Document ID: FDA-2010-N-0274-0095
Agency: fda
Document Type: Notice
Title: Oversight of Laboratory Developed Tests; Public Meeting; Reopening of Comment Periods
Posted Date: 2010-08-19T04:00Z

[Federal Register: August 19, 2010 (Volume 75, Number 160)]
[Notices]               
[Page 51280-51281]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au10-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0274]

 
Oversight of Laboratory Developed Tests; Public 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 
September 15, 2010, the comment period for the notice that published in 
the Federal Register of Thursday, June 17, 2010 (75 FR 34463). In the 
notice, FDA requested input and comments from interested stakeholders 
on the agency's oversight of laboratory developed tests (LDTs). 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 
September 15, 2010.

ADDRESSES: Submit electronic comments or information to http://
www.regulations.gov. Submit written comments or information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration,

[[Page 51281]]

5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Katherine Serrano, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5613, Silver Spring, MD 20993, 301-796-
6652, email: Katherine.serrano@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 17, 2010 (75 FR 34463), FDA 
published a notice announcing a public meeting on July 19 and 20, 2010, 
and the opening of a public docket to seek input and comments from 
interested stakeholders to discuss the agency's oversight of LDTs. 
Interested persons were originally given until August 15, 2010, to 
comment on information.

II. Request for Comments

    Following publication of the June 17, 2010, notice, FDA received a 
request to allow interested persons additional time to comment. The 
requester asserted that the initial time period was insufficient to 
respond fully to FDA's specific requests for comments and to allow 
potential respondents to thoroughly evaluate and address pertinent 
issues.

III. How to Submit 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.

    Dated: August 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20489 Filed 8-18-10; 8:45 am]
BILLING CODE 4160-01-S