Summary of Activities that Continue
The Food and Drug Administration (FDA) activities funded through carryover user fee funding will continue including certain activities related to the regulation of human and animal drugs, biosimilar biological products, medical devices, and tobacco products. User fee work specifically supports the review and approval of new medical products, the review of requests to conduct important clinical research, the issuance of guidance, and other necessary activities to help patients have access to new therapies and important generic and biosimilar treatment options.
Additionally, activities that can be carried out with COVID-19 supplemental funding include work on emergency use authorizations to respond to the COVID-19 pandemic, mitigation efforts related to potential drug and medical product shortages and other supply chain disruptions, medical device infection control, work on enforcement actions for fraudulent, counterfeit and misbranded products related to COVID-19, and work on medical countermeasures, therapies, and vaccines and important generic and biosimilar treatment options.
All vital FDA activities related to imminent threats to the safety of human life will also continue. This includes detecting and responding to public health emergencies, continuing to address existing critical public health challenges, and managing recalls, including drug shortages, and outbreaks related to foodborne illness and infectious diseases. Other vital activities that will continue are surveillance of adverse event reports for issues that could cause human harm, the review of import entries to determine potential risks to human health, determining and conducting systems for cause and certain surveillance inspections of regulated facilities, and criminal enforcement work and certain civil investigations.
Summary of Contingency Staffing Plan
In the event of a lapse of appropriation, 15,602 (81%) of FDA staff will be retained including 12,300 (64%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,302 (17%) who are excepted (their activities are deemed necessary by implication, or for the safety of human life or protection of property). Of the staff retained, 998 would be working directly on COVID-19 response activities.
A total of 12,300 (64%) FDA staff will be exempt. Exempt FDA staff include one HHS Officer appointed by the President and 12,299 staff who support activities that have funding available during a lapse in appropriations. Available funding includes sources such as carryover user fees, Working Capital Fund and COVID-19 supplemental funding. For example, carryover user fee funding can be used for certain FDA activities involving products covered by user fee programs including the approval 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 and important generic and biosimilar treatment options.
A total of 3,302 (17%) FDA staff are considered excepted and 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 vital 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 drug 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 non-funded activities. These FDA staff will continue to provide the necessary operational support to ensure the centers and offices can continue authorized activities.
FDA has 229 Public Health Service Commissioned Corps Officers who will also continue working during any lapse in appropriations.