Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 25747-25749 [2013-10394]
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25747
Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Notices
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the procedure by which an applicant
may obtain an assignment or
designation determination for
combination products.
DATES: Submit either electronic or
written comments on the collection of
information by July 1, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
SUPPLEMENTARY INFORMATION:
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—(OMB Control
Number 0910–0523)—Extension
This regulation relates to Agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), and amended
by the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250), by specifying how FDA will
determine the organizational component
within FDA assigned to have primary
jurisdiction for the premarket review
and regulation of products that are
comprised of any combination of: (1) A
drug and a device; (2) a device and a
biological product; (3) a biological
product and a drug; or (4) a drug, a
device, and a biological product. The
second purpose of this regulation is to
enhance the efficiency of Agency
management and operations by
providing procedures for classifying and
determining which Agency component
is designated to have primary
jurisdiction for any drug, device, or
biological product where such
jurisdiction is unclear or in dispute.
The regulation establishes a
procedure by which an applicant may
obtain an assignment or designation
determination. The regulation requires
that the request include the identity of
the applicant, a comprehensive
description of the product and its
proposed use, and the applicant’s
recommendation as to which Agency
component should have primary
jurisdiction, with an accompanying
statement of reasons. The information
submitted would be used by FDA as the
basis for making the assignment or
designation decision. Most information
required by the regulation is already
required for premarket applications
affecting drugs, devices, biological
products and combination products.
The respondents will be businesses or
other for-profit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Part 3 ...................................................................................
43
1
43
24
1,032
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
sroberts on DSK5SPTVN1PROD with NOTICES
These burden estimates are based on
the number of applications FDA
received over the past two fiscal years.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[Docket No. FDA–2013–N–0001]
[FR Doc. 2013–10376 Filed 5–1–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
Gastroenterology and Urology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
16:50 May 01, 2013
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PO 00000
Notice.
Frm 00057
Fmt 4703
Sfmt 4703
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: Gastroenterology
and Urology 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.
E:\FR\FM\02MYN1.SGM
02MYN1
sroberts on DSK5SPTVN1PROD with NOTICES
25748
Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Notices
Date and Time: The meeting will be
held on June 27, 2013, from 8 a.m. to 6
p.m.
Location: Holiday Inn, Ballroom, 2
Montgomery Village Ave., Gaithersburg,
MD 20879. The hotel’s phone number is
301–948–8900.
Contact Person: Shanika Craig,
Shanika.Craig@fda.hhs.gov, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–6639, 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 June 27, 2013, during
session I, the committee will discuss
and make recommendations regarding
the proposed classification of sorbent
hemoperfusion systems, one of the
remaining preamendments class III
devices. The class III sorbent
hemoperfusion system is a device
intended for the treatment of poisoning,
drug overdose, hepatic coma, and
metabolic disturbances. It consists of an
extracorporeal blood system and a
container filled with adsorbent material
that removes a wide range of substances,
both toxic and normal, from blood
flowing through it. The adsorbent
materials are usually activated carbon or
resins, which may be coated or
immobilized to prevent fine particles
from entering the patient’s blood. The
generic type of device may include lines
and filters specifically designed to
connect the device to the extracorporeal
blood system. Sorbent hemoperfusion
systems may also include the machine
or instrument used to drive and manage
blood and fluid flow within the
extracorporeal circuit, as well as any
accompanying controllers, monitors, or
sensors.
On April 4, 2013 (78 FR 20268), FDA
issued a proposed order which, if made
final, would reclassify sorbent
hemoperfusion systems labeled for the
treatment of poisoning and drug
overdose class II subject to premarket
notification [510(k)] and special
controls, while sorbent hemoperfusion
systems labeled for the treatment of
VerDate Mar<15>2010
16:50 May 01, 2013
Jkt 229001
hepatic coma and metabolic
disturbances would remain class III
requiring premarket approval (PMA)
applications. The committee’s
discussion will involve making
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 sorbent
hemoperfusion devices labeled for the
treatment of poisoning and drug
overdose. The regulatory history of
sorbent hemoperfusion has been
discussed as part of a previously
published proposed rule (77 FR 9610).
During session II on June 27, 2013, the
committee will discuss and make
recommendations regarding the
proposed classification of implanted
blood access devices for hemodialysis
from class III to class II. The class III
implanted blood access devices for
hemodialysis include various flexible or
rigid tubes, such as catheters, cannulae
or hollow needles. Chronic
hemodialysis catheters are soft, blunttipped plastic catheters that have a
subcutaneous ‘‘cuff’’’ for tissue
ingrowth. They are placed in a central
vein to allow blood access. Chronic
hemodialysis catheters serve as conduits
for the removal of blood from the
patient, delivery to a hemodialysis
machine for filtering, and return of
filtered blood to the patient. They have
no moving parts, consisting, essentially,
of flexible tubing terminating in rigid
Luer lock connectors for attachment to
a dialysis machine. Subcutaneous
catheters are totally implanted below
the skin surface with no external
communication. Arteriovenous shunts
and vessel tips are tubing with tapered
tips that are inserted into the artery and
vein. The tubing is attached to the
roughened or etched outer surface of the
tip. The tubing is external to the skin
and can be accessed with needles. They
are similar to subcutaneous catheters.
