FDA would be able to continue some user-fee funded duties if the government is shut down Oct. 1, but would stop some facility inspections and other compliance activities.

The Department of Health and Human Services released its contingency plan Sept. 27 for its agencies in the event Congress does not reach an agreement on an appropriations bill. The fiscal year, along with most government funding, ends Sept. 30.

Overall, HHS expects to furlough more than half of all its employees: 40,512 in all. Another 37,686 would continue working.

If the government is shut down, “FDA would continue limited activities related to its user fee funded programs,” according to the plan.

The agency also would “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.”

The plan did not include further detail on what those services entailed.

Among the activities HHS said would not continue include “the majority of its food safety, nutrition, and cosmetics activities,” according to the plan.

“Routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs … and the majority of laboratory research necessary to inform public health decision-making” also would stop, HHS said in the plan.

Nearly 8,200 FDA Staff Would Be Retained

FDA would retain 8,180 staff members, about 55% of the total. The agency said personnel were learning their status Sept. 27.

The majority of those, 7,311, would be retained because they perform activities without funding issues, are officers appointed by the President, or performing activities authorized by necessary implication, according to the plan.

More than 6,000 were classified as “staff paid from carryover funding” and another 40 are funded by “user fees appropriated in authorizing legislation.”

More than 1,000 were exempt because they were considered officers appointed by the President and 225 are considered performing activities authorized by necessary implication.

FDA also would comprise the majority of the staff “excepted for the protection of human life” other than direct medical services, according to the plan. That includes 578 product and manufacturer inspectors, import inspectors and others.

Another 120 staffers would conduct and oversee adverse event reporting and lot release protocol reviews and other activities.

Throughout HHS, FDA had the highest percentage of employees that would be retained, except for the Indian Health Service, which would retain 94% of its staff.

In 2011, when HHS issued a plan in case a shutdown occurred, FDA had 1,250 employees deemed essential for the safety of human life despite not being involved with patient care Also see "FDA in a Shutdown: The Plan Still Matters" - Pink Sheet, 1 May, 2011..

FDA’s Shutdown Plan: Some User Fee Services Would Continue; Routine Inspections Would Not

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