Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 9733 

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. 

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 

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 

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: 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: 

http://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 http://

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/ 

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 http://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 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 


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