Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 20889-20890 [2014-08217]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 71 / Monday, April 14, 2014 / Notices example of such a manufacturing process is one which intentionally removes the cells and cellular debris, with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under the heading of ‘‘Heart Valve, More than Minimally Manipulated Allograft’’, Product Code OHA, as unclassified devices and reviewed under the premarket notification, 510(k), authority. FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 28, 2014. On May 6, oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. On May 7, oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m. for session I and between 2 p.m. and 2:30 p.m. for session II. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 18, 2014. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public VerDate Mar<15>2010 17:39 Apr 11, 2014 Jkt 232001 hearing session. The contact person will notify interested persons regarding their request to speak by April 21, 2014. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark, Conference Management Staff, at James.Clark@fda.hhs.gov or 301–796– 5293 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 4, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–08198 Filed 4–11–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0314] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 13, 2014, from 8 a.m. to 6 p.m. Location: Holiday Inn Express/ Highlands Conference Center, Oak I and PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 20889 II Conference Rooms, 20260 Goldenrod Lane, Germantown, MD 20876. The hotel’s phone number is 301–605–1434. Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993, 301– 796–5290, Natasha.Facey@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories. The guidance for contact lenses entitled ‘‘Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses’’ and can be found at: https://www.fda.gov/medicaldevices/ deviceregulationandguidance/guidance documents/ucm080928.htm. The guidance for contact lens accessories entitled ‘‘Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products’’ and can be found at: https://www.fda.gov/downloads/ medicaldevices/deviceregulationand guidance/guidancedocuments/ ucm080218.pdf. The discussion will include topics such as microbiological and chemical pre-clinical testing, revision of pre-clinical test requirements to address patient non-compliance, modification of rigid gas permeable lens care regimens, and labeling for these devices. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. E:\FR\FM\14APN1.SGM 14APN1 mstockstill on DSK4VPTVN1PROD with NOTICES 20890 Federal Register / Vol. 79, No. 71 / Monday, April 14, 2014 / Notices Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 6, 2014. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on May 13, 2014. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 25, 2014. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 29, 2014. FDA is opening a docket for public comment on this document. The docket number is FDA–2014–N–0314. The docket will close on May 23, 2014. Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting. Comments received on or before May 6, 2014, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. Submit electronic comments on this meeting to https://www.regulations.gov or written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark at James.Clark@fda.hhs.gov or 301–796– VerDate Mar<15>2010 17:39 Apr 11, 2014 Jkt 232001 5293 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 8, 2014. Jackie Painter, Deputy Director, Division of Policy and Information Coordination. Dated: April 7, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. Recruitment of Sites for Assignment of Corps Personnel Obligated Under the National Health Service Corps Scholarship Program [FR Doc. 2014–08217 Filed 4–11–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on the National Health Service Corps (NHSC). Dates and Times: April 24, 2014, 2:00 p.m.–3:30 p.m. (EST). Place: The meeting will be via audio conference call. Status: The meeting will be open to the public. Agenda: The Council is holding a meeting via conference call to provide program updates and discuss the potential growth of the National Health Service Corps. The public can join the meeting via audio conference call on the date and time specified above using the following information: Dial-in number: 1–800–779–9073; Passcode: 1551759. There will be an opportunity for the public to comment towards the end of the call. An unforeseen administrative error hindered an earlier publication of this meeting notice. Ed Mekeel, Bureau of Clinician Recruitment and Service, Health Resources and Services Administration, Parklawn Building, Room 13–64, 5600 Fishers Lane, Rockville, Maryland 20857; email: emekeel@hrsa.gov; telephone: 301–443–6156. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 [FR Doc. 2014–08267 Filed 4–11–14; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Health Resources and Services Administration, HHS. ACTION: General notice. AGENCY: The Health Resources and Services Administration (HRSA) announces that the listing of entities and associated Health Professional Shortage Area (HPSA) scores that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients serving as Corps members, as well as those serving under the Private Practice Option (‘‘NHSC scholars’’ collectively), during the period July 1, 2014, through September 30, 2015, is posted on the NHSC Web site at https://nhscjobs.hrsa.gov. The NHSC Jobs Center includes all sites that are approved for performance of service by NHSC scholars; however, note that entities on this list may or may not have current job vacancies. SUMMARY: Eligible HPSAs and Entities To be eligible to receive assignment of Corps members, entities must: (1) Have a current HPSA status of ‘‘designated’’ by the Division of Policy and Shortage Designation, Bureau of Clinician Recruitment and Service, HRSA, as of January 1, 2014, for placements July 1, 2014, through December 31, 2014, or January 1, 2015, for placements January 1, 2015, through September 30, 2015; (2) not deny requested health care services, or discriminate in the provision of services to an individual because the individual is unable to pay for the services or because payment for the services would be made under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP); (3) enter into an agreement with the state agency that administers Medicaid and CHIP, accept assignment under Medicare, see all patients regardless of their ability to pay and post such policy, and use and post a discounted fee plan; and (4) be determined by the Secretary to have (a) a need and demand for E:\FR\FM\14APN1.SGM 14APN1

Agencies

[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20889-20890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08217]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0314]


Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Ophthalmic Devices Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 13, 2014, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn Express/Highlands Conference Center, Oak I 
and II Conference Rooms, 20260 Goldenrod Lane, Germantown, MD 20876. 
The hotel's phone number is 301-605-1434.
    Contact Person: Natasha Facey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1552, Silver Spring, MD 20993, 301-796-5290, 
Natasha.Facey@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On May 13, 2014, the committee will discuss and make 
recommendations regarding the guidance documents for contact lenses and 
contact lens accessories. The guidance for contact lenses entitled 
``Premarket Notification [510(k)] Guidance Document for Class II Daily 
Wear Contact Lenses'' and can be found at: https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080928.htm. The guidance for contact lens accessories entitled 
``Premarket Notification [510(k)] Guidance Document for Contact Lens 
Care Products'' and can be found at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080218.pdf. The discussion will include topics such as 
microbiological and chemical pre-clinical testing, revision of pre-
clinical test requirements to address patient non-compliance, 
modification of rigid gas permeable lens care regimens, and labeling 
for these devices.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.

[[Page 20890]]

    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
6, 2014. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on May 13, 2014. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before April 25, 2014. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by April 29, 2014.
    FDA is opening a docket for public comment on this document. The 
docket number is FDA-2014-N-0314. The docket will close on May 23, 
2014. Interested persons are encouraged to use the docket to submit 
electronic or written comments regarding this meeting. Comments 
received on or before May 6, 2014, will be provided to the committee. 
Comments received after that date will be taken into consideration by 
the Agency. Submit electronic comments on this meeting to https://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact James Clark at 
James.Clark@fda.hhs.gov or 301-796-5293 at least 7 days in advance of 
the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-08217 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P

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