Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Reopening of the Comment Period, 58640 [E9-27222]

Download as PDF 58640 Federal Register / Vol. 74, No. 218 / Friday, November 13, 2009 / Notices 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. srobinson on DSKHWCL6B1PROD with NOTICES 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 https:// 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 VerDate Nov<24>2008 17:07 Nov 12, 2009 Jkt 220001 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 https://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. Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) 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] Office of The Director, National Institutes of Health; Amended Notice of Meeting ADDRESSES) DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences, Special Emphasis Panel K99 Pathway to Independence. Date: December 7–8, 2009. Time: 6 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Meredith D. TempleO’Connor, PhD, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN12C, Bethesda, MD 20892, 301–594– 2772, templeocm@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Dated: November 5, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–27172 Filed 11–12–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice is hereby given of a change in the meeting of the Council of Councils, November 16, 2009, 9 a.m. to November 17, 2009, 12 p.m., National Institutes of Health, Building 31C, 31 Center Drive, Conference Room 6, Bethesda, MD, 20892 which was published in the Federal Register on October 8, 2009, 74 FR 51869. This meeting will be held on November 16, 2009 for one day only. The meeting is open to the public. Dated: November 05, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–27173 Filed 11–12–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5281–N–87] Request for Approval of Advance of Escrow Funds AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The Department requires mortgagors/ borrowers and mortgagee/Lenders to execute a Building Loan Agreement setting forth terms and conditions under which progress payments may be advanced during project construction. The Agreement is executed before initial endorsement of mortgage insurance. HUD–92464 is a document used for E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 74, Number 218 (Friday, November 13, 2009)]
[Notices]
[Page 58640]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27222]



[[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.

-----------------------------------------------------------------------

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 https://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 https://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

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