Reagan-Udall Report Upcoming; FY23 Approps Yet to be Determined
Reagan-Udall Foundation Food Report Expected December 6.
Appropriations for FY 23 Yet to be Determined.
Omnibus or CR: What Might Be Attached?
FDA Releases Cybersecurity Modernization Action Plan.
FDA Plans 2023 Launch of Leadership Modernization Action Plan.
FDA to Hold Informational Webinar on Food Traceability: December 7.
CY23 Invoices Sent to Alliance Members.
This week’sAnalysis and Commentaryis entitled “FDA and Continuing Resolutions: Everything You Need to Know.” It expands upon the news article (below) on FY 23 appropriations.
Reagan-Udall Foundation Food Report Expected December 6.The Foundation’s Expert Panel is expected to deliver its report on FDA food programs on December 6. The Foundation will be posting it publicly at that time.
The Alliancetestifiedbefore the panel on September 30. Subsequently, we published threeAnalysis and Commentarycolumns exploring why increased funding and reform are both needed in 2023:The F in FDA,Part 2andPart 3.
Appropriations for FY 23 Yet to be Determined. The federal government is operating under a Continuing Resolution (CR) through Friday, December 16. There have been negotiations to get agreement on spending levels for a full year appropriations bill, but the total spending levels and how much to allocate for defense and nondefense spending have not been settled. While the leadership of both the House and Senate Appropriations Committees want to complete action immediately, some reports suggest that we could see another CR through December 23 to provide time for a final omnibus bill to be completed.
The core of the omnibus would be the twelve FY 23 appropriations bills that have been moving through Congress. However, an omnibus faces obstacles: some Republican members want a CR that will go into the new year when the Republicans will have the majority in the House. Others have suggested the possibility of a CR covering all of FY 23. Just how far such a bill would go and what would be left until next year is a call for the House and Senate leadership looking to secure enough votes to pass the package. This week’s Analysis and Commentary provides greater detail as to what is at stake.
Omnibus or CR: What Might Be Attached?The omnibus or a further CR are likely to be the last legislative vehicles this Congress. As a result, there are dozens of proposals for items to be added to either bill, such as the Electoral Count Reform Act of 2022 and the National Defense Authorization Act. If Congress can agree on a package of items stripped from the user fee legislation in September, the omnibus or the CR would be the legislative vehicle for them to become law.
Friday Releases Cybersecurity Modernization Act Plans. In November, FDA released its Cybersecurity Modernization Action Plan (CMAP). According to the FDA website: the CMAP outlines the measures that FDA will take to modernize its security and cyber defenses through an agency-wide approach to cybersecurity modernization built on zero-trust principles. Strengthening cybersecurity will also facilitate more seamless data sharing across the global regulatory environment and is fundamental to protecting public health.
The new CMAP action plan is designed to build off the progress made by three other modernization plans covering technology, data, and enterprise. CMAP and the prior plans are describedhere.
FDA Plans 2023 Launch of Leadership Modernization Action Plan.FDA has also announced its intent to release a Leadership Modernization Action Plan (LMAP) in 2023. According to the FDA website: The LMAP is being developed by FDA’s Office of Digital Transformation and will reportedly “articulate a strategic framework for new ways of leading, including fundamental leadership competencies and values.” LMAP is further described here.
FDA to Hold Informational Webinar on Food Traceability: December 7.FDA has released theagendafor this webinar, which focuses on the recently released Food Traceability final rule. The rule implements section 204(d) of the FDA Food Safety Modernization Act (FSMA) and is a key component of the FDA’s New Era of Smarter Food Safety Blueprint.
During the webinar, the FDA will provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and discuss the recordkeeping requirements of the rule. The FDA will answer pre-submitted questions and take questions during the webinar.
The webinar will be held on Wednesday, December 7, 2022, from 1:00 pm - 4:00 pm (ET). Registration information can be foundhere.
CY23 Invoices Sent to Alliance Members. Please keep an eye out for your invoice for Alliance 2023 dues. Please letElisaif you haven’t received an invoice or cannot find it.