Medical Devices; Radiology Devices; Reclassification of Bone Sonometers; Correction

Federal Register: August 14, 2008 (Volume 73, Number 158)

Rules and Regulations

Page 47523

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr14au08-1

Rules and Regulations

Federal Register

This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

Prices of new books are listed in the first FEDERAL REGISTER issue of each week.

Page 47523

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 892

Docket No. FDA-2005-N-0346

(formerly 2005N-0467)

Medical Devices; Radiology Devices; Reclassification of Bone

Sonometers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of July 17, 2008 (73 FR 40967). The final rule reclassified bone sonometer devices from class

III into class II, subject to special controls. The document contained an inadvertent error regarding the impact of the final rule on small businesses. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and

Radiological Health (HFZ-215), Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 240-276-2342.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-16354, appearing on page 40969 in the Federal Register of Thursday, July 17, 2008, there was an error regarding the impact of the final rule on small businesses.

Specifically, language certifying that the final rule meets the requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612) was inadvertently omitted during document preparation. Accordingly, the following correction is made: 1. On page 40969, in the middle column, under section ``VI.

Analysis of Impacts,'' in the second full paragraph, the third sentence is revised to read: ``The agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.''

Dated: August 8, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

FR Doc. E8-18792 Filed 8-13-08; 8:45 am

BILLING CODE 4160-01-S