AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; reopening of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening until June 7, 2007, the comment period for the proposed rule, published in the Federal Register of October 31, 2006 (71 FR 63278). The proposed rule would reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is taking this action in response to two requests for an extension of the comment period for this rulemaking. 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in this issue of the Federal Register , FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.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 June 7, 2007.

ADDRESSES:

You may submit comments, identified by Docket No. 2006N-0362, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following ways:

• Federal eRulemaking Portal:http://www.regulations.gov. Follow the instructions for submitting comments.
• Agency Web site:http://www.fda.gov/​dockets/​ecomments. Follow the instructions for submitting comments on the agency Web site.

Written Submissions

Submit written submissions in the following ways:

• FAX: 301-827-6870.
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under Electronic Submissions.

Instructions: All submissions received must include the agency name and Docket No. for this rulemaking. All comments received may be posted without change to http://www.fda.gov/​ohrms/​dockets/​default.htm, including any personal information provided. For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/​ohrms/​dockets/​default.htm and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141.