceed five years. 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 Evolving understanding of molecular mechanism brings unprecedented opportunities for advances in the prevention of cancer based especially on the identification of specific gene products and the modulation of their effects at the molecular level with chemopreventive agents. New developments in the understanding of cellular function and cellular metabolites are occurring that provide information on cell growth, proliferation, differentiation and neoplastic transformation. The endpoints for cancer treatment trials are usually a measured reduction in tumor size or statistically measured survival in a population whose survival is limited. For chemopreventive interventions, no such easily measured endpoints exist. For a clinical endpoint, the primary endpoint is incidence reduction, which occurs years later. Complex biostatistical and epidemiological strategies are necessary in measuring study populations in order to prove efficacy. Another approach is to develop surrogate endpoints to measure effect and for the study of the carcinogenesis process in humans. Inhibition of the post initiation phases of carcinogenesis is an emerging strategy for the prevention of cancer. Recent understanding of the role of oncogenes and tumor suppressor genes in cancer development suggests several strategies. Specifically, gene products appear to act at various points in the intracellular pathway utilized by growth factors, cell surface receptors, GTP-binding proteins, protein kinases, and transcription factors in stimulating cell proliferation. A common characteristic of these genes is that they encode components of the signal transduction system. This system refers to the biochemical mechanisms that permit complex changes in the cytoplasm and in gene expression in the nucleus which are often controlled by extracellular ligands that act through receptors, second messenger molecules and protein kinases. Clinical trials of agents effecting gene expression or gene products are being sought. The goal is the development of short-term clinical trials that will evaluate the modulation/function of genes or gene products by chemopreventive agents. The studies should be developed in phases that may include a pilot phase in humans that could later proceed to a full-scale intervention. One or more biomarker endpoints might be initially evaluated to determine baseline parameters and, subsequently, to serve as a follow-up after the administration of the prevention measure or the chemopreventive agents in vivo and/or in vitro. The main emphasis should be on small, efficient studies aimed at improving future research designs, providing a molecular basis for the action of the chemopreventive agent(s), or providing improved intermediate endpoint biomarkers. After successful completion of the pilot phase (i.e., demonstrated modulation of endpoint biomarkers), subsequent studies could include a clinical trial monitoring the test system, a cancer incidence or mortality endpoint, and a designated agent. Studies that develop and evaluate biotechnologies for the identification of new genes, gene products and DNA probes to identify human disease or to identify individuals at high risk or predisposition to cancer are also encouraged. For the initial human phase, the proposed study might describe the relevance of the marker test system to clinical or public health cancer prevention, the rationale for the selection of the study population, potential intervention agent or procedure. The project could result, later, in the markers and agent being evaluated in a full-scale, double-blind, randomized, risk reduction clinical trial. See RFA for further details. SPECIAL REQUIREMENTS Special requirements will be incorporated in the "Terms and Conditions of Award." Potential applicants should obtain a copy of the RFA to review these requirements prior to submission of their application. SPECIAL POPULATIONS 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 October 15, 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 institution or 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. Winfred F. Malone at the address listed under INQUIRIES. APPLICATION PROCEDURES The regular 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 3021/594-7248; and from the NCI Program Director listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 9/91) 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, "Chemoprevention Clinical Trials Involving Modulation/Function of Genes and/or Gene Products," and the RFA number, CA-94-013, 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 the time of submission two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Rockville, MD 20852 (if hand delivered of delivery service) Bethesda, MD 20892 (if using 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 are 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. The review criteria are provided in the RFA. AWARD CRITERIA The earliest feasible start data for the initial awards will be July 1, 1995. In addition to the technical merit of the applications, in making funding decisions. NCI will consider how well the applicant institutions meet the goals and objectives of the program as described in the RFA, availability of resources, and study populations. INQUIRIES Written and telephone requests for this RFA and the opportunity to clarity any issues or questions from potential applicants are welcome. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Winfred F. Malone, Ph.D., M.P.H. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 218 Bethesda, MD 20892 Telephone: (301) 496-4664 FAX: (301) 402-0553 Direct inquiries regarding fiscal matters to: Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 234 Bethesda, MD 20892 Telephone: (301) 496-7800 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93,399, Cancer Control. Awards will be made under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-401; 42 U.S.C. 241, and Section 412, as amended by Public Law 99-158, 42 U.S.C. 258-1), and administered under PHS grants policies and Federal regulations 42 CFR, Part 52 and 45 CFR, Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R2 END ************************************************************ $$R3 BEGIN HD-94-021 FULL-TEXT ************************************** CHILD HEALTH RESEARCH CENTERS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA AVAILABLE: HD-94-021 P.T. 04, AA; K.W. 0710030, 0770005, 0785170 National Institute of Child Health and Human Development Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: January 18, 1995 THIS IS A NOTICE OF AVAILABILITY OF A REQUEST FOR APPLICATIONS (RFA); IT IS 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 National Institute of Child Health and Human Development (NICHD) invites Center Core Grant applications for a program of Child Health Research Centers (CHRC). These Centers are intended to provide resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that will benefit the health of children. This will be accomplished by increasing the number of pediatric medical centers that can stimulate and facilitate the application of research findings to pressing pediatric problems, as well as increasing the number and effectiveness of pediatric investigators who have a grounding in basic science and research skills that can be applied to the clinical problems of children. 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, Child Health Research Centers, is related to several priority areas. 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 A CHRC grant is an award made to a children's hospital or to a department of pediatrics of an approved medical school in the United States of America that has as a primary teaching site either a general acute children's hospital or a children's program with an identifiable organizational structure that is part of a larger medical institution. Either must have the clinical pediatric specialties and subspecialties and the discrete clinical and research facilities sufficient to ensure the linkage of basic research and clinical application that will meet the purposes of the CHRC program. The applicant institution must also meet the standard eligibility requirements for research grants established in the PHS Grants Policy Statement (rev. 4/94). MECHANISM OF SUPPORT Support for this program will be through Center Core Grant (P30) awards. Policies that govern the grants award programs of the PHS will prevail. The support of grants pursuant to the RFA is contingent upon the receipt of appropriated funds for this purpose. Applications from institutions not previously funded for Child Health Research Centers will compete on an equal basis with competing continuation applications. This RFA is a one-time solicitation. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. FUNDS AVAILABLE The estimated total cost available for the first year of support is $2,400,000. It is anticipated that six or more meritorious applications (new and competing continuation) will be funded from responses to this RFA. The maximum amount will be $400,000 for direct plus indirect costs in the first year, with no increases for inflation in subsequent years. The number of awards will be influenced by the overall merit of applications and by their relevance to program goals. RESEARCH OBJECTIVES The past several years have seen unprecedented advances in the power and speed of basic science methods applicable to investigations of inherited and acquired disease. There is a need for researchers who are skilled with these methods and are interested in applying them to clinical problems in pediatrics. The NICHD has begun to meet this need by establishing Centers in which nascent pediatric investigators can develop the appropriate technological expertise. A CHRC grant provides pediatric research institutions, both developing and established, an opportunity to build a greater capacity for nurturing new pediatric investigators. Established investigators whose research is already funded by NIH or other sources through competitively reviewed grants or contracts combine to establish in their institution a center of research excellence. Individuals with a wide range of scientific backgrounds, especially those with basic science orientation, are encouraged to interact with each other and with newly trained pediatricians just embarking on their research careers. A shared core laboratory, which provides services to complement and extend the capabilities of the established investigators to facilitate the career development of new investigators, may be a major part of the Center. The established investigators make available their expertise, guidance, and laboratory facilities, which together with the shared core laboratory comprise the laboratory resources of the Center, to be utilized by junior investigators for new research projects which will enhance their basic science knowledge and skills. Support for conducting these projects is provided by the Center. The CHRC grant may provide funds for three purposes: A. Administration of the Center. B. Improvements in the child health-related research program of an institution in an area of scientific excellence through the establishment and maintenance of a shared core laboratory. C. Support for new projects, conducted by junior investigators, designed to enhance their research skills and produce preliminary data which could lead to successful competitive grant applications to the NIH or other agencies (New Project Development Funds), thereby providing a bridge between formal research training and the receipt of independent research grants. The novel feature of these grants is the flexibility in the use of the funds awarded for research support and career development, so that decisions about which new projects and which junior investigators are to be supported are made by the grantee institution. Both competing continuation (renewal) and noncompeting continuations of a CHRC grant are contingent on demonstration of good judgment in these decisions, as indicated by scientific progress, success in the initiation of new competitively-supported research grants and contracts, and the development of new pediatric investigators. STUDY POPULATIONS 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 October 1, 1994, a letter of intent that includes a descriptive subtitle for the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload, to seek out appropriate reviewers, and to avoid possible conflict of interest in the review. The letter of intent is to be sent to Dr. Ephraim Levin at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and 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 be received by January 18, 1995. Potential applicants must request the detailed information included in the RFA before preparing an application. REVIEW CONSIDERATIONS Applications will be reviewed by NICHD staff for responsiveness to the RFA. A non-responsive application will be returned to the applicant. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. The NICHD will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. AWARD CRITERIA The anticipated date of award is September 1, 1995, based on the following timetable: Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: January 18, 1995 Initial Review Date: March 1995 Review by Advisory Council: June 1995 Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application will be the predominant criteria for determining funding priorities. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions for potential applicants are encouraged. Direct requests for the RFA, inquiries regarding programmatic issues, and address the letter of intent to: Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B11 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$R3 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PAR-94-083 *********************************************** DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES NIH GUIDE, Volume 23, Number 27, July 22, 1994 PA NUMBER: PAR-94-083 P.T. 34; K.W. 1002002 National Center for Research Resources Application Receipt Dates: October 1, February 1, June 1 PURPOSE The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. The major objectives of this program are to upgrade animal facilities, develop administratively centralized programs of animal care, and enable institutions to comply with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resource, diagnostic laboratory, transgenic animal resources, or similar associated activities. ELIGIBILITY REQUIREMENTS Any domestic public or private institution, organization, or association is eligible to apply for this grant if the institution has one or more research projects supported by the Public Health Service (PHS) that involve the use of laboratory animals. Institutions and commercial firms providing only services or products and without a clearly defined animal related research component are not eligible to apply. Also, this program will not support requests for equipment used for teaching purposes and for housing non-research animals. Applications from other Federal agencies or institutions (e.g., Department of Veterans Affairs) are limited to requests for equipment only. Applicants may not submit more than one application or apply for other NCRR support for developing and improving institutional animal resources in the same Federal fiscal year. For purposes of these guidelines, an "institution" is defined as the organizational component identified on page 1, item 14 of the PHS 398 (rev. 9/91), for which descriptive information is provided on page 15 in the grant application form PHS 398 kit. Separate applications may be submitted from different colleges or schools on the same campus of a university within the same Federal fiscal year if they have different organizational component codes. If this is done, documentation from an appropriate institutional official, stating that the applications are part of a coordinated, campus-wide plan to improve the animal facilities, must be provided. The applicant institution is strongly encouraged to develop a single application for a campus-wide program with a single, centralized animal care program whenever possible or feasible. MECHANISM OF SUPPORT The mechanism available for the support of improvement projects is the Grant for Repair, Renovation, and Modernization of Existing Research Facilities (G20). The total budget request for the improvement grant application and award is limited to $700,000 (direct costs), of which not more than $500,000 may be used for alterations and renovations. Matching funds from non-Federal sources are required, equal to or exceeding one-third of the total allowable costs (equipment and A&R) of the requested project ($2 Federal to $1 non-Federal). These matching funds must be applied to the specific project described in the application and cannot be met by citing other expenditures. Because the nature and scope of the projects proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. Allowable Costs Items that may be requested under this grant mechanism include: o A&R to improve existing laboratory animal facilities, and allowable fees associated with the A&R project o Major resource equipment related to the improvement project, such as animal cage systems and cage washers o Equipment items, or an aggregate of identical equipment items, that have a total cost of at least $1,000. Items that are part of a system and require the purchase of small component parts (e.g., a rack and cages or microisolator units) may be requested and priced as a single item. A description of the individual components of such systems must be provided. o General purpose equipment items for centralized surgeries, diagnostic laboratories, transgenic animal facilities, and other similar associated activities when an integral part of the animal facility and available to all investigators o Basic diagnostic equipment (e.g., microscopes, centrifuges, refrigerators, etc.) to be used in support of the animal facility, but not for research o Environmental monitoring systems. However, if such a system has multiple uses (e.g., the monitoring of research data or security), only those costs related to monitoring or providing for animal care (e.g., environmental monitoring) are allowable Improvement grants are not intended to provide support for: o General operational support for the resource (e.g., funding for personnel, consumable supplies for routine animal care, or small equipment items) o Specialized research equipment or facilities for use by only a few investigators o New construction, including the completion of shell space o Equipment intended for teaching or non-research purposes o Office and research equipment, computers or data processing items o Physical security systems RESEARCH OBJECTIVES Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care. Another major objective is to assist institutions in complying, and maintaining compliance, with provisions of the Animal Welfare Act and PHS policies related to the care and use of laboratory animals. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). Application forms may be obtained from the institution's office of sponsored research and 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. There are three regular receipt dates per year of October 1, February 1, and June 1. Prospective applicants are encouraged to review the PHS Grants Policy Statement (rev. 4/94) sections dealing with alterations and renovations and equipment prior to completing the PHS 398 form. Applications must follow the instructions provided in the form PHS 398 kit, except for the following: Form Page 1: Item 2a - Check the box marked "YES" and type in the number and title of this program announcement. Item 2b - Insert "G20" Item 5 - Check the box marked "No" at Item 5a. Item 5b - Not applicable. Form Page 2: Personnel - Only key personnel should be listed here even though salary support is not requested. This must include the chief or consulting veterinarian. Form Page 4: Detailed Budget for Initial Budget Period Personnel Category - List only key individuals; salary support should not be requested. The total cost of the equipment and A&R needed should be entered in the rectangular space under the appropriate headings on the left. Equipment should be classified as movable or fixed, using the institution's own classification guidelines. Fixed equipment is considered as part of the A&R request. The right hand column should reflect only the PHS request. The Total Direct Costs (bottom right hand column total) should be the total request to the PHS. The total request for PHS support may not exceed $700,000. Of this total, the A&R request may not exceed $500,000. Form Page 5 - Budget for Entire Proposed Project Period - Not applicable (do not complete this section). A cost estimate should be provided, and placed after Form Page 4. This estimate should detail: 1. For movable equipment, the dollar request from NIH, amount to be funded from other sources, and total cost. 2. For eligible A&R costs, the dollar request from NIH, amount to be funded from other sources, and total cost. 3. For total project cost, the dollar request from NIH, amount to be funded from other sources, and total cost. For funding from other sources, please indicate the source(s). For alterations and renovations requests, list separately the projected costs of: (a) Demolition; (b) General; (c) Plumbing; (d) HVAC; (e) Electrical; (f) Architect/Engineer Fee; (g) Other Costs c(Specify); and (h) Fixed Equipment, with the total eligible A&R costs listed. If multiple sites are involved, the A&R and cost estimates should be described separately for each site. List the total net square feet of floor space to be renovated and the estimated cost per net sq. ft., excluding fixed equipment. Additional Form Pages Biographical Sketch Page - Provide a biographical sketch for all key personnel, strictly adhering to the two-page limitation for each. Other Support Page - Provide the information requested for all key personnel. 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 (Items 1-4) must strictly adhere to a limit of 25 pages. The outline suggested below should be followed in describing the program. All information critical to the review must be in the Research Plan, not in an appendix. 1. Specific Aims - Clearly present the aims of the animal resource improvement project and relate them to the short- and long-term goals of the institution's animal resource program. 2. Background and Significance - This section should address two areas: the overall animal care and use program and the significance of the proposed resource improvement project. Background Provide an overall description of the institution's animal care and use program. Provide relevant background information and describe the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Describe the institution's overall involvement in animal-related research. This section should include a description of the following aspects of the animal resource: a. Administrative arrangements and structure of the animal resource. The lines of authority and responsibility for administering the institution's animal care and use program should be clearly presented. The role and composition of the IACUC and how compliance with relevant laws, policies, and guidelines is achieved should be included. b. Animal care procedures and the animal health program. This section should describe housing, caging, feeding, record keeping, sanitation, and other animal care practices; animal health program which includes clinical services, laboratory support, preventive medicine programs, and any relevant specialized procedures; veterinary oversight; vendor surveillance; conditioning programs; colony and environmental monitoring; and diagnostic capabilities in anatomic pathology, clinical chemistry, hematology, and microbiology. Data should be provided to characterize the extent of these activities, such as numbers of laboratory procedures for monitoring animal health, veterinary inspections for animal health, etc. If specialized equipment items are requested, the husbandry program to utilize this equipment should be outlined. c. Staffing. Outline the total staff and organization of the animal resource, both currently in place and as planned following the requested improvements. Briefly describe the qualifications of the animal care staff and the training opportunities available to them. d. Animal Program Data. Indicate the number of animals (by species) used or produced per year and the average daily census (by species) for each facility. Provide a brief description of all on-campus and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who manages each facility. Indicate whether the institution is AAALAC accredited. If equipment is requested for surgical or diagnostic facilities, the case load, species, types and numbers of surgeries or diagnostic tests must be documented. e. Animal Program Funding. Provide, for the most recently completed Federal fiscal year (indicate year): (1) the institution's total annual PHS funding (direct costs) for research, both animal related and non-animal related; (2) the institution's total number and total direct costs of research projects using laboratory animals, indicating separately the number and costs of those funded from PHS and non-PHS sources; (3) for facilities for which improvement support is requested, list by facility name the number of research projects and total direct costs of the projects relevant to each. List all current financial support for the animal resource, including sources and amounts (e.g., recharge, core funding from the institution, etc.) and the annual operating budget (listed by major categories). Provide a copy of per diem and service charge schedules and indicate their method of determination (this information may be included in an Appendix). f. Previous and Future Improvements. Expenditures for capital improvements (facilities and equipment) during the past five years and future plans for meeting such needs should be described. Any previous support for improvement of the institution's animal facilities from the CMP, NCRR, NIH should be noted. The use of this support and its impact on the animal care program should be briefly described. g. Program Needs. List deficiencies in the animal care program that have been cited by the American Association for Accreditation of Laboratory Animal Care (AAALAC), the Institutional Animal Care and Use Committee (IACUC) facility review reports, and the institution's PHS Animal Welfare Assurance Statement. Any problems in meeting the provisions of the Animal Welfare Act should also be addressed. Significance Describe the significance of the proposed resource improvement project to the institution's overall biomedical research programs, as well as to specific research projects that will be affected. If the resource will be used by a relatively small number of research projects, a brief description of those projects, including the source and amount of funding (direct costs) for the most recently completed Federal fiscal year should be indicated. If appropriate, the application should demonstrate both the need for the requested items and a sound plan for obtaining or maintaining the entire animal resource at required standards. 3. Progress Report/Preliminary Studies - Not applicable. 4. Research Design and Methods Describe the improvement project and how the requested improvements will accomplish the goals described in the Specific Aims section above. It is important to describe how the requested improvements will correct the deficiencies and problems described in the Background section. Demonstrate how the proposed facility improvement program fits into the institution's overall plan to meet or maintain PHS standards for animal care and use. If the project is part of an overall (larger) facility improvement plan, the application should describe the larger plan and how the project fits into that plan. Describe and provide detailed justifications for the requested equipment items. The manufacturer, model number, size, capacity, or design criteria, total unit cost and facility where it will be used should be included. Requests for surgical equipment must be justified by listing the number of investigators and PHS grant support received (can be provided in tabular form), the case load, and the types of surgical procedures performed. Failure to adequately justify each requested item will likely result in its deletion from the recommended budget. