82_FR_47949 82 FR 47752 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

82 FR 47752 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 197 (October 13, 2017)

Page Range47752-47753
FR Document2017-22174

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

Federal Register, Volume 82 Issue 197 (Friday, October 13, 2017) 
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47752-47753]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5953]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 47753]]

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Orthopaedic and Rehabilitation 
Devices Panel of the Medical Devices Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will be held on December 12, 2017, from 8 a.m. to 6 
p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, salons A, B, C, and 
D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900.

FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993-0002, 301-
796-7047, [email protected], 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On December 12, 2017, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval application (PMA) for the Barricaid Anular Closure Device by 
Intrinsic Therapeutics. The proposed Indication for Use, as stated in 
the PMA, is as follows: The Barricaid is intended to be implanted 
following a limited discectomy, to prevent reherniation and the 
recurrence of pain or dysfunction. The Barricaid is indicated for 
patients with radiculopathy (with or without back pain), a posterior or 
posterolateral herniation, characterized by radiographic confirmation 
of neural compression using magnetic resonance imaging, and a large 
anular defect (e.g., between 4-6 mm tall and between 6-12 mm wide) post 
discectomy, at one level between L4 and S1.
    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 
December 1, 2017. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.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 November 3, 2017. 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 November 9, 2017.
    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 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at [email protected] 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 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: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22174 Filed 10-12-17; 8:45 am]
 BILLING CODE 4164-01-P

