[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68767-68768]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry and Food and Drug Administration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3, 2012, the comment period for the notice entitled ``Draft Guidance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a draft guidance for industry and FDA staff and requested comments.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ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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the draft guidance for industry and FDA staff entitled ``De Novo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 Comments on the draft guidance will assist FDA in the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
[email protected] 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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