[Federal Register Volume 75, Number 160 (Thursday, August 19, 2010)]
[Notices]
[Pages 51280-51281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20489]
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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: [email protected].
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]
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