Document ID: FDA-2006-D-0356-0004
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period
Posted Date: 2008-09-11T04:00Z

[Federal Register: September 11, 2008 (Volume 73, Number 177)]
[Notices]               
[Page 52861-52862]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11se08-72]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-N-0178] (formerly Docket No. 2006N-0362)

 
Draft Guidance for Industry and Food and Drug Administration 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening until 
October 14, 2008, the comment period for a draft guidance entitled 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 The draft guidance describes a means by which the absorbable 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 requirements of special controls 
if it is reclassified. FDA is reopening the comment period to update 
comments and to receive any new information. 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 Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
October 14, 2008.

ADDRESS: 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

[[Page 52862]]

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) 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.'' FDA invited interested 
persons to comment on the draft guidance document by January 29, 2007. 
In the Federal Register of May 8, 2007 (72 FR 26134), FDA published a 
notice reopening the comment period for 30 days.
    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. 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 Specials 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 applications and manufacturers'' addresses), small 
manufacturer'' 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 is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

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.
    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 submissions will be accepted by FDA through 
FDMS only.

    Dated: September 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21197 Filed 9-10-08; 8:45 am]

BILLING CODE 4160-01-S