E7-18799. Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Direct final rule; correction.

SUMMARY:

The Food and Drug Administration is correcting a direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). That document amended the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. A proposal was published as a companion document to the direct final rule in the same issue of the Federal Register (August 16, 2007, 72 FR 45993). Both documents published with a typographical error in the codified section. This document corrects the error in the direct final rule. Elsewhere in this issue of the Federal Register we are correcting the error in the proposed rule.

DATES:

This correction is effective February 19, 2008.

FOR FURTHER INFORMATION CONTACT:

For information regarding this correction: Joyce Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

For information regarding the direct final rule: Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

In FR Doc. E7-15943, appearing on page 45883, in the Federal Register of Thursday, August 16, 2007, the following correction is made:

§ 610.53

[Corrected]

1. On page 45887, in the amendment to § 610.53 Dating periods for licensed biological products, in the table in paragraph (c), “65° C” is corrected to read “-65° C” everywhere it appears.

Dated: September 17, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.