FY 23 Appropriations Update; User-fee Lay-off Risk; Woodcock Webinar Announcement

This week’s Analysis and Commentary (below) looks at FDA portion of the Senate draft FY 23 funding bills and the funding priorities reflected in it.  

FY 23 Appropriations: House Advances Minibus. Senate Committee Has Begun. We Certainly Have a Way to Go. This week, the Senate Appropriations Committee released the Chairman’s mark of the 12 Senate FY 23 appropriations bills.  amid ambiguity about prospects for their consideration.

The situation has been characterized to us as: “released by Democratic majority, not endorsed by the Republican minority, but in many respects may reflect bipartisan concerns.” However much Republican views have been incorporated into the bills, it is clear that the Republicans have not endorsed the spending levels.

Nonetheless, if there is any chance of enacting appropriations bills in September and avoiding a Continuing Resolution, then these Democratic bills are an important step forward.

Initial Senate Agriculture/FDA Funding Bill Propose $229 Million (7%) Increase for FDA. The draft Agriculture/FDA Senate bill released this week would provide FDA with a $229 million increase in its FY 23 budget authority (BA) funding. This breaks down to a nearly $211 million increase in salaries and expenses (S&E) and an $18 million increase in buildings and facilities (B&F).

A Senate summary document provides the following additional information: “Total discretionary funding for FDA $3.545 billion, an increase of $229 million over fiscal year 2022. Included in these increases are $43.5 million for food safety; $49.8 million for medical product safety; and $85 million for cross cutting activities. The bill also includes $5 million to implement the ALS ACT. In response to the current infant formula crisis, the bill also includes additional resources for maternal and infant formula health.”

This week’s Analysis and Commentary provides additional details on funding priorities reflected in the draft Senate bill.

Will There Be User-fee Related Lay-off Notices on August 1? Furloughs on October 1? User fee reauthorization negotiations have stalled. (Background is here).

The earliest legislation can move will be September, running close to the expiration of existing authorities on October 1. Before that can be resolved, FDA must determine whether to send out 60-day lay-off notices on August 1 to individuals whose positions may not be funded on October 1.

Carryover user fee balances may provide some leeway for Congress and the FDA although there are myriad missing details about how that would work. According to Pink Sheet, FDA plans to hold off issuing lay-off notices until at least early September. That implies that carryover funds could carry the programs forward until early November.

Reflecting this lack of clarity, the National Treasury Employees Union (which represents FDA employees) released the following earlier this week:  
 

“NTEU has alerted FDA employees we represent to the possibility of furlough notices arriving by Aug. 1 because certain agency user fees may not be reauthorized by the Sept. 30 deadline. 

Although legislation is moving through Congress to reauthorize the user fees and avoid furloughs, it will be alarming for employees to receive these notices. This situation is unfair, and we are concerned that these highly skilled employees may question their job security as a result. 

We are providing FDA employees a full explanation of the situation and our assurance that NTEU is pressing Congress to complete its work as soon as possible and avoid the notices and furloughs.

 It is important to note that these potential furloughs would not happen until the end of the fiscal year, on Sept. 30. Even if that deadline is missed, the union is already working to determine if carryover funds can be used to delay any potential furlough and, if so, for how long.

This is not the first time Congress has come close to the user fee deadline, but we have yet to see any actual furloughs due to a lack of reauthorization. While it is unfortunate that the agency may be forced to give employees the required 60-day notice of a possible furlough, NTEU is doing everything possible to get the reauthorization passed before the fiscal year ends and keep employees informed every step of the way.” 

Principal Deputy Commissioner Woodcock to Address Alliance on Data, Technology, and Enterprise Modernization Plans: August 4 from 3:00 to 4:00. Dr. Woodcock will explain and provide updates on the 2019 Technology Modernization Action Plan (here); the 2021 Data Modernization Action Plan (here); and the 2022 Enterprise Modernization Action Plan (here).
 
Dr. Woodcock will also provide insight into how each of these action plans (individually and collectively) contribute to better decision-making by FDA.  Dr. Woodcock’s remarks will be open to Alliance members and media. (Register here). The Alliance welcomes guests at our events. If you are not an Alliance member and would like to attend, please contact Alliance Executive Director, Steven Grossman.
 
Transcripts for Alliance Webinars with Commissioner Califf and CBER Director Marks Now Posted to Alliance Website. We were fortunate to have Dr. Peter Marks speak in May to the Alliance about CBER’s FY23 budget priorities; the transcript is available here. On July 12, Commissioner Califf spent an hour with the Alliance answering a broad array of questions; that transcript Is available here. These transcripts and more are also available on the website.

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Details on the Draft Senate FY 23 Funding Bill for FDA

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Untangling FDA’s FY 23 Funding: Appropriations and User Fees Hit Peak Uncertainty