E6-3522. Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; correction.

SUMMARY:

The Food and Drug Administration is correcting a proposed rule that appeared in the Federal Register of January 9, 2006 (71 FR 1399). That document proposed the reclassification of herpes simplex virus (types 1 and/or 2) serological assays from class III (premarket approval) to class II (special controls). That document inadvertently included a list of references related to a draft guidance that also was announced in the Federal Register of January 9, 2006 (71 FR 1432). The draft guidance contains the correct list of references. This document corrects the error.

FOR FURTHER INFORMATION CONTACT:

Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0496, ext. 114.

SUPPLEMENTARY INFORMATION:

In FR Doc. 06-173, appearing on page 1399, in the Federal Register of Monday, January 9, 2006, the following correction is made:

1. On pages 1402-1403, section XII. References is removed.

Dated: March 3, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.