DHHS/PHS/FDA/Office Of Facilities, Acquisitions, and Central Services, Division of Contracts and Program Management, HFA-521, 5600 Fishers Lane, Rockville, MD 20857

U -- BASIC FOOD AND DRUG LAW TRAINING SOL 223-98-4300 DUE 013098 POC Danny McCauley, Contract Specialist, (301)443-6604, Claudia J. Schleigh, Contracting Officer, (301)443-6604 E-MAIL: Click Here to Contact the Contract Specialist by e-mail, dmccaule@Bangate.fda.gov. The Food and Drug Administration has a requirement to train its field and headquarters operational personnel in the basic legal aspects of the Food, Drug, and Cosmetic Act and related regulations. This includes, but is not limited to the following: Federal Anti-Tampering Act, Safe Medical Devices Act, Nutritional Labeling Education Act, Radiological Control for Health and Safety Act, Public Health Act, Tea Import Act. Training includes providing a minimum of 10 and a maximum of 40 one-week courses in basic food and drug law. These courses will be held at government furnished sites for approximately 40 FDA students per course. All course material shall be provided by the FDA. However, the contractor shall be required to update this material to reflect the latest judicial guidelines and provide applicable case studies. The following knowledge and experience shall be required of the contractor for this requirement: (1) Experience and knowledge of the Food, Drug, and Cosmetic Act, (2) Experience and thorough understanding of current judicial rulings related to all FDA regulated commodities, (3) Experience in adult education and training, (4) Experience in working with the Food and Drug Law, (5) Specific experience in comparable related training programs. A Firm-Fixed Price Requirements contract with cost reimbursement travel is planned for a 3 year period of performance. (0350)

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