[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Notices]
[Pages 6778-6779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1735]


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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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Class II Special Controls 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This draft guidance document describes a means by which these 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 This draft guidance is not 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DATES: Submit written or electronic comments on this draft guidance by 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diskette of the draft guidance document entitled ``Class II Special 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access to the draft guidance.
    Submit written comments concerning this draft guidance to the 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://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://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 on the Division of 
Dockets Management Internet site at 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