Path: utzoo!attcan!uunet!bionet!nihcu.bitnet!CZJ From: CZJ@nihcu.bitnet Newsgroups: bionet.sci-resources Subject: (none) Message-ID: <8905231516.AA27600@net.bio.net> Date: 23 May 89 13:58:19 GMT Sender: daemon@NET.BIO.NET Lines: 526 Vol. 18, No. 18, May 19, 1989 NOTICES NIH/FDA REGIONAL WORKSHOPS - PROTECTION OF HUMAN SUBJECTS ...(84/157)....... 1 National Institutes of Health Food and Drug Administration Index: NATIONAL INSTITUTES OF HEALTH FOOD AND DRUG ADMINISTRATION SHARED INSTRUMENTATION GRANTS ...............................(161/176)....... 2 National Institute of General Medical Sciences Index: GENERAL MEDICAL SCIENCES DATED ANNOUNCEMENTS (RFPs AND RFAs) MAINTENANCE AND OPERATION OF SYNTHETIC PEPTIDE FACILITY (RFP) ..(182/252).... 2 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT LARGE-SCALE ANIMAL CELL PRODUCTION FACILITY FOR BIOMEDICAL RESEARCH (RFA) .......................................(255/349, 564/837)..... 3 Division of Research Resources Index: RESEARCH RESOURCES COMMUNITY CLINICAL ONCOLOGY PROGRAM (RFA) ............(352/457, 840/2426).... 4 National Cancer Institute Index: CANCER TROPICAL MEDICINE RESEARCH CENTERS (RFA) .............(460/517, 2429/2690)... 5 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES NOTICES NIH/FDA REGIONAL WORKSHOPS - PROTECTION OF HUMAN SUBJECTS 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 biomedical and behavioral research. The workshops are open to everyone with an interest in research. The meetings should be of special interest to those persons currently serving or about to begin service as a member of an IRB. The current schedule includes: o Dates: June 1-2, 1989 Location: Indianapolis, Indiana Title of Workshop: "Protection from Research Risks: Whom Are We Protecting?" Contact: Mrs. Roxanne Loomis Research Risk Coordinator Indiana University 355 Lansing Street Administration Building, Room 126 Indianapolis, Indiana 46202 Telephone: (317) 274-8289 o Dates: June 15-16, 1989 Location: Philadelphia, Pennsylvania Title of Workshop: "NIH/FDA Regional Workshop on the Protection of Human Subjects" Contact: Mrs. Ruth Clark Assistant Director for Regulatory Affairs University of Pennsylvania The Office of Research Administration 133 South 36th Street, Suite 300 Philadelphia, Pennsylvania 19104 Telephone: (215) 898-2614 o Dates: July 10-11, 1989 Location: Syracuse, New York Title of Workshop: "Research Involving Human Subjects" Contact: Dr. Eric Holzwarth Syracuse University College of Arts and Science 300 Hall of Languages Syracuse, New York 13244-1170 Telephone: (315) 443-2201 Additional workshops will be announced later. For further information regarding human subjects education programs contact: Darlene Marie Ross Education Program Coordinator Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B62 9000 Rockville Pike Bethesda, Maryland 20892 Telephone: (301) 496-8101 Vol. 18, No. 18, May 19, 1989 - Page 1 SHARED INSTRUMENTATION GRANTS P.T. 34; K.W. 0735000, 1014002 National Institute of General Medical Sciences The National Institute of General Medical Sciences (NIGMS) announces the termination of its Shared Instrumentation Program announced in the November 5, 1982 issue of the NIH Guide for Grants and Contracts, Vol. 11, No. 12. The final receipt date for applications was February 15, 1989; applications received for that receipt date will be considered for funding from the FY 1990 budget. NIGMS grantees in need of new equipment or desiring to update existing major research instruments are advised to avail themselves of the Shared Instrumentation Program of the Division of Research Resources or to discuss their needs with their NIGMS Program Administrator. Applications for this program will no longer be accepted by NIGMS. DATED ANNOUNCEMENTS (RFPs AND RFAs) MAINTENANCE AND OPERATION OF SYNTHETIC PEPTIDE FACILITY RFP AVAILABLE: NICHD-CD-89-22 P.T. 34; K.W. 0780000, 0780017, 0760060, 1003006 National Institute of Child Health and Human Development The Contraceptive Development Branch of the Center for Population Research, National Institute for Child Health and Human Development, has a requirement for maintenance and operation of a synthetic peptide facility capable of synthesizing gram-scale quantities (1-50 grams) of peptides for toxicology studies, primate testing and clinical investigation, as well as smaller quantities (5-100 milligrams) of new peptides for initial biological testing in small animals. Offerors should have expertise in the synthesis of peptides (by solid phase techniques), especially those of MW>1000, on a small scale and on a large scale as noted above. Specific assignment of peptides and quantities to be prepared will be determined by the Project Officer. Major emphasis will be on the preparation of peptides on a gram-scale (1-50 grams). The Contractor's facilities must meet the requirements for Good Manufacturing Practices (GMP) inasmuch as GMP must be followed for all peptides prepared for toxicology and clinical studies. The Contractor may be required to supply all gram-scale batches (1-50 grams) of peptides at a minimum purity of 97 percent. The minimum purity requirements for small quantities (5-100 mg) of peptides is anticipated to be 93 percent. The Contractor shall furnish, package, and distribute all peptides synthesized under the contract, as requested by the Project Officer, in the amounts designated, together with evidence of purity and characterization including but not limited to HPLC, TLC, optical rotation, quantitative amino acid analysis, mass spectral analysis, NMR, and mixed and parallel chromatograms of the peptide(s) against the standard peptide(s) to be furnished by the