Document ID: FDA-2011-N-0066-0017
Agency: fda
Document Type: Notice
Title: Medical Devices Advisory Committee Molecular and Clinical Genetics Panel; Notice of Meeting; Reopening of the Comment Period
Posted Date: 2011-04-01T04:00Z

[Federal Register Volume 76, Number 63 (Friday, April 1, 2011)]
[Notices]
[Page 18227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0066]

Molecular and Clinical Genetics Panel of the Medical Devices 
Advisory Committee; Notice of Meeting; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until May 
2, 2011, the comment period for the notice announcing a meeting of the 
Molecular and Clinical Genetics Panel (the panel) of the Medical 
Devices Advisory Committee that published in the Federal Register of 
February 7, 2011 (76 FR 6623). In the notice, FDA requested public 
comment regarding the March 8 and 9, 2011, meeting of the panel to 
discuss and make recommendations on scientific issues concerning direct 
to consumer (DTC) genetic tests that make medical claims. FDA is 
reopening the comment period to update comments and to receive any new 
information.

DATES: Submit either electronic or written comments and information by 
May 2, 2011.

ADDRESSES: Submit electronic comments or information 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: Elizabeth Mansfield, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave, Bldg. 66, rm. 5676, Silver Spring, MD 20993-0002, 
301-796-4664.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 7, 2011 (76 FR 6623), FDA 
published a notice announcing a meeting of the Molecular and Clinical 
Genetics Panel of the Medical Devices Advisory Committee, and the 
opening of a public docket to seek input and comments from interested 
stakeholders to discuss scientific issues concerning DTC tests. 
Interested persons were given until March 1, 2011, to submit comments.

II. Request for Comments

    Following publication of the February 7, 2011, notice, FDA received 
requests to allow interested persons additional time to comment. The 
requesters asserted that the initial time period was insufficient to 
allow potential respondents to thoroughly evaluate and assess pertinent 
issues. The Agency has considered the requests and is reopening the 
comment period until May 2, 2011.

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
meeting. 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.

    Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7708 Filed 3-31-11; 8:45 am]
BILLING CODE 4160-01-P