H.R. 5791: Boosting Lifesaving Operations, Opening Donation Centers Act

This bill, known as the Boosting Lifesaving Operations, Opening Donation Centers Act or the BLOOD Centers Act, aims to streamline the approval process for certain applications related to blood centers in the United States. Here are the key points of the bill:

1. Expedited Approval Process

The bill mandates the Secretary of Health and Human Services to create a faster approval procedure within 180 days of the bill's enactment. This process will specifically apply to supplemental applications from blood center operators who wish to add an apheresis collection device at a site that was not previously authorized for such devices.

2. Timelines for Approval

Once the expedited process is established, the Secretary must approve these supplemental applications within 30 days of submission. However, this approval can be delayed if there are concerns regarding:

• The safety, purity, or potency of blood products produced at the new location.
• A systematic failure by the applicant to meet safety and quality standards at existing locations under their biologics license.

3. Eligibility Criteria for the Expedited Process

The expedited approval will be available to operators of blood centers who meet certain qualifications:

• The operator must hold a biologics license for at least one blood center.
• The operator must be approved for a biologics license at three or more Food and Drug Administration (FDA) registered locations or must be accredited and in good standing with an organization that meets or exceeds the applicable regulatory requirements for blood collection.

4. Definitions

The bill includes specific terms defined for clarity:

• BLA: Biologics License Application.
• Blood center: A facility where human blood is donated.
• Expedited procedure: The fast-track approval process established by the bill.
• Secretary: Refers to the Secretary of Health and Human Services acting through the Commissioner of Food and Drugs.

5. Purpose of the Bill

The main goal of this legislation is to enhance the efficiency of blood collection and increase the availability of blood products, which are essential for various medical treatments and emergency responses.

Relevant Companies

• ABT (Abbott Laboratories): A company focused on healthcare, including blood transfusion technologies and diagnostics, which may benefit from increased blood collection efficiency.
• BAX (Baxter International): Engaged in medical products related to blood and plasma treatment, potentially experiencing an expanded market due to more accessible blood centers.
• CSL (CSL Limited): Involved in the biopharmaceutical sector focusing on blood plasma products, likely to see enhanced operations with quicker access to blood supplies.