Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 66942-66944 [2013-26722]
Download as PDF
<![CDATA[
66942
Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
For devices regulated by CDRH:
Gregory Campbell, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2110, Silver Spring,
MD 20993–0002, 301–796–5750.
For devices regulated by CBER:
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
I. Background
The guidance document is intended
to provide guidance to those involved in
designing clinical studies that support
premarket submissions for medical
devices and FDA staff who review those
submissions. Although the Agency has
articulated policies related to design of
studies intended to support specific
device types, and a general policy of
tailoring the evidentiary burden to the
regulatory requirement, the Agency has
not attempted to describe the different
clinical study designs that may be
appropriate to support a device
premarket submission, or to define how
a sponsor should decide which pivotal
clinical study design should be used to
support a submission for a particular
device. The guidance document
describes different study design
principles relevant to the development
of medical device clinical studies that
can be used to fulfill premarket clinical
data requirements. The guidance is not
intended to provide a comprehensive
tutorial on the best clinical and
statistical practices for investigational
medical device studies.
A medical device pivotal study is a
definitive study in which evidence is
gathered to support the safety and
effectiveness evaluation of the medical
device for its intended use. Evidence
from one or more pivotal clinical
studies generally serves as the primary
basis for the determination of reasonable
assurance of safety and effectiveness of
the medical device of a premarket
approval application (PMA) and FDA’s
overall risk-benefit assessment. In some
cases, a PMA may include multiple
studies designed to answer different
scientific questions.
The guidance describes principles
that should be followed for the design
VerDate Mar<15>2010
16:24 Nov 06, 2013
Jkt 232001
of premarket clinical studies that are
pivotal in establishing the safety and
effectiveness of a medical device.
Practical issues and pitfalls in pivotal
clinical study design are discussed,
along with their effects on the
conclusions that can be drawn from the
studies concerning safety and
effectiveness.
In the Federal Register of August 15,
2011 (76 FR 50484), FDA announced the
availability of the draft guidance.
Interested persons were invited to
comment by November 14, 2011. FDA
considered the comments and revised
the guidance, as appropriate.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on pivotal clinical
investigations for medical devices. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. To receive
‘‘Device Considerations for Pivotal
Clinical Investigations for Medical
Devices,’’ you may either send an email
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1776 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under 0910–0120; the
collections of information in 21 CFR
part 812 have been approved under
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
0910–0078; the collections of
information in 21 CFR part 814 have
been approved under 0910–0231.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: November 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–26690 Filed 11–6–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Orthopaedic and Rehabilitation
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: Orthopaedic and
Rehabilitation 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 December 12, 2013, from 8 a.m.
to 6:30 p.m.
Location: 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.
Contact Person: Sara Anderson,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 1643, 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
E:\FR\FM\07NON1.SGM
07NON1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
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 December 12, 2013,
during Session I, the committee will
discuss and make recommendations
regarding the classification of spinal
sphere devices. These devices are
spheres manufactured from metallic
(e.g., cobalt chromium molybdenum) or
polymeric (e.g., polyetheretherketone)
materials. They are intended to be
inserted between the vertebral bodies
into the disc space from L3–S1 to help
provide stabilization and to help
promote intervertebral body fusion.
During the arthrodesis procedure, they
are to be used with bone graft. These
devices are not intended for use in
motion-sparing, non-fusion procedures.
Spinal sphere devices are considered
preamendment devices because they
were in commercial distribution prior to
May 28, 1976, when the Medical Device
Amendments became effective. Spinal
sphere devices are currently regulated
under the heading of ‘‘Intervertebral
Fusion Device with Bone Graft, SolidSphere, Lumbar’’, Product Code NVR, as
unclassified devices and reviewed
under the 510(k) premarket notification
authority. FDA is seeking committee
input on the safety and effectiveness of
spinal sphere devices and the regulatory
classification for spinal sphere devices.
On December 12, 2013, during
Session II, the committee will discuss
and make recommendations regarding
the reclassification petition received on
November 20, 2012, from DEKA
Research & Development Corp.
requesting that FDA reclassify stair
climbing wheelchairs (21 CFR 890.3890)
from Class III to Class II. A stairclimbing wheelchair is a device with
wheels that is intended for medical
purposes to provide mobility to persons
restricted to a sitting position. The
device is intended to climb stairs. On
June 12, 2013 (78 FR 35173), FDA
issued a proposed order which, if made
final, would reclassify stair-climbing
wheelchairs as Class II subject to
premarket notification (510(k)) and
special controls. The petitioner has one
stair-climbing wheelchair approved, the
iBot (P020033), and it is indicated for
the following: to provide indoor and
VerDate Mar<15>2010
16:24 Nov 06, 2013
Jkt 232001
outdoor mobility in confined spaces, at
an elevated height, climb curbs, ascend/
descend stairs, traverse obstacles, travel
over a wider variety of terrain, and
negotiate uneven/inclined surfaces.
