2010-23638. Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays; Confirmation of Effective Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Direct final rule; confirmation of effective date.

SUMMARY:

The Food and Drug Administration (FDA) is confirming the effective date of December 7, 2009, for the direct final rule that appeared in the Federal Register of August 25, 2009 (74 FR 42773). The direct final rule corrects the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. This document confirms the effective date of the direct final rule.

DATES:

Effective date confirmed: December 7, 2009.

FOR FURTHER INFORMATION CONTACT:

Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5543, Silver Spring, MD 20993-0002, 301-796-6217.

SUPPLEMENTARY INFORMATION:

In the Federal Register of August 25, 2009 (74 FR 42773), FDA solicited comments concerning the direct final rule for a 44-day period ending October 8, 2009. FDA stated that the effective date of the direct final rule would be on December 7, 2009, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended. Accordingly, the amendments issued thereby are effective.

Dated: September 16, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.