On June 20, 2012 (77 FR 36951), FDA
issued a proposed rule which, if made
final, would make the class III
implanted blood access devices class II
subject to premarket notification
[510(k)] and special controls. The
regulatory history of implanted blood
access devices has been discussed as
part of the proposed rule (77 FR 36951).
The committee’s discussion will
involve making recommendations
regarding regulatory classification to
either reaffirm class III or reclassify
these devices into class II and comment
on whether special controls are
adequate to reasonably ensure the safety
and effectiveness of this device.
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Frm 00058
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Sfmt 4703
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 June 11, 2013. Oral
presentations from the public will be
scheduled between approximately 9
a.m. and 10 a.m. for session I and
session II will start immediately after
lunch between approximately 1:30 p.m.
and 2:30 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 June 3,
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 June 4, 2013.
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 James Clark,
Committee Management Staff, at
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/
E:\FR\FM\02MYN1.SGM
02MYN1
Federal Register / Vol. 78, No. 85 / Thursday, May 2, 2013 / Notices
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: April 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–10394 Filed 5–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0294]
Submission of New Drug Application/
Abbreviated New Drug Application
Field Alert Reports: Notice of Form
FDA 3331—Automated Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSK5SPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
pilot program to test an XML (extensible
markup language)-enabled Adobe PDF
form, Form FDA 3331—Automated to
submit new drug application (NDA) and
abbreviated new drug application
(ANDA) Field Alert Reports (FARs) as
required by FDA regulations. This pilot
program is intended to provide FDA
with information to allow the Agency to
modernize the FAR submission and
review pathway and will permit
integration with electronic archive filing
systems.
DATES: The XML-enabled Adobe PDF
form, Form FDA 3331—Automated, will
be available for piloting between May 1,
2013, and January 1, 2014.
ADDRESSES: Electronic or written
general comments regarding the pilot
may be submitted to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
The automated form, detailed
instructions for use, and frequently
asked questions are available at https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDER/ucm347604.htm.
Questions or feedback about the pilot
program should be sent to district Drug
Field Alert Monitors (contact
information for each of these
individuals is available on FDA’s Web
site at https://www.fda.gov/ICECI/
Inspections/IOM/ucm124063.htm).
FDA’s Center for Drug Evaluation and
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16:50 May 01, 2013
Jkt 229001
Research (CDER) has also established an
email account, CDER-FARXML@fda.hhs.gov, to receive feedback
on participants’ experiences using the
XML-enabled Form FDA 3331—
Automated.
FOR FURTHER INFORMATION CONTACT:
Mark Browning, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–5342.
SUPPLEMENTARY INFORMATION:
I. Background
This pilot program seeks to modernize
the FAR submission and review
pathway using an XML-enabled PDF
form to enable integration with
electronic archive filing systems and
simplify data integration across the
enterprise. Under existing procedures,
firms typically submit FARs via fax or
scanned copy to their respective FDA
district offices, and the district offices
then provide them to CDER for
additional review and analysis. Under
this pilot program, participants will be
able to send the FAR report
simultaneously to the selected FDA
district office and to CDER’s Office of
Compliance, allowing for improved
coordination within the Agency as well
as more efficient reporting by industry.
The pilot program will also offer
industry participants the opportunity to
provide the Agency with feedback
regarding the use of the automated form.
FDA will take industry feedback into
account when improving the FAR
reporting process overall.
The pilot is open to all NDA and
ANDA holders. Participation in the pilot
program is voluntary and no additional
software or licenses are needed to use
the proposed Form FDA 3331—
Automated. For the period of the pilot
program, firms that elect to participate
must continue to submit a signed Form
FDA 3331 (whether the traditional or
the automated version) via email, along
with the pilot automated form. This
parallel process during the pilot
program will ensure delivery of all field
alert reports and allow FDA to evaluate
the utility of an automated form.
The pilot program will run for 8
months following the date of the
Federal Register Notice and may be
extended as needed to accrue sufficient
reports and experience for a meaningful
evaluation. After the pilot concludes,
CDER and the Office of Regulatory
Affairs will evaluate the forms
submitted along with any direct
industry feedback about using the
automated form. If the pilot is
successful, FDA would likely seek to
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25749
adopt a more permanent, required
electronic reporting system, which
would be implemented in accordance
with existing regulation- and guidancemaking processes, as needed.