Stair-climbing wheelchairs are
preamendment devices because they
were in commercial distribution prior to
May 28, 1976, when the Medical Device
Amendments became effective. Stairclimbing wheelchairs are currently
regulated as Class III devices. A call for
premarket approval (PMA) applications
was issued on April 13, 2000 (effective
July 12, 2000) (65 FR 19834).
The committee’s discussion will
include recommendations regarding the
regulatory classifications noted above.
The committee will also discuss
whether the proposed special controls
are adequate to reasonably ensure the
safety and effectiveness of stair-climbing
wheelchairs.
On December 12, 2013, during
Session III, the committee will discuss
and make recommendations regarding
the possible reclassification of
mechanical wheelchairs (21 CFR
890.3850) from Class I, currently subject
to premarket notification (510(k)), to
Class II, subject to special controls. The
mechanical wheelchairs are being
considered for exemption from
premarket notification (510(k))
requirements. A mechanical wheelchair
is a manually operated device with
wheels that is intended for medical
purposes to provide mobility to persons
restricted to a sitting position. No
proposed order has been issued for this
proposed change in classification.
Mechanical wheelchairs are
preamendment devices because they
were in commercial distribution prior to
May 28, 1976, when the Medical Device
Amendments became effective.
Mechanical wheelchairs are currently
regulated as Class I devices that are
subject to premarket notification
(510(k)) requirements (48 FR 53041).
The committee will discuss whether
general and/or special controls are
appropriate to demonstrate a reasonable
assurance of safety and effectiveness of
mechanical wheelchairs and whether, if
reclassified to Class II, these devices
should be exempt from premarket
notification (510(k)) requirements.
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
66943
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 November 21, 2013.
Oral presentations will be scheduled
between approximately 9:15 a.m. and
9:35 a.m. for Session I and between
approximately 2:40 p.m. and 3:20 p.m.
for Session II and Session III. 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 the
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before November 13, 2013. 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 14, 2013.
Persons attending FDAs 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 James Clark,
James.Clark@fda.hhs.gov or 301–796–
5293, 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).
E:\FR\FM\07NON1.SGM
07NON1
66944
Federal Register / Vol. 78, No. 216 / Thursday, November 7, 2013 / Notices
Dated: November 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–26722 Filed 11–6–13; 8:45 am]
Information Collection Request Title:
Scholarships for Disadvantaged
Students Application and Performance
Report (SDSPR); OMB No. 0915–0149—
Revision
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
SUMMARY:
Abstract: The purpose of the
Scholarships for Disadvantaged
Students (SDS) Program is to promote
diversity among health profession
students and practitioners by providing
funds to eligible schools to provide
scholarships to full-time, financially
needy students from disadvantaged
backgrounds enrolled in health
professions and nursing programs.
To qualify for participation in the SDS
program, a school must be carrying out
a program for recruiting and retaining
students from disadvantaged
backgrounds, including students who
are members of racial and ethnic
minority groups (section 737(d)(1)(B) of
the PHS Act). A school must meet the
eligibility criteria to demonstrate that
the program has achieved success based
on the number and/or percentage of
disadvantaged students who graduate
from the school. In awarding SDS funds
to eligible schools, funding points must
be given to schools based on the
proportion of graduate students
practicing in primary care, the
proportion of underrepresented
minority students, and the proportion of
graduates working in medically
underserved communities (section
737(c) of the PHS Act).
Information collected from the SDS
application and SDS report is needed by
the Department to determine whether
applicant schools meet the statutory and
regulatory requirements, to determine
eligibility for program participation, and
to establish priority points for funding.
Applicant schools are requested to
complete an application for each
discipline or program. Data are provided
on numbers of full-time student
enrollment and the applicant schools’
racial/ethnicity data, disadvantaged fulltime enrollment by class year, full-time
students graduated, full-time
disadvantaged students graduated, and
full-time graduates serving in Medically
Underserved Communities. Numbers of
full-time graduates serving in primary
care must be provided only for schools
of medicine, osteopathic medicine,
dentistry, nursing (graduate degree
program), physician assistants, dental
hygiene, and mental and behavioral
health.
Each school will determine the
eligibility of students based on financial
need and whether a student is from a
disadvantaged background.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
400
99
1
1
400
99
13
24
5,200
2,376
Total ..............................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
SDS Application Program Specific form ..............................
