E8-21200. General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; reopening of the comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a proposed rule published in the Federal Register of October 31, 2006 (71 FR 63728) to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). FDA is reopening the comment period to update comments and to receive any new information. Elsewhere in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

DATES:

Submit written or electronic comments on the proposed rule by October 14, 2008.

ADDRESSES:

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3638.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 31, 2006 (71 FR 63728), FDA published a proposed rule to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) to class II (special controls). FDA invited interested persons to comment on the proposed rule by January 29, 2007. In the Federal Register of May, 8, 2007 (72 FR 26011), FDA reopened the comment period for 30 days in response to two requests for additional time for preparation of comments.

On July 2, 2007, FDA received a petition under 21 CFR 10.30 and 10.35 requesting that the agency refrain from issuing a final regulation for the proposed reclassification and the draft special controls guidance for the absorbable hemostatic device until an updated and complete administrative record is made available to the public. The petitioner also requested that FDA reopen the rulemaking for the proposed reclassification to allow submission of comments based on the administrative record. FDA has updated the administrative record in the Division of Dockets Management (see ADDRESSES). FDA is also reopening the comment period for 30 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), elsewhere in this issue of the Federal Register, FDA is reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if the device is reclassified.

II. How to Submit Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments to http://www.regulations.gov or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only.

Dated: September 4, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.