Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Correction, 9733 [2015-03688]

Download as PDF Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting’’ that appeared in the Federal Register of February 6, 2015 (80 FR 6731). The document announced a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993, 301–796– 9115. SUMMARY: In the Federal Register of February 6, 2015, in FR Doc. 2015–02408, on page 6731, the following correction is made: On page 6731, in the first column, in the Docket No. heading, ‘‘[Docket No. FDA–2011–N–0824]’’ is corrected to read ‘‘[Docket No. FDA–2015–N–0001]’’. SUPPLEMENTARY INFORMATION: Dated: February 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–03688 Filed 2–23–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting tkelley on DSK3SPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 17:31 Feb 23, 2015 Jkt 235001 Name of Committee: Neurological 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 April 17, 2015, from 8 a.m. to 4 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Jamie.Waterhouse@ fda.hhs.gov, 301–796–3063, 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 April 17, 2015, the committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology. FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies, for flow diverter technology indicated for the neurovasculature. Flow diverters are an endoluminal treatment option for intracranial aneurysms. They are similar to traditional stents in their tubular metal structure but with a significantly higher mesh density. The working principle is that the high-mesh density reduces flow rate into the aneurysm which promotes blood stasis and occlusion of the aneurysm. Flow diverters are advantageous for the treatment of large/ PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 9733 giant wide-neck aneurysms and offer an alternative to other interventional techniques or surgery. 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 3, 2015. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. 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 March 24, 2015. 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 March 27, 2015. 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 AnnMarie Williams at Annmarie.Williams@ fda.hhs.gov, or 301–796–5966 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 E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Page 9733]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03688]



[[Page 9733]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Anesthetic and Analgesic Drug Products Advisory Committee; Notice 
of Meeting; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Anesthetic and Analgesic Drug Products Advisory Committee; 
Notice of Meeting'' that appeared in the Federal Register of February 
6, 2015 (80 FR 6731). The document announced a forthcoming meeting of a 
public advisory committee of the Food and Drug Administration (FDA). 
The document was published with the incorrect docket number. This 
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, 
Planning, Legislation, and Analysis, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993, 
301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 6, 2015, 
in FR Doc. 2015-02408, on page 6731, the following correction is made:
    On page 6731, in the first column, in the Docket No. heading, 
``[Docket No. FDA-2011-N-0824]'' is corrected to read ``[Docket No. 
FDA-2015-N-0001]''.

    Dated: February 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03688 Filed 2-23-15; 8:45 am]
BILLING CODE 4164-01-P

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