[Federal Register: April 6, 2006 (Volume 71, Number 66)]
[Notices]
[Page 17476-17477]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ap06-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0112]
Draft Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Topical Oxygen
Chamber for Extremities; 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availability of the draft guidance for industry and FDA entitled
``Class II Special Controls Guidance Document: Topical Oxygen Chamber
for Extremities.'' It was developed as a special control to support the
reclassification of the topical oxygen chamber for extremities (TOCE)
from class III (premarket approval) into class II (special controls).
Elsewhere in this issue of the Federal Register, FDA is publishing a
proposed rule to reclassify the TOCE device from class III into class
II (special controls). This draft guidance is neither final nor is it
in effect at this time.
DATES: Submit written or electronic comments on this draft guidance by
July 5, 2006.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Class II Special Controls Guidance
Document: Topical Oxygen Chamber for Extremities 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Submit written comments concerning this draft guidance to the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: Charles N. Durfor, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301- 594-3090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Class II Special Controls Guidance Document:
Topical Oxygen Chamber for Extremities.''
Following the effective date of any final reclassification rule
based on this proposal, any firm submitting a premarket notification
(510(k)) for the TOCE will need to address the issues covered in the
special controls guidance document. However, the firm need only show
that its device meets the recommendations of the guidance document 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 the TOCE. 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.
[[Page 17477]]
III. Electronic Access
To receive ``Class II Special Controls Guidance Document: Topical
Oxygen Chamber for Extremities'' by fax, call the 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 (1582) 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 notices, information on premarket
submissions (including lists of approved applications and
manufacturers' addresses), small manufacturers' 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 refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the
PRA). The collections of information in 21 CFR part 807, subpart E,
have been approved under OMB control number 0910-0120. The collections
of information in 21 CFR part 801 have been approved 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: March 27, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-4961 Filed 4-5-06; 8:45 am]
BILLING CODE 4160-01-S