NEWS

09/13/1996



<TITLE> FDA's COMPLIANCE SYSTEM RECEIVES VICE PRESIDENTIAL AWARD

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NOTE TO CORRESPONDENTS                   Donald C. McLearn

September 13, 1996                       (301) 827-6242           

                                                       

FDA's NEW COMPLIANCE SYSTEM RECEIVES VICE PRESIDENTIAL AWARD

     FDA Associate Commissioner for Regulatory Affairs Ronald G.

Chesemore will receive on September 16 Vice President Al Gore's

Hammer Award for the development of a reporting program that

emphasizes compliance results over regulatory penalties. The new

system, now employed by the agency's Office of Regulatory Affairs

(ORA) headed by Chesemore, increases the speed of manufacturers'

compliance, reduces regulatory costs, and cuts red tape.

     The Hammer Award is given to federal officials who have

advanced the President's National Performance Review by putting

consumers first, empowering government workers, and getting back

to basics. It will be presented to Chesemore by Bob Stone,

director of Vice President Al Gore's National Performance Review.

     "FDA is doing precisely what the Clinton Administration

asked the agency to do in March 1995," Stone said, discussing the

reason for the award. "Achieving compliance through cooperation

is greatly preferable to seizing substandard goods. Focusing on

what truly matters is the essence of common-sense government."

     FDA's new computer-based Compliance Achievement Reporting

System (CARS), designed as part of the agency's Regulatory Reform

                             -MORE-



                                     Page 2, NTC, Chesemore

Initiative, emphasizes prompt and voluntary correction of

regulatory problems over imposition of penalties for non-

compliance.

     Under CARS, the performance of FDA's investigators in the

field is judged by compliance results achieved as well as such

legal actions as seizures, injunctions or prosecutions when

necessary.  Compliance resulting from an inspection, notification

of analytical results, or other means short of legal enforcement

is reported to ORA directly by the involved FDA personnel,

thereby bypassing the customary management layer. This empowering

of the agency employees can speed up the necessary corrective

actions and save the firms huge costs of suspended production.

     Benefits of the new approach were exemplified in a recent

inspection of a food canning plant in which an FDA investigator

found a malfunction in the sealing equipment. The containers were

not properly sealed, thereby creating the hazard of a potential

botulism outbreak. With the problem identified on the spot, all

cans in the lot were destroyed, and the production was promptly

resumed after the sealing equipment was repaired.

     The award consists of a $6.00 hammer, a ribbon, and a card

from Vice President Gore, all set in an aluminum frame.

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