[Federal Register: February 9, 2006 (Volume 71, Number 27)]
[Notices]
[Page 6778-6779]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09fe06-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0020]
Draft Guidance for Industry and Food and Drug Administration
Staff; Draft Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Class II Special Controls
Guidance Document: Intervertebral Body Fusion Device.'' It was
developed as a special control to support the reclassification of
intervertebral body fusion devices that contain bone grafting material
from class III (premarket approval) into class II (special controls).
This draft guidance document describes a means by which these
intervertebral body fusion devices may comply with the requirement of
special controls for class II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a proposed rule to reclassify the
intervertebral body fusion device that contains bone grafting material
from class III into class II (special
[[Page 6779]]
controls) and retain those that contain any therapeutic biologic (e.g.,
bone morphogenic protein) in class III. This draft guidance is not
final, nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
May 10, 2006.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Intervertebral Body Fusion 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 301-443-8818. See the SUPPLEMENTARY
INFORMATION section of this document for information on electronic
access to the draft guidance.
Submit written comments concerning this draft guidance to the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 to 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: Jodi N. Anderson, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036, ext. 186.
SUPPLEMENTARY INFORMATION:
I. Background
On December 11, 2003, the Orthopedic and Restorative Devices Panel
(the panel) recommended that intervertebral body fusion devices that
contain bone grafting material be reclassified from class III into
class II. The panel also provided recommendations on the types of
information the agency should include in a class II special controls
guidance document for these devices. This document announces the draft
guidance that is based on these recommendations. Elsewhere in this
issue of the Federal Register, FDA is publishing a proposed rule to
reclassify these devices.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on
intervertebral body fusion devices. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device'' by fax, call the Center for Devices
and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt, press 1 to order a document. Enter
the document number (1540) followed by the pound sign ().
Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. 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'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 is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.
guidance.html. 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.
IV. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information addressed in the draft guidance
document have been approved by OMB in accordance with the PRA under the
regulations governing premarket notification submissions (21 CFR part
807, subpart E, OMB control number 0910-0120). The labeling provisions
addressed in the draft guidance have been approved by OMB under OMB
control number 0910-0485.
V. 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 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: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-1735 Filed 2-8-06; 8:45 am]
BILLING CODE 4160-01-S