SDS Performance Report Form ..........................................
499
........................
499
........................
7,576
VerDate Mar<15>2010
16:24 Nov 06, 2013
Jkt 232001
PO 00000
Frm 00055
Fmt 4703
Sfmt 9990
E:\FR\FM\07NON1.SGM
07NON1
]]>Agencies
[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66942-66944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26722]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 December 12, 2013, from
8 a.m. to 6:30 p.m.
Location: 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.
Contact Person: Sara Anderson, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1643, 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
[[Page 66943]]
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 December 12, 2013, during Session I, the committee will
discuss and make recommendations regarding the classification of spinal
sphere devices. These devices are spheres manufactured from metallic
(e.g., cobalt chromium molybdenum) or polymeric (e.g.,
polyetheretherketone) materials. They are intended to be inserted
between the vertebral bodies into the disc space from L3-S1 to help
provide stabilization and to help promote intervertebral body fusion.
During the arthrodesis procedure, they are to be used with bone graft.
These devices are not intended for use in motion-sparing, non-fusion
procedures.
Spinal sphere devices are considered preamendment devices because
they were in commercial distribution prior to May 28, 1976, when the
Medical Device Amendments became effective. Spinal sphere devices are
currently regulated under the heading of ``Intervertebral Fusion Device
with Bone Graft, Solid-Sphere, Lumbar'', Product Code NVR, as
unclassified devices and reviewed under the 510(k) premarket
notification authority. FDA is seeking committee input on the safety
and effectiveness of spinal sphere devices and the regulatory
classification for spinal sphere devices.
On December 12, 2013, during Session II, the committee will discuss
and make recommendations regarding the reclassification petition
received on November 20, 2012, from DEKA Research & Development Corp.
requesting that FDA reclassify stair climbing wheelchairs (21 CFR
890.3890) from Class III to Class II. A stair-climbing wheelchair is a
device with wheels that is intended for medical purposes to provide
mobility to persons restricted to a sitting position. The device is
intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a
proposed order which, if made final, would reclassify stair-climbing
wheelchairs as Class II subject to premarket notification (510(k)) and
special controls. The petitioner has one stair-climbing wheelchair
approved, the iBot (P020033), and it is indicated for the following: to
provide indoor and outdoor mobility in confined spaces, at an elevated
height, climb curbs, ascend/descend stairs, traverse obstacles, travel
over a wider variety of terrain, and negotiate uneven/inclined
surfaces.
Stair-climbing wheelchairs are preamendment devices because they
were in commercial distribution prior to May 28, 1976, when the Medical
Device Amendments became effective. Stair-climbing wheelchairs are
currently regulated as Class III devices. A call for premarket approval
(PMA) applications was issued on April 13, 2000 (effective July 12,
2000) (65 FR 19834).
The committee's discussion will include recommendations regarding
the regulatory classifications noted above. The committee will also
discuss whether the proposed special controls are adequate to
reasonably ensure the safety and effectiveness of stair-climbing
wheelchairs.
On December 12, 2013, during Session III, the committee will
discuss and make recommendations regarding the possible
reclassification of mechanical wheelchairs (21 CFR 890.3850) from Class
I, currently subject to premarket notification (510(k)), to Class II,
subject to special controls. The mechanical wheelchairs are being
considered for exemption from premarket notification (510(k))
requirements. A mechanical wheelchair is a manually operated device
with wheels that is intended for medical purposes to provide mobility
to persons restricted to a sitting position. No proposed order has been
issued for this proposed change in classification.
Mechanical wheelchairs are preamendment devices because they were
in commercial distribution prior to May 28, 1976, when the Medical
Device Amendments became effective. Mechanical wheelchairs are
currently regulated as Class I devices that are subject to premarket
notification (510(k)) requirements (48 FR 53041).
The committee will discuss whether general and/or special controls
are appropriate to demonstrate a reasonable assurance of safety and
effectiveness of mechanical wheelchairs and whether, if reclassified to
Class II, these devices should be exempt from premarket notification
(510(k)) requirements.
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
November 21, 2013. Oral presentations will be scheduled between
approximately 9:15 a.m. and 9:35 a.m. for Session I and between
approximately 2:40 p.m. and 3:20 p.m. for Session II and Session III.
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 the proposed participants, and an indication of the
approximate time requested to make their presentation on or before
November 13, 2013. 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 14,
2013.
Persons attending FDAs 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 James Clark,
James.Clark@fda.hhs.gov or 301-796-5293, 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).
[[Page 66944]]
Dated: November 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-26722 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P
