In the event of a lapse of appropriation, 13,872 (

In the event of a lapse of appropriation, 13,872 (86%) of FDA staff will be retained, including 10,740 (66%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,132 (19%) who are excepted (their activities are deemed necessary by implication, or for the safety of human life or protection of property).Exempt Staff:A total of 10,740 (66%) FDA staff who support activities with funding available during a lapse in appropriation will be exempt. Available funding includes sources such as carryover user fees and Working Capital Fund. For example, carryover user fee funding can be used for certain FDA activities involving products covered by user fee programs including the marketing authorization of new medical products, the ability to review requests to conduct important clinical research, issue guidance, and conduct other necessary activities to help patients have access to new therapies diagnostics, vaccines, and other medical products, including important generic and biosimilar treatment options.Excepted Staff:A total of 3,132 (19%) FDA staff are considered excepted. Excepted FDA staff include one HHS Officer appointed by the President and 3,131 staff who can legally continue their activities in the absence of appropriations. These staff fall into three categories: 1) those whose work is necessary to address imminent threats to the safety of human life, 2) those whose work is necessary for the protection of property, and 3) those whose work is "necessarily implied" from the authorized continuation of other activities.Excepted FDA staff will continue to perform tasks related to imminent threats to the safety of human life including detecting and responding to emergencies, managing recalls, pursuing criminal enforcement work and certain civil investigations, reviewing import entries to determine potential risks to human health, conducting for cause and certain surveillance inspections of regulated facilities, conducting surveillance of adverse events reports for issues that could cause human harm, and other critical public health issues as appropriate. These excepted staff will also be responsible for continuing efforts to address other serious public health challenges, including medical product shortages and outbreaks related to foodborne illness and infectious diseases.Excepted staff will also continue activities ensuring the protection of government research property, animals, and inanimate property. Examples include the care and feeding of any animals associated with research activities and maintaining research property used for regulatory science research such as high-performance computational equipment.Additionally, staff will be considered excepted and continue to work if their duties are necessary to ensure the ongoing support and operations of activities to avert imminent threats to the safety of human life; necessary to ensure the ongoing support and operation of activities to protect government property; or if they are needed for the orderly phase down and suspension of nonfunded activities. These FDA staff will continue to provide the necessary operational support to ensure the centers and offices can continue authorized activities.