Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Request for Comments, 17155-17156 [2014-06766]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
Keith A. Tucker,
Information Collection Clearance Officer.
[FR Doc. 2014–06765 Filed 3–26–14; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0238]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Neurological
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 24, 2014, from 8 a.m. to
6 p.m.
Location: Holiday Inn, Main
Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel’s
telephone number is 301–948–8900.
Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, 301–796–
3805, 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 April 24, 2014, the
committee will discuss the current
knowledge about the safety and
effectiveness of aversive conditioning
devices that are intended to deliver a
noxious electrical stimulus to a patient
VerDate Mar<15>2010
18:40 Mar 26, 2014
Jkt 232001
to modify undesirable behavioral
characteristics. FDA is convening this
committee to seek clinical and scientific
expert opinion on the risks and benefits
of certain aversive conditioning devices
based on available scientific data and
information. The Agency is considering
whether to ban aversive conditioning
devices that are intended to administer
a noxious electrical stimulus to a patient
to modify undesirable behavioral
characteristics. The meeting will
concern only devices classified under
21 CFR 882.5235 (aversive conditioning
device, class II) that are not selfadministered. Devices which deliver a
noxious electrical stimulus
automatically are not considered to be
self-administered devices. Section 516
of the FD&C Act (21 U.S.C. 360f) sets
forth the standard for banning devices.
Under that provision, in order to ban a
device, FDA must make a finding that
a device ‘‘presents substantial deception
or an unreasonable and substantial risk
of illness or injury’’ based on all
available data and information. FDA
regulations provide additional details
about the procedures and standards for
banning a device (21 CFR part 895).
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: FDA will work with
affected industry, professional
organizations, and societies that have an
interest in aversive conditioning devices
and who wish to make a presentation
separate from the general open public
hearing; time slots on April 24, 2014,
between approximately 11 a.m. and 12
p.m. Representatives from industry,
professional organizations and societies
interested in making formal
presentations to the committee should
notify the contact person on or before
March 28, 2014.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
April 14, 2014. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
17155
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 April 4, 2014. 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 April 7, 2014.
FDA is opening a docket for public
comment on this document. The docket
number is FDA–2014–N–0238. The
docket will close on June 24, 2014.
Interested persons are encouraged to use
the docket to submit electronic or
written comments regarding this
meeting. Comments received on or
before April 14, 2014, will be provided
to the committee for their consideration.
Comments received after May 27, 2014
will be taken into consideration by the
Agency.
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.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov, or 301–796–5966 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
E:\FR\FM\27MRN1.SGM
27MRN1
17156
Federal Register / Vol. 79, No. 59 / Thursday, March 27, 2014 / Notices
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 20, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–06766 Filed 3–26–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0021]
AbbVie Inc., et al.; Proposal To
Withdraw Approval of Abbreviated
New Drug Applications for Prescription
Pain Medications Containing More
Than 325 Milligrams of
Acetaminophen; Opportunity for a
Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity to request a hearing on the
Agency’s proposal to withdraw approval
of abbreviated new drug applications
(ANDAs) from multiple sponsors for
prescription pain medications
containing more than 325 milligrams
(mg) of acetaminophen. The basis for
this proposal is that the Agency has
determined that fixed-combination
prescription drugs containing more than
325 mg of acetaminophen per dosage
unit (tablet or capsule) do not provide
a sufficient margin of safety to protect
the public against the serious risk of
acetaminophen-induced liver injury.
DATES: Submit written requests for a
hearing by April 28, 2014; submit data
and information in support of the
hearing request by May 27, 2014.
ADDRESSES: Identify your requests for a
hearing, supporting data, and other
comments with Docket No. FDA–2011–
N–0021 and submit this information to
SUMMARY:
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Rachel Turow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–5094.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 14, 2011 (76
FR 2691), FDA published a notice
announcing its plans to reduce the
maximum dosage unit strength of
acetaminophen in prescription drug
products. The notice announced FDA’s
conclusion that, based on a reevaluation
of the relative risks and benefits of
prescription acetaminophen products,
fixed-combination prescription drugs
containing more than 325 mg of
acetaminophen per dosage unit (tablet
or capsule) do not provide a sufficient
margin of safety to protect the public
against the serious risk of
acetaminophen-induced liver injury.
Accordingly, we asked product sponsors
to limit the maximum amount of
acetaminophen per dosage unit to 325
mg and, for those products containing
more than 325 mg of acetaminophen per
dosage unit, to submit requests that FDA
withdraw approval of their applications
under § 314.150(d) (21 CFR 314.150(d)).
FDA asked that all such requests be
made before January 14, 2014, after
which date the Agency would use its
authority under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) to
initiate approval withdrawal
proceedings for any prescription drug
products containing more than 325 mg
of acetaminophen per dosage unit that
remain on the market. The full text of
that notice is provided in this
document, and provides a detailed
description and analysis of the specific
facts resulting in today’s action.
FDA did not receive a request for
withdrawal of approval of an
application containing more than 325
mg of acetaminophen per dosage unit
from one sponsor. In addition, FDA
received requests for withdrawal of
approval of applications for products
containing more than 325 mg of
acetaminophen per dosage unit for
which sponsors either submitted
requests under § 314.150(c) or failed to
cite a relevant regulatory provision.
