
[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]


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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: Notice; correction.

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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 The document published inadvertently with outdated 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 http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are available at http://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


