Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability; Correction, 29251 [2011-12409]
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[FR Doc. 2011–12508 Filed 5–19–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–D–0094]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls; Guidance Document:
Topical Oxygen Chamber for
Extremities; Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of April 25, 2011 (76 FR
22906). The document announced the
availability of the guidance entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Documents:
Topical Oxygen Chamber for
Extremities.’’ The document published
inadvertently with outdated information
in the ADDRESSES, FOR FURTHER
INFORMATION CONTACT, and Electronic
Access sections. This document corrects
those errors.
FOR FURTHER INFORMATION CONTACT:
Charles N. Durfor, Center for Devices
and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. G424,
Silver Spring, MD 20993–0002, 301–
796–6438.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–9898, appearing on page 22906, in
the Federal Register of Monday, April
25, 2011, the following corrections are
made:
1. On page 22906, in the first column,
correct the ADDRESSES caption to read:
ADDRESSES: Submit written request for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Topical Oxygen
Chamber for Extremities’’ to the Division
of Small Manufacturers, International,
and Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
2. On page 22906, in the second
column, correct the FOR FURTHER
INFORMATION CONTACT caption to read:
FOR FURTHER INFORMATION CONTACT:
Charles N. Durfor, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G424, Silver Spring,
MD 20993–0002, 301–796–6438.
3. On page 22906, in the third
column, correct the Electronic Access
caption to read:
III. Electronic Access
Notice; correction.
SUMMARY:
29251
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are available at
https://www.regulations.gov. To receive
‘‘Class II Special Controls Guidance
Document: Topical Oxygen Chamber for
Extremities’’ you may send an e-mail
request to dismica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1582 to
identify the guidance you are
requesting.
Dated: May 17, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–12409 Filed 5–19–11; 8:45 am]
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E:\FR\FM\20MYN1.SGM
20MYN1
Agencies
[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Notices]
[Page 29251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12409]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2006-D-0094]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls; Guidance Document: Topical Oxygen Chamber
for Extremities; Availability; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of April 25, 2011 (76 FR 22906).
The document announced the availability of the guidance entitled
``Guidance for Industry and Food and Drug Administration Staff; Class
II Special Controls Guidance Documents: Topical Oxygen Chamber for
Extremities.'' The document published inadvertently with outdated
information in the ADDRESSES, FOR FURTHER INFORMATION CONTACT, and
Electronic Access sections. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G424,
Silver Spring, MD 20993-0002, 301-796-6438.
SUPPLEMENTARY INFORMATION: In FR Doc. 2011-9898, appearing on page
22906, in the Federal Register of Monday, April 25, 2011, the following
corrections are made:
1. On page 22906, in the first column, correct the ADDRESSES
caption to read: ADDRESSES: Submit written request for single copies of
the guidance document entitled ``Class II Special Controls Guidance
Document: Topical Oxygen Chamber for Extremities'' to the Division of
Small Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
2. On page 22906, in the second column, correct the FOR FURTHER
INFORMATION CONTACT caption to read:
FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G424, Silver Spring, MD 20993-0002, 301-
796-6438.
3. On page 22906, in the third column, correct the Electronic
Access caption to read:
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are available at https://www.regulations.gov. To receive
``Class II Special Controls Guidance Document: Topical Oxygen Chamber
for Extremities'' you may send an e-mail request to dismica@fda.hhs.gov
to receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1582 to identify the guidance you are requesting.
Dated: May 17, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12409 Filed 5-19-11; 8:45 am]
BILLING CODE 4160-01-P