Document ID: FDA-2011-D-0215-0003
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Staff; Availability: In Vitro Companion Diagnostic Devices
Posted Date: 2011-08-19T04:00Z

[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Page 51993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21226]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0215]

Draft Guidance for Industry and Food and Drug Administration 
Staff on In Vitro Companion Diagnostic Devices; 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 October 
12, 2011, the comment period for the notice that appeared in the 
Federal Register of July 14, 2011 (76 FR 41506). In the notice, FDA 
requested comments on a draft guidance document entitled ``In Vitro 
Companion Diagnostic Devices.'' The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: Submit either written or electronic comments by October 12, 
2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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. 1601, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Mansfield, Center for Devices and Radiologic Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5676, 
Silver Spring, MD 20993-0002, 301-796-4664; or
Christopher Leptak, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5102, 
Silver Spring, MD 20993-0002, 301-796-0017; 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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 14, 2011 (76 FR 41506), FDA 
published a notice announcing the availability of the draft guidance 
entitled ``In Vitro Companion Diagnostic Devices,'' and the opening of 
a public docket to receive comments on the draft guidance document. 
Interested persons were invited to submit comments by September 12, 
2011. At this time the Agency is extending the comment period until 
October 12, 2011, to continue to receive public comments. Comments 
submitted to the docket will assist in identifying issues to be 
addressed in the finalized guidance document.

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. 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.

    Dated: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21226 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P