Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ, 53028-53029 [E8-21339]

Download as PDF 53028 Federal Register / Vol. 73, No. 178 / Friday, September 12, 2008 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request; Proposed Projects Title: Survey of State Implementation of Public Law 109–239, The Safe and Timely Interstate Placement of Foster Children Act of 2006. OMB No.: New collection. Description: The Safe and Timely Interstate Placement of Foster Children Act, effective October 1, 2006, encourages States to improve protections for children and holds States accountable for the safe and timely placement of children across State lines. The purpose of this brief survey is to document how States have implemented the home study provisions of the law, to identify problems in following the requirements, and to discover the solutions that have been developed to address such problems. The results of the survey will be used to prepare a Report to Congress, as mandated by the law. Respondents: States, the District of Columbia, and Puerto Rico. ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Average burden hours per response Total burden hours Survey .............................................................................................................. 52 1 2 104 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 104 ebenthall on PROD1PC60 with NOTICES In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: September 8, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–21129 Filed 9–11–08; 8:45 am] BILLING CODE 4184–01–P VerDate Aug<31>2005 15:18 Sep 11, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0129] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. SUPPLEMENTARY INFORMATION: In the Federal Register of June 3, 2008 (73 FR 31694), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the SUMMARY: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 information collection and has assigned OMB control number 0910–0037. The approval expires on August 31, 2011. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: September 8, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–21353 Filed 9–11–08; 8:45 am] BILLING CODE 4160–01–S 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; Establishing a Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the opening of a public docket to receive information and comments on laserassisted in situ keratomileusis (LASIK). We are opening the docket to gather additional information from interested persons on the post market experience associated with the use of LASIK devices. DATES: Submit written or electronic information and comments by September 14, 2009. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug E:\FR\FM\12SEN1.SGM 12SEN1 Federal Register / Vol. 73, No. 178 / Friday, September 12, 2008 / Notices Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments or information to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and Radiological Health (HFZ–215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276– 2342, e-mail: domini.cassis@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 24, 2008 (73 FR 15530), FDA published a notice of a meeting for the Ophthalmic Devices Panel of the Medical Devices Advisory Committee (the panel). At the meeting on April 25, 2008, the panel was asked to consider general issues concerning the post market experience with laser-assisted in situ keratomileusis (LASIK) procedures. Interested persons were invited to present data, information, or views, orally or in writing, to the panel regarding these topics. At the conclusion of the meeting, FDA requested that interested persons provide input on LASIK, including comments regarding tools the agency uses to improve patient safety, such as patient labeling, information on FDA’s LASIK Web site, and other outreach initiatives. Using information gathered at the April 25, 2008, panel meeting, the agency has updated information contained on its LASIK Web site, has strengthened its post market surveillance activities, and is now seeking ways to better understand quality of life issues following LASIK procedures that may relate to safety and effectiveness of LASIK devices. At this time, the agency is interested in receiving public comments regarding the post market experience associated with the use of LASIK, as well as information regarding potential barriers that may exist in providing the agency with feedback regarding LASIK procedures. 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. ebenthall on PROD1PC60 with NOTICES II. Submission of Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic 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. VerDate Aug<31>2005 15:18 Sep 11, 2008 Jkt 214001 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. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA only through the FDMS at https://www.regulations.gov. Dated: September 8, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–21339 Filed 9–11–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0474] Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data AGENCY: Food and Drug Administration, HHS. Notice of eligibility; request for data and information. ACTION: SUMMARY: The Food and Drug Administration is announcing a call-fordata for safety and effectiveness information on the following condition as part of FDA’s ongoing review of overthe-counter (OTC) drug products: Ecamsule (terephthalylidene dicamphor sulfonic acid), in concentrations of up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients that are generally recognized as safe and effective (GRASE) and are found in the sunscreen monograph regulations. FDA reviewed a time and extent application (TEA) for ecamsule and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether ecamsule can be generally recognized as safe and effective (GRASE) for its proposed OTC use. DATES: Submit data, information, and general comments by December 11, 2008. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 53029 You may submit comments, identified by docket number FDA– 2008–N–0474, by any of the following methods: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • FAX: 301–827–6870. • Mail/Hand delivery/Courier (For paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, we are no longer accepting comments submitted to the agency by email. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the ADDRESSES portion of this document under Electronic Submissions. Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Michael L. Chasey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301–796– 2090. ADDRESSES: SUPPLEMENTARY INFORMATION: I. Eligibility of Ecamsule In September 2007, FDA received a TEA (Ref. 1) requesting that ecamsule be eligible for review under our OTC sunscreen drug monograph (part 352 (21 CFR part 352)). After reviewing the TEA, the agency believes that it E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

[Federal Register Volume 73, Number 178 (Friday, September 12, 2008)]
[Notices]
[Pages 53028-53029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21339]


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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; Establishing a Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
opening of a public docket to receive information and comments on 
laser-assisted in situ keratomileusis (LASIK). We are opening the 
docket to gather additional information from interested persons on the 
post market experience associated with the use of LASIK devices.

DATES: Submit written or electronic information and comments by 
September 14, 2009.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug

[[Page 53029]]

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments or information to https://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Domini Cassis, Center for Devices and 
Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2342, e-mail: 
domini.cassis@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 24, 2008 (73 FR 15530), FDA 
published a notice of a meeting for the Ophthalmic Devices Panel of the 
Medical Devices Advisory Committee (the panel). At the meeting on April 
25, 2008, the panel was asked to consider general issues concerning the 
post market experience with laser-assisted in situ keratomileusis 
(LASIK) procedures. Interested persons were invited to present data, 
information, or views, orally or in writing, to the panel regarding 
these topics. At the conclusion of the meeting, FDA requested that 
interested persons provide input on LASIK, including comments regarding 
tools the agency uses to improve patient safety, such as patient 
labeling, information on FDA's LASIK Web site, and other outreach 
initiatives.
    Using information gathered at the April 25, 2008, panel meeting, 
the agency has updated information contained on its LASIK Web site, has 
strengthened its post market surveillance activities, and is now 
seeking ways to better understand quality of life issues following 
LASIK procedures that may relate to safety and effectiveness of LASIK 
devices. At this time, the agency is interested in receiving public 
comments regarding the post market experience associated with the use 
of LASIK, as well as information regarding potential barriers that may 
exist in providing the agency with feedback regarding LASIK procedures. 
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) written or electronic 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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA only through the FDMS at https://www.regulations.gov.

    Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21339 Filed 9-11-08; 8:45 am]
BILLING CODE 4160-01-S

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