[Federal Register: May 8, 2007 (Volume 72, Number 88)]
[Proposed Rules]
[Page 26011]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08my07-23]
[[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on a notice of availability of a draft guidance document that would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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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