Alliance Obtains HHS FY14 Contingency Plan for Shutdown

The Alliance for a Stronger FDA has been able to obtain the latest FY 14 HHS Contingency Plan in case of a government shutdown.

The plan is available here on this web site or it can be found on the HHS web site if you want to click here.The main headline is: 55% of FDA will be retained in a shutdown, while about 45% will be furloughed. This is dramatically better than the FY 11 plan that we described in last Friday's Analysis and Commentary, under which only about 14% of FDA staff would have been retained in a shutdown. Making direct comparisons between the two plans, the FY 14 plan anticipates the retention of virtually all personnel paid for by carryover funds (i.e., user fees) and also about 1,000 commissioner corps officers.Here are the specific statements about FDA contained within the HHS plan:

  • Food and Drug Administration (FDA): FDA would continue limited activities related to its user fee funded programs including the activities in the Center for Tobacco Products. FDA would also continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.

  • FDA: FDA will be unable to support the majority of its food safety, nutrition, and cosmetics activities. FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.

DHHS contingency plan

Please note carefully: the fact that a majority of FDA employees will be retained does not answer the many questions we have received about advisory committees, user fee deadlines, and various other product-critical, non-safety functions. Since the underlying activities and staff are paid for by a combination of user fees and appropriated funds, it is too early to predict the priorities and achievable workload of the retained staff.Below is the summary chart from the HHS plan, with FDA specifics contained in the first column. If you click on this chart you will be able to see an enlarged version.

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Update from FDA re Medical Product Activities

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What Happens at FDA in a Shutdown?