Project Officer. A functional group analysis by TLC spray reagent, and evidence of electrophoretic homogeneity may also be required as well as sequence analysis of the peptides. An additional requirement for peptides prepared under GMP will be water, salt and C, H, & N analysis (including ash content) and an estimation of peptide content. No subcontracting will be permitted. As a minimum requirement, the Contractor's facilities must meet the requirements for current Good Manufacturing Practices (GMP) required by the U.S. Food and Drug Administration and must meet requirements in compliance with OSHA for protection of its workers. The Government estimates the effort to be approximately 3.0 technical staff years annually. The Principal Investigator should be an established peptide chemist and should devote approximately 15 percent effort to this project. All responsible sources may submit a proposal which will be considered by the agency. One 5-year cost-reimbursement, incrementally funded contract is expected to be awarded, beginning November 29, 1989, as a result of this RFP. The RFP represents a recompetition of the project "Maintenance and Operation of a Synthetic Peptide Facility" currently being performed by the Salk Institute for Biological Studies, San Diego, California. Vol. 18, No. 18, May 19, 1989 - Page 2 This is not a Request for Proposals. RFP-NICHD-CD-89-22 will be issued on or about May 19, 1989. Proposals will be due approximately 60 days thereafter. Copies of the RFP may be obtained by sending written requests to Mr. Paul J. Duska at the address listed below. Requests may also be made by FAX Telephone (301) 496-0962. Paul J. Duska, Contracting Officer Contracts Management Section, OGC National Institute of Child Health and Human Development Executive Plaza North, Room 610 9000 Rockville Pike Bethesda, Maryland 20892 REQUEST FOR COOPERATIVE AGREEMENT APPLICATIONS (RFA) LARGE-SCALE ANIMAL CELL PRODUCTION FACILITY FOR BIOMEDICAL RESEARCH RFA AVAILABLE; 89-RR-01 P.T. 34; K.W. 0780005, 0780015, 0760045, 1002045 Division of Research Resources Application Receipt Date: August 22, 1989 The Biological Models and Materials Resources Section (BMMRS), Animal Resources Program, Division of Research Resources (DRR), invites applications for a cooperative agreement to support a cell culture center providing large quantities of animal cells and cell products, e.g., viruses and monoclonal antibodies, to investigators unable to produce such quantities in their own laboratories. One center may be supported in response to this announcement. BACKGROUND The BMMRS, DRR, is developing a focus for the NIH's activities in the development and support of nonmammalian models, such as cell systems, lower organisms and nonbiological systems, for biomedical research. The Section also provides critical biological materials through support of centers that make such materials available to the biomedical research community. The DRR seeks to continue support of a national culture facility for the production of large quantities of cells or their products to provide the biomedical research community with a ready means of scaling up from normal laboratory operations when large quantities of cells or materials become essential to their research. Examples of the types of research projects in the biomedical sciences that will benefit from a large scale cell culture facility include production of cells for the isolation of cell surface molecules for functional and/or structural studies, production of monoclonal antibodies for protein purification, and the production of viruses for immunological studies. RESEARCH GOALS AND SCOPE The purpose of this RFA is to solicit applications from qualified organizations with cell culture facilities on site who are interested in providing biomedical investigators a customized service for producing large quantities of animal cells and their products. The application should contain the following information: 1. A plan offering customized services to investigators. This should include mechanisms for scaling up cell culture production. This process will involve collaborations of the awardee and the investigators to develop methods, as necessary, for the large scale production of cells and their products and to insure that the materials produced meet the investigators' needs. 2. A plan to maintain commonly used cultures and produce them in large quantities on relatively short notice. 3. A plan to establish an advisory/feasibility committee that will assist in the review and prioritization of requests for the services of the center. This committee should consist primarily of researchers outside the awardee institution and be wide in its geographical distribution. The plan should include a means for processing applications. 4. A plan for tracking users of the center and the research resulting from the use of the biomaterials obtained from the center. 5. A description of the equipment and facilities available for the center. No equipment will be available from the current facility. 6. A plan for quality control, including plans to maintain cell production and assure the absence of contamination in cells and materials used in culture production. 