DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

B -- SPECIAL STUDIES AND ANALYSES -- NOT R&D SOL F63323DG DUE 040599 POC Dee Gibson, Contract Administrator, (301) 827-7177 or (301) 827-7151 This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a written solicitation will not be issued. This solicitation is issued as a Request for Quotation (RFQ No. F63323DG). The solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-06. The Standard Industrial Classification (SIC) Code for this acquisition is 8731. The Food and Drug Administration (FDA) has a requirement to study the emergence of antibiotic resistance in a human pathogen by using infection of mice as a model system. The experiments involve injection of CBA and C57Bl/10 mice (6 mice per sample for each dose, timepoint, etc.) with two strains of Salmonella bacteria genetically modified at a locus controlling host adaptation and mutation frequency of the strains; observation of mice for signs of infection for up to two weeks; euthanizing infected mice (anticipated 5-7 days after infection); removal of spleen and liver from euthanized animals; and recovery of Salmonella from these organs for microbiological plating experiments. Mice will also be challenged with a fluorquinolone antibiotic such as enrofloxacin and the experiments repeated. Bacteria will be plated for total counts and for determination of the number of bacteria resistant to the antibiotic nalidixic acid, rifampicin, and/or spectinomycin. Procedures followed will be published protocols, not restricted to those in BAM/AOAC, and procedures used previously by project investigators. Contract personnel will not be required to develop new protocols. Standards for animal housing and care will be met by staff of the FDA animal care facility and are carefully reviewed by institutional IACUC Center for Food Safety and Applied Nutrition or Center for Veterinary Medicine (CFSAN or CVM) committees. Most experimentation will be carried out at the FDA MOD l &ll facilities in Laurel, MD, where supervisory researchers are engaged in the project. Some consultation with the Project Director and lab personnel at CFSAN headquarters in Washington, DC may be required, but that is expected to be infrequent (not more than once per month). FDA will provide laboratory space in order to house the contractor's employee(s) on-site at FDA/CFSAN facilities located at 8301 Muirkirk Road, Laurel MD 20708. Contract employee(s), shall meet monthly with FDA laboratory personnel located at 200 "C" Street, S.W. The contract employee(s) shall work 8 1/2 hours/day work schedules, Monday through Friday except government holidays. Contract employee(s) working at government facilities shall conform to the norm of CFSAN for monitoring time and attendance. Contract employee(s) shall follow the schedule for Federal employee(s)s in not working on the following Federal holidays and any other special closing of the facilities (e.g. Inauguration, closing due to weather, etc.): New Year's Holiday, Martin Luther King, Jr. Birthday, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving Day, and Christmas Holiday. Personnel Requirements -- The contract personnel shall have technical knowledge and expertise in microbiological techniques, biological sciences and use of common instruments such as pH meters, balances, centrifuges, incubators, and pipettors. A critical requirement is that the contract personnel shall have practical experience one year or more in handling small animals and experience using aseptic techniques for collection of blood and tissue samples for microbial culturing. The contractor shall: Provide one experienced person to provide technical assistance for implementing the laboratory project. Conduct mouse infection experiments using the human bacterial pathogen Salmonella and observe mice for signs of infection. Conduct mouse euthanasia, dissection, and organ disruption procedures to recover bacteria from infected organs using aseptic conditions. Conduct microbiological experiments to enumerate bacteria in samples recovered from infected animals. The microbiological assays shall include the full range of experimentation from media preparation to calculation of data. The following FAR provisions apply to this solicitation: 52.212-1, Instructions to Offerors -- Commercial; 52.212.2 Evaluation -- Commercial Items. All offerors are to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items, with their offer. The following FAR Clauses apply to this acquisition: 52.212-4 Contract Terms and Conditions -- Commercial Items:52.212-5 Contract terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items; Along with following additional FAR clauses; cited in clause 52.215-5; 52-222-26 Equal Opportunity; 52.222-35 Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36 Affirmative Action for Handicapped Workers; 52.222-37 Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era; 52-225-3 Buy American Act -- Supplies. The following provision also applies to this acquisition, 52.232-33 Mandatory Information for Electronic Funds Transfer Payment, FDA 1335 Personnel Security Clearance Requirement. All sources must submit along with their written quotes a nine digit numeric DUNS number that is assigned by Dun & Bradstreet. To apply for a DUNs number please call 1-800-333-0505. An award will be made twenty days from date of this notice by April 5, 1999, 4:00pm. Eastern Standard Time. Sources may submit descriptive literature which fully demonstrate that their product meets the specification, which shall be considered by the agency. This procurement is being awarded as a simplified acquisition in accordance with FAR 13.5. Posted 03/18/99 (W-SN309989). (0077)

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