47752 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices for FDA’s Agricultural Biotechnology Fax: 240–641–9042, email: Streaming Webcast of the Public Education and Outreach Initiative. simone.katz@strategicresults.com no Meeting: Each public meeting will also later than October 20, 2017, for the be webcast. Individuals who wish to III. Participating in the Public Meeting Charlotte, NC, meeting and no later than participate by webcast are asked to Registration: To register for a public October 27, 2017, for the San Francisco, preregister at: https://www.fda.gov/ meeting, please include your name, CA, meeting. Food/NewsEvents/ title, firm name, address, and phone and WorkshopsMeetingsConferences/ Requests for Oral Presentations: fax numbers in your registration default.htm information and send to: Simone Katz, During online registration you may If you have never attended a Connect Strategic Results, 101 Lakeforest Blvd., indicate if you wish to present during a Pro event before, test your connection at Suite 390, Gaithersburg, MD 20877, public comment session or participate https://collaboration.fda.gov/common/ 240–449–8427, Fax: 240–641–9042, in a specific session, and which topic(s) help/en/support/meeting_test.htm. To email: simone.katz@ you wish to address. We will do our get a quick overview of the Connect Pro strategicresults.com. You can register for best to accommodate requests to make program, visit https://www.adobe.com/ one or both meetings. public comments. Individuals and go/connectpro_overview. FDA has Registration is free and based on organizations with common interests are verified the Web site addresses in this space availability, with priority given to urged to consolidate or coordinate their document, as of the date this document early registrants. Persons interested in presentations, and request time for a publishes in the Federal Register, but attending this public meeting must joint presentation, or submit requests for Web sites are subject to change over register by October 30, 2017, for the designated representatives to participate time. Charlotte, NC, meeting and must register in the focused sessions. Following the Transcripts: Please be advised that as by November 6, 2017, for the San close of registration, we will determine soon as a transcript of each public Francisco, CA, meeting. Early the amount of time allotted to each meeting is available, it will be accessible registration is recommended because presenter and the approximate time at https://www.regulations.gov. It may seating is limited; therefore, FDA may each oral presentation is to begin, and be viewed at the Dockets Management limit the number of participants from will select and notify participants by Staff (see ADDRESSES). A link to the each organization. Registrants will October 24, 2017, for the meeting in transcript will also be available on the receive confirmation when they have Charlotte, NC, and by November 1, internet at https://www.fda.gov/Food/ been accepted. 2017, for the meeting in San Francisco, NewsEvents/ If you need special accommodations CA. All requests to make oral WorkshopsMeetingsConferences/ due to a disability, please contact presentations must be received by default.htm. Simone Katz, Strategic Results, 101 October 20, 2017, for the meeting in Other Issues for Consideration: A Lakeforest Blvd., Suite 390, Charlotte, NC, and by October 27, 2017, summary of key information on Gaithersburg, MD 20877, 240–449–8427, for the meeting in San Francisco, CA. participating in a meeting follows: TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING Request to Special Submit either electronic or Date Address Preregister Electronic address make an oral accommoda- written comments presentation tions November 7, Omni Charlotte October 30, Please preregister at https:// October 20, October 20, Submit Comments by November 2017, from 8:30 Hotel, 132 E 2017: Closing www.fda.gov/Food/ 2017. 2017: Closing 17, 2017, to: https:// a.m. to 1 p.m. Trade St., date for reg- NewsEvents/ date to re- www.regulations.gov, or Dock- EST. Charlotte, NC istration. WorkshopsMeetingsConferen- quest special ets Management Staff (HFA– 28202. ces/default.htm. accommoda- 305), Food and Drug Adminis- tions due to a tration, 5630 Fishers Lane, disability. Rm. 1061, Rockville, MD 20852. November 14, San Francisco November 6, Please preregister at https:// October 27, October 27, Same as above. 2017, from 8:30 Marriott Mar- 2017: Closing www.fda.gov/Food/ 2017. 2017: closing a.m. to 1 p.m. quis, 780 Mis- date for reg- NewsEvents/ date to re- PST. sion St., San istration. WorkshopsMeetingsConferen- quest special Francisco, CA ces/default.htm. accommoda- 94103. tions due to a disability. You may also register via email, mail, WorkshopsMeetingsConferences/ DEPARTMENT OF HEALTH AND or fax. Please include your name, title, default.htm. HUMAN SERVICES firm name, address, and phone and Fax Dated: October 6, 2017. numbers in your registration Food and Drug Administration Anna K. Abram, information and send to: Simone Katz, Deputy Commissioner for Policy, Planning, Strategic Results, 101 Lakeforest Blvd., [Docket No. FDA–2017–N–5953] asabaliauskas on DSKBBXCHB2PROD with NOTICES Legislation, and Analysis. Suite 390, Gaithersburg, MD 20877, 240–449–8427, Fax: 240–641–9042, [FR Doc. 2017–22172 Filed 10–12–17; 8:45 am] Orthopaedic and Rehabilitation email: simone.katz@ BILLING CODE 4164–01–P Devices Panel of the Medical Devices strategicresults.com. Advisory Committee; Notice of Meeting Individuals who wish to participate AGENCY: Food and Drug Administration, by webcast are asked to preregister at: HHS. https://www.fda.gov/Food/NewsEvents/ ACTION: Notice. VerDate Sep<11>2014 18:05 Oct 12, 2017 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47753 SUMMARY: The Food and Drug than 2 business days before the meeting. Dated: October 6, 2017. Administration (FDA) announces a If FDA is unable to post the background Anna K. Abram, forthcoming public advisory committee material on its Web site prior to the Deputy Commissioner for Policy, Planning, meeting of the Orthopaedic and meeting, the background material will Legislation, and Analysis. Rehabilitation Devices Panel of the be made publicly available at the [FR Doc. 2017–22174 Filed 10–12–17; 8:45 am] Medical Devices Advisory Committee. location of the advisory committee BILLING CODE 4164–01–P The general function of the committee is meeting, and the background material to provide advice and recommendations will be posted on FDA’s Web site after to the Agency on FDA’s regulatory the meeting. Background material is DEPARTMENT OF HEALTH AND issues. The meeting will be open to the available at https://www.fda.gov/ HUMAN SERVICES public. AdvisoryCommittees/Calendar/ DATES: The meeting will be held on default.htm. Scroll down to the National Institutes of Health December 12, 2017, from 8 a.m. to 6 appropriate advisory committee meeting p.m. link. Government-Owned Inventions; Procedure: Interested persons may Availability for Licensing ADDRESSES: Hilton Washington DC North/Gaithersburg, salons A, B, C, and present data, information, or views, AGENCY: National Institutes of Health, D, 620 Perry Pkwy., Gaithersburg, MD orally or in writing, on issues pending HHS. 20877. The hotel’s telephone number is before the committee. Written ACTION: Notice. 