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FDA INSPECTION EFFICIENCY AT DISTRICT OFFICES IS SUBJECT OF A SIX-MONTH STUDY TO BEGIN THIS MONTH, AGENCY TELLS REP. DINGELL; AUTOMATION CONTRACT UNDERWAY

Executive Summary

FDA plans to review the efficiency of inspections conducted by district office import facilities beginning this month, according to a June 2 letter from the agency to Rep. Dingell (D-Mich.). The six-month study, scheduled to be completed in December, is part of an attempt to determine "why some districts perform given tasks in less time than others," FDA said in the letter. The recent letter from FDA is in response to a May 4 letter from Dingell in which he expressed concerns about FDA's inspection capabilities. Dingell, who chairs the House Energy and Commerce/Oversight and Investigations Subcommittee, had urged FDA officials to adopt the recommendations made by the General Accounting Office in an April 28 report that examined how FDA inspectors spend their time. The report found that FDA physically examines imports only 9% of the time, down from 20% 10 years ago ("The Pink Sheet" May 29, T&G-5). FDA plans to study several factors that may affect district performance, such as the percentage of product entries that violate import laws. In addition, the study will look at the number of entries versus available resources at particular offices, dispersed ports of entry versus land ports, multi-line entries of small lots and whether an insufficient number of entries in particular offices results in less efficient district offices. FDA said that its study "will not be duplicative of GAO's effort," but will "review the GAO raw data, identify the most promising districts and develop a study plan, including site visits." The study will be conducted by senior import specialists and management analysts who will compile a report for FDA management and develop beneficial procedures that "will be made available to all districts," according to the letter. Dingell's May 4 letter admonished FDA officials for rejecting GAO's recommendation that FDA expand the use of U.S. Customs' centralized examination stations (CESs) to inspect import products. FDA responded in the June 2 letter that it is a "misconception" on Dingell's part that FDA is not taking advantage of the CESs. In fact, FDA said, "many of the facilities FDA uses to examine imported goods are recognized CESs. When possible, we are requesting Customs to require [that] cargo be devanned in these facilities for our examination." Furthermore, the agency said it plans to investigate in its proposed study "the extent to which our use of CESs can be expanded and the impact of doing so." FDA's recently released Action Plan-Phase III highlights imports as a key area for reform. The agency said it "will strengthen working relationships with other regulatory agencies to minimize duplication of effort, and explore strategies of mutual benefit." In response to Dingell's request that FDA explain how it planned to expedite the automation of the inspection paperwork process, FDA said that it has awarded a software development contract and that it is developing an Import Support and Information System, which will be pilot tested in early 1990. The agency also has had in place since 1987 another paperwork reduction aid, the Import Alert Retrieval System, which transmits abbreviated alert notices to district offices.

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