Document ID: FDA-2006-N-0178-0049
Agency: fda
Document Type: Proposed Rule
Title: General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period
Posted Date: 2008-09-11T04:00Z

[Federal Register: September 11, 2008 (Volume 73, Number 177)]
[Proposed Rules]               
[Page 52804-52805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11se08-13]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR 878

[Docket No. FDA-2006-N-0178] (formerly 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 the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
October 14, 2008, the comment period for a proposed rule published in 
the Federal Register of October 31, 2006 (71 FR 63728) to reclassify 
the absorbable hemostatic device from class III (premarket approval) 
into class II (special controls). FDA is reopening the

[[Page 52805]]

comment period to update comments and to receive any new information. 
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the comment period on a notice of availability of a draft guidance 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 
October 14, 2008.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: David Krause, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3638.

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) to class II (special controls). FDA invited interested 
persons to comment on the proposed rule by January 29, 2007. In the 
Federal Register of May, 8, 2007 (72 FR 26011), FDA reopened the 
comment period for 30 days in response to two requests for additional 
time for preparation of comments.
    On July 2, 2007, FDA received a petition under 21 CFR 10.30 and 
10.35 requesting that the agency refrain from issuing a final 
regulation for the proposed reclassification and the draft special 
controls guidance for the absorbable hemostatic device until an updated 
and complete administrative record is made available to the public. The 
petitioner also requested that FDA reopen the rulemaking for the 
proposed reclassification to allow submission of comments based on the 
administrative record. FDA has updated the administrative record in the 
Division of Dockets Management (see ADDRESSES). FDA is also reopening 
the comment period for 30 days. Although you can comment on any 
guidance at any time (see 21 CFR 10.115(g)(5)), elsewhere in this issue 
of the Federal Register, FDA is reopening the comment period on a 
notice of availability of a draft guidance document that would serve as 
the special control if the device is reclassified.

II. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://
www.regulations.gov 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: September 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21200 Filed 9-10-08; 8:45 am]

BILLING CODE 4160-01-S