Document ID: FDA-2011-D-0689-0004
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period
Posted Date: 2011-11-07T05:00Z

[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68767-68768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0689]

Draft Guidance for Industry and Food and Drug Administration 
Staff; De Novo Classification Process (Evaluation of Automatic Class 
III Designation); Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to January 
3, 2012, the comment period for the notice entitled ``Draft Guidance 
for Industry and Food and Drug Administration Staff; De Novo 
Classification Process (Evaluation of Automatic Class III Designation); 
Availability,'' that appeared in the Federal Register of October 3, 
2011 (76 FR 61103). In that document, FDA announced the availability of 
a draft guidance for industry and FDA staff and requested comments. The 
Agency is taking this action due to a discrepancy in the comment period 
in the notice as compared to the comment period listed in the guidance 
document.

DATES: Submit either electronic or written comments by January 3, 2012.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 
Melissa Burns, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1646, 
Silver Spring, MD 20993-0002, (301) 796-5616; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville, Pike, Suite 200N, 
Rockville, MD 20852, (301) 827-6210.

I. Background

    In the Federal Register of October 3, 2011 (76 FR 61103), FDA 
published a notice with a 60-day comment period to request comments on 
the draft guidance for industry and FDA staff entitled ``De Novo 
Classification Process (Evaluation of Automatic Class III 
Designation).'' Comments on the draft guidance will assist FDA in the 
development of a final guidance for industry and FDA staff on the de 
novo classification process.
    The Agency received a comment that the 60-day comment period in the 
notice was inconsistent with the 90-day comment period in the draft 
guidance document. FDA is extending the comment period for the notice 
until January 3, 2012. The Agency believes that this extension allows 
adequate time for interested persons to submit comments without 
significantly delaying action by the Agency.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all Center for 
Devices and Radiological Health (CDRH) guidance documents is available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available

[[Page 68768]]

at http://www.regulations.gov or from the Center for Biologics 
Evaluation and Research at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``De 
Novo Classification Process (Evaluation of Automatic Class III 
Designation)'' from CDRH you may either send an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to (301) 847-8149 to receive a paper copy. Please 
use the document number 1769 to identify the guidance you are 
requesting.

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28766 Filed 11-4-11; 8:45 am]
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