7. A plan for a cost-recovery system from the users of the facility. ELIGIBILITY Any of the following types of organizations are eligible to apply: Non-profit and for-profit organizations and institutions; State and local governments and their agencies; and authorized Federal institutions. MECHANISM OF SUPPORT The award will be made as a Cooperative Agreement. This is an assistance relationship involving cooperation by the BMMRS staff. The major difference between a cooperative agreement and a research grant is that there is substantial programmatic involvement of the NIH staff above and beyond the levels regularly required for traditional program management of grants. The intent of the involvement of the BMMRS staff is to be helpful to the project. The awardee has the authority and responsibility to initiate, develop and implement the project activities. Support may be requested for a period of up to 5 years. Annual awards will be made subject to continued availability of funds and progress achieved. The total direct costs requested for the first year may not exceed $200,000. Based on the research community's need, the national use of this resource and the satisfactory production of cells and their products from the facility, the incumbent will be invited to submit a competitive continuation application for support after the initial 5 year award. TERMS AND CONDITIONS OF THE AWARD 1. The terms of programmatic involvement of the BMMRS Program Administrator are to: a. Aid the facility in the identification of potential users, b. Help publicize the facility's existence, c. Function to insure that the facility is a national center, d. Monitor the extent to which the facility's services meet existing needs, and e. Coordinate activities necessary to track the impact of the facility's services on the research community through user publications. 2. The awardee authorities and responsibilities are to initiate, develop and implement the project activities. The awardee will be required to submit an annual progress report to the BMMRS Program Administrator. The report should identify the users, their research projects and all published research resulting from the use of the facility. These special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS Grant Administrations Regulations at 45 Part 74, and other DHHS, PHS, and NIH grant administration policy statements. The awardee has the 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. REVIEW PROCEDURES AND CRITERIA 1. Review procedures Applications submitted for this RFA will be reviewed by BMMRS staff for responsiveness to this request. If a comparatively large number of applications are received, BMMRS also may submit the applications to preliminary peer review to identify those applications that are competitive for award. The applications will be reviewed for scientific and technical merit by a DRR Special Review Committee and by the National Advisory Research Resources Council at its February 1990 meeting. The anticipated award date is April 1, 1990. 2. Review Criteria Review of applications will be based on the following criteria: a. Experience and qualifications of the key personnel in large scale cell culture techniques, and their ability to provide the services of the facility. b. Adequacy of the plan to grow suspension and monolayer cultures in large quantities. The facility should be able to produce cells in batches of about 100 liters or several hundred roller bottles, and up to 20 kilograms wet weight cells per year, depending on the level of demand. c. Adequacy of the proposed plan for solicitation of requests for cells or their products. Adequacy of the plan to review these applications. d. Adequacy of the facility, including equipment. e. Adequacy of the plan for quality control. f. A capability to conduct research focused on methods to improve large scale cell culture productivity is desirable, but not essential. g. Reasonableness of the proposed budget. APPLICATION PROCEDURES Applications must be submitted on Form PHS 398. Application kits are available from most institutional business offices or may be obtained from the Grants Inquiries Office, DRG, 5333 Westbard Avenue, Room 449, NIH, Bethesda, MD 20892. Applicants should check the box marked "yes" in item 2 of the PHS 398 face page, and insert "Large-Scale Animal Cell Production Facility", and RFA number 89-RR-01. The application should address the requirements listed under Research Goals and Scope. A detailed budget with justification should be given. THE RFA LABEL FOUND IN THE PHS 398 KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL COMPLETED APPLICATION FORM, PHS 398, AND DUPLICATED ON ALL COPIES. FAILURE TO USE THIS LABEL COULD RESULT IN DELAYED PROCESSING OF YOUR APPLICATION SUCH THAT IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW. THERE WILL BE NO OBLIGATION TO REVIEW SUCH APPLICATIONS. The original and four copies of the application should be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two copies of the application should be mailed to: BMMRS, DRR at the address given below. The deadline for receipt of applications by DRG is 5 p.m. Eastern time, August 22, 1989. Applications received after that date will be returned to the applicant. INQUIRIES For further information, please contact: James D. Willett, Ph.D. Chief, Biological Models and Materials Resources Section Division of Research Resources, NIH Westwood Bldg., Room 8A07 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-5507 or Louise E. Ramm, Ph.D. Biological Models and Materials Resources Section Division of Research Resources, NIH Westwood Bldg., Room 853 5333 Westbard Avenue Bethesda, Maryland 20892 Telephone: (301) 496-5175 This Program is described in the Catalog of Federal Domestic Assistance, Number 13.306, Laboratory Animals Sciences and Primate Research Program. Cooperative Agreements will be awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241), and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This Program is not subject to intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review.