U -- BASIC FOOD AND DRUG LAW TRAINING

Notice Date

November 20, 2000

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs, 5600 Fishers Lane, HFA-511, Rockville, MD, 20857

ZIP Code

20857

Solicitation Number

223-01-4300

Response Due

January 12, 2001

Point of Contact

Danny McCauley, Contract Specialist, Phone (301) 827-7176, Fax (301) 827-7106, Email dmccaule@oc.fda.gov -- Claudia Scheigh, Contract Specialist, Phone (301) 827-7173, Fax (301) 827-7106, Email

E-Mail Address

Danny McCauley (dmccaule@oc.fda.gov)

Description

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, Title 19; Section 10001 Section 2 and Section 372, Tea Import Act. Training includes providing a minimum of 5 and a maximum of 20 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, (6) Past Performance will be evaluated on information obtained from references provided by the Offeror as well as other relevant past performance information obtained from other sources known to the Government. A Firm-Fixed Price Requirements contract with cost reimbursement travel is planned for a 3 year period of performance. SEE Note 22.

Web Link

Visit this URL for the latest information about this (http://www2.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=P&P=223-01-4300&L=3044)

Record

Loren Data Corp. 20001122/USOL001.HTM (D-325 SN5070V7)