What Comes Next in the Congressional Process

This week’s Analysis and Commentary is entitled “Status of FY 24 and FY 25 Funding for FDA: Addressing Some FAQs.”

Senate and House Approve 6-week Continuing Resolution Avoiding a Shutdown.  Last Friday, the Senate and House approved HR 2872, extending the Continuing Resolution (CR) by 6 weeks.  The new deadline is March 1 for bills covering funding for Agriculture/FDA, Energy & Water, Military Construction/VA, and Transportation-HUD bills. The 8 other appropriations bills, including Labor-HHS, have a CR deadline of March 8.

For all agencies, including FDA, funding will continue at FY 2023 levels and conditions carried forward from that year.

What Comes Next in the Congressional Process. The Alliance is hopeful that the additional six weeks is enough time for Congress to complete action on the Ag/FDA funding bill. Progress has been made since the start of the fiscal year, but some difficult challenges must still be resolved.  

First and foremost, the two Houses must reach an agreement on subcommittee allocations, something that has eluded them up to now. This is discussed further in this week’s Analysis and Commentary. 

Between now and March 1, the House and Senate both have significant recess time scheduled. This is not an impediment to negotiations, but could affect availability of floor time to move funding bills. 

Upcoming Events in the Alliance Webinar Series: 

• Dr. Robert Califf, FDA Commissioner, January 31st at 2:00 p.m. ET. Register here!

  Alliance President Tom Kraus (ASHP; former FDA chief of staff) and Alliance Vice President Esther Krofah (Faster Cures/Milken Institute) will be the co-moderators.

• Kimberlee Trzeciak, FDA Deputy Commissioner for Policy, Legislation, and International Affairs, February 8 at 3 p.m. Register here!      

  Alliance board members Emily Holubowich (American Heart Association) and Nancy Myers (Catalyst Health Care) will be the co-moderators.

You can also find all the transcripts & summaries of our past Alliance webinars on our website here.

Did You Catch This Week’s Alliance Webinar on FDA’s Planned Reorganization? More than 450 members of the FDA stakeholder community attended. The transcript can be found here, the summary can be found here, and the slide presentation can be found here.

This event was featured across the media, including: here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, and here.

Our guests were: 

• Principal Deputy Commissioner Janet Woodcock, 

• Deputy Commissioner for Human Foods Jim Jones,

• Associate Commissioner for Regulatory Affairs Michael Rogers, and 

• Chief Scientist Namandje Bumpus, 

• Acting Director of CFSAN Donald Prater and Deputy Commissioner for Operations/COO Jim Sigg were available to answer questions. 

FDA Releases List of Planned Food and Dietary Supplements Guidances. The updated list covers guidances for food and dietary supplements that are expected to be published by December 2024 (here), subject to change. According to FDA, the following five topics have been added to the list: 

• Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry;

• Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry;

• The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry;

• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry; and

• Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry.

FDA Launches Tech-Enabled Traceability Video Series. FDA has published its first video in an educational series focused on how food companies’ use of tech-enabled traceability can enhance food safety and protect consumers from foodborne illness. 

The video is a resource for food producers, tech providers, and stakeholders interested in advancing end-to-end traceability in line with FDA’s New Era of Smarter Food Safety blueprint.

CDRH Announces Creation of New Super Office. CDRH’s Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a Super Office within the Center. Under the continued leadership of Director Suzanne Schwartz (who presented to the Alliance in October 2022), OST will continue to partner collaboratively with various medical device stakeholders, including patient organizations, health care professional organizations, industry, and scientific and other organizations in the U.S. and abroad.

By elevating OST to a Super Office, several organizational shifts will occur, including the establishment of the following five offices within OST:

• Office of Supply Chain Resilience (OSCR);

• Digital Health Center of Excellence (DHCoE);

• Office of Technology and Data Services (OTDS);

• Office of Readiness and Response (ORR); and

• Office of Equity and Innovative Development (OEID).