301–977–8900. submissions may be made to the contact FOR FURTHER INFORMATION CONTACT: Sara person on or before December 1, 2017. SUMMARY: The inventions listed below J. Anderson, Center for Devices and Oral presentations from the public will are owned by an agency of the U.S. Radiological Health, Food and Drug be scheduled between approximately 1 Government and are available for Administration, 10903 New Hampshire p.m. and 2 p.m. Those individuals licensing in the U.S. Ave., Bldg. 66, Rm. G616, Silver Spring, interested in making formal oral FOR FURTHER INFORMATION CONTACT: MD 20993–0002, 301–796–7047, presentations should notify the contact Licensing information and copies of the Sara.Anderson@fda.hhs.gov, or FDA person and submit a brief statement of patent applications listed below may be Advisory Committee Information Line, the general nature of the evidence or obtained by emailing the indicated 1–800–741–8138 (301–443–0572 in the arguments they wish to present, the licensing contact at the National Heart, Washington, DC area). A notice in the names and addresses of proposed Lung, and Blood, Office of Technology Federal Register about last minute participants, and an indication of the Transfer and Development Office of modifications that impact a previously approximate time requested to make Technology Transfer, 31 Center Drive announced advisory committee meeting their presentation on or before Room 4A29, MSC2479, Bethesda, MD cannot always be published quickly November 3, 2017. Time allotted for 20892–2479; telephone: 301–402–5579. enough to provide timely notice. each presentation may be limited. If the A signed Confidential Disclosure Therefore, you should always check the number of registrants requesting to Agreement may be required to receive Agency’s Web site at https:// speak is greater than can be reasonably copies of the patent applications. www.fda.gov/AdvisoryCommittees/ accommodated during the scheduled SUPPLEMENTARY INFORMATION: This default.htm and scroll down to the open public hearing session, FDA may notice is in accordance with 35 U.S.C. appropriate advisory committee meeting conduct a lottery to determine the 209 and 37 CFR part 404 to achieve link, or call the advisory committee speakers for the scheduled open public expeditious commercialization of information line to learn about possible hearing session. The contact person will results of federally-funded research and modifications before coming to the notify interested persons regarding their development. Foreign patent meeting. request to speak by November 9, 2017. applications are filed on selected SUPPLEMENTARY INFORMATION: Persons attending FDA’s advisory inventions to extend market coverage Agenda: On December 12, 2017, the committee meetings are advised that the for companies and may also be available committee will discuss, make Agency is not responsible for providing for licensing. A description of the recommendations, and vote on access to electrical outlets. technology follows. information regarding the premarket FDA welcomes the attendance of the public at its advisory committee Derivatives of approval application (PMA) for the meetings and will make every effort to Docosahexaenoylethanolamide (DEA) Barricaid Anular Closure Device by accommodate persons with disabilities. for Neurogenesis Intrinsic Therapeutics. The proposed Indication for Use, as stated in the PMA, If you require accommodations due to a The invention pertains to derivatives is as follows: The Barricaid is intended disability, please contact AnnMarie of docosahexaenoylethanolamide to be implanted following a limited Williams at Annmarie.Williams@ (synaptamide or DEA) and their use in discectomy, to prevent reherniation and fda.hhs.gov or 301–796–5966 at least 7 inducing neurogenesis, neurite growth, the recurrence of pain or dysfunction. days in advance of the meeting. and/or synaptogenesis. As such, these The Barricaid is indicated for patients FDA is committed to the orderly DEA derivatives can be used as with radiculopathy (with or without conduct of its advisory committee therapeutics for neurodegenerative back pain), a posterior or posterolateral meetings. Please visit our Web site at diseases such as traumatic brain injury, https://www.fda.gov/ asabaliauskas on DSKBBXCHB2PROD with NOTICES herniation, characterized by spinal cord injury, peripheral nerve radiographic confirmation of neural AdvisoryCommittees/ injury, stroke, multiple sclerosis, compression using magnetic resonance AboutAdvisoryCommittees/ autism, Alzheimer’s disease, imaging, and a large anular defect (e.g., ucm111462.htm for procedures on Huntington’s disease, Parkinson’s between 4–6 mm tall and between 6–12 public conduct during advisory disease, amyotrophic lateral sclerosis. mm wide) post discectomy, at one level committee meetings. The DEA derivatives of the invention between L4 and S1. Notice of this meeting is given under have increased potency and hydrolysis FDA intends to make background the Federal Advisory Committee Act (5 resistance as compared to native DEA. material available to the public no later U.S.C. app. 2). Docosahexaenoic acid (DHA), an n-3 VerDate Sep<11>2014 18:05 Oct 12, 2017 Jkt 244001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1


Document Created: 2017-10-13 04:34:10
Document Modified: 2017-10-13 04:34:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on December 12, 2017, from 8 a.m. to 6 p.m.
ContactSara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993-0002, 301- 796-7047, [email protected], 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.
FR Citation82 FR 47752 
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