80 FR 8326 - Orthopaedic and Rehabilitation Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

Page Range		8326-8327
FR Document		2015-03155

Federal Register, Volume 80 Issue 31 (Tuesday, February 17, 2015)

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8326-8327]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Orthopaedic and Rehabilitation 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 February 20, 2015, from 
8 a.m. to 6 p.m.
    Location: Hilton/Washington DC North, 620 Perry Pkwy., 
Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. 
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: Sara Anderson, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm.1643, Silver Spring, MD 20993-0002, 
[email protected], 301-796-7047, 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

[[Page 8327]]

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 February 20, 2015, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval application (PMA) for the Superion InterSpinous Spacer device 
sponsored by Vertiflex Inc. The proposed indication for use for the 
Superion InterSpinous Spacer device, as stated in the PMA, is as 
follows: The Superion InterSpinous Spacer (the Superion ISS) is 
intended to treat skeletally mature patients suffering from pain, 
numbness, and/or cramping in the legs (neurogenic intermittent 
claudication) secondary to a diagnosis of moderate lumbar spinal 
stenosis, with or without grade 1 spondylolisthesis, confirmed by x 
ray, magnetic resonance imaging, and/or computed tomography evidence of 
thickened ligamentum flavum, narrowed lateral recess, and/or central 
canal or foraminal narrowing. The Superion ISS is indicated for those 
patients with impaired physical function who experience relief in 
flexion from symptoms of leg/buttock/groin pain, numbness, and/or 
cramping, with or without back pain. The Superion ISS may be implanted 
at one or two adjacent lumbar (L) levels in patients in whom treatment 
is indicated at no more than two levels, from L1 to L5.
    The meeting was originally scheduled for December 12, 2014. The 
meeting date is being postponed from December 12, 2014, until February 
20, 2015, due to FDA needing additional time to review information 
supplied by sponsor.
    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 
February 18, 2015. 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 February 13, 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 February 17, 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 Anne Marie 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 http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the February 20, 2015, Orthopaedic and Rehabilitation Panel of the 
Medical Devices Advisory Committee meeting. Because the Agency believes 
there is some urgency to bring these issues to public discussion and 
qualified members of the Orthopaedic and Rehabilitation Panel of the 
Medical Devices Advisory Committee were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03155 Filed 2-13-15; 8:45 am]
BILLING CODE 4164-01-P

