[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]
[Page 58640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no09-67]
[[Page 58640]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0488]
Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ
Keratomileusis (LASIK) Devices; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
reopening until November 15, 2010 of a public docket to receive
information and comments on laser-assisted in situ keratomileusis
(LASIK) devices.
DATES: The agency encourages interested parties to submit information
and comments by November 15, 2010.
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: Domini Bean, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., WO66 Rm. 4422, Silver Spring, MD 20993, 301-796-5733, e-mail:
domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 12, 2008 (73 FR 53028), FDA
published a notice announcing the opening of a public docket to receive
information and comments on the post market experience associated with
the use of laser-assisted in situ keratomileusis (LASIK) devices, as
well as information regarding potential barriers that may exist in
providing the agency with feedback regarding LASIK procedures.
Interested persons were invited to submit comments by September 14,
2009. At this time, the agency is reopening the docket to continue to
receive public comments. Information and comments submitted to the
docket will assist us in identifying ways in which we can improve our
public outreach efforts regarding the safety and effectiveness of LASIK
devices.
II. Submission of Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy. All
comments submitted to the public docket are public information and may
be posted to the FDA's Web site at http://www.fda.gov for public
viewing. Comments are to be identified 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: October 30, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-27222 Filed 11-12-09; 8:45 am]
BILLING CODE 4160-01-S