Fast-breaking News from AABB PulsePoints The following has been reproduced from the September 13, 2006 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

September 13, 2006
No. 750

Withdrawal of Direct Final Rule: Regulation of Blood Vessels Recovered with Organs Intended for Use in Organ Transplantation

AABB PulsePoints

The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are withdrawing a direct final rule issued in May after receiving significant adverse comments about the decision to officially classify blood vessels recovered with an organ for transplant purposes as part of the organ itself and to exclude such blood vessels from the definition of human cells, tissues, and cellular- and tissue-based products (HCT/Ps). Withdrawal of the direct final rule will take effect Sept. 14, 2006, when a notice is published in the Federal Register. The agencies intend to consider the comments submitted and then issue a proposed rule at a later date.

The new federal regulation, which would have taken effect later this month, was intended to simplify compliance requirements for organ procurement organizations that have had to comply with both FDA and HRSA rules regarding blood vessels.

To view a pre-publication notice about the withdrawal of this direct final rule, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/06n-0051-nwl0001.pdf.