[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Pages 26134-26135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8780]


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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Draft Guidance for Industry and Food and Drug Administration 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7, 2007, the comment period for a draft guidance entitled ``Class II 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published a notice of availability of the draft guidance in the Federal 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 The draft guidance 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 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    Submit written comments concerning this draft guidance to the 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://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 <a href="/cdn-cgi/l/email-protection#294d5a44404a48694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="355146585c5654755351541b5d5d461b525a43">[email protected]</span></a> 
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://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://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


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