FDA contacted all of these sponsors on
multiple occasions to ask that they
submit a request that FDA withdraw
approval of their applications under
§ 314.150(d), but they failed to respond.
With respect to those applications for
which FDA received no request for
withdrawal, FDA is proceeding under
§ 314.150(a) and (b) to withdraw
approval. With respect to requests for
withdrawal of approval submitted under
§ 314.150(c), the Agency notes that
because FDA has made a determination
under § 314.150(a) that approval of
these applications should be withdrawn
for reasons of safety, application holders
may not withdraw their applications
pursuant to § 314.150(c). The text of
§ 314.150(c) expressly precludes
withdrawal of an application under the
subsection if FDA has made a safety
determination under § 314.150(a).
Similarly, when a request for
withdrawal is made without a citation
to any regulation, FDA is not
appropriately notified that an
application holder has voluntarily
waived the opportunity for a hearing.
Accordingly, FDA has determined to
proceed with withdrawal of approval of
applications for which sponsors either
submitted requests under § 314.150(c) or
failed to cite a relevant regulatory
provision pursuant to the withdrawal
procedures outlined in §§ 314.150 (a)
and (b).
Table 1 lists the applications for
products for which FDA received no
request for withdrawal, a request for
withdrawal citing § 314.150(c), or a
request for withdrawal with no
regulatory citation.
TABLE 1—APPLICATIONS FOR FIXED-COMBINATION PRESCRIPTION DRUGS CONTAINING MORE THAN 325 MG OF
ACETAMINOPHEN PER DOSAGE UNIT THAT HAVE NOT BEEN VOLUNTARILY WITHDRAWN AS OF JANUARY 14, 2014
Application
No.
tkelley on DSK3SPTVN1PROD with NOTICES
ANDA 40117
ANDA 88058
ANDA 89736
VerDate Mar<15>2010
Drug product(s)
Vicodin
HP
(Acetaminophen
Hydrocodone Bitartrate Tablets),
mg/10 mg.
Vicodin
(Acetaminophen
Hydrocodone Bitartrate Tablets),
mg/5 mg.
Vicodin
ES
(Acetaminophen
Hydrocodone Bitartrate Tablets),
mg/7.5 mg.
18:40 Mar 26, 2014
Jkt 232001
PO 00000
Applicant or holder
Reason
and
660
AbbVie Inc., 1 N. Waukegan Rd., North
Chicago, IL 60064.
Submitted a voluntary request for withdrawal under § 314.150(c).
and
500
AbbVie Inc ...............................................
Submitted a voluntary request for withdrawal under § 314.150(c).
and
750
AbbVie Inc ...............................................
Submitted a voluntary request for withdrawal under § 314.150(c).
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Notices]
[Pages 17155-17156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0238]
Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Neurological Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 24, 2014, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Main Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900.
Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov,
301-796-3805, 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 April 24, 2014, the committee will discuss the current
knowledge about the safety and effectiveness of aversive conditioning
devices that are intended to deliver a noxious electrical stimulus to a
patient to modify undesirable behavioral characteristics. FDA is
convening this committee to seek clinical and scientific expert opinion
on the risks and benefits of certain aversive conditioning devices
based on available scientific data and information. The Agency is
considering whether to ban aversive conditioning devices that are
intended to administer a noxious electrical stimulus to a patient to
modify undesirable behavioral characteristics. The meeting will concern
only devices classified under 21 CFR 882.5235 (aversive conditioning
device, class II) that are not self-administered. Devices which deliver
a noxious electrical stimulus automatically are not considered to be
self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f)
sets forth the standard for banning devices. Under that provision, in
order to ban a device, FDA must make a finding that a device ``presents
substantial deception or an unreasonable and substantial risk of
illness or injury'' based on all available data and information. FDA
regulations provide additional details about the procedures and
standards for banning a device (21 CFR part 895).
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: FDA will work with affected industry, professional
organizations, and societies that have an interest in aversive
conditioning devices and who wish to make a presentation separate from
the general open public hearing; time slots on April 24, 2014, between
approximately 11 a.m. and 12 p.m. Representatives from industry,
professional organizations and societies interested in making formal
presentations to the committee should notify the contact person on or
before March 28, 2014.
Interested persons may present data, information, or views, orally
or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before April 14,
2014. 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 April 4, 2014. 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 April 7, 2014.
FDA is opening a docket for public comment on this document. The
docket number is FDA-2014-N-0238. The docket will close on June 24,
2014. Interested persons are encouraged to use the docket to submit
electronic or written comments regarding this meeting. Comments
received on or before April 14, 2014, will be provided to the committee
for their consideration. Comments received after May 27, 2014 will be
taken into consideration by the Agency.
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.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams at
Annmarie.Williams@fda.hhs.gov, or 301-796-5966 at least 7 days in
advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
[[Page 17156]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 20, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-06766 Filed 3-26-14; 8:45 am]
BILLING CODE 4160-01-P
