Document ID: FDA-2012-N-0165-0002
Agency: fda
Document Type: Rule
Title: Immunology and Microbiology Devices: Classification of Norovirus Serological Reagents; Correction
Posted Date: 2012-04-02T04:00Z

[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Rules and Regulations]
[Page 19534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7757]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2012-N-0165]

Medical Devices; Immunology and Microbiology Devices; 
Classification of Norovirus Serological Reagents; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: In the Federal Register of March 9, 2012 (76 FR 14272), the 
Food and Drug Administration (FDA) classified norovirus serological 
reagents into class II (special controls) because special controls, in 
addition to general controls, will provide a reasonable assurance of 
safety and effectiveness of these devices. The document published with 
inadvertent errors in the Analysis of Impacts section. This document 
corrects those errors.

DATES: Effective April 9, 2012.

FOR FURTHER INFORMATION CONTACT: Steven Gitterman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5518, Silver Spring, MD 20993-0002, 301-
796-6694.

SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5675 appearing on page 14272 
in the Federal Register of Friday, March 9, 2012, the following 
corrections are made:
    1. On page 14274, in the first column, in section VI. Analysis of 
Impacts, in the first paragraph, in the last sentence, correct the 
phrase ``proposed rule'' to read ``final rule'', and in the second 
paragraph, in the last sentence, correct the phrase ``proposes to 
certify'' to read ``certifies''.
    2. On page 14274, in the second column, in the first full sentence, 
correct the phrase ``proposed rule'' to read ``final rule''.

    Dated: March 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7757 Filed 3-30-12; 8:45 am]
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