[Federal Register: June 30, 2004 (Volume 69, Number 125)]
[Notices]
[Page 39485-39486]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn04-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0178]
Guidance for Industry and FDA Staff; Draft Class II Special
Controls Guidance Document: Dental Bone Grafting Material; 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availability of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Dental Bone Grafting Material.'' Elsewhere
in this issue of the Federal Register, FDA is publishing a proposed
rule to reclassify tricalcium phosphate granules for dental bone repair
from class III (premarket approval) to class II (special controls) and
to classify other dental bone grafting materials into the same class II
(special controls) classification identification. The draft guidance
describes a means by which dental bone grafting material devices may
comply with the requirement of special controls for class II devices.
This guidance is neither final nor is it in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
September 28, 2004.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Class II Special
Controls Guidance Document: Dental Bone Grafting Material'' 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 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Submit written comments concerning this draft guidance to the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 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: Michael E. Adjodha, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 123, e-mail:
mea@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a proposed rule to reclassify tricalcium phosphate granules for dental
bone repair from class III (premarket approval) to class II (special
controls) and to classify other dental bone grafting materials into the
same class II (special controls) classification identification. This
draft guidance document describes a means by which the device may
comply with the requirement of special controls for class II devices.
Following the effective date of the final rule, any firm submitting a
510(k) premarket notification for the device will need to address the
issues covered in the special control guidance. However, the firm need
only show that its device meets the recommendations of the guidance or
in some other way provides equivalent assurances of safety and
effectiveness.
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 dental bone
grafting material. 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 an approach satisfies the
requirements of the applicable statute and regulations.
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Dental
Bone Grafting Material'' by fax machine, call the CDRH Facts-On-Demand
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone.
Press 1 to enter
[[Page 39486]]
the system. At the second voice prompt, press 1 to order a document.
Enter the document number (1512) 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 cleared submissions and 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 collection of information addressed in the guidance document
has 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 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 two paper copies of any mailed comments, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Comments received may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 4, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-14768 Filed 6-29-04; 8:45 am]
BILLING CODE 4160-01-S