What does Preamble of BLOOD Centers Act do?

This bill aims to direct the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to establish an expedited approval process. The expedited process is specifically for biologics license application supplements for blood centers. The bill includes provisions for 'other purposes' which are not detailed in this section.

What does SHORT TITLE. of BLOOD Centers Act do?

This bill is formally titled the ``Boosting Lifesaving Operations, Opening Donation Centers Act'' or the ``BLOOD Centers Act''.

What does EXPEDITED PROCESS FOR APPROVAL OF CERTAIN BLA SUPPLEMENTS FOR of BLOOD Centers Act do?

This section establishes an expedited process for the approval of supplemental applications from blood centers seeking to add an apheresis collection device to an existing biologics license application (BLA) license at a location not previously licensed for such a device. The Secretary must establish this expedited process within 180 days of the Act's enactment. Under the expedited procedure, the Secretary shall approve applications within 30 days unless there are safety concerns or systemic failures. The expedited procedure applies to blood center owners or operators who hold a biologics license for at least one site and meet specific criteria regarding FDA registered locations or accreditation. The term 'BLA' is defined as a biologics license application. The term 'blood center' is defined as a human blood donation center. The term 'expedited procedure' refers to the process established under subsection (a). The term 'Secretary' refers to the Secretary of Health and Human Services acting through the Commissioner of Food and Drugs.

Back to bills

BLOOD Centers Act

Last updated: 10/17/2025 · Introduced: 10/17/2025

Author: Tony Wied (R-WI)

TL;DR (AI)

The bill creates an expedited approval process for blood centers seeking to add apheresis collection devices at new locations.
The Secretary of Health and Human Services must approve these applications within 30 days unless safety concerns or systemic failures exist.
The legislation defines key terms like 'BLA,' 'blood center,' and 'expedited procedure' to clarify the scope of the new process.

119th Congressin committeeOfficial page

Verified Votes

No verified votes yet.

Community Votes

No community votes yet. Be the first!

Voting as guest · Sign in for verified votes

Other Sections

Includes provisions on preamble, short title., and 1 more.

3 sections

Click "Show details" to explore individual sections. Use the community vote above or visit All Sections to vote per section.

Read official text

Want the full experience?

Create a free account to cast verified votes on each section, get a personalized summary, and track your voting history.

Create Free Account