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following format is suggested: Narrative Summary (1) Relate the proposed renovations to projected animal populations (by species) and research projects that will use the facility; (2) List the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle, etc.) that will be directly affected by the renovation project; (3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam, etc.; (4) List appropriate architectural criteria, such as width of corridors and doors, surface finishes, etc.; (5) List all fixed equipment items requested for the renovated area; and (6) List all movable equipment items requested for the renovated area. Line Drawings (1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS). These drawings will not be counted against the 25 page limit. All floor plans must be legible, with the scale clearly indicated. (2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (3) The plan should indicate the location of the proposed renovation area in the building. (4) Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished. (5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan. (6) Indicate the type(s) of new finishes to be applied to room surfaces. Cost Estimates Detailed cost estimates must be included. Assurance to Provide Matching Funds A letter of assurance to provide matching funds and the projected source of those funds, signed by the responsible institutional official, must be provided by the applicant prior to the time an award is made. If such a letter is not included with the application, the applicant must include a letter of intent, also signed by the appropriate institutional official, to provide the necessary matching funds. The letter of assurance or the letter of intent should be placed as the final page of the application. The completed original application (signed original including appendices, if any) 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 20892-4500** At the time of submission, two additional copies of the application (with appendices, if any) must be sent under separate cover to: Scientific Review Administrator Comparative Medicine Review Committee National Center for Research Resources Westwood Building, Room 10A16 Bethesda, MD 20892-4500* REVIEW CONSIDERATIONS All applications will be reviewed for scientific and technical merit by an appropriate review committee managed by the Office of Review, NCRR. Second level review will be provided by the National Advisory Research Resources Council (NARRC). Review of the applications will be based on scientific merit, technical soundness, and cost effectiveness. Factors considered in the appraisal of an animal resource improvement project include: A. The Improvement Request 1. Need - The application should show how this grant support will help the institution meet or maintain standards of the Animal Welfare Act and PHS policies concerning the care and use of laboratory animals. The amount(s) and source(s) of funding for animal-related biomedical research which use the resource will be considered. 2. Scope of Institutional Planning - The institutional plan to assure a comprehensive and acceptable animal care and use program will be evaluated. 3. Budget - The budget will be evaluated in relationship to the application's responsiveness to these guidelines, justification provided for each of the requested items, cost effectiveness, and the institution's perceived commitment to the animal care program. 4. Animal Welfare - The extent to which the project will enhance the welfare of animals maintained in the facility to be improved will be evaluated. The benefit of the improvements to the welfare of animals in the facility, including advances in the humane treatment of the animals due to husbandry changes allowed by the improvements, will be assessed. 5. Design Considerations - The proposed project will be judged for technical soundness, appropriateness and suitability of the proposed renovation/project, and ability of the project to correct existing deficiencies. B. The Animal Care Program The scope of the animal care and use program to be enhanced by this facility improvement request should be carefully defined. For the purpose of this application, the animal care program should cover the entire applicant institution. 1. Animal Care - The quality of the animal husbandry program at the applicant institution will be assessed. The application should demonstrate that animals at all facilities of the institution will receive uniform, high-quality animal care. 2. Personnel - The technical and professional staff will be evaluated. The institution should have a sufficient number of professional staff with appropriate qualifications and experience to operate the animal resource in a competent manner. The facility should also have qualified non- professional staff and supporting services. 3. Administrative Arrangements - An evaluation will be made of the administrative arrangements for routine management of the animal resource. The institution should have a record of commitment and a sound plan for financial support of the resource, through a recharge system, per diem charges, institutional support, etc. 4. Resources and Environment - The suitability of the institutional setting for achieving the goals of the program will be considered. This will include an appraisal of the academic environment and the support for the animal resource by the administration and faculty. AWARD CRITERIA Applications will compete with all others in the G20 category for available funds. An institution must have current PHS funding for research involving laboratory animals to be eligible for an award. The following will also be considered when making funding decisions: o Quality of the proposed project as determined by peer review o Institutional assurance of non-federal matching funds o Availability of funds Evidence of continued PHS research funding will be verified prior to award. Award Conditions Following the actual award, funds for A&R will not be released until final architectural drawings, specifications, and updated cost estimates are approved by NCRR. No requests to initiate alterations or renovations will be entertained prior to receipt of the grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. Renovations and equipment purchases must be initiated no later than twelve months after the start date of award. Awards will be made for one year and are not renewable. INQUIRIES Inquiries about the program may be directed to: Director, Laboratory Animal Sciences Program Comparative Medicine Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892-4500 Telephone: (301) 594-7933 FAX: (301) 594-9149 Questions regarding fiscal matters are to be directed to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892-4500 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306, Laboratory Animal Sciences and Primate Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78.410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PAR-94-084 *********************************************** ANIMAL FACILITY IMPROVEMENT FOR SMALL RESEARCH PROGRAMS NIH GUIDE, Volume 23, Number 27, July 22, 1994 PA NUMBER: PAR-94-084 P.T. 34; K.W. 1002002 National Center for Research Resources Application Receipt Dates: October 1, February 1, June 1 PURPOSE The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from small biomedical research institutions. The major objectives of this program are to upgrade animal facilities, develop administratively centralized programs of animal care, and enable institutions to comply with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. These awards do not require matching funds from the awardee institution. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resource, diagnostic laboratory, transgenic animal resources, or similar associated activities. ELIGIBILITY REQUIREMENTS Any domestic public or private institution, organization, or association is eligible to apply for this grant if it meets the following two requirements: (1) The institution must have one or more research projects supported by the PHS that involve the use of From owner-sci-resources@net.bio.net Fri Jul 22 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 27, pt. 2of2, 22 July 1994 Date: 22 Jul 1994 17:50:11 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 772 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30ppg3$biv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940722 V23N27 P2O2 ************************************ laboratory animals, and (2) The institution must have received less than $1,500,000 (direct costs) of PHS support for research projects during the most recently completed Federal fiscal year. Institutions and commercial firms providing only services or products and without a clearly defined animal related research component are not eligible to apply. Also, this program will not support requests for equipment used for teaching purposes and for housing non-research animals. Applications from other Federal agencies or institutions (e.g., Department of Veterans Affairs) are limited to requests for equipment only. Applicants may not submit more than one application or apply for other NCRR support for developing and improving institutional animal resources in the same Federal fiscal year. For purposes of these guidelines, an "institution" is defined as the organizational component identified on page 1, item 14, of the form PHS 398 (rev. 9/91), for which descriptive information is provided on page 15 in the grant application form PHS 398 kit. Separate applications may be submitted from different colleges or schools on the same campus of a university within the same Federal fiscal year if they have different organizational component codes. If this is done, documentation from an appropriate institutional official, stating that the applications are part of a coordinated, campus-wide plan to improve the animal facilities, must be provided. The applicant institution is strongly encouraged to develop a single application for a campus-wide program with a single, centralized animal care program whenever possible or feasible. MECHANISM OF SUPPORT The mechanism available for the support of improvement projects is the Grant for Repair, Renovation, and Modernization of Existing Research Facilities (G20). The total budget request for the improvement grant application and award is limited to $300,000 (direct costs), of which not more than $200,000 may be used for alterations and renovations. Matching funds are not required. Because the nature and scope of the projects proposed in response to this PA may vary, it is anticipated that the size of an award will vary also. Allowable Costs Items that may be requested under this grant mechanism include: o A&R to improve existing laboratory animal facilities, and allowable fees associated with the A&R project o Major resource equipment related to the improvement project, such as animal cage systems and cage washers o Equipment items, or an aggregate of identical equipment items, that have a total cost of at least $1,000. Items that are part of a system and require the purchase of small component parts (e.g., a rack and cages or microisolator units) may be requested and priced as a single item. A description of the individual components of such systems must be provided. o General purpose equipment items for centralized surgeries, diagnostic laboratories, transgenic animal facilities, and other similar associated activities when an integral part of the animal facility and available to all investigators o Basic diagnostic equipment (e.g., microscopes, centrifuges, refrigerators, etc.) to be used in support of the animal facility, but not for research o Environmental monitoring systems. However, if such a system has multiple uses (e.g., the monitoring of research data or security), only those costs related to monitoring or providing for animal care (e.g., environmental monitoring) are allowable Improvement grants are not intended to provide support for: o General operational support for the resource (e.g., funding for personnel, consumable supplies for routine animal care, or small equipment items) o Specialized research equipment or facilities for use by only a few investigators o New construction, including the completion of shell space o Equipment intended for teaching or non-research purposes o Office and research equipment, computers or data processing items o Physical security systems RESEARCH OBJECTIVES Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care. Another major objective is to assist institutions in complying, and maintaining compliance, with provisions of the Animal Welfare Act and PHS policies related to the care and use of laboratory animals. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). Application forms may be obtained from the institution's office of sponsored research and 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. There are three regular receipt dates per year of October 1, February 1, and June 1. Prospective applicants are encouraged to review the PHS Grants Policy Statement (rev. 4/94) sections dealing with alterations and renovations and equipment prior to completing the PHS 398 form. Applications must follow the instructions provided in the form PHS 398 kit, except for the following: Form Page 1: Item 2a - Check the box marked "YES" and type in the number and title of the program announcement. Item 2b - Insert "G20" Item 5 - Check the box marked "No" at Item 5a. Item 5b - Not applicable. Form Page 2: Personnel - Only key personnel should be listed here even though salary support is not requested. This must include the chief or consulting veterinarian. Form Page 4: Detailed Budget for Initial Budget Period Personnel Category - List only key individuals; salary support should not be requested. The total cost of the equipment and A&R needed should be entered in the rectangular space under the appropriate headings on the left. Equipment should be classified as movable or fixed, using the institution's own classification guidelines. Fixed equipment is considered as part of the A&R request. The right hand column should reflect only the PHS request. The Total Direct Costs (bottom right hand column total) should be the total request to the PHS. The total request for PHS support may not exceed $300,000. Of this total, the A&R request may not exceed $200,000. Form Page 5 - Budget for Entire Proposed Project Period - Not applicable (do not complete this section). A cost estimate should be provided, and placed between Form Page 4. This estimate should detail: 1. For movable equipment, the dollar request from NIH, amount to be funded from other sources, and total cost. 2. For eligible A&R costs, the dollar request from NIH, amount to be funded from other sources, and total cost. 3. For total project cost, the dollar request from NIH, amount to be funded from other sources, and total cost. For funding from other sources, please indicate the source(s). For alterations and renovations requests, list separately the projected costs of: (a) Demolition; (b) General; (c) Plumbing; (d) HVAC; (e) Electrical; (f) Architect/Engineer Fee; (g) Other Costs (Specify); and (h) Fixed Equipment, with the total eligible A&R costs listed. If multiple sites are involved, the A&R and cost estimates should be described separately for each site. List the total net square feet of floor space to be renovated and the estimated cost per net sq. ft., excluding fixed equipment. Additional Form Pages Biographical Sketch Page - Provide a biographical sketch for all key personnel, strictly adhering to the 2 page limitation for each. Other Support Page - Provide the information requested for all key personnel. 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 (Items 1-4) must strictly adhere to a limit of 25 pages. The outline suggested below should be followed in describing the program. All information critical to the review must be in the Research Plan, not in an appendix. 1. Specific Aims - Clearly present the aims of the animal resource improvement project and relate them to the short- and long-term goals of the institution's animal resource program. 2. Background and Significance - This section should address two areas: the overall animal care and use program and the significance of the proposed resource improvement project. Background Provide an overall description of the institution's animal care and use program. Provide relevant background information and describe the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Describe the institution's overall involvement in animal-related research. This section should include a description of the following aspects of the animal resource: a. Administrative arrangements and structure of the animal resource. The lines of authority and responsibility for administering the institution's animal care and use program should be clearly presented. The role and composition of the IACUC and how compliance with relevant laws, policies, and guidelines is achieved should be included. b. Animal care procedures and the animal health program. This section should describe housing, caging, feeding, record keeping, sanitation, and other animal care practices; animal health program which includes clinical services, laboratory support, preventive medicine programs, and any relevant specialized procedures; veterinary oversight; vendor surveillance; conditioning programs; colony and environmental monitoring; and diagnostic capabilities in anatomic pathology, clinical chemistry, hematology, and microbiology. Data should be provided to characterize the extent of these activities, such as numbers of laboratory procedures for monitoring animal health, veterinary inspections for animal health, etc. If specialized equipment items are requested, the husbandry program to utilize this equipment should be outlined. c. Staffing. Outline the total staff and organization of the animal resource, both currently in place and as planned following the requested improvements. Briefly describe the qualifications of the animal care staff and the training opportunities available to them. d. Animal Program Data. Indicate the number of animals (by species) used or produced per year and the average daily census (by species) for each facility. Provide a brief description of all on-campus and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who manages each facility. Indicate whether the institution is AAALAC accredited. If equipment is requested for surgical or diagnostic facilities, the case load, species, types and numbers of surgeries or diagnostic tests must be documented. e. Animal Program Funding. Provide, for the most recently completed Federal fiscal year (indicate year): (1) the institution's total annual PHS funding (direct costs) for research, both animal related and non-animal related; (2) the institution's total number and total direct costs of research projects using laboratory animals, indicating separately the number and costs of those funded from PHS and non-PHS sources; (3) for facilities for which improvement support is requested, list by facility name the number of research projects and total direct costs of the projects relevant to each. List all current financial support for the animal resource, including sources and amounts (e.g., recharge, core funding from the institution, etc.) and the annual operating budget (listed by major categories). Provide a copy of per diem and service charge schedules and indicate their method of determination (this information may be included in an Appendix). f. Previous and Future Improvements. Expenditures for capital improvements (facilities and equipment) during the past five years and future plans for meeting such needs should be described. Any previous support for improvement of the institution's animal facilities from the CMP, NCRR, NIH should be noted. The use of this support and its impact on the animal care program should be briefly described. g. Program Needs. List deficiencies in the animal care program which have been cited by the American Association for Accreditation of Laboratory Animal Care (AAALAC), the Institutional Animal Care and Use Committee (IACUC) facility review reports, and the institution's PHS Animal Welfare Assurance Statement. Any problems in meeting the provisions of the Animal Welfare Act should also be addressed. Significance Describe the significance of the proposed resource improvement project to the institution's overall biomedical research programs, as well as to specific research projects that will be affected. If the resource will be used by a relatively small number of research projects, a brief description of those projects, including the source and amount of funding (direct costs) for the most recently completed Federal fiscal year should be indicated. If appropriate, the application should demonstrate both the need for the requested items and a sound plan for obtaining or maintaining the entire animal resource at required standards. 3. Progress Report/Preliminary Studies - Not applicable. 4. Research Design and Methods Describe the improvement project and how the requested improvements will accomplish the goals described in the Specific Aims section above. It is important to describe how the requested improvements will correct the deficiencies and problems described in the Background section. Demonstrate how the proposed facility improvement program fits into the institution's overall plan to meet or maintain PHS standards for animal care and use. If the project is part of an overall (larger) facility improvement plan, the application should describe the larger plan and how the project fits into that plan. Describe and provide detailed justifications for the requested equipment items. The manufacturer, model number, size, capacity, or design criteria, total unit cost and facility where it will be used should be included. Requests for surgical equipment must be justified by listing the number of investigators and PHS grant support received (can be provided in tabular form), the case load, and the types of surgical procedures performed. Failure to adequately justify each requested item will likely result in its deletion from the recommended budget. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following format is suggested: Narrative Summary (1) Relate the proposed renovations to projected animal populations (by species) and research projects that will use the facility; (2) List the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle, etc.) that will be directly affected by the renovation project; (3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam, etc.; (4) List appropriate architectural criteria, such as width of corridors and doors, surface finishes, etc.; (5) List all fixed equipment items requested for the renovated area; and (6) List all movable equipment items requested for the renovated area. Line Drawings (1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS). These drawings will not be counted against the 25 page limit. All floor plans must be legible, with the scale clearly indicated. (2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (3) The plan should indicate the location of the proposed renovation area in the building. (4) Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished. (5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan. (6) Indicate the type(s) of new finishes to be applied to room surfaces. Cost Estimates Detailed cost estimates must be included. The completed original application (signed original including appendices, if any) 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 20892-4500* At the time of submission, two additional copies of the application (with appendices, if any) must be sent under separate cover to: Scientific Review Administrator Comparative Medicine Review Committee National Center for Research Resources Westwood Building, Room 10A16 Bethesda, MD 20892-4500* REVIEW CONSIDERATIONS All applications will be reviewed for scientific and technical merit by an appropriate review committee managed by the Office of Review, NCRR. Second level review will be provided by the National Advisory Research Resources Council (NARRC). Review of the applications will be based on scientific merit, technical soundness, and cost effectiveness. Factors considered in the appraisal of an animal resource improvement project include: A. The Improvement Request 1. Need - The application should show how this grant support will help the institution meet or maintain standards of the Animal Welfare Act and PHS policies concerning the care and use of laboratory animals. The amount(s) and source(s) of funding for animal-related biomedical research which use the resource will be considered. 2. Scope of Institutional Planning - The institutional plan to assure a comprehensive and acceptable animal care and use program will be evaluated. 3. Budget - The budget will be evaluated in relationship to the application's responsiveness to these guidelines, justification provided for each of the requested items, cost effectiveness, and the institution's perceived commitment to the animal care program. 4. Animal Welfare - The extent to which the project will enhance the welfare of animals maintained in the facility to be improved will be evaluated. The benefit of the improvements to the welfare of animals in the facility, including advances in the humane treatment of the animals due to husbandry changes allowed by the improvements, will be assessed. 5. Design Considerations - The proposed project will be judged for technical soundness, appropriateness and suitability of the proposed renovation/project, and ability of the project to correct existing deficiencies. B. The Animal Care Program The scope of the animal care and use program to be enhanced by this facility improvement request should be carefully defined. For the purpose of this application, the animal care program should cover the entire applicant institution. 1. Animal Care - The quality of the animal husbandry program at the applicant institution will be assessed. The application should demonstrate that animals at all facilities of the institution will receive uniform, high-quality animal care. 2. Personnel - The technical and professional staff will be evaluated. The institution should have a sufficient number of professional staff with appropriate qualifications and experience to operate the animal resource in a competent manner. The facility should also have qualified non- professional staff and supporting services. 3. Administrative Arrangements - An evaluation will be made of the administrative arrangements for routine management of the animal resource. The institution should have a record of commitment and a sound plan for financial support of the resource, through a recharge system, per diem charges, institutional support, etc. 4. Resources and Environment - The suitability of the institutional setting for achieving the goals of the program will be considered. This will include an appraisal of the academic environment and the support for the animal resource by the administration and faculty. AWARD CRITERIA Applications will compete with all others in the G20 category for available funds. An institution must have current PHS funding for research involving laboratory animals to be eligible for an award. The following will also be considered when making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds Evidence of continued PHS research funding will be verified prior to award. Award Conditions Following the actual award, funds for A&R will not be released until final architectural drawings, specifications, and updated cost estimates are approved by NCRR. No requests to initiate alterations or renovations will be entertained prior to receipt of the grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. Renovations and equipment purchases must be initiated no later than twelve months after the start date of award. Awards will be made for one year and are not renewable. INQUIRIES Inquiries about the program are to be directed to: Director, Laboratory Animal Sciences Program Comparative Medicine Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892-4500 Telephone: (301) 594-7933 Questions regarding fiscal matters are to be directed to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources Westwood Building, Room 849 Bethesda, MD 20892-4500 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306, Laboratory Animal Sciences and Primate Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78.410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-94-085 ************************************************ NATIONAL RESEARCH SERVICE AWARDS INSTITUTIONAL TRAINING GRANTS IN GENOMIC SCIENCE NIH GUIDE, Volume 23, Number 27, July 22, 1994 PA NUMBER: PA-94-085 P.T. 22; K.W. 0720005, 1215018 National Center for Human Genome Research PURPOSE [This is a reissue of a Program Announcement that appeared in the NIH Guide for Grants and Contracts, Vol. 20, No. 46, December 3, 1991.] The National Center for Human Genome Research (NCHGR) announces the availability of support for institutional training programs in genomic sciences to train scientists with multi-disciplinary skills that will allow them to engage in research that will accomplish the goals of the Human Genome Program (HGP) and to take full advantage of the resulting genomic data and resources to solve biomedical problems and increase our understanding of human biology. These research training opportunities will be supported through institutional training grants, which may support pre-doctoral, postdoctoral, and short-term trainees. The genomic sciences multidisciplinary training program is intended to expand the research capabilities of individuals with backgrounds in either molecular biology or a non-biological scientific discipline relevant to genomic sciences (e.g., physical, chemical, mathematical, computer, and/or engineering sciences). Short-term training opportunities are intended for students in non-biological scientific disciplines who wish to learn more about genomic sciences. The NCHGR wishes to expand the number of institutions capable of training scientists in genomic sciences and strongly encourages institutions with academically outstanding departments in molecular biology and one or more of the non-biological scientific disciplines relevant to genomic sciences to consider developing training programs that would be responsive to the needs of the HGP. ELIGIBILITY REQUIREMENTS Only domestic universities and medical colleges may apply for training grants supported under the National Research Service Award (NRSA) mechanism. Only U.S. citizens, non-citizen nationals, or permanent residents of the United States may be appointed as trainees on NRSA-funded training grants. MECHANISM OF SUPPORT Support for this program will be through the National Research Service Award (T32) Program. Institutional training grants are made for project periods of up to five years and are renewable. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) is currently engaged, along with several other federal, private, and international organizations, in a 15-year research program designed to characterize the human genome and the genomes of selected model organisms. The HGP has the following interrelated goals: the construction of high-resolution genetic linkage maps, the development of detailed physical maps, and the determination of the complete nucleotide sequence of the human genome and the genomes of selected organisms; the development of efficient methods of identifying genes and for placement of known genes on physical maps or sequenced DNA; the development of the capability to collect, store, distribute and analyze the data and materials produced; the development of new technologies to achieve these goals; and the identification of major issues related to the ethical, legal and social implications (ELSI) of genome research, and the development of policy options to address them. The products of the HGP will include information and material resources, as well as new technologies, that will be available to the entire research community to facilitate further research leading to the prevention, diagnosis, and therapy of disease, as well as to further understanding of human biology. In 1990, the NCHGR and the Department of Energy (DOE) jointly published a plan that set out specific goals to be achieved in the first five-year phase of the U.S. human genome program. Anticipating the attainment of much of the initial set of goals, the NCHGR and DOE recently extended the original goals of the Human Genome Program. These goals are described in the article, "A New Five-Year Plan for the U.S. Human Genome Project," (Science, Vol. 262, pp. 43-46, October 1, 1993) and cover the years 1994-1998. The HGP is opening up new approaches to biomedical problems. Attaining the solutions to these problems will require that the research methods of the biological sciences be augmented and complemented by the approaches and methods of non-biological scientific disciplines. There is a critical shortage of scientists with the appropriate complementary skills to bring such multidisciplinary approaches to genomic research. Individuals capable of developing new technology and tools are needed, as are molecular biologists capable of taking multi-disciplinary approaches and using the resources provided by the HGP to address important biomedical and biological research problems. The intent of the NCHGR's research training program is to fill this need. Successful training programs will attract individuals with backgrounds in relevant non-biological scientific disciplines or molecular biology and should have sufficient flexibility to provide the appropriate interdisciplinary training to individual candidates. It is essential that trainees who are supported under this program receive thorough training in multi-disciplinary approaches to modern biomedical research. Training Program Genomic science represents a new scientific approach to solving biomedical research problems. Thus, most institutions have not, as yet, developed graduate and post-graduate training programs in genomic science that would enroll students or postdoctoral fellows trained in molecular biology or one of the non-biological scientific disciplines appropriate for genomic science and provide training that would allow them to develop complementary expertise in another discipline. Because of the unique training requirements of the HGP, the NCHGR recognizes that institutions will need to develop new training programs. Therefore, the NCHGR strongly encourages applications from institutions that can demonstrate academic excellence in molecular biology and one or more of the non-biological scientific disciplines appropriate for genomic science, have outstanding faculties that are committed and willing to cooperate in developing a genomic sciences training program, have access to a pool of highly qualified graduate students and postdoctoral fellows, and have sound training plans, but have not as yet established training programs in genomic science. Applications from institutions that wish to apply as a consortium are welcomed, but must demonstrate that they can mount a well-coordinated and integrated program. Format. The NCHGR is seeking to support training programs that allow trainees access to broad research opportunities across disciplinary and departmental lines, while not sacrificing the standards of depth and creativity characteristic of the best doctoral and postdoctoral programs of individual departments. The NCHGR recognizes that there is no one model for this type of training and encourages institutions to develop innovative training programs that are responsive to the needs of genomic sciences as well as to the needs of individual trainees. Types of Training Positions Allowed. An institutional training grant may include all of the following types of training positions: 1. Predoctoral positions--for students with undergraduate degrees in chemistry, physics, mathematics, computer sciences or engineering sciences who wish to pursue training in molecular biology or for individuals with undergraduate degrees in a biological science who wish to pursue an interdisciplinary doctoral degree that incorporates one or more of the non-biological disciplines mentioned above. An exposure to technology development is encouraged for all predoctoral trainees. 2. Postdoctoral positions--for postdoctoral students trained in chemistry, physics, mathematics, computer sciences, or engineering sciences who wish to pursue additional training in molecular biology or for individuals with training in molecular biology who wish to pursue an area of technology development as it relates to genomic science. 3. Short-term training positions--only for undergraduate or graduate students trained in chemistry, physics, mathematics, computer sciences or engineering sciences who wish to spend three to six months in a molecular biology laboratory in order to get acquainted with the field. The number of postdoctoral positions should be limited to approximately one-third of the total full-time training positions. No application that requests only postdoctoral positions will be accepted. Stipends and Other Allowable Costs. The stipends for predoctoral and postdoctoral trainees are at the new level, which was announced in the NIH Guide for Grants and Contracts, Vol. 23, No. 10, March 11, 1994. Full tuition may be requested for full-time predoctoral trainees only. Institutional costs of up to $1,500 per year per predoctoral trainee and up to $2,500 per year per postdoctoral trainee may be requested to defray the costs of other training-related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel. The institution may receive up to $125 per month to offset the cost of tuition, fees, travel, supplies, and other expenses for each short-term research training position. Indirect cost allowance based on eight percent of total allowable direct costs exclusive of tuition, fees, health insurance, and expenditures for equipment, or actual indirect costs, whichever is less, may be requested. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Submission dates for new and competing applications are January 10, May 10, and September 10, annually. Application kits are 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 title and number of this program announcement must be typed in Item 2a on the face page of the application. The completed original application and five legible copies must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Postdoctoral trainees and fellows supported under the National Research Service Award Program may be subject to payback provisions. Details about the policies and payback provisions governing payback requirements were published in the NIH Guide for Grants and Contracts, Vol. 22, No. 27, July 30, 1993. REVIEW CONSIDERATIONS Applications submitted in response to this program announcement will be reviewed in accordance with the usual NIH peer review procedures. The following review criteria will be applied: the research and training experience and leadership capabilities of the program director; the qualifications and commitment of the training faculty as measured by research grant support, publication record, and past training record; the quality of the applicant pool; the number of predoctoral students currently receiving training; the design of the training program including, for applications assigned to the NCHGR, its relevance to the goals of the Human Genome Program; provisions for guidance and quality control of the individual trainee's programs; and adequacy of the resources and environment. For institutions that are in the process of developing a genomic science training program, greater weight will be given to the design of the institution's training program. For institutions that are submitting competing renewals, greater weight will be given to both the past performance of the training program and the future directions of the training program. Following assessment of the quality of the proposed training program and assignment of priority scores indicative of the merit, the initial review group will evaluate each application on its (1) plans for attracting and retaining individuals from underrepresented minority groups and (2) plans for instructing trainees in the responsible conduct of research. If an application is deficient in one of these areas, it may not be funded, regardless of scientific merit. Site visits will not be conducted as part of the review process, except in unusual circumstances. Therefore, applicants must present a complete and well-justified written application and not depend on a site visit to amplify the application. Subsequent to the initial review, applications will be reviewed by the appropriate National Advisory Council. Among the information the Council will consider in addition to the merit of the training program is the initial review group's comments on plans for, or experience in, the recruitment and retention of individuals from underrepresented minority groups into the training program. AWARD CRITERIA For applications assigned to the National Center for Human Genome Research, the following criteria will be used in making funding decisions: quality of the training program as determined by its potential to meet the short- and long-term goals of the HGP; leadership capabilities of the program director and the quality of the participating faculty; commitment of the biology and non-biology faculty to the training program; and availability of funds. The NCHGR understands that it takes time for institutions to develop cooperative efforts across departmental and scientific discipline lines and this factor will also be considered when funding decisions are made. INQUIRIES Written, telephone, and e-mail inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Bettie J. Graham, Ph.D. Mapping Technology Branch National Center for Human Genome Research Building 38A, Room 610 Bethesda, MD 20892 Telephone: (301) 496-7531 E-mail: Bettie_Graham@occshost.nlm.nih.gov For information about PHS grants policy, applicants may contact: Ms. Jean Cahill Grants and Contracts Management Branch National Center for Human Genome Research Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 E-mail: Jean_Cahill@occshost.nlm.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards are made under the authority of the Section 487, Public Health Service Act as amended (42 USC 288) and administered under PHS Grants Policies and Title 42 of the Code of Federal Regulations, Part 66. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Jul 22 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-94-013 - V23(27) 07/22/94 Date: 22 Jul 1994 17:50:16 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 864 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30ppg8$bj8@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA94013 CA-94-013 P1O1 *************************************** CHEMOPREVENTION CLINICAL TRIALS INVOLVING MODULATION/FUNCTION OF GENES AND/OR GENE PRODUCTS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA: CA-94-013 P.T. 34; K.W. 0745003, 0765014, 0760020, 0740020 Letter of Intent Receipt Date: October 15, 1994 Application Receipt Date: November 23, 1994 PURPOSE The Chemoprevention Branch, Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), invites applications for cooperative agreements to encourage coordinated submissions of projects from investigators dedicated to chemoprevention clinical trials of agents that may effect gene expression and cellular growth. 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), Chemoprevention Clinical Trials Involving Modulation/Function of Genes and/or Gene Products, is related to the priority area of chemoprevention. 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 or local governments, and eligible agencies of the Federal government. Applications from minority and women investigators are encouraged. Each application will be considered on its own merit as an individual research project. Applicants for "Chemoprevention Clinical Trials Involving Modulation/Function of Genes and/or Gene Products" MAY NOT concurrently submit R01 applications that represent significant duplication of efforts. MECHANISM OF SUPPORT This RFA will use the cooperative agreement (U01) mechanism. The cooperative agreement is an assistance mechanism in which substantial NCI programmatic involvement with the recipient during performance of the planned activity is anticipated. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant/awardee. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section, "Terms and Conditions of Awards." The total project period for an application submitted in response to the present RFA may not exceed five years. The anticipated award date is July 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. This RFA is a one-time solicitation for applications for new awards. Future unsolicited competitive continuation applications will compete with all other investigator-initiated research applications and be peer reviewed by a study section in the Division of Research Grants (DRG), NIH. However, 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 continuation applications for review according to procedures described below under APPLICATION PROCEDURES and REVIEW CONSIDERATIONS. FUNDS AVAILABLE Approximately $2.0 million in total costs per year for five years will be committed to specifically fund applications that are submitted in response to RFA. It is anticipated that three 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 1, 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 A. Background Evolving understanding of molecular mechanisms brings unprecedented opportunities for advances in the prevention of cancer based especially on the identification of specific gene products and the modulation of their effects at the molecular level with chemopreventive agents. New developments in the understanding of cellular function and cellular metabolites are occurring that provide information on cell growth, proliferation, differentiation and neoplastic transformation. In vitro, in vivo, and animal model systems and the chemoprevention decision network have identified a number of potential chemopreventive agents and have resulted in a rational approach to cancer preventive agent development and testing. The endpoints for cancer treatment trials are usually a measured reduction in tumor size or statistically measured survival in a population whose survival is limited. For chemopreventive interventions, no such easily measured endpoints exist. For a clinical endpoint, the primary endpoint is incidence reduction, which occurs years later. Complex biostatistical and epidemiological strategies are necessary in measuring study populations in order to prove efficacy. Another approach is to develop surrogate endpoints to measure effect and for the study of the carcinogenesis process in humans. Inhibition of the post initiation phases of carcinogenesis is an emerging strategy for the prevention of cancer. Recent understanding of the role of oncogenes and tumor suppressor genes in cancer development suggests several strategies. Specifically, gene products appear to act at various points in the intracellular pathway utilized by growth factors, cell surface receptors, GTP-binding proteins, protein kinases, and transcription factors in stimulating cell proliferation. A common characteristic of these genes is that they encode components of the signal transduction system. This system refers to the biochemical mechanisms that permit complex changes in the cytoplasm and in gene expression in the nucleus which are often controlled by extracellular ligands that act through receptors, second messenger molecules and protein kinases. Clinical trials of agents effecting gene expression or gene products are being sought. Initially, knowledge of genes involved in carcinogenesis will provide tools for screening and diagnosis. The challenge will be to move as rapidly as possible from structural defects evident in disease alleles to improved methods of compensation for these defects. This will involve the development of pharmaceuticals that will inhibit the function of these altered gene products in the carcinogenesis process. The identification of oncogenes and tumor suppressor genes opens up a number of opportunities or targets for their study in precancers and will result in improved capabilities for drug screening and rationale drug design. The major types of cancer appear to be polygenic. This means that transformation is not due to a single mutation, but from multiple mutations and can result from a composite number of different mutagenic events. Although this has many disadvantages, it also has the advantage that there may be many targets for chemopreventive activity. Currently, there is no method to rationalize these events or to predict them a priori. By correlating differences in responses to various inhibitors with variations at the DNA level, investigators may be able to develop a predictive ability for assessing risk and its modulation by using a battery of DNA based tests. What is the most promising is a possibility for the utilization of a number of different preventive agents utilized in combinations. At the preclinical level, the screening of agents with transgenic mice with gene knockouts will be helpful. The prospect of collecting and understanding responsiveness to various agents is likely to be a major aspect of future cancer prevention research. Oncogene abnormalities might be used as markers for the detection of high risk groups, and markers for the study and evaluation of precancer progression. Mutant oncogene products could be utilized as major targets for the development of new molecular forms designed to specifically inhibit to alter the function of effected pathways. At this time, targeting gene products and their function is a most advantageous strategy for chemopreventive interventions. For example, the technology might be used with extracellular molecules such as surface receptors which would not require the compound to enter the cells. Failure to permeate cells might also reduce the potential side effects. Several examples of types of studies that might be considered are as follows: Ras oncogenes have been detected in 90 percent of human pancreatic cancers, 50 percent of colorectal tumors, 30 percent of lung cancers, and 10 to 40 percent of numerous other cancers, making them the most prevalent oncogenes in human cancer. It has been known that ras proteins interact with the inner surface of the plasma membrane, where they play a role in signal transduction. In cancer cells, a single mutation in the ras oncogene impairs the ability of the ras protein to turn off the signal and continues to stimulate the cell to grow. GTP binding is one of the two requirements that the ras protein must meet to be active. The other is that the protein must be anchored to the cell membrane. This involves binding to farnesyl pyrophosphate. Blocking farnesylation with chemopreventive agents might block the ras protein attachment and, therefore, its activity. Isoprenylation of the protein can be blocked by intermediates in the cholesterol biosynthesis pathway. For example, a compound L731,735 has been developed by Merck which inhibits one of the enzymes, farnesyl transferase, in the cholesterol biosynthesis pathway. A number of other inhibitors of farnesyl protein transferase have been identified. These include the monoterpene, limonene, a major constituent of orange peel oil. The mechanism of action appears related to inhibition of isoprenylation of a 21-26 Kda protein, which is associated with cell growth. Lovastatin, a cholesterol biosynthetic inhibitor has been shown to be effective earlier in the pathway. This compound may be a model for less toxic derivatives that may be equally effective in inhibiting ras activation. The compound, Riverstatin, has inhibited the pathway with a 100-fold greater potency than Lovastatin. Other potential compounds are available and could be evaluated in clinical trials. A widely accepted general model for colorectal tumorigenesis suggests that an early and critical step in carcinogenesis is the development of altered DNA methylation, the most common form of which is global hypomethylation. This is frequently accompanied by over-expression of the c-myc proto-oncogene, as well as by genomic mutations in other proto-oncogenes and anti-oncogenes such as K-ras and p53, DCC (deleted in colon cancer), and MCC (mutated in colon cancer), respectively. Because strong associations exist between DNA hypomethylation, mutations in the above mentioned oncogenes and the evolution of colonic adenomas, these biochemical indices are considered to be excellent candidates for intermediary markers of colonic carcinogenesis. Folate is an essential cofactor in the production of S-adenosylmethionine (SAM), the primary methyl donor in the body. The SAM dependent methylation of specific DNA cytosine bases to form 5 methylcytosine may block ras gene expression and abnormalities in DNA methylation. Its deficiency may contribute to the loss of normal control of proto-oncogene expression. In rats, a chronic dietary deficiency of methyl donors (i.e., choline and methionine) and methyl transfer factors (i.e., folate and vitamin B12) lowers the concentration of SAM, increases DNA methyltransferase activity, and reduces methylation of DNA cytosine and increases the incidence of liver cancer. Several clinical reports point to the possibility that diminished folate status might also result in altered cell proliferation and neoplasia. The colonic epithelium is among the list of epithelia where epidemiological studies have established an association between diminished folate status and an enhanced risk of dysplasia and cancer. Epidemiologically, this principle applies to individuals who have an underlying predisposition to colonic dysplasia as well as to the general population. It has recently been observed that among individuals with ulcerative colitis, the prevalence of colonic dysplasia in those receiving folate supplements was about on-half that of these receiving no supplements. Two epidemiologic studies in the general population have established a significant association between diminished dietary folate intake and an enhanced risk of colon and/or rectal cancer. Adenomatous polyps, especially those that are multiple, greater than 1 cm. in diameter, and/or have villous or tubule-villous components, are widely regarded as early neoplastic lesions that will progress to frank invasive cancer if left untreated. They also serve as markers to identify individuals who are at increased risk of developing invasive colon cancer. Such patients receive regular screening colonoscopy and are an ideal target group for chemoprevention studies with folate or SAM that would include studies to evaluate the modulation of gene expression. Studies to evaluate aberrant methylation (both hypt and hyper) in oncogene activation or tumor suppressor gene inactivation might be considered. With recent results from human clinical trials, it is of interest to examine whether the effects of Sulindac and aspirin occur as a result of alterations of gene expression. It is believed that aspirin reduces DNA transcription primarily through acetylation of the serine residue of cyclooxygenase. An appropriate panel of genes implicated in colonic carcinogenesis has been identified. The rationale for the selection of biological markers, the various agents associated with colorectal cancer and adenomas and the agents that might effect the prostaglandin pathway are known. Specifically, measuring the steady state levels of RNA transcribed from adenomatous polyposis coli (APC), deleted in colon cancer (DCC), mutated in colon cancer (MCC), ras, and ornithine decarboxylase (OPC) genes in response to chemopreventive agents is possible. In addition, examining the inhibition of cyclic AMP second messenger systems which might effect the expression of colon genes could be undertaken. These types of experiments may provide further understanding of the role of NSAID drugs in the inhibition of colon neoplasia. Such projects are timely and studies of the effects of chemopreventive agents on gene expression and function are of intense interest. B. Scope and Objectives The emphasis is on the development of short-term clinical trials that will evaluate the modulation/function of genes or gene products by chemopreventive agents. The studies should be developed in phases that may include a pilot phase in humans that could later proceed to a full-scale intervention. One or more biomarkers endpoints might be initially evaluated to determine baseline parameters and, subsequently, to serve as a follow-up after the administration of the prevention measure or the chemopreventive agents in vivo and/or in vitro. The main emphasis should be on small, efficient studies aimed at improving future research designs, providing a molecular basis for the action of the chemopreventive agent(s), or providing improved intermediate endpoint biomarkers. After successful completion of the pilot phase (i.e., demonstrated modulation of endpoint biomarkers), subsequent studies could include a clinical trial monitoring the test system, a cancer incidence or mortality endpoint, and a designated agent. Studies that develop and evaluate biotechnologies for the identification of new genes, gene products and DNA probes to identify human disease or to identify individuals at high risk or predisposition to cancer are also encouraged. For the initial human phase, the proposed study might describe the relevance of the marker test system to clinical or public health cancer prevention, the rationale for the selection of the study population, and the potential intervention agent or procedure. The project could result later in the markers and agent being evaluated in a full-scale, double-blind, randomized, risk reduction clinical trial. SPECIAL REQUIREMENTS The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator, as well as the institutional official at the time of award. Terms and Conditions of Award These special Terms and Conditions of Award are, in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines Federal grant administration policy statements and regulations. A. Awardee Rights and Responsibilities The administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NCI scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI's purpose is to support and/or stimulate the recipient's activity by involvement in and, otherwise, working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardee(s) and the NCI Program Director. 