The automated form, detailed
instructions for use, and frequently
asked questions are available on FDA’s
Web site at https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDER/ucm347604.htm.
II. Comments and Other Feedback
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written general 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.
Participants should contact their
district Drug Field Alert Monitors for
questions or feedback about the pilot
program. Contact information for each
district Drug Field Alert Monitor is
available on FDA’s Web site at https://
www.fda.gov/ICECI/Inspections/IOM/
ucm124063.htm. CDER has also
established an email account, CDERFAR-XML@fda.hhs.gov, to receive
feedback on participants’ experiences
using the XML-enabled Form FDA
3331—Automated.
III. The Paperwork Reduction Act of
1995
This notice refers to previously
approved collections of information that
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 collection of
information in Form FDA 3331 has been
approved under OMB control number
0910–0001.
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–10379 Filed 5–1–13; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Notices]
[Pages 25747-25749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10394]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Gastroenterology and Urology 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: Gastroenterology and Urology 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.
[[Page 25748]]
Date and Time: The meeting will be held on June 27, 2013, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's phone number is 301-948-8900.
Contact Person: Shanika Craig, Shanika.Craig@fda.hhs.gov, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6639, 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 June 27, 2013, during session I, the committee will
discuss and make recommendations regarding the proposed classification
of sorbent hemoperfusion systems, one of the remaining preamendments
class III devices. The class III sorbent hemoperfusion system is a
device intended for the treatment of poisoning, drug overdose, hepatic
coma, and metabolic disturbances. It consists of an extracorporeal
blood system and a container filled with adsorbent material that
removes a wide range of substances, both toxic and normal, from blood
flowing through it. The adsorbent materials are usually activated
carbon or resins, which may be coated or immobilized to prevent fine
particles from entering the patient's blood. The generic type of device
may include lines and filters specifically designed to connect the
device to the extracorporeal blood system. Sorbent hemoperfusion
systems may also include the machine or instrument used to drive and
manage blood and fluid flow within the extracorporeal circuit, as well
as any accompanying controllers, monitors, or sensors.
On April 4, 2013 (78 FR 20268), FDA issued a proposed order which,
if made final, would reclassify sorbent hemoperfusion systems labeled
for the treatment of poisoning and drug overdose class II subject to
premarket notification [510(k)] and special controls, while sorbent
hemoperfusion systems labeled for the treatment of hepatic coma and
metabolic disturbances would remain class III requiring premarket
approval (PMA) applications. The committee's discussion will involve
making 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 sorbent hemoperfusion devices labeled for the treatment of poisoning
and drug overdose. The regulatory history of sorbent hemoperfusion has
been discussed as part of a previously published proposed rule (77 FR
9610).
During session II on June 27, 2013, the committee will discuss and
make recommendations regarding the proposed classification of implanted
blood access devices for hemodialysis from class III to class II. The
class III implanted blood access devices for hemodialysis include
various flexible or rigid tubes, such as catheters, cannulae or hollow
needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic
catheters that have a subcutaneous ``cuff''' for tissue ingrowth. They
are placed in a central vein to allow blood access. Chronic
hemodialysis catheters serve as conduits for the removal of blood from
the patient, delivery to a hemodialysis machine for filtering, and
return of filtered blood to the patient. They have no moving parts,
consisting, essentially, of flexible tubing terminating in rigid Luer
lock connectors for attachment to a dialysis machine. Subcutaneous
catheters are totally implanted below the skin surface with no external
communication. Arteriovenous shunts and vessel tips are tubing with
tapered tips that are inserted into the artery and vein. The tubing is
attached to the roughened or etched outer surface of the tip. The
tubing is external to the skin and can be accessed with needles. They
are similar to subcutaneous catheters.
On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which,
if made final, would make the class III implanted blood access devices
class II subject to premarket notification [510(k)] and special
controls. The regulatory history of implanted blood access devices has
been discussed as part of the proposed rule (77 FR 36951).
The committee's discussion will involve making recommendations
regarding regulatory classification to either reaffirm class III or
reclassify these devices into class II and comment on whether special
controls are adequate to reasonably ensure the safety and effectiveness
of this device.
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 June
11, 2013. Oral presentations from the public will be scheduled between
approximately 9 a.m. and 10 a.m. for session I and session II will
start immediately after lunch between approximately 1:30 p.m. and 2:30
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 June
3, 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 June 4, 2013.
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 James Clark,
Committee Management Staff, at 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/
[[Page 25749]]
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: April 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-10394 Filed 5-1-13; 8:45 am]
BILLING CODE 4160-01-P
