OMB Reviewing Final Guidance Documents on Sepsis and Mtb

On April 18, 2025, the White House Office of Management and Budget (OMB) received the two guidance documents from the US Food and Drug Administration (FDA) for final review under the Administration’s mandate to evaluate guidance issued during the previous administration:

• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps

These documents were initially issued as final for immediate implementation on January 6, 2025, and are currently scheduled for implementation on May 4, 2025, pending action by either FDA or the OMB. 

In its ongoing efforts to advocate on behalf of the industry, AATB contacted the OMB and subsequently is scheduled to meet for 30 minutes on Tuesday afternoon, April 29. The purpose of this meeting is to discuss our ongoing concerns and formally request the rescission of both guidance documents. We will share additional updates with our members following that meeting. 

AATB members who wish to request a meeting with OMB regarding these guidance documents may do so by selecting the “Request EO Meeting” option on the respective OMB pages for sepsis and Mtb.