1. Safety and Toxicity Review Each awardee institution and principal investigator agree to comply with the recommendations of the safety and protocol review conducted by the Program Director to assure that all FDA requirements are satisfied. 2. Quality Assurance and Adverse Reaction Reporting (a) 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. (b) 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. (c) The awardee is required to adhere to NCI guidelines for the use of investigational drugs, including investigator registration (FDA Form 1573), and maintaining a record of drug receipt. Adverse drug reactions, whether 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. 3. Data Management and Reporting Requirements Data acquisition and analysis is the responsibility of the investigator. Each awardee institution will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS and NIH policies. Investigators will be required to submit semi-annual and annual reports to NCI using the following schedule and format as required by FDA Investigational Drug Regulations. (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: o 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. o 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. o 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 nonclinical investigations, including: o A narrative or tubular summary showing the most frequent and most serious adverse experiences by body system. o A list of subjects who died during participation in the investigation, with the cause of death for each subject. o A list of subjects who dropped out during the course of the investigation in association with any adverse experience, whether or not thought to be drug related. o 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. o A list of 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 trial protocol modifications made during the previous year and not previously reported to the FDA 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. The Grants Administration Branch will not issue an award 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. Due Dates for Reports January 1 and July 1 for the semi-annual report. (f) 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. B. NCI Staff Responsibilities 1. Study/Protocol Plan The NCI Program Director (see INQUIRIES) 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 pharmacological agents. 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 proposals which are ultimately funded. Such a review is legally required by the Food and Drug Administration to assure that all safety, toxicity, monitoring, and reporting issues are in conformance with Investigational New Drug (IND) guidelines. The awardee institutions and principal investigator must agree to comply with the recommendations of the review. 2. 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 the Code of Federal Regulations (CFR) 21. The awardees, however, will retain custody of, and primary rights to, their data. 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. 3. 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 this cooperative agreement. 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. 4. Assistance with Obtaining or Purchasing Investigational Drugs If an investigator anticipates requesting considerable assistance in obtaining the chemopreventive agents and in securing the Investigational New Drug (IND) permit from the Food and Drug Administration (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. 5. Protocol Modification No protocol modifications shall be implemented without approval from the NCI Program Director, consistent with FDA requirements. 6. 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 in C. below. 7. 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 above). Recommendations of the NCI Program Director will be communicated by letter to the investigator to which he/she is expected to respond. 8. Quality Assurance (1) The NCI has established a clinical chemistry quality assurance program with the National Institute of Standards and Technology, Gaithersburg, Maryland, which may provide chemical standards for some of the agents being used and assayed in clinical trials. These standards will contribute to the quality control of selected laboratory determinations. If available, the awardee will participate in the laboratory quality control activity when so notified. (2) Periodically, the NCI Program Director will review the mechanisms established by each awardee for quality control of clinical studies. These mechanisms must conform with Food and Drug Administration (FDA) regulations. 9. Other Terms No patients may be enrolled in this study 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. C. 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 10-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women 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 subject 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 October 15, 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 and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Winfred F. Malone at the address listed under INQUIRIES. APPLICATION PROCEDURES The regular research grant application form PHS 398 (rev. 9/91) is to be used in applying for cooperative agreements. These forms are available at most institutional offices of sponsored research, from the Office of Grants 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 form PHS 398 (rev. 9/91) 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, "Chemoprevention Clinical Trials Involving Modulation/Function of Genes and/or Gene Products," and the RFA number, CA-94-013, must be typed in line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact, 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 Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Rockville, MD 20852 (if hand-delivered or delivery service) Bethesda, MD 20892 (if using U.S. Postal Service) Applications must be received by November 23, 1994. No addenda or appendix materials will be accepted after the receipt date. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an introduction addressing the previous critique. Preparation of the Application The general instructions provided for the preparation of the applications contained in the Grant Application Form PHS-398 are to be used in preparing Cooperative Agreement applications. Because of the award terms and conditions included in the section under SPECIAL REQUIREMENTS, Terms and Conditions of Award, it is important that applicants indicate in the Research Plan how they will meet the requirements stated in the RFA. 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. The following items apply to all applications: 1. The study should clearly address a pilot trial and optionally a definitive trial. The pilot trial must involve the application of a biological and/or biochemical marker and its modulation by the study agent. The definitive trial involves the implementation of a full-scale, randomized, double-blind, risk reduction, prevention clinical trial. For applicants seeking to conduct only a pilot trial, the study must describe relevance to a clinical trial application, including a marker, agent and target group that might be appropriate for a full-scale intervention after completion of the pilot study. 2. The applicant should provide a rationale for selection of the biological or biochemical marker, its relevance to risk identification or modulation, and its relevance to the intervention agent and the target population. 3. The applicant should provide the rationale for selection of the proposed intervention agent. This should include relevant epidemiologic and laboratory data. Preclinical and clinical data on any potential untoward effects of the intervention agent should also be presented. In circumstances where there might be some doubt as to the availability or the safety of the agent, the applicant may wish to consult with the pharmaceutical company and the NCI Program Director prior to preparing the application. If an investigator anticipates requiring considerable assistance in obtaining the chemopreventive agents or in securing the Investigational New Drug (IND) permit from the Food and Drug Administration, such assistance must be sought in writing from the Program Director, prior to submitting the application. 4. The applicant should provide a rationale for selection of a specific target group and provide an estimate of the number of participants required for the completion of the study. Criteria and calculations used to estimate sample size should be included. The applicant should provide a description of the target population or group chosen and should justify the selection of this group. The group should be defined, as appropriate, by age, sex, race, dietary customs, education, geographic location, occupational or lifestyle risk factors, and relevancy to a specific cancer problem or to its possible prevention by the designated inhibitor(s). The accrual rate should be estimated. If multiple institutions are involved, the proposal should include verification of the coinvestigators' willingness to participate, and pertinent additional information regarding the cooperating institutions' staff qualifications, resources, research plans, including patient availability and data flow, as well as corresponding budget requirements. 5. The applicant should clearly indicate the clinical chemistry and biologic aspects of the study to include collection, storage, handling, analysis, and quality control of biological or biochemical samples. The methods and equipment to be used and the technical qualifications and experience of the personnel involved must be addressed. If these aspects of the study are to be conducted by groups other than at the applicant's institution, a letter from the cooperating institutions indicating their willingness to participate should be included. 6. The applicant should elucidate any known or potential safety or toxicity considerations, the techniques and procedures to monitor and report any adverse health effects and appropriate dose modifications based on toxicity monitoring. 7. The applicant should specify the methods to be used to document nutrient intake, if indicated, and adherence to the prescribed intervention during the course of the trial. 8. The applicant must indicate a willingness to work cooperatively with the assistance of the NCI Program Director in the implementation and conduct of the study. 9. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. 10. Availability of the chemopreventive agents or dietary factors. 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) 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, intervention agents, etc., procedures for their collection and analysis, and assurances of 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 1, 1995. In addition to the technical merit of the applications, the NCI will consider how well the applicant institutions meet the goals and objectives of the program as described in the RFA, availability of resources, and study populations, in making funding decisions. INQUIRIES Written and telephone inquiries concerning the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Winfred F. Malone, Ph.D., M.P.H. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 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 93.399, 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 grant policies 45 CFR Part 74 and 92. This program is not subject to the intergovernmental review requirement 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 22 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DE-94-008 - V23(27) 07/22/94 Date: 22 Jul 1994 17:50:21 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 407 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30ppgd$bjh@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DE94008 DE-94-008 P1O1 *************************************** RESEARCH ON PERIODONTAL COMPLICATIONS OF DIABETES MELLITUS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA: DE-94-008 P.T. 34; K.W. 0715075, 0715157, 0765033, 0755030 National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 1994 PURPOSE The National Institute of Dental Research (NIDR) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite investigator-initiated grant applications to conduct multidisciplinary basic and clinical research on the periodontal complications of diabetes mellitus (DM). One purpose of this initiative is to further our understanding of the pathogenesis of periodontal diseases associated with DM. Another purpose is to increase research on the effects of periodontal diseases on glucose metabolism in diabetics. Investigators who are well-trained in the modern techniques of cellular and molecular biology are encouraged to focus their expertise and work closely with oral clinicians on issues directly related to the diagnosis, etiology, pathogenesis, and treatment of periodontal diseases associated with DM. 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 on Periodontal Complications of Diabetes, is related to the priority areas of oral health and diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, non-profit and for-profit, public and private organizations, such as dental or medical schools, universities and research institutions. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) Award. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The mechanisms available for the support of research in response to this RFA are the traditional research project grant (R01), and the FIRST (R29) award. Responsibility for the planning, direction, and execution of the projects will be solely that of the applicants. This RFA is a one-time solicitation. Future unsolicited continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The project period for applications submitted in response to this RFA may not exceed five years for R29 grants and four years for R01 grants. A maximum of three years may be requested for foreign awards. Applicants for R01 grants must limit their request to not more than $160,000 direct costs for the initial budget period. FUNDS AVAILABLE For Fiscal Year 1995, $1.0 million total costs will be committed by the NIDR to fund applications submitted in response to this RFA. An additional $200,000 will be committed by the NIDDK. Depending on the receipt of a sufficient number of applications of high scientific merit, an estimated five awards will be made. Although this program is provided for in the financial plans of the NIDR and the NIDDK, the award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background In April 1993, the NIDR convened a Dental Research Programs Advisory Committee (PAC) in Bethesda, Maryland, which addressed the issue of research on the periodontal complications of systemic diseases. The PAC recognized that diabetes may affect the progression and treatment of periodontal diseases. A subsequent review of the literature published since 1985 indicated that there have been approximately 260 publications on oral complications or conditions associated with DM. Approximately 75 percent of the papers reported investigations on the effects of DM on periodontal disease. In particular, the incidence of aggressive and difficult to treat forms of periodontitis is well-documented in patients with DM. Epidemiological studies have clearly shown that periodontal diseases tend to be more prevalent, more severe, and progress more rapidly in persons with diabetes than in non-diabetic subjects. Periodontitis is now recognized as one of the six major complications of diabetes. It appears that although all diabetics may be at a higher risk for periodontal diseases than the general population, certain subgroups are at particularly high risk, including individuals who do not maintain good oral hygiene, individuals with other complications of diabetes such as retinopathy, neuropathy, individuals with a history of poorly controlled diabetes, and teenagers and pregnant women undergoing fluctuations in hormonal levels. A detailed epidemiological analysis of periodontitis and tooth loss in the Pima Indians showed that the incidence of diabetes-specific complications, poor glycemic control, and severity of Type 2, non-insulin dependent diabetes mellitus (NIDDM) are associated with increased risk of periodontitis. Careful control of blood glucose/insulin levels seems to reduce the periodontal complications associated with DM. Thus, the prevalence of periodontal diseases in well-controlled diabetics is reportedly no higher than that found in healthy control subjects. The molecular and cellular basis for the pathogenesis of periodontal diseases in uncontrolled DM patients remains to be investigated. While DM appears to have an impact on periodontal diseases, it also appears to be true that oral infections associated with periodontitis may destabilize the metabolic balance of the diabetic. Diabetics with infections tend to have difficulty in maintaining normal blood glucose/insulin levels, and often experience hyperglycemia. Understanding the association between infections in the oral cavity and impaired metabolic control is central to attaining effective therapy for the diabetic patient. Scope Applications may address any objective that would advance the diagnosis, etiology, pathogenesis or treatment of periodontal complications of diabetes. Because research in this area can involve several scientific specialties, including microbiology, immunology, physiology, endocrinology, cell biology, and clinical medicine and dentistry, collaboration of investigators having expertise in these and other appropriate disciplines is encouraged. Large-scale epidemiological studies and clinical trials are specifically excluded from this RFA. Because Type 1, insulin-dependent diabetes mellitus (IDDM) and NIDDM are pathologically and genetically different, studies that examine the molecular and cellular basis of periodontal complications of both types of diabetes are encouraged. A selection of research topics appropriate for responses to this RFA is given below. This list is illustrative and not exclusive, restrictive, or in priority order. Investigators are encouraged to submit scientifically meritorious applications in any area of research responsive to the overall research objectives of this RFA. o Identification of unique host products in the gingival crevicular fluid or saliva of diabetics that can be used as a non-invasive prognostic or diagnostic indicators of periodontal diseases. o Molecular and cellular characterization of the effects of diabetes on the humoral and cellular immune effector systems in the oral cavity. o Oral tissue regeneration and wound healing in subjects with diabetes. o Identification of drugs, growth factors, cytokines, or biological response modifiers that can be used therapeutically to repair the damaged periodontal tissues. o Development of well-characterized diabetic animals systems and ex vivo and in vitro tissue models to study periodontal complications. o Clarification of the microbiological and biochemical role of calculus in the onset of periodontitis in diabetic subjects. o Characterization of the effect of diabetes on the periodontal vasculature. o Role of diabetes in abnormal collagen metabolism in the periodontium. o Characterization of the immune response of diabetics to purified oral microbial components. o Studies that specifically address periodontal diseases in minority populations at high risk for DM (e.g. Hispanics, African-Americans and Native Americans). o Investigations on the association of periodontal diseases with gestational diabetes. o Role of periodontal diseases in control of glucose metabolism in diabetics. 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 for Inclusion of Women and Minorities as Subjects in Clinical Research", which has been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), 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 encouraged to submit, by October 21, 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 identities of other key personnel and participating institutions, and the number and title of this RFA. Such letters are requested only for the purpose of providing an indication of the number and scope of applications to be reviewed; therefore their receipt is usually not acknowledged. A letter of intent is not binding, and it will not enter into the review of any application subsequently submitted, nor is it a necessary requirement for the application. The letter of intent is to be sent to Dr. Dennis Mangan 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 grants. These forms are available at most institutional offices of sponsored research, as well as from the Office of Grants Information, Division of Research Grants (DRG), National Institutes of Health, Westbard Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or Principal Investigator should be included with the application. A signed original copy of the application, and three signed photocopies, must be submitted in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Also send two copies of the completed application to: H. George Hausch, Ph.D. National Institute of Dental Research Westwood Building, Room 519 Bethesda, MD 20892 Telephone: (301) 594-7632 FAX: (301) 594-7601 Applications must be received by November 22, 1994. If an application is received after that date, it will be returned to the applicant without review. The DRG will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. Applications that have been reviewed, but not funded, can be resubmitted provided substantial revisions have been made and the application contains an introduction section addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NIDR and NIDDK. Incomplete applications will be returned to the applicant without further consideration. If NIDR or NIDDK 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 NIDR 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 and the official signing for the applicant organization will be promptly notified. Following scientific-technical review, competitive applications will receive a second level review by the NIDR and NIDDK Advisory Councils unless not recommended for further consideration by the initial review group. Review criteria for this RFA are generally the same as those for unsolicited research grant applications and include: o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o responsiveness to the RFA objectives. Schedule Letter of Intent Receipt Date: October 21, 1994 Application Receipt Date: November 22, 1994 Initial Scientific Review: March 1995 Council Review of Applications: May 1995 Earliest Possible Funding: September 1, 1995 AWARD CRITERIA The anticipated award date is September 1, 1995. The following will be considered in making funding decisions: o Merit of the proposed project as determined by peer review o Availability of funds o Program priorities of the funding ICD The value of complementary funding from other public and private sources, including foundations and industrial concerns, for activities that will complement and expand those supported by the NIDR and NIDDK is appreciated. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Dennis F. Mangan, Ph.D. National Institute of Dental Research Westwood Building, Room 509 Bethesda, MD 20892 Telephone: (301) 594-7641 FAX: (301) 594-9720 Email: UFD@CU.NIH.GOV Dr. Charles A. Wells National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 622 Bethesda, MD 20892 Telephone: (301) 594-7505 FAX: (301) 594-9011 Direct inquiries regarding fiscal matters to: Ms. Theresa Ringler National Institute of Dental Research Westwood Building, Room 510 Bethesda, MD 20892 Telephone: (301) 594-7629 FAX: (301) 594-7600 Ms. Betty E. Bailey Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 649 Bethesda, MD 20892 Telephone: (301) 594-7543 FAX: (301) 594-7594 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, (42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service 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 22 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HD-94-021 - V23(27) 07/22/94 Date: 22 Jul 1994 17:50:27 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 694 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30ppgj$bjq@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HD94021 HD-94-021 P1O1 *************************************** CHILD HEALTH RESEARCH CENTERS NIH GUIDE, Volume 23, Number 27, July 22, 1994 RFA: HD-94-021 P.T. 04, AA; K.W. 0710030, 0770005, 0785170 National Institute of Child Health and Human Development Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: January 18, 1995 PURPOSE The National Institute of Child Health and Human Development (NICHD) supports a program of Child Health Research Centers (CHRC), intended to provide resources to speed the transfer of knowledge gained through studies in basic science to clinical applications that will benefit the health of children. This will be accomplished by increasing the number of pediatric medical centers that can stimulate and facilitate the application of research findings to pressing pediatric problems, as well as increasing the number and effectiveness of pediatric investigators who have a grounding in basic science and research skills that can be applied to the health problems of children. 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), Child Health Research Centers, is related to several priority areas. 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 A CHRC grant is awarded to a children's hospital or a department of pediatrics of an approved medical school in the United States of America that has as a primary teaching site either a general children's hospital or a children's program with an identifiable organizational structure that is part of a larger medical institution. Recipient institutions must have the clinical pediatric specialties and subspecialties and the discrete clinical and research facilities sufficient to ensure the linkage of basic research and clinical application that will meet the purposes of the CHRC program. The applicant institution must also meet the standard eligibility requirements for research grants established in the PHS Grants Policy Statement (rev. 4/94). The CHRC must have a strong, well-established research base, resting on the interests of established investigators who make their expertise available to the junior investigators and act as mentors or senior collaborators for them. The research must relate to the current areas of interest of the research program of the NICHD and should be broadly-based, not defined by a specific disease category or organ system. There should be an adequate pool of junior investigators likely to benefit from career development under the guidance of established investigators. In addition, each Center must have a scientifically sound and equitable system for choosing which junior investigators and which projects are to be supported. Finally, there should be evidence of an institutional commitment to support of the Center resources and to the development and retention of pediatric investigators. MECHANISM OF SUPPORT Support for this program will be through Center Core Grant (P30) awards, which provide core support for laboratories and administrative resources applicable to a number of different research projects. Policies that govern the grants award programs of the PHS will prevail. The support of grants pursuant to the RFA is contingent upon ultimate receipt of appropriated funds for this purpose. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. The maximum will be $400,000 for direct plus indirect costs in the first year, with no increases for inflation in subsequent years. The number of awards will be influenced by the amount of funds available to the NICHD, by the overall merit of applications, and by their relevance to program goals. Applications from institutions not previously funded for Child Health Research Centers will compete on an equal basis with competing continuation applications. It is expected that RFAs similar to this one will be issued in FY 1995 and FY 1996. FUNDS AVAILABLE The estimated total costs awarded will be $2.4 million for the first year of support. It is anticipated that six or more awards (new and competing continuations) will be made. The maximum amount will be $400,000 for direct plus indirect costs in the first year, with no increases for inflation in subsequent years. The number of awards will be influenced by the overall merit of applications and by their relevance to program goals. RESEARCH OBJECTIVES A CHRC grant provides pediatric research institutions, both developing and established, an opportunity to build a greater capacity for nurturing pediatric investigators. Established investigators whose research is already funded by NIH or other sources through competitively reviewed grants or contracts combine to establish in their institution a center of research excellence. Individuals with a wide range of scientific backgrounds, especially those with basic science orientation, are encouraged to interact with each other and with newly trained pediatricians just embarking on their research careers. A shared core laboratory, which provides services to complement and extend the capabilities of the established investigators to facilitate the career development of new investigators, may be a major part of the Center. The established investigators make available their expertise, guidance, and laboratory facilities, which together with the shared core laboratory comprise the laboratory resources of the Center, to be utilized by junior investigators for research projects which will enhance their basic science knowledge and skills. Support for conducting these projects is provided by the Center grant. The CHRC grant may provide funds for three purposes: A. Administration of the Center. B. Improvements in the child health-related research program of an institution in an area of scientific excellence through the establishment and maintenance of a shared core laboratory. C. Support for new projects, conducted by junior investigators, designed to enhance their research skills and produce preliminary data which could lead to successful competitive grant applications to the NIH or other agencies (New Project Development Funds), thereby providing a bridge between formal research training and the receipt of independent research grants. The novel feature of these grants is the flexibility in the use of the funds awarded for research support and career development, so that decisions about which new projects and which junior investigators are to be supported are made by the grantee institution. Both competing (renewal) and noncompeting continuations of a CHRC grant are contingent on demonstration of good judgment in these decisions, as indicated by scientific progress, success in the initiation of new competitively-supported research grants and contracts, and the development of new pediatric investigators. Components of a CHRC A. Principal Investigator The principal investigator of the CHRC is the chairperson of the department of pediatrics or the chief of the pediatric service. He or she is responsible for development and maintenance of the Center as an institutional resource and for its general oversight, appointing the program director and members of the advisory committee (see below). He or she makes the decisions as to appropriate recipients of the Center funds for research and career development, taking into consideration recommendations from the Center advisory committee. The principal investigator does not receive salary or fringe benefit support from the CHRC for this responsibility. B. Administrative Staff The day-to-day administration of the Center grant may be made the responsibility of a senior faculty member, called the program director, supported for up to 10 percent time and effort for this activity. The program director must be a physician knowledgeable about pediatric research, with a record of success at laboratory or clinical investigation and preferably a demonstrated skill in career development. The principal investigator may also serve as program director, with appropriate support. The program director may be assisted by a part-time Center-supported secretary. Administrative staff funds may also be used for a well-qualified recruitment officer, supported up to 20 percent time and effort, to enhance participation in the program by women and by members of minority groups under-represented in pediatric research (see below). C. Advisory Committee The advisory committee is a group of Center scientists, drawn from the pediatric department and from other departments or institutions as appropriate, who have interests and expertise relevant to modern pediatric research. The advisory committee should be chaired by the principal investigator and should include the program director, the core laboratory director, and some or all of the established investigators. It may also include the recruitment officer and any other persons considered potentially contributory by the principal investigator. It is the function of the advisory committee to evaluate applications for the use of the Center's New Project Development Funds and make recommendations to the principal investigator as to appropriate awardees. It evaluates ongoing activities annually, makes recommendations as to their continuation, and recommends to the principal investigator priorities for use of the resources of the core laboratory. For these functions the committee may utilize institutional or outside consultants as necessary. The advisory committee provides expert counsel essential to the principal investigator for his or her administration of the Center. Its meetings should be regular and its evaluation activities formalized. Minutes of the advisory committee meetings will be scrutinized as part of any competing continuation application. D. Established Investigators At least six established investigators, supported by NIH or other competitively-awarded grants, are required for a CHRC. They should be expert in the application of new advances in basic science methodology to problems of human development and pediatric disease that are relevant to the mission of the NICHD and within its authority to support. Their research interests must contribute to areas that justify their collective designation as a Child Health Research Center, making the CHRC attractive to recently-trained pediatricians as a place to develop their investigative careers. The established investigators need not be pediatric department members; linkage to other departments can enhance the power of the CHRC, and is expected to be a key feature of each Center. When a junior investigator is to be supported by the Center through New Project Development Funds, at least one of the established investigators must agree to provide his or her expertise as a mentor and collaborator and allow the junior investigator access to his or her laboratories. The established investigators do not receive support for their salaries or fringe benefits from the Center grant. Established investigators may be added as appropriate to the roster of an ongoing funded Center. E. Laboratory Resources The laboratory resources of the CHRC comprise the research laboratories of the established investigators, as well as a shared core laboratory to be utilized by the established investigators and the Center-supported junior investigators whose activities they will supervise. The justification for the shared core laboratory is its provision of a cost-effective expansion or centralization of the research resources that make the Center a magnet for beginning investigators. The CHRC grant may support professional supervision of the shared core laboratory (core laboratory director, maximum 50 percent time and effort), as well as technical assistance, supplies, and equipment purchase and maintenance. The principal investigator, program director, and core laboratory director are responsible for efficient and equitable utilization of the core laboratory on the basis of recommendations from the advisory committee. Core laboratory log books are subject to review by NICHD staff and outside consultants upon request of the former. There must be an institutional commitment to this shared core laboratory, which may take the form of alterations and renovations to establish it, the purchase of research equipment, the assignment of research space, and/or the support of personnel. Creative approaches to stimulating interactions between diverse investigators who can contribute to Center goals are particularly desirable. The laboratories of the established investigators are not supported directly by the Center grant. Funds for supplies, small equipment, and technical assistance needed for the conduct of Center-supported research projects in these laboratories are provided through New Project Development Funds. Support for projects conducted in the core laboratory by recipients of New Project Development Funds may come either from those funds, from the core laboratory budget, or from both. F. New Project Development Funds The principal investigator, after considering recommendations from the advisory committee, is to use Center funds to make annual awards to junior faculty members for the pursuit of research projects which will utilize the Center laboratory resources and established investigator expertise. The projects may be clinical or non-clinical, as long as they relate to the goal of the Center. Each junior investigator must be under the mentorship of an established investigator who will provide supervision of the research to be undertaken. The maximum award to any individual for a project in this category is $50,000 per year. These funds may be used to defray the costs of materials, supplies, technical assistance, and miscellaneous expenses generated by these projects in the laboratories of the established investigators who serve as preceptors and collaborators of the awardees; for supplies needed for work in the core laboratory which are beyond the capacity of that laboratory's budget; for small items of equipment; for travel; and for a portion of the salaries and fringe benefits of the junior investigators. These funds may not be used for patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the research. The recipient of New Project Development Funds should be a physician who has completed pediatric training, who has not previously been the principal investigator of a competitively awarded NIH research grant or contract* (except for an NICHD-supported R03 grant), and who is no more than three years beyond fellowship training at the time the first New Project Development Fund award is made. The awards are renewable at the discretion of the principal investigator, contingent upon presentation of evidence of satisfactory progress to the advisory committee and the NICHD in the Center annual progress report. Each recipient should make a commitment of time and effort to research which is appropriate for the magnitude of the award. Institutions with CHRC grants are encouraged to develop novel mechanisms for recruiting qualified pediatricians to become grant-supported investigators in the Center. Such mechanisms could include, for example, part-time appointments for persons with families and special efforts to recruit members of minority groups. *Note: This restriction does not apply to NIH CIDA (K08) awards or any of its precursors (CIA, PSA), which are career development awards and not research grants. Recipients of New Project Development Funds are especially encouraged to apply for CIDA awards, which may be held prior to, concurrently with (subject to the relevant CIDA salary restriction), or subsequent to New Project Development Funds. Allowable Budgetary Items and Supportable Activities Allowable costs in NIH grants are governed by rules set forth in the Public Health Service Grants Policy Statement and the NIH Guide for Grants and Contracts unless otherwise stated on the Notice of Grant Award. Under these rules the principal investigator may exercise flexibility in meeting unexpected Center requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the Center (as shown on the Notice of Grant Award), within the ceilings set in these guidelines. CHRC grants are for five years, at a maximum level of $400,000 (direct plus indirect cost) annually, and are renewable. Competing continuation (renewals) are limited by Congressional action to one five-year period. No institution will be funded for a CHRC for more than ten years in any twelve-year period. That is, institutions which have been funded for a new CHRC and one competing continuation may not reapply until after a lapse of two years. An institution not funded for a competing continuation application may make a new application when a new RFA is issued. Items fundable under a CHRC grant include: A. Administration 1. Salaries and support for a Center program director (maximum 10 percent time and effort), a part-time secretary, and a recruiting officer (maximum 20 percent time and effort). 2. Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment when not covered by institutional overhead charges. 3. Travel of principal investigator and Center program director to administrative meetings with NICHD staff and to an annual scientific meeting of Centers. B. Shared Core Laboratory (maximum annually) 1. Salaries and support for shared core laboratory staff. 2. Supplies and animals. 3. Scientific equipment (purchase and maintenance). 4. Computer facilities. C. New Project Development Funds (maximum $200,000 annually) Up to $50,000 annually can be used to provide support for projects of individual junior investigators which are pursued in their own laboratories, in the shared core laboratory, and/or in the laboratories of the established investigators. For each person supported in this category, the maximum expenditure for equipment is $7,000 annually and for travel $1,500 annually. The grant application should indicate the number of awards proposed for each year, and provide evidence that this number of worthwhile projects is likely to be forthcoming. No investigator may receive more than one such award per year. It is not a requirement that any CHRC grant be funded at the allowable budgetary maximum in any particular year. The number of New Project Development Awards to be supported must be commensurate with the institution's capacity to develop and recruit appropriate candidates. Small size is not a disadvantage for Center funding, provided the support for core resources (administration, shared core laboratory) is in proportion to the activity in new investigator development which is the Center's primary purpose. To encourage use of these funds only for the most deserving candidates, requests will be considered for the carry-over of unexpended New Project Development Funds into subsequent budget periods. Items not fundable under a CHRC grant include: 1. Direct support of the laboratories, salaries, fringe benefits, travel, and research projects of the established investigators, except for reimbursement for costs from New Project Development Funds within the Center. 2. Salary and support for central institutional administrative personnel usually paid from institutional overhead charges, such as budget officers, grant assistants, and building maintenance personnel. 3. Salary and support for administrative activities such as public relations or health and educational services. 4. Travel of principal investigator, program director, core laboratory director, or established investigators to scientific meetings. 5. Costs of clinical care, such as patient bed days or outpatient visit charges. 6. Alterations and renovations. Application Format A. Text Applicants should follow the instructions for applications included in the "National Institute of Child Health and Human Development Research Center Programs P30 Center Core Grant Guidelines," except where these are at variance with these specific guidelines for CHRC grants. Since P30 Guidelines were not designed primarily to be used for CHRC-type applications, considerable flexibility in format will be permitted. Applicants should take care, however, that adequate information is provided for evaluation with respect to the eleven review criteria described above. Prospective applicants are urged to discuss their plans with Institute staff. Specific research projects proposed for support need not be described in the initial application. However, a brief description of examples of junior investigators who might be supported through this award, their training background, research areas in which they would work, and established investigators who would supervise them might provide evidence that enough worthy projects will be available to justify the requested budget. B. Budget Each application submitted in response to this RFA should include several separate budget pages (plus any budget justification pages): 1. A composite budget, the sum of the other budgets, in categories, for the first year. New project development funds should be listed under Other Expenses. 2. A budget for the administrative core (unless no funds are requested for this core), including personnel or supplies, travel for the principal investigator and program director to the Centers' meeting, and any other expenses requested, for the first year. 3. A budget for the shared core laboratory (unless no funds are requested for this laboratory), including personnel, equipment, supplies, and other expenses. 4. A budget for New Project Development, providing under Other Expenses the total dollars and minimum number of positions requested, according to the following format: (Example) New Project Development Awards: 3 @$ 50,000 or 5 @$ 30,000 = $150,000 The New Project Development Funds budget need not be allocated into categories, since these will vary with the situations of the recipients. However, it should be specified to what extent these funds will be used for salaries. The number of such awards planned should be appropriate for the size of the institution, the number and skills of the established investigators, and the magnitude of the request for Center administration and core laboratory resources. 5. The usual future-year continuation page, listing New Project Development Awards under Other Expenses. 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 For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151), 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 October 1, 1994, a letter of intent that includes a descriptive title of the proposed Center, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload, to recruit appropriate reviewers, and to avoid possible conflicts of interest in the review. The letter of intent is to be sent to Dr. Ephraim Levin 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 grants. These forms are available at most institutional offices of sponsored research and 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. 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 an application such that it may not reach the review committee in time for review. The title of the application on page 1 of the grant application must be "CHILD HEALTH RESEARCH CENTER." The phrase "PREPARED IN RESPONSE TO RFA HD-94-021" must be typed on line 2a of the face page of the application. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 Applications prepared in response to this RFA must be received by January 18, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed by NICHD staff for responsiveness to the RFA. A non-responsive application will be returned to the applicant. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. The NICHD will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Applications considered responsive to this RFA and competitive will be reviewed for technical merit by an Initial Review Group convened by the scientific review staff of the NICHD solely to evaluate these applications. Criteria for the initial review are described below. Following review by the Initial Review Group, applications will be evaluated by the NICHD Advisory Council for program relevance and policy issues before awards are made. Review Criteria A. The review criteria for the evaluation of new and competing continuation CHRC applications include the following: 1. Relevance of the research at the Institution to programmatic needs of the NICHD. 2. Probable impact of the Center on enhancing the capacity of the grantee institution for developing well-qualified new pediatric investigators, thereby advancing pediatric research at the grantee institution, in the local medical environment, and in the nation, especially with regard to the application of basic research developments to clinical problems in pediatrics. 3. Quality and productivity of the research activities of the participating established investigators, and relevance of their programs to the NICHD mission. 4. Nature and quality of the shared core laboratory: technical merit, scientific justification, evidence of cost-effectiveness, procedures for quality control and allocation of resources, qualifications of the core laboratory director and technical staff, and probable utility to the investigators. 5. Institutional commitment to the requirements of the program, such as recruitment efforts, salaries, equipment, or other forms of cost sharing. 6. Evidence for a pool of prospective investigators, trained locally or recruited from elsewhere, who could benefit from receiving support from the Center. 7. Opportunities for faculty positions emphasizing research for recipients of New Project Development Funds at the applicant institution or elsewhere. 8. Previous success of the institution in developing new pediatric investigators. 9. Efforts to develop novel mechanisms for recruiting candidates for New Project Development Awards from groups under-represented in pediatric research. 10. Procedures established for evaluating candidates for New Project Development Funds and providing internal quality control of ongoing research. 11. For renewal (competing continuation) applications, or subsequent new applications from an institution with a previously-funded Center, success of the Center-funded junior investigators in producing research publications and in obtaining independent, competitively-funded support for pediatric research. B. Non-competing continuations: Annual progress reports of a CHRC grant will be reviewed by NICHD staff and outside consultants in order to confirm that the Center is continuing to meet its goal of recruiting promising new pediatric investigators and stimulating and facilitating their career development. In addition, each Center will be asked to send some of its recent recipients of research support as well as the principal investigator and/or program director to an annual meeting. One purpose of this meeting will be to allow these junior investigators to present their Center-supported research to their peers as well as to other critics. Center principal investigators and program directors are expected to make a special effort to attend these meetings to demonstrate their support of the program and the junior investigators. In addition, they will have an opportunity at these meetings to exchange ideas about common problems and make suggestions to NICHD staff about possible modifications in the program. AWARD CRITERIA The anticipated date of award is September 1, 1995, based on the following timetable: Letter of Intent Receipt Date: October 1, 1994 Application Receipt Date: January 18, 1995 Initial Review Date: March 1995 Review by Advisory Council: June 1995 Scientific merit and technical proficiency, based on the demonstrated and projected capabilities described in the application will be the predominant criteria for determining funding priorities. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions for potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Ephraim Y. Levin, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Building, Room 4B11 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Building, Room 8A17 6100 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. From owner-sci-resources@net.bio.net Sun Jul 24 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Ray Dobert Newsgroups: bionet.announce,bionet.sci-resources Subject: Alt Ag Res and Commer.(AARC) accepting proposals Date: 24 Jul 1994 22:37:51 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 19 Sender: kristoff@net.bio.net Approved: bionews-moderator@net.bio.net Distribution: world Message-ID: <30vj3f$j8o@net.bio.net> Reply-To: Ray Dobert NNTP-Posting-Host: net.bio.net Xref: biosci bionet.announce:1300 bionet.sci-resources:1071 Please respond to the AARC office mentioned below. AARC NOW ACCEPTING GRANT PROPOSALS The USDA's Alternative Agricultural Research and Commercialization (AARC) center recently announced it is accepting funding proposals for projects that use agricultural products to produce an industrial materials. AARC defines an industrial product as a nonfood, nonfeed or nontraditional fiber. Agricultural products that can be used include traditional or new crops, forest products and animal by- products. Interested parties are invited to submit either full proposals or brief pre-proposals. The center prefers faxed inquires at (202) 401-6068; however, if a fax machine is not available, the center can be reached at (202) 401-4860. The deadline is September 30, 1994. Source: "Potential Applicants for AARC Center Funding," AARC CENTER MEMORANDUM, June, 1994. From owner-sci-resources@net.bio.net Sun Jul 24 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 - 24 July 1994 Date: 24 Jul 1994 23:14:49 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 99 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <30vl8p$l75@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: Letter Title: NSF 94-99 Dear Colleague Letter -- Cost-Reducing Health Care Technologies File size (bytes): 14481 STIS Filename: nsf9499 Document Type: Program Guideline Title: NSF 94-96 Macromolecular Structure Database Program Announcement File size (bytes): 27535 STIS Filename: nsf9496 Document Type: Recruit Title: Biological Science Administrator (Assistant Program Manager) File size (bytes): 4500 STIS Filename: vex9435 ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Issuance Title: inndx - Listing of Current Important Notices File size (bytes): 1909 STIS Filename: inndx Document Type: Letter Title: Current List of REU Sites File size (bytes): 78497 STIS Filename: reulist Document Type: Phone Book Title: NSF Alpha Telephone Directory Type- Phone Book Exposure- Public NSF Org- DAS Date- 18 July 1994 Delete- NONE Replaces- NONE File size (bytes): 100853 STIS Filename: phnalpha Title: NSF Organizational Directory File size (bytes): 124373 STIS Filename: phnorg Document Type: Program Guideline Title: NSF 94-84 Directorate for Biological Sciences File size (bytes): 10337 STIS Filename: nsf9484 ------------------------------------------------------------------------ ** 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 nsf9484, the text of your message should be as follows: get nsf9484 Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9484, you would enter: ftp> get nsf9484 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 Wed Jul 27 23:00:00 1994 Path: biosci!biosci!not-for-mail From: "smithp01@mcrcr6.med.nyu.edu"@mcclb0.med.nyu.edu Newsgroups: bionet.sci-resources Subject: ANNOUNCE: The NIH-Guide via WWW from NYU's database. Date: 27 Jul 1994 19:40:59 -0700 Organization: NYU Medical Center, 550 First Ave., New York, NY 10016 Lines: 39 Sender: kristoff@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <1994Jul27.190548@mcrcr6.med.nyu.edu> NNTP-Posting-Host: net.bio.net I'm not convinced we 've found all the bugs, but here goes.... We would like to announce that people can access the NIH-Guide via www by connecting to NYU's WWW server. The URL is.. http://www.med.nyu.edu/nih-guide.html To put responsibilities where they belong: NIH writes the guide and distributes it electronically (and has done so since 1990). NYU (and several other sites) maintain a copy of the so-called "E-Guide" as distributed. We have written server software for our DEC 3000 Model 400 AXP running OSF/1 that uses the NCSA httpd to serve up the data we have via WWW. There are no guarantees here: this is not a NIH-guaranteed service. I THINK its all 100% OK, but I've been wrong before :-) I'm hoping that the updating of the Guide will be automatic, starting next week. Which means that the new guide will be available on Monday following the post from NIH, this is about 2 days later than it might be, but the update job runs on Sunday evenings. As a kindness to us, if there are problems, please batch them and mail them to me. Suzy Gottesman, who programmed most of this is on vacation for two weeks so there will be little done to fix errors until she returns. Future Plans ============ This software will be bundled with the Guide-Reader package we developed. This will mean that people who have used our s/w to maintain a NIH-Guide database will be able to set up their own WWW server to distribute the information in that database to their users (so they won't have to use us directly, and also, they can control the access to these data, monitor usage, etc...). Have fun! +----------------------------------------------------------------------------+ |Ross Smith, Research Computing Resource, Department of Cell Biology, NYU-MC| |E-Mail: SMITH@NYUMED.BITNET (BITNET), SMITH@MCCLB0.MED.NYU.EDU (Internet)| +----------------------------------------------------------------------------+ From owner-sci-resources@net.bio.net Thu Jul 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 28, pt. 1of2, 29 July 1994 Date: 28 Jul 1994 20:15:48 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1499 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <319s94$hj6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940729 V23N28 P1O2 ************************************ X-comment: RFAs described: MH-94-010, TW-95-001 NIH GUIDE - Vol. 23, No. 28 - July 29, 1994 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** SUPPORT OF SCIENTIFIC COURSES National Institute of General Medical Sciences INDEX: GENERAL MEDICAL SCIENCES NOTICES OF AVAILABILITY (RFPs AND RFAs) $$INDEX R1 ********************************************************** AVAILABILITY OF SITE TO CONDUCT A LARGE SCALE EFFICACY TRIAL OF CANDIDATE PNEUMOCOCCAL VACCINES IN A LESS DEVELOPED COUNTRY National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R2 ********************************************************** VACCINE AVAILABILITY National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R3 ********************************************************** MONITOR AND MAINTAIN PHARMACY RESIDENCY PROGRAM OF THE CLINICAL CENTER (RFP OPC-CC-94-23) Warren Grant Magnuson Clinical Center INDEX: CLINICAL CENTER $$INDEX R4 ********************************************************** LEPROSY RESEARCH SUPPORT AND MAINTENANCE OF AN ARMADILLO COLONY (RFP NIH-NIAID-DMID-95-07) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R5 10/19/94 ************************************************* GENETIC ANALYSIS OF BIPOLAR DISORDER AND SCHIZOPHRENIA (RFA MH-94-010) National Institute of Mental Health INDEX: MENTAL HEALTH $$INDEX R6 03/15/94 ************************************************* MINORITY INTERNATIONAL RESEARCH TRAINING GRANTS (RFA TW-95-001) Fogarty International Center Office of Research on Minority Health INDEX: FOGARTY INTERNATIONAL CENTER; MINORITY HEALTH ONGOING PROGRAM ANNOUNCEMENTS $$INDEX P1 ********************************************************** INVESTIGATOR-INITIATED INTERACTIVE RESEARCH PROJECT GRANTS (PA-94-086) National Institute on Alcohol Abuse and Alcoholism National Institute on Aging National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Library of Medicine National Institute of Mental Health National Institute of Nursing Research National Center for Research Resources INDEX: ALCOHOL ABUSE, ALCOHOLISM; AGING; ALLERGY, INFECTIOUS DISEASES; ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CANCER; CHILD HEALTH, HUMAN DEVELOPMENT; DENTAL RESEARCH; DIABETES, DIGESTIVE, KIDNEY DISEASES; DRUG ABUSE; ENVIRONMENTAL HEALTH SCIENCES; NATIONAL LIBRARY OF MEDICINE; MENTAL HEALTH; NURSING RESEARCH; RESEARCH RESOURCES $$INDEX P2 ********************************************************** NEUROENDOCRINOLOGY OF AGING (PA-94-087) National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases INDEX: AGING; DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX P3 ********************************************************** MALNUTRITION IN OLDER PERSONS (PA-94-088) National Institute on Aging INDEX: AGING $$INDEX P4 ********************************************************** MECHANISMS OF SENSORIMOTOR ADAPTATION (PA-94-089) National Institute on Aging National Institute on Deafness and Other Communication Disorders National Institute of Neurological Disorders and Stroke National Aeronautical and Space Administration INDEX: AGING; DEAFNESS, COMMUNICATION DISORDERS; NEUROLOGICAL DISORDERS, STROKE, NATIONAL AERONAUTICAL AND SPACE ADMINISTRATION ERRATA $$INDEX E1 ********************************************************** MINORITY HIGH SCHOOL STUDENT RESEARCH APPRENTICE PROGRAM (PAR-94-081) National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX E2 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION This publication is available electronically to institutions via BITNET or INTERNET and is also on the NIH GOPHER. Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221). Contact Dr. John James at 301/594-7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** SUPPORT OF SCIENTIFIC COURSES NIH GUIDE, Volume 23, Number 28, July 29, 1994 P.T. 34; K.W. 1014006 National Institute of General Medical Sciences This announcement updates the policy of the National Institute of General Medical Sciences (NIGMS) regarding the support of scientific courses through the conference grant (R13) mechanism. Applicants planning to submit investigator-initiated conference grant applications for scientific courses are advised that it is important that they contact NIGMS program staff for guidance in the areas appropriate for the NIGMS and the preparation of the application itself. Applications received without prior contact may be delayed in the review process or returned to the applicant without review. INQUIRIES For further information, contact: Dr. Michael R. Martin Deputy Associate Director for Program Activities National Institute of General Medical Sciences Westwood Building, Room 936 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-7753 $$N1 END ************************************************************ NOTICES OF AVAILABILITY (RFPs AND RFAs) $$R1 BEGIN XX-XX-XXX ************************************************ AVAILABILITY OF SITE TO CONDUCT A LARGE SCALE EFFICACY TRIAL OF CANDIDATE PNEUMOCOCCAL VACCINES IN A LESS DEVELOPED COUNTRY NIH GUIDE, Volume 23, Number 28, July 29, 1994 SOURCES SOUGHT ANNOUNCEMENT P.T. 34; K.W. 0740075, 1002003 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), is seeking sources in developing countries that are capable of conducting one or more randomized, controlled, double-blind field trials to demonstrate the protective efficacy of new candidate pneumococcal vaccines against vaccine-type pneumococcal infections in an infant population. A pneumococcal vaccine containing capsular polysaccharide antigens of 23 serotypes is currently available and used in adults and high risk children over two years of age. Unfortunately, the vaccine is poorly immunogenic in children below the age of two years and in other high-risk groups. To enhance the immunogenicity in these latter populations, capsular polysaccharides have been coupled to carrier proteins to form conjugate vaccines similar to the Hib conjugate vaccines recently licensed and now part of the routine infant vaccination schedule in many countries worldwide. Because Streptococcus pneumoniae is a primary etiological agent of pneumonia and contributes significantly to the development of bacteremia and sepsis among young children in developing countries, it is very important to test the safety and efficacy of these new candidate pneumococcal vaccines in this setting. In selecting a site, it will be essential that information be available on the epidemiology of pneumococcal disease especially with regard to the etiology of pneumonia in young children in addition to knowledge of the individual serotypes causing disease among children with invasive infections. Other important factors that will be considered in the site selection process include: (1) availability of a population from a developing or intermediate country that is sufficiently large and stable to facilitate enrollment and follow-up; (2) an existing EPI program with a coverage greater than 75 percent; (3) the ability to demonstrate that a sufficient number of cases of confirmed pneumococcal infection can be detected to meet trial requirements; (4) an existing laboratory infrastructure to conduct serologic assays and perform definitive diagnostic tests for pneumonia; (5) the ability to collect both acute and convalescent serum specimens from suspected cases; (6) the ability to collect and store sterile site specimens and biological specimens, including nasopharyngeal aspirates, before and after immunization and during and after disease; (7) the capability to recruit a sufficient number of infants to have a high probability that the lower limit of a two-sided 95 percent confidence interval for absolute efficacy to prevent pneumococcal bacteremia with a new pneumococcal candidate vaccine compared to a control vaccine will be greater than 40 percent if true VE is 80 percent. The sample size should also take into consideration drop-out rates and other local factors that might affect the overall calculations; (8) efforts to ensure that the quality of the data for use by vaccine manufacturers when submitting applications for licensure will meet the standards established by the FDA; (9) an adequate morbidity and mortality surveillance mechanism in place; (10) good access to medical care and treatment; (11) the ability to randomize by individual and ensure the vaccine assignment of those enrolled; and (12) the ability to maintain surveillance for a period of up to two years. The proposed study will represent a joint collaborative effort among the NIH, NIAID, the WHO, and USAID. The purpose of this advertisement is to determine if there are sources capable of conducting efficacy trials with the primary emphasis on assessing the absolute efficacy of new candidate pneumococcal vaccines compared to a control vaccine in preventing invasive pneumococcal infections in infants. Secondary aims might include examining the general safety of the vaccine under investigation, exploring serological correlates of protection among immunized infants, and determining the effect of the vaccine on nasopharyngeal colonization and overall mortality. Interested parties should submit six copies of a capability statement no later than September 30, 1994. The statement should, at a minimum, address each of the areas outlined above. This Sources Sought Announcement is a request for information to assist the NIAID in planning for future efficacy trials. It may or may not result in a solicitation; at this time, no funds are available for these purposes. INQUIRIES Interested parties are encouraged to respond by September 30, 1994. Respondents are invited to discuss additional terms or conditions with NIAID by contacting: David L. Klein, Ph.D. Division of Microbiology & Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3B03 6003 Executive Boulevard, MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-5305 FAX: (301) 496-8030 $$R1 END ************************************************************ $$R2 BEGIN XX-XX-XXX ************************************************ VACCINE AVAILABILITY NIH GUIDE, Volume 23, Number 28, July 29, 1994 SOURCES SOUGHT ANNOUNCEMENT P.T. 34; K.W. 0740075, 1002003 National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting the interest of manufacturers of pneumococcal conjugate vaccines or other new candidate pneumococcal vaccines to have their products considered for use in Phase II and Phase III clinical trials in developing and intermediate countries. Although sources of pneomococcal vaccine are sought, no contract will result from this announcement. To be considered, conjugate vaccines must be multivalent and contain the following serotypes: 1, 5, 6B, 14, 19F, and 23F in addition to 9V and/or 18C. Data must be available demonstrating successful Phase I clinical trials in infants with an experimental lot of vaccine containing at least four of the above serotypes in addition to information that the vaccine meets U.S. FDA licensing requirements. Quantities of vaccine sufficient to conduct a large scale Phase III trial must also be made available by June 1995 without cost to the government. Manufacturers are required to provide information on basic manufacturing methods and the total content of the candidate pneumococcal vaccines including the type of adjuvant and preservative used, the type of carrier protein, and the chemical constructs. Selected products will be evaluated for safety and immunogenicity in a pre-determined Phase III trial site in addition to several of NIAID's contracted Vaccine Evaluation and Treatment Units. If more than one product is under consideration, the products will be compared to each other for safety and immunogenicity to facilitate the selection of a vaccine for eventual use in the field trial. The NIAID plans to cross-reference the manufacturer's Investigational New Drug (IND) exemption application or Master File for information to support studies submitted under NIAID's IND. INQUIRIES Interested parties are encouraged to respond by September 30, 1994. Respondents are invited to discuss additional terms or conditions with NIAID by contacting: David L. Klein, Ph.D. Division of Microbiology & Infectious Diseases National Institute of Allergy & Infectious Diseases Solar Building, Room 3B03 6003 Executive Boulevard, MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-5305 FAX: (301) 496-8030 $$R2 END ************************************************************ $$R3 BEGIN OPC-CC-94-23 ********************************************* MONITOR AND MAINTAIN PHARMACY RESIDENCY PROGRAM OF THE CLINICAL CENTER NIH GUIDE, Volume 23, Number 28, July 29, 1994 RFP AVAILABLE: OPC-CC-94-23 P.T. 34; K.W. 0710130 Warren Grant Magnuson Clinical Center The Warren Grant Magnuson Clinical Center, National Institutes of Health, has a requirement for an academic institution located within two and one-half hours travel time from the Washington, DC metropolitan area, which offers a pharmacy degree program to monitor and maintain the current Pharmacy Residency Program. The academic institution must be formally accredited by the American Council on Pharmaceutical Education. The program currently includes the pharmacy practice residency and three specialized residencies: (1) Oncology pharmacy practice, (2) primary care pharmacy practice, and (3) drug information and pharmacotherapy. Pharmacy practice residents rotate among the following areas: acute care in oncology and internal medicine, ambulatory care, pharmaceutical development, drug information and pharmacotherapy, and pharmacy management. Elective rotations are also offered in pediatric oncology, mental health, critical care medicine and pharmacokinetics. Off-site rotations at nearby organizations, such as the Food and Drug Administration (FDA), and U.S. Pharmacopoeia Convention are also available. In addition to a regular 40-hour week, residents will be required to work every other weekend (two eight-hour shifts) and an eight-hour shift on five federal holidays. The period of performance will be for one year with four 12-month option periods. This will be a five-year contract. The contractor shall be required to provide the services of a pharmacy resident each year of the contract in the following four categories: (1) General Hospital Pharmacy Practice, (2) Primary Care, (3) Oncology Pharmacy Practice, and (4) Drug Information and Pharmacotherapy. Each year, the contractor will develop a mechanism to provide a list of qualified candidates to fill each of the four residency positions. The residents will be replaced yearly by the contractor upon completion of the training goals and objectives that have been prepared for each program. Additionally, the contractor shall be required to review and evaluate the residency training goals and objectives, qualifications of the Pharmacy Department preceptors, and training sites and provide recommendations on how to improve and/or expand the existing programs. INQUIRIES This Request for Proposals (RFP) will be issued on or about August 1, 1994, with the estimated proposal due by September 15, 1994. All sources who consider themselves qualified are encouraged to submit proposals. Telephone requests for copies of the solicitation or other requests for information are not acceptable and will not be honored. All written requests must cite the RFP number and include two self- addressed mailing labels. Requests for copies of the solicitation are must be directed to: Mrs. Johnnie L. Rice ATTN: RFP-CC-94-23 Office of Purchasing and Contracts Warren Grant Magnuson Clinical Center 6010 Executive Boulevard, Room 216 Bethesda, MD 20892 $$R3 END ************************************************************ $$R4 BEGIN NIH-NIAID-DMID-94-07 ************************************* LEPROSY RESEARCH SUPPORT AND MAINTENANCE OF AN ARMADILLO COLONY NIH GUIDE, Volume 23, Number 28, July 29, 1994 RFP AVAILABLE: NIH-NIAID-DMID-95-07 P.T. 34; K.W. 1002002 National Institute of Allergy and Infectious Diseases The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals from investigators who have the capability and facilities to separate M. leprae bacilli from infected armadillo tissues, devise an analytical method(s) for the determination of the profile of M. leprae surface antigens to be employed in biological test systems, establish and maintain an armadillo colony of the nine-banded species (Dasypus novemcinctus), propagate M. leprae in the armadillos, monitor the colony and determine when an armadillo is highly infected with M. leprae, and aseptically harvest the infected tissues from the armadillos. These purified antigens and other cell products will be distributed to researchers at the direction of this institute. Request for Proposals (RFP) NIH-NIAID-DMID-95-07 will be available on or about August 1, 1994. Responses are due by close of business on October 17, 1994. It is estimated that one contract for Parts I and II together, or two separate contracts for Parts I and II separately will be awarded incrementally for a period of seven years. Any responsible offeror may submit a proposal that will be considered by the Government. INQUIRIES To receive a copy of this RFP, supply this office with a self-addressed mailing label. Telephone inquiries will not be honored and all inquiries must be in writing and addressed to: Contracting Officer National Institute of Allergy and Infectious Diseases Solar Building, Room 3C07 6003 Executive Boulevard Bethesda, MD 20892 This advertisement does not commit the Government to award a contract. $$R4 END ************************************************************ $$R5 BEGIN MH-94-010 FULL-TEXT ************************************** GENETIC ANALYSIS OF BIPOLAR DISORDER AND SCHIZOPHRENIA NIH GUIDE, Volume 23, Number 28, July 29, 1994 RFA AVAILABLE: MH-94-010 P.T. 34; K.W. 0715177, 1002019, 1002058, 0785055 National Institute of Mental Health Application Receipt Date: October 19, 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 National Institute of Mental Health (NIMH) is soliciting applications to use the resources and experience of funded investigators of the Institute's "Diagnostic Centers for Psychiatric Linkage Studies" to complete the objectives outlined in the original RFA for this program (RFA: MH-89-05), and to move to the second phase of study of the genetics of bipolar disorder and schizophrenia: genotyping and genetic analysis of material from subjects ascertained during the data collection phase of this study. Combining expertise in the areas of diagnosis, genetic epidemiology, biostatistics, and molecular genetics should make it possible to identify those genetic factors which have a significant impact on the expression of these disorders. The applicants are expected to use data from the families ascertained and assessed by the Diagnostic Centers. 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, Genetic Analysis of Bipolar Disorder and Schizophrenia, is related to the priority area of mental disorders in adults. 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 Only currently funded bipolar disorder or schizophrenia Diagnostic Centers for Psychiatric Linkage Studies are eligible to apply for up to three years of support. The six currently active Diagnostic Centers for Psychiatric Linkage Studies are considered uniquely structured to undertake this study for several reasons: their use of a common protocol for data collection that has included uniform assessments and extension rules permitting pooling of data across sites; their ability to follow subjects longitudinally and track changes in diagnoses or compare diagnoses; and their existing infrastructure, scope and aims, and multidisciplinary staffing. MECHANISM OF SUPPORT Awards will be made as cooperative agreements (U01). In cooperative agreements, unlike traditional research grants, substantial NIMH programmatic involvement with the recipient is anticipated during the performance of the planned activity. It is expected that up to $250,000 in direct costs for each cooperative agreement study site will be available in fiscal year 1995. FUNDS AVAILABLE The NIMH expects to support six cooperative agreements funded during fiscal year 1995. The total cost available is $1.5 million. RESEARCH OBJECTIVES Background The NIMH initiated its "Diagnostic Centers for Psychiatric Linkage Studies" in fiscal year 1989. After rigorous peer review, three centers were selected to plan and coordinate the assessment and collection of data from affected sibling pairs and family members with schizophrenia, three centers for bipolar disorder, and a fourth center for bipolar disorder at the NIMH Intramural Research Program. Concomitantly, NIMH established a National Cell Repository (Coriell Institute for Medical Research) to store DNA and cell lines immortalized from subjects' blood in addition to a repository of clinical information, the Data Management Center (SRA, Inc). In accord with the assistance aspects of a cooperative agreement, the Principal Investigators retain primary custody of all collected data that include subject identifiers, while anonymous information about family structure, age, sex, and diagnosis is sent to the Data Management Center to form a national resource. Since their primary function is the acquisition and storage of cells and data to be used as a national resource, these repositories were funded through separate contract mechanisms. Objectives and Scope This cooperative agreement for genetic analysis of data collected by the Diagnostic Centers for Psychiatric Linkage Studies project is intended to allow participants to: (1) screen DNA from bipolar and schizophrenia families (collected as described above) for potentially relevant mutations; (2) perform the necessary computer simulations using existing family structures and various genetic models to determine optimum analytic strategies as new data become available; (3) search for genes associated with bipolar disorder or schizophrenia, using the best available genetic analytic techniques; and (4) use existing and new highly polymorphic markers to better define the regions where linkages are found. It is anticipated that once genotyping begins these data will be transferred to the data management center on a regular basis. SPECIAL REQUIREMENTS Special Requirements, Terms and Conditions of Award, data rights, and arbitration guidelines are explained in the RFA. Collaborative Responsibilities The Steering Committee will be the primary decision-making body of this collaborative multi-site study. Membership will be composed of the Principal Investigator from each site including the NIMH Intramural site (one vote per site), and the NIMH Project Coordinator (one vote). The Steering Committee will meet at least three times per year, generally in the Washington, DC Metropolitan Area. 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. APPLICATION PROCEDURES Applications are to be prepared on the research grant application form PHS 398 (rev. 9/91). The application form is available at most institutional offices of sponsored research and 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 RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. A completed original application and five copies must be sent to: Division of Research Grants National Institutes of Health Westbard Building, Room 240 Bethesda, MD 20892** This is a one-time only application with a receipt date of October 19, 1994. Applications received after that date will be returned to the applicant's institutional organization without review. Scientific/technical merit review will take place in November 1994; National Advisory Mental Health Council review will be in early 1995, with a possible start date in March 1995. REVIEW CONSIDERATIONS Applications submitted in response to this RFA will be reviewed in accordance with the usual NIH peer review procedures for research grant applications. They will be reviewed for scientific and technical merit by an initial review group (IRG) convened by NIMH and composed primarily of non-Federal scientific experts. A second level of review will be conducted by the National Advisory Mental Health Council. Review Criteria Review criteria and award criteria are explained in the RFA. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct requests for the RFA and inquiries regarding programmatic issues to: David Shore, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18C-26 Rockville, MD 20857 Telephone: (301) 443-3683 Direct inquiries regarding grants management to: Bruce L. Ringler Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 as implemented through DHHS Regulations at 45 CFR Part 100. $$R5 END ************************************************************ $$R6 BEGIN TW-95-001 FULL-TEXT ************************************** MINORITY INTERNATIONAL RESEARCH TRAINING GRANTS NIH GUIDE, Volume 23, Number 28, July 29, 1994 RFA AVAILABLE: TW-95-001 P.T. 22, FF; K.W. 0720005 Fogarty International Center Office of Research on Minority Health Application Receipt Date: March 15, 1995 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 Fogarty International Center (FIC) and the Office of Research on Minority Health (ORMH) support a program to provide international research training opportunities for minority undergraduate students, minority graduate students, and minority faculty members in biomedical and behavioral research. Training grant awards will be made for three years to U.S. colleges and universities to: o encourage minority students to pursue degrees and careers in the biological sciences, especially biomedical and behavioral research, by broadening their undergraduate and graduate education through international experiences; o promote qualities of leadership by expanding cultural perspectives in minority students and faculty; o help prepare the next generation of scientific leaders to work effectively in a global environment; o establish linkages between U.S. scientists and institutions and established centers of biomedical and behavioral research abroad. ELIGIBILITY REQUIREMENTS U.S. Participants and Program Requirements: These institutional training grants will be awarded to U.S. institutions for the purpose of collaborating with one or more foreign research centers that can provide a substantial research training experience for the U.S. minority participants. The applicant institution and any associated institution in a consortium must be a two- or four-year domestic school, college or university. Minority participants must be from underrepresented minority groups including African Americans, Hispanic Americans, American Indians, and Pacific Islanders. The program director at the applicant institution will be responsible for the selection and appointment of participants, selection of the foreign training site(s) and the overall direction of the training program. Participating students and faculty members must be members of the minority groups listed above and be U.S. citizens or permanent residents who are pursuing degrees, studying and/or conducting research in the biomedical or behavioral sciences at the time of appointment and during the program. Undergraduate student trainees must be pre-baccalaureate, pursuing a relevant biomedical or behavioral science curriculum, and must show evidence of a commitment to obtaining a postgraduate research related degree in a biomedical or behavioral field of science. The foreign training for undergraduate students will be for approximately 10 to 12 weeks. Predoctoral students must be enrolled in a U.S. graduate research training program in the biomedical or behavioral sciences. The predoctoral training period at the foreign site may be from approximately 3 to 12 months for the purpose of learning a technique or carrying out a special project or portion of a project related to their doctoral studies. The minority faculty development portion of the training grant will provide support for research and studies for approximately 3 to 12 months at a foreign training site. Participants must have regular, full-time faculty appointments at the grantee institution or an institution in the consortium. The research plan must indicate the expected benefits of the proposed work. The foreign research centers should be universities, colleges or other research institutions that have strong, well-established biomedical or behavioral research and research training programs. MECHANISMS OF SUPPORT The mechanism of support is the institutional training grant award (T37). Domestic institutions may request up to three years of support. The stipend level during the period of foreign stay is up to $1,000 per month for undergraduate and graduate students and up to $3,000 per month for the faculty member. Stipends may be supplemented from non-Federal sources only. The stipend plus the home institution support cannot exceed the appointee's annual salary. Requests may be made for undergraduate and graduate students and faculty of up to $500 per month each at the foreign training site. Training-related expenses for use at the foreign training site of up to $500 per month may be requested for each undergraduate student, graduate student, or faculty member. Foreign living expenses will be up to $1,000 per month for undergraduate and graduate students and up to $2,000 per month for faculty members. Stipends, training and travel expenses are offered only for the time period participants are en route to or working in the foreign country. No expenses are provided for domestic research or training. If especially justified, the domestic applicant institution may request up to five percent of the requested total direct costs for the support of the principal investigator and/or other grant-related personnel for domestic administrative efforts. These costs must be specifically related to this grant. Indirect costs will be awarded to the grantee institution at a rate of eight percent of the allowable direct costs. Each of the training grant awards will not exceed a total of $400,000 per year, including direct and indirect costs. FUNDS AVAILABLE It is expected that 6 to 10 new, competitive awards will be made in FY 95. RESEARCH OBJECTIVES The Minority International Research Training grants are designed to offer research training grant awards to enable qualified minority undergraduate students, graduate students, and faculty members to participate in international biomedical and behavioral research programs. This training grant program is expected to attract students and scientists in the developmental stages of their educations and careers to increase their awareness of international research opportunities and to acquaint them with the full range of career opportunities in biomedical and behavioral research. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) using the special instructions related to Institutional National Research Service Awards (Section VII). Note the requirement to use NRSA substitute pages MM, NN, OO to be acceptable for initial review. Application kits are available at most institutional offices of sponsored research and may also 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 completed application and three legible copies must be sent or delivered to the following address and received by March 15, 1995: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the completed application must be sent to Dr. Wolff at the address listed under INQUIRIES. REVIEW CONSIDERATIONS All applications responding to this RFA will be reviewed for scientific and technical merit by an NIH initial review group, followed by a second level review by the Fogarty International Center Advisory Board. To be eligible for review, applications must be complete and submitted in accordance with the application procedures stated above. Letters from the foreign collaborators and their institutional officials indicating their willingness to participate in this training program must accompany the application. The review criteria are listed in the RFA. INQUIRIES Written and telephone requests for the RFA and the opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues and two copies of the application to: Dr. David Wolff International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 Direct inquiries regarding fiscal matters to: Ms. Silvia Mandes International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892** Telephone: (301) 496-1653 FAX: (301) 402-0779 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.106. Awards are made under the authority of the Public Health Service Act, Title III, Part A, Section 307b (42 USC 2421) and administered under PHS grants policies and Federal regulations, most specifically 42 CFR part 61. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. $$R6 END ************************************************************ ONGOING PROGRAM ANNOUNCEMENTS $$P1 BEGIN PA-94-086 ************************************************ INVESTIGATOR-INITIATED INTERACTIVE RESEARCH PROJECT GRANTS NIH GUIDE, Volume 23, Number 28, July 29, 1994 PA NUMBER: PA-94-086 P.T. 34; K.W. 0710030, 1014006 National Institute on Alcohol Abuse and Alcoholism National Institute on Aging National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Library of Medicine National Institute of Mental Health National Institute of Nursing Research National Center for Research Resources Application Receipt Dates: February 15, June 15, October 15 Introduction: This is to rescind NIH PA-93-078, on Investigator- Initiated Interactive Research Project Grants (Volume 22, Number 16, April 23, 1993), and replace it with the following Program Announcement. The purpose of this revised Program Announcement is to clarify several important aspects of the Interactive Research Project Grant (IRPG) program, as originally announced in the NIH Guide for Grants and Contracts, Vol. 22, No. 16, April 23, 1993. The full text of the revised Program Announcement, which replaces and supersedes the original text, is available electronically, as well as from the Institute or Center contacts listed under INQUIRIES. In addition, a new brochure, "Special Instructions for Preparing Applications for Investigator-Initiated Interactive Research Project Grants," is available from the Office of Grants Information, Division of Research Grants, NIH, 301/594-7248, and from the Institute or Center contacts. The key clarifications in this revised Program Announcement are as follows: 1. The important characteristics of IRPG applications and their differences from Program Projects are explained more clearly. 2. The section on STUDY POPULATIONS has been updated to reflect the latest NIH policy required under the NIH Revitalization Act of 1993 and announced in the Federal Register of March 28, 1994 (FR 59 14508- 14513), and printed in the NIH Guide for Grants and Contracts, Vol. 23, No. 23, March 18, 1994. All applications received on or after June 1, 1994 must conform to this new policy. 3. The requirements for format and layout of each application in the IRPG group have been stated more clearly. 4. The procedures for submission of applications and the receipt dates for applications, including AIDS and AIDS-related applications, have been clarified. 5. The guidelines for requesting limited shared resources for projects in the IRPG group have been clarified. 6. The special instructions for preparation of Section 7, Consultants/ Collaborators, of the Research Plan have been clarified. 7. Table II, Distribution of Effort of All Personnel in the IRPG, is no longer required. 8. The process for referral of the applications and the review criteria for the collaborative arrangements have been clarified. PURPOSE Certain questions in biomedical and behavioral research require research efforts that extend beyond the level practicable in a single project or require a variety of technical approaches beyond the means of a single investigator. There may be areas of investigation that are under-represented in individual research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications because of the lack of available collaborative effort on a local level. Further, the perceived merit of individual projects may be diminished by the lack of a comprehensive, interdisciplinary approach or by limitations in resident technical expertise. The National Institutes of Health (NIH) has used many ways to encourage strong collaboration among research scientists. These have ranged from specific interaction of the Federal government with academia/industry through contract or cooperative agreement solicitations to Requests for Applications (RFAs) that solicit research applications involving various forms of cooperation among applicants. This Program Announcement provides for a new kind of formal interaction, based on the initiative of applicants, to enhance existing interactions with colleagues or to develop new collaborative relationships. The Interactive Research Project Grant (IRPG) program encourages the coordinated submission of related research project grant (R01) and, to a limited extent, FIRST award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must be scientifically interrelated in some manner and must describe the objectives and scientific importance of the interchange of, e.g., ideas, data, and materials, among the collaborating investigators. A minimum of two independent investigators with related research objectives are encouraged to submit concurrent, collaborative, cross-referenced individual R01 and/or R29 applications. The proposed projects must not be dependent upon each other to the extent that one could not be accomplished in the absence of the other. Applicants may be from one or several institutions. Applications will be reviewed independently for scientific merit. Applications judged to have significant and substantial merit will be considered for funding both as independent awards and in the context of the proposed IRPG collaboration. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions, however, are not eligible for the R29 award. Applications may be submitted from one or more institutions. Applications from or involving minority institutions, minority individuals, and women are encouraged. Applicants for IRPG awards may not concurrently submit additional R01 or R29 applications (either investigator-initiated or in response to an RFA) that represent significant duplication of the efforts described in the IRPG. Concurrent submission of program project (P01) or cooperative agreement (U01, U10, U19, etc.) applications requesting support for essentially similar work also is prohibited. MECHANISM OF SUPPORT Support of this program will be by the traditional research project (R01) grant and the FIRST (R29) award. The IRPG group must consist of a minimum of two independent applications. An IRPG package may consist of a combination of R01 and R29 applications, or R01 applications only, but may not consist solely of R29 applications. Applications for both new (Type 1) and competing renewal (Type 2) awards may be submitted as IRPGs. Occasionally, Institutes and Centers of the NIH may issue additional Program Announcements that include IRPGs. The RFA also may be used, in limited circumstances, to solicit applications for IRPG awards in a discrete scientific area. Although the level of interaction for IRPGs between or among applicants in these solicitations will conform to those outlined here for the investigator-initiated IRPG, there may be minor differences outlined in the RFA. For example, all RFA solicitations will specify a single receipt date that will be different from those listed in this program announcement. All Public Health Service (PHS) and NIH grants policies will apply to applications received in response to this program announcement. This revised program announcement supersedes any previous program announcements regarding IRPG awards. Future IRPG applications must follow the instructions presented in this program announcement. RESEARCH OBJECTIVES The NIH encourages qualified independent investigators to develop and submit coordinated R01 and R29 applications that address any research area supported by the Institutes or Centers listed above. The IRPG program could be used constructively to support collaborative efforts designed to accelerate the development of fundamental knowledge and/or enhance the clinical application of that knowledge. The IRPG award may fit well with clinical applications that propose limited, testable research questions or focused therapeutic and related correlative laboratory studies. However, the IRPG program is not appropriate for large epidemiologic studies or multi-institutional clinical trials using common protocols. If there is a question about the appropriateness of a set of applications for the IRPG program, applicants are encouraged to discuss the issues with NIH staff contacts listed under INQUIRIES. IRPG Characteristics The IRPG application consists of a number of investigator-initiated projects that share an aspect of relationship of objectives. The projects may involve several institutions and may be interdisciplinary. The IRPG program is intended to promote collaborative efforts between or among projects, while providing a record of independently acquired awards credited to each individually funded investigator and allowing retention of research autonomy by the named Principal Investigator (PI) of each project. Each grantee will have the ability to submit on his/her behalf competing supplements as appropriate to incorporate promising new directions of research as they evolve. The freedom to establish collaborations on an equal footing at separate sites (including foreign locations, with the exception that only domestic organizations and institutions are eligible to receive FIRST (R29) awards), and the transferability of awards made to individual investigators, are other benefits. Nevertheless, each investigator may benefit, because the IRPG award establishes a larger framework of reference for the proposed work and facilitates formal collaborations tailored to achieving investigator-initiated research objectives. Thus, the IRPG application must demonstrate a sense of collaboration toward related goals. It must describe how the participants intend to take the opportunity to participate in mutually-beneficial interactions, while maintaining the independence of their projects. The IRPG application may involve utilization of shared resources in advancing effective collaborations. It is important for each individual application comprising a portion of the overall IRPG to describe the proportion of the shared resources needed for that individual project. Since each component R01 and R29 is an independent application, it should be prepared in the same level of detail and with the same care as a traditional R01 or R29 application. Each project also should be able to stand on its own scientifically; the projects proposed must not be dependent on each other, but should be designed so that they could be accomplished independently. For example, one project should not be completely dependent on another project for provision of a critical chemical or reagent, testing or processing of key samples, or interpretation of data. Comparison with Program Projects Historically, the NIH has relied on multi-component awards, such as program projects (P01), center grants (P30, P50), and cooperative agreements (U01) to encourage multi-disciplinary collaboration in areas requiring integration and coordinated direction of basic and clinical research components. In general, such awards include the provision of extensive core facilities/resources and appointment of a program director to manage the overall effort. However, for many research areas it may be appropriate to consider an intermediate level of collaboration that is beyond that practicable for single projects. For such scientifically originated collaborative efforts, the exchanges of data, materials, and ideas, rather than shared extensive physical resources or central oversight, are the primary requirement. The concept of the IRPG put forth in this program announcement is meant to address and facilitate this class of research activity. The IRPG allows interaction to be initiated among applicants, as is the case with a program project grant (P01) application, but the IRPG differs from the P01 in important ways. The IRPG group consists of investigator-initiated applications on related but independent topics, with a formalized agreement to collaborate in specific ways. The collaboration may include limited shared scientific resources. The IRPG program can be useful where interdependency among efforts is not a requirement, but where the intended collaboration would enhance goal achievement. The IRPG application must provide for interaction between or among the investigators arising from their desire to collaborate as independent investigators. The scope of research in each component of a successful IRPG group should be greater than could be achieved without the collaboration. The proposed collaborations should have a demonstrable impact on ability of the investigators to achieve the projects' goals. In contrast, the P01 has a well-defined major objective or central theme, most commonly incorporates collaborative efforts among investigators from the same institution, may involve significant core resources, and is under the direct control of a central principal individual with authority over research direction and budget. If significant core resources beyond a limited amount are needed, applicants should consider applying for a P01. STUDY POPULATIONS If human subjects are involved, each component application must address these issues. 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) ad supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the contact person listed below. The contact person may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and 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. Before preparing an IRPG application, applicants should obtain the brochure "Special Instructions for Preparing Applications for Investigator-Initiated Interactive Research Project Grants," available from the Office of Grants Information, Division of Research Grants, NIH, 301-594-7248, and from the Institute or Center contacts. Each application must be identified by checking "YES" on line 2a of the PHS 398 face page, citing this IRPG program announcement number, and including the title: "Investigator-initiated IRPG." All requirements with regard to type size, page limitations, appendix material, etc., must be followed or applications will be returned without review. FIRST applications (new and revised) must be accompanied by three letters of reference. FIRST applications without these letters will be considered incomplete and will be returned without review. IRPG applications, whether new (Type 1), competing renewal (Type 2), or revised applications, will have common receipt dates as shown in the table below. Receipt dates for AIDS and AIDS-related applications also are given. For each component IRPG application, a signed, printed original, five exact single-sided copies, and five sets of appendix material must be submitted. Each application must be complete in itself, with all necessary approvals, budgets, and signatures from the appropriate officials of the applicant institution. Each application must have its own descriptive title and a separate Principal Investigator. Since each component project of an IRPG application is an independent R01 or R29 application, the component projects should NOT be presented as subcontracts to one parent project. Each requested shared resource must be included in one of the component applications; no shared resource may be submitted separately. If the shared resource is in other than an applicant institution, the shared resource may be supported as a subcontract to one of the component institutions. All information about the interactive nature of the projects should be included in a subsection of Section 7 of the Research Plan of each component IRPG application. Specific detailed instructions for completing all parts of Section 7 of the Research Plan, are provided in the brochure, "Special Instructions for Preparing Applications for Investigator-Initiated Interactive Research Project Grants." In addition to a description of project-specific collaborations, each component application of the IRPG Group must contain an identical subsection (entitled "IRPG INTERACTIONS") and identical information showing utilization of any requested shared resources. The IRPG INTERACTIONS subsection of Section 7 should address the intended interactions among the component projects of the IRPG group and the perceived benefits of supporting all of the components of the IRPG group as a combined effort. Description of the shared resources that will be supported through one of the IRPG component applications, if any, should be inserted as a separate section of the application after Section 8 (Consortium/ Contractual Arrangements) of the Research Plan and before Section 9 (Literature Cited). As described in detail in the instructions brochure, this should include an explicit description of the methods and procedures to be used, the services, tests, animals, facilities, etc. to be provided, and a description of the involvement and protection of human subjects or vertebrate animals, if appropriate. Extensive shared resources, or those with large budgets, may be more appropriate for full-fledged Cores in program projects. Applicants are urged to contact the NIH staff listed under INQUIRIES to discuss the nature and extent of proposed shared resources in an IRPG group. In no case should a resource be submitted as a separate application. All R01 or R29 applications constituting the proposed IRPG cohort must be submitted in a single package, whether or not the applications arise from the same institution. Each application within the package must be clearly identified and a cover letter must list the total number of applications submitted for the IRPG cohort, indicating the Principal Investigator of each. The various projects comprising the IRPG application should not be collated together, as is done for a program project. For each application of the IRPG group, the original, five copies, and the appendix material must be bundled together and clearly identified. If two or more, but not all, applications within an IRPG Group receive initial funding as an IRPG, and unfunded applications within that group are subsequently amended and submitted on later receipt dates, the awarded IRPG component(s) should be identified and may be cited in the amended applications. In such cases, those amended R01/R29 applications must make reference to being part of a partially funded IRPG. They may, however, request support to extend beyond the end date of the already awarded component R01(s), consistent with the scientific goals of the application. Revised applications should highlight the changes made in the Research Plan in response to the previous critique, and also should indicate in Section 7 how the delay in initiating the collaboration will be addressed. This is particularly important if some projects in the IRPG group were awarded and research on those projects already has begun. If the IRPG group is not fundable as such, any individual application within the IRPG group may be considered as a possible candidate for funding as an individual R01. IRPG Receipt and Review Schedule Application Receipt Date: Feb 15 Jun 15 Oct 15 Initial Review: Jun Oct Feb Council Review: Sep/Oct Jan/Feb May/Jun Anticipated Date of Award: Dec 1 Apr 1 Jul 1 Instructions for AIDS and AIDS-related applications IRPG applications for AIDS-related research must be identified as such, and should be submitted in accordance with the AIDS expedited review process. The receipt and review schedule for AIDS-related IRPG applications is given below. Application Receipt Date: Jan 2 May 1 Sep 1 Initial Review: Mar/Apr Jul Nov Council Review: May/Jun Sep/Oct Jan/Feb Anticipated Date of Award: Jul 1 Dec 1 Apr 1 Failure to follow the instructions regarding submission date and packaging may lead to a delay in review. The IRPG application package must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Any questions regarding the format for submission of an IRPG package may be directed to the Referral Office, Division of Research Grants, Westwood Building, Room 248, telephone (301) 594-7250. REVIEW CONSIDERATIONS Upon receipt, applications and supporting material will be examined by the Division of Research Grants for completeness. Incomplete applications will be returned without further consideration. Each application in an IRPG Group will be referred to the most appropriate Initial Review Group (IRG), according to standard NIH referral and review procedures, for scientific and technical merit review. The IRG could be either a DRG Study Section or an Institute or Center-managed review committee, depending on the referral guidelines for the particular research proposed. Since applications in the IRPG might be referred to different IRGs, the IRPG INTERACTIONS part of Section 7 must be complete so that reviewers can understand the collaborations and interactions without necessarily seeing any of the other applications in the Group. Following scientific and technical merit review, applications that may be considered for award will receive a second level review by the appropriate national advisory council(s). Institute or Center assignment of each component application in the IRPG also will be governed by established PHS referral guidelines. Therefore, depending on the subject matter of each IRPG, it is possible that the component applications will be assigned to different NIH Institutes or Centers for funding consideration. This underscores the need for each application to be complete within itself and for all component applications to have identical subsections on IRPG INTERACTIONS in Section 7 of the Research Plan. As with any R01 or R29 application, each component of the IRPG Group must be able to stand on its own merit. Consequently, the application must be prepared with the same detail as a traditional R01 or R29 application. The initial review for scientific and technical merit will focus on each application independently, using standard review criteria for R01 and R29 applications generally, and each application will be assigned its own priority score. In addition, the reviewers will read Section 7 and will assess the intended IRPG interactions. In an Administrative Note, the reviewers will indicate the effectiveness and feasibility of the proposed IRPG interactions and whether they enhance the prospects for reaching the stated objectives of the Group, and the extent of synergy between the various projects derived from the interactions. The appropriate national advisory council or board and the program staff in the Institute or Center to which the applications are assigned will consider these comments on the proposed collaborations in making award decisions. The IRG will evaluate the requested Shared Resource component(s) in the application (qualifications of key personnel; adequacy of approaches, methods, and facilities; appropriateness for the IRPG Group; and utilization by component IRPGs) independently from the research project. The IRG may also make recommendations about the Shared Resource(s) or the reasonableness of the budget. These recommendations will be taken into account when funding decisions are made by the awarding Institute or Center. The actual amount of Shared Resource(s) awarded may depend on the number of component projects actually awarded. AWARD CRITERIA Applications will compete for available funds with all other applications found to have significant and substantial merit. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o The interactive nature of the program and of the component IRPGs o Availability of funds o Program balance among research areas Each Institute or Center will have the opportunity to fund some or all of the component IRPG applications assigned to it. If the components are assigned to more than one Institute or Center, co-funding may be considered. If some component IRPG applications are considered not supportable, the collaborative plans may need to be changed. If an Institute or Center chooses to fund an entire IRPG package, a review of the collaborative plans in toto will be conducted by an appropriate advisory council. As stated above, if the IRPG group is not fundable as such, any individual application within the IRPG group may be considered as a possible candidate for funding as an individual R01 or R29. INQUIRIES Additional written instructions for the preparation of applications are available upon request. This document, "Special Instructions for Preparing Applications for Investigator-Initiated Interactive Research Project Grants," is available from the Office of Grants Information, Division of Research Grants, NIH, 301-594-7248. Applicants should be aware that not all Institutes or Centers are participating in this program. Contact any of the following individuals for further information: Dr. Kenneth Warren Director, Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Telephone: (301) 443-4375 Dr. Miriam Kelty Associate Director, Extramural Affairs National Institute on Aging Telephone: (301) 496-9322 Mr. Allan Czarra Director, Office of Program Coordination and Operations National Institute of Allergy and Infectious Diseases Telephone: (301) 402-0160 Dr. Michael Lockshin Director, Extramural Program National Institute of Arthritis and Musculoskeletal and Skin Diseases Telephone: (301) 496-0802 Dr. Marvin Kalt Deputy Director, Division of Extramural Activities National Cancer Institute Telephone: (301) 496-4218 Ms. Hildegard Topper Special Assistant to the Deputy Director National Institute of Child Health and Human Development Telephone: (301) 496-0104 Dr. Norman Braveman Assistant Director for Program Development National Institute of Dental Research Telephone: (301) 594-7648 Dr. Walter Stolz Director, Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Telephone: (301) 594-7277 Ms. Eleanor Friedenberg Director, Office of Extramural Program Review National Institute on Drug Abuse Telephone: (301) 443-2755 Dr. Thor Fjellstedt Deputy Director, Division of Extramural Research and Training National Institute of Environmental Health Sciences Telephone: (919) 541-0131 Dr. Milton Corn Acting Associate Director, Division of Extramural Programs National Library of Medicine Telephone: (301) 496-4621 Dr. Hugh Stamper Director, Division of Extramural Activities National Institute of Mental Health From owner-sci-resources@net.bio.net Thu Jul 28 23:00:00 1994 Path: biosci!biosci!not-for-mail From: Dave Kristofferson Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 23, no. 28, pt. 2of2, 29 July 1994 Date: 28 Jul 1994 20:15:58 -0700 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1022 Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <319s9e$hjv@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19940729 V23N28 P2O2 ************************************ Telephone: (301) 443-3367 Dr. Theresa S. Radebaugh Director, Division of Extramural Programs National Institute of Nursing Research Telephone: (301) 594-7590 Dr. Louise Ramm Deputy Director National Center for Research Resources Telephone: (301) 496-6023 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.113, 93.114, 93.115, 93.121, 93.198, 93.306, 93.333, 93.371, 93.393, 93.394, 93.395, 93.396, 93.397, 93.847, 93.848, 93.849, 93.855, 93.856, 93.864, 93.865, 93.929, 93.866, 93.879, 93.361, 93.846, 93.242, 93.273, and 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P1 END ************************************************************ $$P2 BEGIN PA-94-087 ************************************************ NEUROENDOCRINOLOGY OF AGING NIH GUIDE, Volume 23, Number 28, July 29, 1994 PA NUMBER: PA-94-087 P.T. 34; K.W. 0710010, 0785105 National Institute on Aging National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute on Aging (NIA) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announce an ongoing interest in supporting basic and clinical research addressing aging of neuroendocrine systems and their sequelae. Mechanistic approaches at either the organismic, cellular, or molecular levels are encouraged. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Neuroendocrinology of Aging, is related to the priority area of aging and the increasing years of healthy productive life. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (rev. 4/1/94). Research will be supported by research project grants (R01) and FIRST awards (R29). RESEARCH OBJECTIVES Background Research accumulated over the past decade has solidified the view that changes in neuroendocrine control systems underlie the wide range of impaired body functions normally associated with advanced chronological age. The major challenge that now faces investigators in the field is to understand more clearly how deficits in brain-pituitary function arise with age, and the relationship of these deficits to imbalances in peripheral organ system homeostatic control. The maintenance of homeostasis in the face of environmental stress is largely under the control of the neuroendocrine system. With age, there appears to be a decreased capacity to adapt to changes in the environment. Frequently, the response is delayed and of lower magnitude in the older individual. These responses are mediated primarily through the neuroendocrine system. Thus, it is important to identify and elucidate the mechanisms underlying age-related changes in the neuroendocrine system, and conversely, to understand and to characterize how the endocrine system impinges upon and controls the nervous system. For example, circadian and other biological rhythms are central to these homeostatic processes. At least some of these rhythms are coupled to circadian fluctuations in the secretion of aminergic and peptidergic neurotransmitters as well as pituitary hormones. Blended on top of these daily rhythms in hormone release are more frequent ultradian fluctuations. To date, few data exist that examine the relationship between circadian rhythms and the shorter ultradian rhythms. Such information is critical since disruption of the central timing mechanism governing circadian rhythms such as sleeping and eating as seen in older individuals could underlie a cascade of age-associated changes in neuroendocrine function, and in particular, pulsatile hormone release, which could compromise processes involved in growth, metabolism, and reproduction. The NIA also continues to encourage research leading to a better understanding of the menopause and its sequelae. It has long been thought that menopause, or the cessation of regular reproductive cycles, is due to the exhaustion of ovarian follicles with aging. More recently, it has become clear that the decline in reproductive function that occurs in aging may also be due to age-related disruption of the biological clock, which results in altered secretion and secretory patterns of neurotransmitters and hormones and altered gene expression in cells producing these substances. Thus, research focusing on the identification and elucidation of the mechanisms underlying the neuroendocrine etiologies of menopause are encouraged. It has been proposed that age-related degeneration in certain central nervous system (CNS) tissues can be related, in part, to the neurotoxic effect caused by their repeated exposure to circulating steroids. This has been most evident in the relationships between corticosteroids and estrogens to hippocampal and hypothalamic degeneration, respectively. Additional research is needed to further explore and delineate the processes potentially responsible for these neurodegenerative disorders associated with aging. Estrogen receptor mRNA has been demonstrated to be distributed in the adult rat brain not only in regions that are known targets of estrogen, such as the hippocampus and the hypothalamic preoptic nuclei, but also in regions not typically considered as targets for estrogen action such as the basal forebrain. Recent findings indicate that estrogen receptors colocalize with neurotrophin receptors in cholinergic neurons within the basal nucleus of Meynert, suggesting that estrogen may modulate the functioning of these cells that form part of the neural substrate of cognition. Colocalization of estrogen and nerve growth factor receptors also have been found in the dorsal root ganglia of adult female rats; the expression of both classes of receptors were regulated by estrogen, supporting the hypothesis that estrogen may play a functional role in the regulation of neuronal responsiveness to neurotrophins. Further research is required to elucidate these estrogen-neurotrophin interactions. Furthermore, it is becoming more evident that cytokines produced by various immune tissues may affect the neuroendocrine axis. These cytokines can be released either into the bloodstream or in the local vicinity of nervous tissue to exert their actions. This bidirectional communication between the immune and endocrine systems is paramount to homeostatic control. Noting the well-documented decline in the function of both these systems with age, it would seem that senescence could alter the precise balance in immune-endocrine communication. Consequently, research is encouraged to examine potential consequences of the aging immune and endocrine systems and their interactions on neuroendocrine function. The NIDDK has long been interested in understanding the interrelationships between the hypothalamic-pituitary-adrenal/gonadal axes and the immune system in response to stress and disease. The NIDDK is acutely aware of the role(s) played by external sensory inputs, related through these axes, on circadian and ultradian cycles of hormonal and behavioral regulation. The NIDDK also continues to foster research on the roles of both members of the steroid/thyroid/ retinoid supergene family and growth factors on brain function. To help identify opportunities for further research in this area, the NIA convened a workshop on the Neuroendocrinology of Aging: Perspectives and Prospectives. The proceedings of this meeting have been published in Neurobiology of Aging, 15(4), 1994 Specific Goals and Scope To address the general objectives discussed above, NIA and NIDDK encourage submission of applications for research relating to the neuroendocrinology of aging that address one or more of the following areas, which are illustrative and are not intended to be restrictive. o Investigations of the molecular and cellular processes modulating the aging hypothalamic neuroendocrine system, as well as the mechanisms causing neuroendocrine decline with age. o Elucidation of the mechanisms underlying the loss of, or alterations in, neuroendocrine rhythms with age. o Studies of how the aging circadian system acts upon ultradian hormone rhythms (e.g., pulsatile hormone release). o Identification of the effects of systemic steroids (e.g., glucocorticoids, estrogens) on cytoarchitecture and synaptic organization and remodeling, and the elucidation of the mechanisms of action of hormones on neural cells. o Evaluation of steroid antagonists or agonists as a means to mitigate or delay potential neurotoxic consequences of steroid exposure. o Investigation of CNS mechanisms that may alter the rate of reproductive senescence. o Studies of how networks of organ systems that share signal molecules, such as the endocrine, immune, and nervous systems, mutually regulate their complex interactions, and whether alterations in these interactions result in impaired neural homeostatic controls leading to increased likelihood of pathologies and disease. o Determination of the mechanisms controlling the effects of dietary restriction on the neuroendocrine system. o Identification of the roles and underlying mechanisms played by the hypothalamic neuroendocrine system in the aging process, and establishment of whether neuroendocrine interventions can inhibit or reverse the aging process. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the National Institutes of Health (NIH) that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are 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 title and number of this program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate National Advisory Council. The following criteria will be used in evaluating applications submitted in response to this program announcement: o Scientific and technical merit, significance, and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology to be used; o Qualifications of the principal investigator and staff in the area of research, and the principal investigator's prior research experience and record; o Adequacy of the available facilities. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute, Center, or Division. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Andrew A. Monjan, Ph.D., M.P.H. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 FAX: (301) 496-1494 Phillip Smith, Ph.D. Endocrine and Metabolic Diseases Program Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 621 Bethesda, MD 20892 Telephone: (301) 594-7531 FAX: (301) 594-9011 Direct inquiries regarding fiscal matters to: Vicki Maurer Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496 1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P2 END ************************************************************ $$P3 BEGIN PA-94-088 ************************************************ MALNUTRITION IN OLDER PERSONS NIH GUIDE, Volume 23, Number 28, July 29, 1994 PA NUMBER: PA-94-088 P.T. 34; K.W. 0710010, 0710095 National Institute on Aging PURPOSE Recently, attention has focused on the nutritional status and nutrition-related needs of older individuals in this country. Nutritionists have indicated that a substantial proportion of Americans over the age of 50 have dietary intakes or diseases that place them at a high risk of malnutrition. The limited available information estimates levels of malnutrition ranging from 10 to 60 percent. The purpose of this Program Announcement is to encourage research into the extent, causes and potential interventions in malnutrition in the elderly. 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, Malnutrition in Older Persons, is related to the priority area of nutrition. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-00473-1) through the superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, unit of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Only R01 application will be accepted from foreign institutions. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) and Research Scientist Development (K01) awards. MECHANISM OF SUPPORT Support of this program will be through the research project grant (R01), FIRST (R29) award, and Research Scientist Development (K01) award. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH) 94-50,000 (rev. 4/1/94). The NIA has a Special Emphasis Research Career Award (K01): "Nutritional and Metabolic Factors in Aging" RESEARCH OBJECTIVES Background and Significance Considerable epidemiologic data indicate that malnutrition may be common among older persons, and may have important morbid consequences. Malnutrition may be due either to under- or over-consumption of macro- or micro-nutrients or calories. Both of these may be important among older persons. In addition, changes in nutrient absorption or metabolism, which may be introduced at different levels within the organism (i.e., gut, muscle, brain), and may be either idiopathic or due to age-related diseases, may contribute to malnutrition among older persons even when intake of nutrients is within recommended limits for the general public. Such age-related changes may occur chronically, or may be manifested in response to acute conditions such as infection, surgery, or trauma. National survey data show that large percentages of community-dwelling older persons consume less than the recommended amounts of several micronutrients. Data on residents of nursing homes, hospitalized older patients, as well as community elderly populations, show a high prevalence of persons with low body mass index and other findings consistent with the possibility of protein energy malnutrition. (To date there is limited information on the clinical consequences of many of these nutritional findings per se.) Conversely, many older persons may consume some nutrients, e.g., fat, well in excess of current recommendations. The health effects of such consumption are also incompletely understood. Recommendations for increased physical activity by older persons may alter nutrient requirements, incurring the risk of malnutrition if diet is not modified accordingly. There have been few controlled randomized studies on the efficacy of nutritional supplementation or other dietary modification on clinical outcomes in malnourished older patients. In addition, data indicate that a substantial amount of malnutrition in older persons may be due to diminished food intake spanning all nutrient categories. Although some known risk factors (e.g., depression) undoubtedly explain this phenomenon in some older patients, the causes of diminished food intake in older persons are not completely understood. Although some pharmacologic agents (e.g., megestrol) and non-pharmacologic approaches (e.g., exercise) may lead to increased food intake, there are almost no data on the effects of such interventions on food consumption in undernourished older persons. Objectives The NIA continues to encourage research on the full spectrum of issues related to the causes, prevention, and treatment as well as the socio-behavioral and economic aspects related to malnutrition in older persons. Specific topics of interest include, but are not limited to, studies on: o Evaluation of nutritional assessment criteria and instruments used in elderly people. Currently available methods have not necessarily been validated in aging populations. Screening and intervention measures differ, depending on standards used to judge if an individual is malnourished, and present standards are intended for younger adults. o Age-associated alterations in absorption and metabolism of essential nutrients, dietary factors, and metabolic processes that may contribute to malnutrition. o The effects of age on neurons of the satiety centers that influence and regulate appetite and thirst, as well as the effect of changes in sensitivity and acuity, or receptor thresholds for sensory stimulation, especially olfaction and taste, associated with hedonic behaviors. o Mechanism for predisposition to dehydration in older persons and implication of dehydration in terms of clinical symptoms and medical outcomes. o The effects of malnutrition on specific central nervous system cell types, including, in addition to neurons, the neuroglia and cerebrovascular cells. o Gender differences in the metabolism of macro- and micro-nutrients during the late stages of development and in aging in both the so-called healthy aging or malnourished individual. o Effects of under- or over-consumption (in relation to current recommended levels) of calories or specific nutrients on risk of acute or chronic diseases in older persons (e.g., infections, cardiovascular diseases) and mechanisms responsible for these effects. o Influence of medications commonly prescribed for the elderly on aspects of nutrition. o Effects of nutritional supplementation or other dietary modification on clinical outcomes in well-characterized specific populations of malnourished older persons. Studies in acute situations (e.g., recovering hospitalized patients) and in chronic conditions (e.g., chronic weight loss) are encouraged. o Causes of pathologically low food intake in older persons e.g., identification of forms of malnutrition in the elderly such as "anorexia dementia" or feeding dependency. o Efficacy of interventions to increase spontaneous food intake (drugs, exercise) in undernourished patients in negative energy balance, and effects of different levels and types of exercise and physical activity on nutrient needs of older persons. o The role of socio-economic, cultural or behavioral factors as predictors of malnutrition, as well as modifiers of any diagnosis/ treatment plans. o Evaluation of efficacy and cost-effectiveness of screening for malnutrition in the free-living, hospitalized and long-term care elderly populations STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91), available at most institutional offices of sponsored research and 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. New applications will be accepted on February 1, June 1, and October 1 receipt dates. Revised applications will be accepted on March 1, July 1, and November 1. The program announcement title and number must be typed on line 2a of the face page. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be received by the NIH Division of Research Grants. The review criteria are the traditional considerations underlying scientific merit. Applications will be reviewed in accordance with the usual NIH peer review procedures, based on scientific merit. Following study section review, the applications will be evaluated by the appropriate National Advisory Council. AWARD CRITERIA Applications will compete for available funds on the basis of scientific merit with all other applications assigned to the institute. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Pamela Starke-Reed, Ph.D. Biology Of Aging Program Gateway Building, Suite 2C231 National Institute on Aging Bethesda, MD 20892 Telephone: (301) 496-6402 Direct inquiries regarding fiscal matters to: Mr. Robert Pike Grants Management Office National Institute in Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, Aging Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. $$P3 END ************************************************************ $$P4 BEGIN PA-94-089 ************************************************ MECHANISMS OF SENSORIMOTOR ADAPTATION NIH GUIDE, Volume 23, Number 28, July 29, 1994 PA NUMBER: PA-94-089 P.T. 34; K.W. 0705048, 0775017 National Institute on Aging National Institute on Deafness and Other Communication Disorders National Institute of Neurological Disorders and Stroke National Aeronautical and Space Administration PURPOSE The National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Neurological Disorders and Stroke (NINDS), and National Aeronautics and Space Administration (NASA) announce a continuing interest in supporting ground-based studies of sensorimotor adaptation and multisensory integration focusing on such functions as posture, gait, and other limb and body spatially directed movements, in health, in disease, and in special gravito-inertial environments. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Mechanisms of Sensorimotor Adaptation, is related to the priority area of aging and balance impairment, a significant cause of morbidity and disability in older individuals. Potential applicants may obtain a copy of "Healthy People-2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are ineligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Awards will be administered under PHS grants policy as stated in the PHS Grants policy statement, DHHS Publication No. (OASH) 94-50,000 (rev. 4/1/94). Research will be supported by the research project grants (R01) and FIRST awards (R29) mechanisms. RESEARCH OBJECTIVES Problems associated with impaired balance, such as falls and restricted ambulation, are prominent causes of morbidity and disability among older persons. Correspondingly, problems associated with balance control and spatial orientation are important in connection with space flight. During aging and during exposure to the microgravity environment of space, sensorimotor functions may be similarly challenged. Changes and ambiguities in the processing of sensory inputs lead to potential errors in cognition and perception affecting equilibrium and spatial orientation. Errors in reflexes and perceptions can lead to dysfunctional consequences, such as falls in the elderly and space motion sickness in astronauts. Human spatial orientation and spatially directed motor performance is facilitated by the central nervous system integrating multiple sensory inputs and initiating appropriate motor commands. Under natural terrestrial conditions, the visual, vestibular, tactile, somesthetic, and auditory sensory systems interact in a highly adaptive fashion; the functional importance of individual systems is modulated by intrinsic and extrinsic conditions. Aging and exposure to microgravity both entail sensory and motor modifications that stimulate neuroplastic mechanisms to restore, or compensate for, compromised function. In the older individual, natural aging involves slow structural deterioration of the nervous system, but the consequent loss of function may be considerably hastened by acute disease, such as stroke. In astronauts, sensory and motor relationships are altered soon after liftoff, without apparent anatomical or physiological compromise although "deconditioning" accompanies prolonged exposure to microgravity. As in the older person, such deconditioning is marked by homeostatic changes, including those related to the cardiovascular and musculoskeletal systems. Central to these changes and adaptations are neural events underlying vestibular function, vision, proprioception, and the integration of sensorimotor function. In the weightless environment of space, the vestibular otolithic receptors and the tactile proprioceptors no longer signal changes in body orientation as they do on earth. Central motor programs for the reinterpretation of sensory inputs and coordination of muscle actions must undergo adaptation. It is hypothesized that the rearrangement and mismatch of sensory cues gives rise to the syndrome of space motion sickness, to which the body gradually adapts. The NIA and NASA convened a Workshop on Sensorimotor Integration and Disintegration to identify biomedical topics in sensorimotor integration and disintegration relevant to aging populations on Earth and to life in space under the unique conditions of microgravity. The research opportunities and directions, particularly as they relate to spatial orientation, balance, and sensorimotor coordination, identified at this workshop form the basis for this program announcement. A copy of the report of this workshop can be obtained by contacting one of the program officials listed under INQUIRIES. Research Goals and Scope The NIA, NIDCD, NINDS, and NASA encourage submission of applications for research related to the mechanisms of sensorimotor adaptation and coordination, particularly in aging and in the microgravity conditions of space flight. Possible areas of research include, but are not limited to: o Development of new indices of sensorimotor adaptation. o Neural circuits and mechanisms subserving sensorimotor adaptation and learning in three-dimensional coordinate systems, including age-related changes. o CNS mechanisms contributing to the formation of a gravito-inertial frame of reference for cognitive activities and spatially directed motor tasks. o Neural and cognitive mechanisms underlying the transformation of extrinsic frames of reference into internal reference frames involved in coordination of volitional and reflexive movements of the joints, torso, head, neck, and eyes, such as reaching movements and eye-head gaze movements. o Strategies employed adaptively for the maintenance of spatial orientation with the loss or degradation of sensory inputs across the life-span. o Biomechanical and cognitive strategies used adaptively in spatially directed tasks, particularly with aging. o CNS mechanisms underlying the changes in multisensory and sensorimotor integration that accompany aging and exposure to altered gravito-inertial fields. o Adaptive change in the vestibulo-ocular reflex and/or visual- vestibulo-ocular functions as models for understanding motor learning and plasticity within the central nervous system. o Adaptive change in the vestibulospinal and postural reflexes. o The roles of interventions and prior experience in triggering compensation for the loss of sensorimotor functions. o Effect of time course, e.g., sudden onset vs. slow insidious onset, on the mechanisms underlying sensory adaptation to motor and environmental alterations. While all research solicited in this program announcement will be conducted on Earth, NASA will provide access to special facilities in which various aspects of the real or perceived acceleration environment may be examined in ways not readily available to most researchers. Applicants are strongly encouraged to incorporate the utilization of NASA research facilities and resources and the collaboration with NASA scientists in their research plans. For more information contact the NASA program official. A brief listing of available facilities and the appropriate contact person(s) at each facility is available. NASA will contribute the costs associated with utilizing these facilities at no charge to the grantee. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available 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 title and number of this program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 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 NIH peer review procedures. Following scientific-technical review, including responsiveness to the objectives of this program announcement, the applications will receive a second-level review by the appropriate national advisory council. The following criteria will be used in evaluating applications submitted in response to this announcement: o Scientific and technical merit, significance, and originality of the proposed research; o Appropriateness and adequacy of the experimental approach and methodology to be used; o Qualifications of the principal investigator and staff in the area of research, and the principal investigator's prior research experience and record; o Adequacy of the available facilities. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute or Center. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds; o Program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Deborah Claman, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Building, Suite 3C307 Bethesda, MD 20892 Telephone: (301) 496-9350 Daniel Sklare, Ph.D. Division of Communication Sciences and Disorders National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C Bethesda, MD 20892 Telephone: (301) 496-1804 William J. Heetderks, M.D., Ph.D. Division of Fundamental Neurosciences National Institute of Neurological Disorders and Stroke Federal Building, Room 9C02 Bethesda, MD 20892 Telephone: (301) 496-5745 Victor Schneider, M.D. Life and Biomedical Sciences and Applications Division National Aeronautics and Space Administration 300 E Street, S.W., Code UL Washington, DC 20546 Telephone: (202) 358-2359 Direct inquiries regarding fiscal matters to: Vicki Maurer Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 Bethesda, MD 20892 Telephone: (301) 496-1472 Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400D 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-0909 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866 and No. 93.173. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executiv