Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 489 [2015-33262]

Download as PDF Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices Agenda The purpose of the meeting is for the GLMRC to discuss the Council’s focus for the upcoming year and consider Agency initiatives. The topics to be discussed include Council metrics & GSA EVS results, GSA EEO program, and Council subcommittee updates. Meeting Access The meeting is open to the public. The meeting will be held in Room 6044 of the General Services Administration’s Headquarters Building, 1800 F Street NW., Washington, DC 20405. This site is accessible to individuals with disabilities. In order to gain entry into the Federal building where the meeting is being held, public attendees who are Federal employees should bring their Federal employee identification cards, and members of the general public should bring their driver’s license or other government-issued identification. Availability of Materials for the Meeting Please see the GLRMC Web site: https://www.gsa.gov/portal/content/ 225831 for any materials available in advance of the meeting and for meeting minutes that will be made available after the meeting. Detailed meeting minutes will be posted within 90 days of the meeting. mstockstill on DSK4VPTVN1PROD with NOTICES Procedures for Providing Public Comments The public is invited to submit written comments for the meeting until 5:00 p.m. Eastern Time on the Monday prior to the meeting, by either of the following methods: Electronic or Paper Statements: Submit electronic statements to Ms. Paula Lucak, Designated Federal Officer, at paula.lucak@gsa.gov; or send paper statements in triplicate to Ms. Lucak at 1800 F Street NW., Suite 7003A, Washington, DC 20405. In general, public comments will be posted on the GLMRC Web site. All comments, including attachments and other supporting materials received, are part of the public record and subject to public disclosure. Any comments submitted in connection with the GLMRC meeting will be made available to the public under the provisions of the Federal Advisory Committee Act. VerDate Sep<11>2014 17:32 Jan 05, 2016 Jkt 238001 Dated: December 30, 2015. Wade Hannum, Office of Human Resources Management, OHRM Director, Office of HR Strategy and Services, Center for Talent Engagement (COE4), General Services Administration. [FR Doc. 2015–33302 Filed 1–5–16; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 23, 2015. The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1643, 10903 New Hampshire Ave., Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301–796– 7047, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUMMARY: In the Federal Register of November 23, 2015, 80 FR 72971, FDA announced that a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee would be held on February 19, 2016. On page 72972, in the first column, the Agenda portion of the document is changed to read as follows: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with SUPPLEMENTARY INFORMATION: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 489 or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2–L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. 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. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: December 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–33262 Filed 1–5–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–4952] Food and Drug Administration Safety and Innovation Act 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration’s (FDA or Agency) Office of Minority Health (OMH), Office of Women’s Health (OWH), the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) SUMMARY: E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Page 489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Orthopaedic and Rehabilitation Devices Panel of the Medical 
Devices Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Orthopaedic and 
Rehabilitation Devices Panel of the Medical Devices Advisory Committee. 
This meeting was announced in the Federal Register of November 23, 
2015. The amendment is being made to reflect a change in the Agenda 
portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Sara Anderson, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1643, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 
Sara.Anderson@fda.hhs.gov, 301-796-7047, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). Please call the Information Line for up-to-date information on 
this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 23, 
2015, 80 FR 72971, FDA announced that a meeting of the Orthopaedic and 
Rehabilitation Devices Panel of the Medical Devices Advisory Committee 
would be held on February 19, 2016. On page 72972, in the first column, 
the Agenda portion of the document is changed to read as follows:
    The Committee will discuss, make recommendations, and vote on 
information regarding the premarket application (PMA) for the DIAM 
Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. 
The DIAM Spinal Stabilization System is indicated for skeletally mature 
patients that have moderate low back pain (with or without radicular 
pain) with current episode lasting less than 1 year in duration 
secondary to lumbar degenerative disc disease (DDD) at a single 
symptomatic level from L2-L5. DDD is confirmed radiologically with one 
or more of the following factors: (1) Patients must have greater than 2 
mm of decreased disc height compared to the adjacent level; (2) 
scarring/thickening of the ligamentum flavum, annulus fibrosis, or 
facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device 
is implanted via a minimally invasive posterior approach.
    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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33262 Filed 1-5-16; 8:45 am]
 BILLING CODE 4164-01-P

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