[Federal Register Volume 71, Number 40 (Wednesday, March 1, 2006)]
[Rules and Regulations]
[Page 10433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1871]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2003P-0564]


Microbiology Devices; Reclassification of Hepatitis A Virus 
Serological Assays; Correction

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; correction.

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SUMMARY:  The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of February 9, 2006 (71 FR 
6677). That document reclassified hepatitis A virus (HAV) serological 
assays from class III (premarket approval) into class II (special 
controls). That document inadvertently published with an error. This 
document corrects the error.

DATES:  This rule is effective March 13, 2006.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION: In FR Doc. 06-1206, appearing on page 6677 
in the Federal Register of Thursday, February 9, 2006, the following 
correction is made:
    1. On page 6679, beginning in the first column, under section ``VI. 
Analysis of Impacts,'' the second paragraph is corrected to read:
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a 
rule on small entities. Reclassification of HAV serological assays 
from class III into class II will relieve manufacturers of the cost 
of complying with the premarket approval requirements in section 515 
of the act. Because reclassification will reduce regulatory costs 
with respect to these devices, the agency certifies that the final 
rule will not have a significant economic impact on a substantial 
number of small entities.

    Dated: February 21, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-1871 Filed 2-28-06; 8:45 am]
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