2011-12409. 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 The document published inadvertently with outdated information in the ADDRESSES, FOR FURTHER INFORMATION CONTACT, and Electronic Access sections.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 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 [e-mail] 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.