Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF FEBRUARY 12,1998 PSA#2031

FDA/DCFSC/CFCB/5600 Fishers Lane, Park Bldg., HFA-531, Room 3-32, Rockville, MD 20857

R -- ANIMAL HUSBANDRY SERVICES SOL 223-98-2334 DUE 022598 POC Hamilton Brown (301) 443-4460 The Food and Drug Administration has a requirement to provide animal husbandry services for on-going research at its Muirkirk Research Complex, Laurel, MD. FDA research studies involve contractor-provided animal care and handling which generally include: (1) cleaning, sanitizing and preparing various caging configurations for animals; (2) inventory all animal husbandry equipment; (3) feeding, watering, changing pans/cages/racks, monitoring and recording animal status (moribund/dead) and room temperature and humidity; (4) providing technical assistance, as requested (e.g., gavaging, injecting, tattoo, etc. procedures as specified by protocol); and (5) operating autoclave and cage/bottle wash equipment. These support services must be in compliance with the Good Laboratory Practices regulations and carried out in accordance with the Animal Welfare Act, Public Law 89-544, 1966 as amended (P.L. 91-579, P.L. 94-279 and P.L. 99.198) 7 U.S.C. 2131 -- 2159, 7 CFR 2.17, 2.51 and 371.2 (g), Guide for the Care and Use of Laboratory Animals, Institute of Laboratory Animal Resource (ILAR) 1996, PHS Policy on Humane Care and Use of Laboratory Animals -- 1996 and the Good Laboratory Practice Regulation (21 CFR Section 58). The Contractor shall comply with all safety and health policies and procedures as identified in the Maryland (MD) or United States (US) OSHA guidelines and FDA Safety Office. Some experimental animal studies may be conducted using chemicals or radiological products that are known or suspected to be toxic to humans. Strict biological, chemical, or radiological containment for safe work practices and proper waste disposal procedures shall be employed to minimize exposures to personnel and the work environment. If available, Material Safety Data Sheets (MSDS) from chemical manufacturers shall be used to determine the hazards and appropriate work practices. Any new safety SOPs for activities with hazardous chemicals shall be developed by the Contractor based on researchers' approved protocols. SOPs shall be in compliance with the OSHA regulations including the Hazard Communication Standard (29 CFR 1910.1200), the OSHA Occupational Exposure to Hazardous Chemicals in the Laboratory (29 CFR 1920.1450), the Occupational Health and Safety in the Care and Use of Research Animals, National Research Council, 1997, and Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 1993). Special personnel qualifications are as follows: the Contract Manager shall have a Bachelor's Degree, preferably in biological science or related disciplines (Animal Science, Agriculture, Biology, etc.), certification as a Laboratory Animal Technologist (LATG) and at least 3 years of training and experience in supervising and managing a full service animal facility. The Assistant Contract Manager shall have similar background and training as the Contract Manager except the formal education requirement shall, at a minimum, be two years of college (i.e. -- AA degree). Floor Supervisors shall be Laboratory Animal Technician (LAT) certified at time of employment and LATG certified within two (2) years of employment. The Technical Training Specialist shall be LAT certified and have experience in training other contract personnel to obtain AALAS (American Association of Laboratory Animal Scientists) certification. Animal Caretakers shall be Assistant Laboratory Animal Technician (ALAT) certified within two (2) years of employment. Animal Technicians shall be ALAT certified at time of employment and LAT certified within two (2) years of employment. Laboratory Assistants shall have, as a minimum, a Bachelor of Science degree in order to provide technical research assistance to FDA Principal Investigators. The Cagewash Supervisor, Assistant Cagewash Supervisor and Cagewasher Level I shall be ALAT certified or achieve ALAT certification within 6 months of appointment. Cagewasher Level II shall be ALAT certified or achieve certification within one year of appointment. This synopsis is for gathering information on possible interested 8(a) or small business sources which have the demonstrated capabilities, personnel, and experience for providing the scope of animal husbandry services described above. It is not a commitment by the Government. The information contained herein is for planning purposes and does not constitute an invitation for bids nor a request for proposal. The Government does not intend to award a contract on the basis of this notification or otherwise pay for any information provided. If your 8(a) or small business firm is interested, send your letter of interest along with information supporting your capabilities to perform the work to Food and Drug Administration, Construction and Facilities Contracts Branch, HFA-531, Park Building, Room 3-32, Attn.: Hamilton Brown, 5600 Fishers Lane, Rockville, MD 20857 no later than February 20, 1998. (0041)

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