Document ID: FDA-2009-N-0344-0003
Agency: fda
Document Type: Rule
Title: Microbiology Devices: Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays; Confirmation of Effective Date
Posted Date: 2010-09-28T04:00Z

[Federal Register: September 28, 2010 (Volume 75, Number 187)]
[Rules and Regulations]               
[Page 59611]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se10-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2009-N-0344]

 
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.

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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.

0
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.
[FR Doc. 2010-23638 Filed 9-27-10; 8:45 am]
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