8326 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices

clinical investigators, of IRB, and of physicians. CNE for Nurses: Society of closely with stakeholders and
research sponsors. Clinical Research Associates is maximizing the availability and clarity
Date and Time: The conference will accredited as a provider of continuing of information to stakeholders and the
be held on March 11 and 12, nursing education by the American public. The workshop also is consistent
(Wednesday and Thursday) 2015, from Nurses Credentialing Center’s with the Small Business Regulatory
8:00 a.m. to 5 p.m. Commission on Accreditation. Enforcement Fairness Act of 1996 (Pub.
Location: The conference will be held Registration Instructions: To register, L. 104–121), as outreach activities by
at the Holiday Inn Golden Gateway please submit a registration form with Government Agencies to small
Hotel, 1500 Van Ness Ave., San your name, affiliation, mailing address, businesses.
Francisco, CA 91409, 415–441–4000. telephone, FAX number, and email,
Attendees are responsible for their Dated: February 10, 2015.
along with a check or money order Leslie Kux,
own accommodations. Please mention payable to ‘‘SOCRA’’. Mail to:
SOCRA to receive the hotel room rate of Associate Commissioner for Policy.
SOCRA(see Contact Person for address).
$159.00 plus applicable taxes (available To register via the Internet, go to http:// [FR Doc. 2015–03118 Filed 2–13–15; 8:45 am]
until February 13, 2015, or until the www.socra.org/html/ BILLING CODE 4164–01–P
SOCRA room block is filled). FDA_Conference.htm. Payment by
Contact Person: Jane Kreis, Food and major credit card is accepted (Visa/
Drug, Administration, 1301 Clay St., MasterCard/AMEX only). For more
DEPARTMENT OF HEALTH AND
Suite 1180N, Oakland, CA 94612, 510– HUMAN SERVICES
information on the meeting registration,
287–2708, FAX: 510–287–2739 or
or for questions on the workshop, Food and Drug Administration
Society of Clinical Research Associates
contact SOCRA (see Contact Person).
(SOCRA), 530 West Butler Ave., Suite [Docket No. FDA–2015–N–0001]
109, Chalfont, PA 18914. 800–762–7292 SUPPLEMENTARY INFORMATION: The
or 215–822–8644, FAX: 215–822–8633, public workshop helps fulfill the
Orthopaedic and Rehabilitation Panel
email: Office@socra.org Web site: Department of Health and Human
of the Medical Devices Advisory
www.socra.org. (FDA has verified the Services’ and FDA’s important mission
Committee; Notice of Meeting
Web site addresses throughout this to protect the public health. The
document, but we are not responsible workshop will provide those engaged in AGENCY: Food and Drug Administration,
for any subsequent changes to the Web FDA-regulated (human) clinical trials HHS.
sites after this document publishes in with information on a number of topics ACTION: Notice.
the Federal Register). concerning FDA requirements related
Registration: The registration fee will informed consent, clinical investigation This notice announces a forthcoming
cover actual expenses including requirements, institutional review board meeting of a public advisory committee
refreshments, lunch, materials and inspections, electronic record of the Food and Drug Administration
speaker expenses. Seats are limited; requirements, and investigator initiated (FDA). The meeting will be open to the
please submit your registration as soon research Topics for discussion include public.
as possible. Workshop space will be the following: (1) The Role of the FDA Name of Committee: Orthopaedic and
filled in order of receipt of registration. District Office Relative to the Rehabilitation Panel of the Medical
Those accepted into the workshop will Bioresearch Monitoring Program Devices Advisory Committee.
receive confirmation. The cost of the (BIMO); (2) Modernizing FDA’s Clinical General Function of the Committee:
registration is as follows: SOCRA Trials/BIMO Programs; (3) What FDA To provide advice and
member—$575, SOCRA nonmember Expects in a Pharmaceutical Clinical recommendations to the Agency on
(includes membership)—$650, Federal Trial: (4) Medical Device Aspects of FDA’s regulatory issues.
Government member—$450.00, Federal Clinical Research; (5) Adverse Event Date and Time: The meeting will be
Government nonmember—$525.00, Reporting—Science, Regulation, Error held on February 20, 2015, from 8 a.m.
FDA Employee—(free) Fee Waived. and Safety; (6) Working with FDA’s to 6 p.m.
If you need special accommodations Center for Biologics Evaluation and Location: Hilton/Washington DC
due to a disability, please contact Research; (7) Ethical Issues in Subject North, 620 Perry Pkwy., Gaithersburg,
SOCRA (see Contact Person) at least 21 Enrollment; (8) Keeping Informed and MD 20877. The hotel’s telephone
days in advance. Working Together; (9) FDA Conduct of number is 301–977–8900. Answers to
Extended periods of question and Clinical Investigator Inspections; (10) commonly asked questions including
answer and discussion have been Investigator Initiated Research; (11) information regarding special
included in the program schedule. Meetings with the FDA—Why, When accommodations due to a disability,
SOCRA designates this education and How; (12) Part 11 Compliance— visitor parking, and transportation may
activity for a maximum of 13.3 Electronic Signatures; (13) IRB be accessed at: http://www.fda.gov/
Continuing Education Credits for Regulations and FDA Inspections; (14) AdvisoryCommittees/AboutAdvisory
SOCRA continuing education (CE) and Informed Consent Regulations; (15) The Committees/ucm408555.htm.
Nurse continuing nurse education Inspection is Over—What Happens Contact Person: Sara Anderson, Food
(CNE), SOCRA designates this live Next? Possible FDA Compliance and Drug Administration, 10903 New
activity for a maximum of 13.3 Actions; (16) Question and Answer Hampshire Ave., Bldg. 66, Rm.1643,
American Medical Association Session/Panel Discussion. Silver Spring, MD 20993–0002,
Physician’s Recognition Award Category FDA has made education of the drug sara.anderson@fda.hhs.gov, 301–796–
tkelley on DSK3SPTVN1PROD with NOTICES

1 Credit(s)TM. Physicians should claim and device manufacturing community a 7047, or FDA Advisory Committee
only the credit commensurate with the high priority to help ensure the quality Information Line, 1–800–741–8138
extent of their participation. Continuing of FDA-regulated drugs and devices. (301–443–0572 in the Washington, DC
medical education (CME) for The workshop helps to achieve area). A notice in the Federal Register
Physicians: SOCRA is accredited by the objectives set forth in section 406 of the about last minute modifications that
Accreditation Council for Continuing FDA Modernization Act of 1997 (21 impact a previously announced
Medical Education to provide CME for U.S.C. 393) which includes working advisory committee meeting cannot

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Document Created: 2015-12-18 13:20:06
Document Modified: 2015-12-18 13:20:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
FR Citation		80 FR 8326

80 FR 8326 - Orthopaedic and Rehabilitation Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration