[Federal Register: May 8, 2007 (Volume 72, Number 88)]
[Notices]
[Page 26134-26135]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08my07-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0363]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Absorbable
Hemostatic Device; Availability; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; 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7, 2007, the comment period for a draft guidance entitled ``Class II
Special Controls Guidance Document: Absorbable Hemostatic Device.'' FDA
published a notice of availability of the draft guidance in the Federal
Register of October 31, 2006 (71 FR 63774). The draft guidance
describes a means by which the absorbable hemostatic device may comply
with the requirement of special controls for class II devices, if the
device is reclassified. Elsewhere in this issue of the Federal
Register, FDA is reopening the comment period on a proposed rule to
reclassify the absorbable hemostatic device from class III (premarket
approval) into class II (special controls)
DATES: Submit written or electronic comments on the draft guidance by
June 7, 2007. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Absorbable Hemostatic Device'' to the Division of Small
Manufacturers, International, and Consumer Assistance (HFZ-220), Center
for Devices and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with
the docket number found in brackets in the heading of this document.
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). In the same issue of the
Federal Register (71 FR 63774), FDA published a notice of availability
of a draft guidance document entitled ``Class II Special Controls
Guidance Document: Absorbable Hemostatic Device.'' The draft guidance
describes a means by which the absorbable hemostatic device may comply
with the requirement of special controls if they were reclassified. FDA
invited interested persons to comment on the proposed
[[Page 26135]]
rule and on the draft guidance document by January 29, 2007.
Two companies requested FDA to extend the comment period on the
proposed rule 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.
Elsewhere in this issue of the Federal Register, FDA is reopening the
comment period on the proposed rule for 30 days. Because the issues
presented by the guidance document are intertwined with those presented
by the proposed rule, FDA is reopening the comment period on the
guidance document for the same period.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive the draft guidance document
entitled ``Class II Special Controls Document: Absorbable Hemostatic
Device,'' you may either send an e-mail request to dsmica@fda.hhs.gov
to receive an electronic copy of the document, or send a fax request to
240-276-3151 to receive a hard copy. Please use the document number
1558 to identify the guidance you are requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved submissions, approved applications, and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH Web site may be
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH
guidance documents are also available on the Division of Dockets
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
III. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance
document. 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. E7-8780 Filed 5-7-07; 8:45 am]
BILLING CODE 4160-01-S