[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Proposed Rules]
[Page 26011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8784]



[[Page 26011]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 2006N-0362]


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 comment period.

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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on a notice of availability of a draft guidance document that would 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.

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) into class II (special controls). FDA invited interested 
persons to comment on the proposed rule by January 29, 2007. Two 
companies requested FDA to extend the comment period by 90 days because 
the proposal presented complex medical and scientific issues that 
required the company to assemble a team of many different specialties 
in order to prepare their comments.
    FDA was unable to respond to the request to extend the comment 
period before the comment period ended. Therefore, FDA is reopening the 
comment period for 30 days in order to allow the requestors and other 
interested persons to complete and prepare their comments. FDA believes 
that these 30 days in addition to the time that has already passed 
since the proposal was published allows for sufficient time for 
preparation of comments.
    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.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the proposed rule. 
Submit a single copy of electronic comments 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.

    Dated: April 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8784 Filed 5-7-07; 8:45 am]
BILLING CODE 4160-01-S